(JAGX) Positive Results from Proof-of-Concept Study of Neonorm

Jaguar Animal Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, announced positive results today for its Neonorm^™ Foal proof-of-concept study. Neonorm^™ Foal is a non-drug product comprised of an orally-administered paste formulation of a standardized botanical extract derived from the Croton lechleri tree, in combination with a third-party probiotic.

The objective of the randomized, multi-site, blind-controlled study was to evaluate the safety, tolerability, and efficacy of Neonorm^™ Foal for treatment of foals suffering from secretory or watery diarrhea. Sixty foals participated in the study, which consisted of a 72-hour treatment period followed by an observation period. Each participating foal was placed into one of three groups: a group that received treatment twice a day (the BID group), a group that received treatment four times a day (the QID group), and a placebo-treated group. Physicals, ultrasounds and the collection of blood samples took place at intervals throughout the study, which took place in Argentina during foaling season.

During the treatment period, 68% of foals in the BID group were identified as clinical responders versus 35% of placebo-treated foals, with a p-value of 0.03. For the purposes of the study, clinical responders were defined as foals that achieved a formed stool by the end of the reported period. Within the period that included treatment and 24-hours of observation, 79% of foals in the BID group were identified as clinical responders versus 47% of placebo-treated foals, with a p-value of 0.03. At the 120-hour point for a subset of the QID group which was comprised of the sickest foals enrolled in the study—animals that would be expected to take longer to recover—statistically significant results indicated that sicker foals may benefit from more frequent treatment. Within the period that included treatment and 48-hours of observation, 94% of foals in this QID group subset were identified as clinical responders versus 46% of placebo-treated foals, with a p-value of 0.02.

Resolution of diarrhea was attained in 74% of foals in the BID group within the treatment period versus 41% of placebo-treated foals, with a p-value of 0.09. For the purposes of the study, resolution of diarrhea was defined as a foal that produced a formed stool at any point during the reported period. Within the period that included treatment and 24-hours of observation, resolution of diarrhea was attained in 84% of foals in the BID group versus 53% of placebo-treated foals, with a p-value of 0.07. Within the period including treatment and 48-hours of observation, resolution of diarrhea was attained in 94% of foals in the QID group versus 62% of placebo-treated foals, with a p-value of 0.06.

“We are excited to share these top-line results from our foal study, which we believe establish the supportive benefits of our non-prescription Neonorm^™ product in yet another species. Neonorm^™ and crofelemer, which are both derived from the sustainably harvested Croton lechleri tree, act at the same last step in a physiological pathway generally present in mammals. Clinical research investigating this unique Mechanism of Action have provided efficacy results with significance in people, calves, dogs, and now horses,” stated Conte. “The results of our foal study support our belief that the first-in-class anti-secretory properties of Neonorm^™ will redefine the standard of care for the management of gut health, stool formation and the normalization of hydration in foals.”

Diarrhea is one of the most common clinical complaints in foals, especially within the first 30 days of life, and to the Company’s knowledge there are currently no commercially available products with anti-secretory properties for foals. The crippling effects of dehydration that often occur as a result of secretory diarrhea in foals can manifest quickly, precipitate adverse health effects and result in death.

Jaguar will be launching Neonorm^™ Foal and exhibiting the study results at the American Association of Equine Practitioners Annual Convention in Las Vegas from December 5-9^th. Members of Jaguar’s management team will be available for meetings at the event.

Neonorm^™ Calf, the Company’s lead non-drug product, contains the same standardized botanical extract as Neonorm^™ Foal and has been clinically demonstrated to address the normalization of stool formation and ion and water flow in the intestinal lumen of pre-weaned dairy calves. Jaguar currently owns enough of this extract to formulate a combination of approximately one million treatments of Neonorm^™ Calf or Neonorm^™ Foal.

About Jaguar Animal Health, Inc.

Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. Canalevia^™ is Jaguar’s lead prescription drug product candidate for the treatment of various forms of diarrhea in dogs. Neonorm^™ Calf is the Company’s lead non-drug product. Canalevia is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm is a standardized botanical extract derived from the Croton lechleri tree. Canalevia and Neonorm are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm in six additional target species, and formulations of Canalevia for cats, horses and dogs.

For more information, please visit www.jaguaranimalhealth.com.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expected commercial launch of Neonorm^™ Foal this December, the Company’s belief that the unique anti-secretory properties of Neonorm^™ Foal will redefine the standard of care for the management of gut health, stool formation and the normalization of hydration in foals, the Company’s belief that sicker foals may benefit from more frequent treatment with Neonorm^™ Foal, Jaguar’s intention to develop species-specific formulations of Neonorm^™ in additional target species, and the Company’s plan to develop formulations of Canalevia^™ for cats, horses and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Jaguar-JAGX

KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
or
Allison Soss, 212-896-1267
asoss@kcsa.com

(FNJN) Signs Licensing Agreement With Avast Software

(LGCY) LP Announces $900 Million Borrowing Base

MIDLAND, Texas, Nov. 16, 2015  — Legacy Reserves LP (“Legacy”) (NASDAQ:LGCY) today announced the semi-annual borrowing base review under its $1.5 billion secured revolving credit facility has resulted in a revised borrowing base of $900 million, a $50 million reduction from the previous figure.

Legacy also announced today that Paul Horne, President and Chief Executive Officer, and Dan Westcott, Executive Vice President and Chief Financial Officer, will participate in a discussion panel at the 2015 RBC Capital Markets’ MLP Conference in Dallas on Wednesday, November 18, 2015, at 10:20 a.m. Central Time. Presentation slides will be available on Legacy’s website at www.LegacyLP.com.

About Legacy Reserves LP

Legacy Reserves LP is a master limited partnership headquartered in Midland, Texas, focused on the acquisition and development of oil and natural gas properties primarily located in the Permian Basin, East Texas, Rocky Mountain, and Mid-Continent regions of the United States. Additional information is available at www.LegacyLP.com.

CONTACT: Legacy Reserves LP
         Dan Westcott
         Executive Vice President and Chief Financial Officer
         432-689-5200

(SMLR) to Present at the LD Micro Main Event

PORTLAND, Ore., Nov. 16, 2015  — Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides diagnostic and testing services to healthcare insurers and physician groups, today announced that it will be presenting at the 8th annual LD Micro Main Event on Thursday, December 3rd at 9:00 AM PST / 12:00 PM EST. Doug Murphy-Chutorian, M.D., chief executive officer of Semler, will be giving the presentation. The presentation will be webcast live and may be accessed using this link:  http://wsw.com/webcast/ldmicro9/smlr.  The webcast will be archived for 90 days following the live presentation.

“We are very excited to have Semler Scientific present for the first time at the Main Event,” commented Chris Lahiji, President of LD Micro.

The conference will be held at the Luxe Sunset Bel Air Hotel and will feature 230 companies in the small / micro-cap space.

About LD Micro
LD Micro is an investment newsletter firm that focuses on finding undervalued companies in the micro-cap space. Since 2002, the firm has published reports on select companies throughout the year. The firm also hosts the LD Micro Invitational in June. It is a non-registered investment advisor. For more information, please contact 408-457-1042 or visit www.ldmicro.com

About Semler Scientific, Inc.
Semler Scientific, Inc., is a company that provides diagnostic and testing services to healthcare insurers and physician groups. Its mission is to develop, manufacture and market innovative proprietary products and services that assist healthcare providers in evaluating and treating chronic diseases. The company’s first patented and U.S. Food and Drug Administration, or FDA, cleared product, introduced commercially in 2011, measured arterial blood flow in the extremities to aid in the diagnosis of peripheral arterial disease. In March 2015, the FDA granted 510(k) clearance for the next generation version of this product named QuantaFlo™, which was commercially launched in August 2015. In April 2015, the company launched its multi-test service offering, WellChec™, to more comprehensively evaluate patients for chronic disease. Additional information about Semler can be found at http://semlerscientific.com.

(OCRX) Positive Phase 1 Results for Oral OCR-002

Preliminary Pharmacokinetic Data Demonstrate Promising Extended-Release Profiles

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Nov. 16, 2015  — Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced positive results from the Company’s Phase 1 study of the oral formulation of OCR-002, ornithine phenylacetate, in healthy subjects.  OCR-002 exhibited encouraging extended-release properties, demonstrated a desirable pharmacokinetic (PK) profile and was well-tolerated.

The open-label, single-dose, five-treatment, five-period crossover study evaluated the PK, safety and tolerability of three prototype, extended-release oral formulations of OCR-002 compared to an immediate release oral solution of OCR-002 and the ammonia-lowering agent, glycerol phenylbutyrate (RAVICTI®), a pre-pro-drug of phenylacetate, a component of OCR-002.

The results demonstrated a robust, extended-release pattern for all three pilot OCR-002 extended-release formulations, with mean plasma phenylacetate (PAA) concentrations exceeding those achieved with RAVICTI at all timepoints for at least 12 hours post-dose. In addition, mean plasma phenylacetylglutamine (PAGN) concentrations and urinary PAGN excretion were greater for all three OCR-002 extended release dosage forms than for RAVICTI at an equivalent molar PAA dose. PAGN is formed by conjugation of PAA with glutamine, an end product of the ammonia scavenging activity of PAA.

“We are extremely encouraged by both the PAA exposure profiles and urinary PAGN excretion of the extended-release oral forms of OCR-002 in this evaluation, and believe these findings support the potential for convenient twice-daily dosing,” said Linda Grais, M.D., president and chief executive officer of Ocera.  “The strength of these results and the prior clinical proof of concept established with RAVICTI in preventing hepatic encephalopathy (HE) in patients suffering from liver cirrhosis provide clear validation for the continued development of oral OCR-002 in this indication. Our next step will be to further optimize the formulations to enhance controlled delivery of the drug under various conditions.”

Complete results from this Phase 1 study in healthy subjects will be submitted for presentation at an upcoming scientific conference.

Ocera is currently conducting a Phase 2b clinical trial, STOP-HE, to evaluate the safety and efficacy of intravenously-administered OCR-002 in resolving neurocognitive symptoms of acute HE in hospitalized patients with elevated ammonia. The Company expects to complete enrollment in the trial in the second half of 2016.

About Hepatic Encephalopathy

Hepatic encephalopathy, or HE, is a debilitating and progressive complication of liver cirrhosis or liver failure, marked by mental changes including confusion, impaired motor skills, disorientation, and in its more severe form, stupor, coma and even death.

About Ocera

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous and oral formulations. OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease. For additional information, please see www.ocerainc.com.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without limitation, all statements related to the OCR-002 clinical development program, including but not limited to the potential benefits of OCR-002 to help patients with hepatic encephalopathy, the timing of clinical and enrollment milestones, and the anticipated next steps for oral OCR-002. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’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, including those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

Susan Sharpe
Ocera Therapeutics, Inc.
contact@ocerainc.com
919-328-1109

(ETAK) Reports 2015 Third Quarter Financial Results and Conference Call

NEW YORK, Nov. 16, 2015  — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced its financial results for the third quarter ending September 30, 2015. A conference call will be held on Tuesday, November 17, 2015 at 4:15pm EDT.

Revenue totaled approximately $3.5 million for the quarter ended September 30, 2015 as compared to restated revenue of $4.4 million recorded in the third quarter of 2014. Revenue in the quarter also reflects the negative impact of exchange rates in the amount of approximately $550,000. Non-GAAP revenue* decreased to approximately $3.4 million in the third quarter of 2015 as compared to approximately $7.7 million for the same period of the prior year. Net loss for the third quarter of 2015 was approximately $4.2 million as compared to a restated loss of approximately $5.2 million reported in the third quarter of 2014. Adjusted EBITDA* loss was approximately $1.2 million for the third quarter of 2015 as compared to approximately a restated $1.4 million profit in the same quarter of the prior year.

The decrease in 2015 third quarter revenue reflects the impact of the termination of the Company’s relationship with Iusacell and the Iusacell settlement agreement dated June 12, 2015 which provided the Company with net proceeds of $12.6 million. The termination of the Iusacell contract resulted in the loss of approximately $3.9 million of anticipated quarterly cash flow (based on historical monthly billings). The Company continued to transition the business, following the Iusacell settlement, without any significant revenue benefit during the quarter of new customer additions which included the wholesale division of a Tier 1 Mobile Operator in the United States and a Tier 1 license holder in Brazil. Restructuring initiatives will be ongoing and shareholders will be updated as progress is achieved. The Company anticipates a return to revenue and EBITDA growth taking place in 2016.

Operational Update:

• During the third quarter, Elephant Talk continued its global expansion:
  • In Brazil, the Company was selected as the platform provider for EU TV/Surf Telecom. Given the platform’s proven ability to reduce operating expenses significantly, while greatly accelerating time to market, the Company believes that our software is the ideal solution to address the business model challenges now faced by operators in this market.
  • Shortly following the end of the third quarter, Elephant Talk signed a Cloud Service and Software License Agreement with the wholesale division of a Tier 1 US Mobile Operator. Feedback from its partner on the value proposition being offered is very positive and the two companies are collaborating in the sales process, having already partnered on pursuing 8 MVNO opportunities, in addition to responding to multiple new leads being generated each week.

• ValidSoft momentum continued during the quarter:
  • ValidSoft added AurionPro as a new channel partner. AurionPro is a technology products and solutions provider serving enterprises, financial services, government and logistics companies in 22 different countries. AurionPro has added the Company’s voice biometric technology into their product portfolio and recently demonstrated it in their unique ‘bank in a box’ kiosk that was shown at the Money2020 conference and is scheduled to be rolled out across a number of developing countries in the coming year.
  • ValidSoft was selected by the European Union as the voice biometrics provider to the ‘Octave Project’ which is part of its latest Horizon2020 program. The program is focused on the development of a cloud based voice biometric user authentication solution. The project, which is now underway, includes a consortium of technology providers and leading research institutes and has received funding from the European Union for the further development of the solution.

All interested in participating should dial in approximately 5 to 10 minutes prior to the 4:15 p.m. EST conference call. Participants should ask for the Elephant Talk 2015 third quarter conference call.

* Non-GAAP financial measures

In order to provide investors additional information regarding our financial results, the Company is disclosing Adjusted EBITDA, a non-GAAP financial measures. Adjusted EBITDA is defined as earnings before income and income taxes, depreciation and amortization, share-based compensation, changes in deferred revenue, income interest and expenses, expenses from derivative accounting, such as debt discount and conversion feature expensing, changes in fair value of the conversion feature and warrant liabilities, amortization of deferred financing cost, loss on extinguishment of debt, impairment of tangible and intangible assets and impairments of loans. Adjusted EBITDA further eliminates share-based compensation. Adjusted EBITDA is designed to show a measure of the Company’s operating performance. The Company uses Adjusted EBITDA because it removes the impact of items not directly resulting from the Company’s core operations, allowing the Company to better assess whether the elements of the Company’s growth strategy are yielding the desired results. Accordingly, the Company believes that Adjusted EBITDA provide useful information for investors and others which allow them to better understand and evaluate the Company’s operating results.

Non-GAAP revenue is defined as GAAP revenue adjusted for changes in deferred revenue.

In particular, as a result of the characteristics of our services, the long term nature of the contracts and the small customer base, new and substantial sales will remain unnoticed to investors due to the fact that most of these sales will need to be deferred over a period of 3-5 years. The Company therefore adds back to the revenue in the income statement the revenues that were invoiced in the reporting period. At the same time the Company removes from the revenue in the income statement the revenues that have been recognized as a result of sales prior to the reporting period. These two adjustments we refer to us as changes in deferred revenue.

A reconciliation of GAAP Revenue to Non-GAAP Revenue, for each of the periods indicated, is as follows:

A reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA, for each of the periods indicated, is as follows:

About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK) is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.

About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.

Cautionary Note Regarding Forward-Looking Statements:
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Elephant Talk’s plans and objectives, projections, expectations and intentions (including, without limitation, Elephant Talk’s plans with regard to its ValidSoft subsidiary). These forward-looking statements are based on current expectations, estimates and projections about Elephant Talk’s industry, operations, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Elephant Talk may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Elephant Talk also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Elephant Talk’s filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Elephant Talk.

Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com

Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net

(ISCO) Announces Operating Results for Q3

(JNP) Adds Three New Products to its Proprietary Pipeline

BOSTON and NEW YORK, Nov. 13, 2015  — Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (“Juniper” or the “Company”), announced details of its portfolio pipeline, focused on three new product candidates to treat women’s health conditions, at its Investor Day Wednesday.

The three new product candidates utilize the Company’s proprietary multi-segment intra-vaginal ring (IVR):

• JNP-0101, an oxybutynin IVR for the treatment of overactive bladder;
• JNP-0201, a combination IVR delivering estrogen and progesterone hormone replacement therapy (HRT); and,
• JNP-0301, a progesterone IVR for the prevention of preterm birth.

The new IVR product candidates complement COL-1077, the Company’s sustained-release 10% lidocaine bioadhesive gel intended for the treatment of gynecologic procedure-related pain.  A Phase 2b trial is currently enrolling female patients and results from this clinical trial are expected in mid-2016.

Frank Condella, the Company’s Chief Executive Officer, stated, “We are very pleased to announce the advancement of these new product candidates. They represent significant potential commercial opportunities for Juniper in the United States and globally.”

Summaries of the IVR product candidates and their target indications follow.  For more detailed information, please access the replay of the Investor Day webcast at www.juniperpharma.com or click here. The archived webcast will be available for 90 days.

About JNP-0101 Oxybutynin IVR

Overactive bladder (OAB) is a widespread, chronic condition caused by involuntary contraction of the detrusor muscles before the bladder is full. OAB affects approximately 20 million women in the United States, with an estimated nine million receiving pharmacotherapy to treat the condition.^1,2,3 In 2014, the U.S. OAB market was estimated to be $1.3 billion, comprised of branded and generic products. ⁴ More than 70% of women discontinue first line treatments within the first year due to adverse events or inadequate efficacy.^5,6,7,8

Juniper’s oxybutynin IVR has the potential to address the most pressing unmet needs in the market by offering more localized absorption, reduced side effects and sustainable delivery. Juniper plans to submit an Investigational New Drug (“IND”) application to the FDA and initiate clinical studies with JNP-0101 in the second half of 2016.

About JNP-0201 Estrogen + Progesterone IVR

Approximately 45 million American women are menopausal or approaching menopause.⁹  In 2014, the U.S. Hormone Replacement Therapy (HRT) market was estimated at $2.2 billion.¹⁰ Juniper’s combination estrogen and progesterone IVR candidate has the potential to offer patients multiple benefits as compared with currently available therapies, including: integrated administration of natural progesterone and estrogen; improved patient compliance; improved side effect profile; and vaginal delivery of natural hormones, while eliminating the need for daily administration.

About JNP-0301 Progesterone IVR

Preterm birth is a significant public health issue, with an estimated 1.3 million women in the United States at risk for preterm birth due to short cervical length (“SCL”).¹¹ Clinical data supports the use of vaginal progesterone to prevent preterm birth.^12,13,14  Despite the medical need and cost savings associated with prevention of preterm birth, no products are FDA approved to prevent preterm birth in women at risk due to a short cervix.

Juniper’s progesterone IVR may offer meaningful benefits to women with SCL. By providing continuous, consistent, local delivery of natural progesterone, this product candidate may increase patient compliance as compared to current off-label progestogens, which require daily administration, thereby potentially improving overall outcomes. Juniper expects JNP-0301 development will be facilitated by development of JNP-0201 for HRT.

About Juniper Pharmaceuticals

Juniper Pharmaceuticals, Inc. is focused on developing therapeutics that address unmet medical needs in women’s health.  Juniper has a commercial product, CRINONE^® 8% (progesterone gel), which is marketed by Allergan, Inc. in the U.S. and by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide. The Company is advancing a pipeline of proprietary drug candidates leveraging novel delivery technologies.  Please visit www.juniperpharma.com for more information.

Juniper Pharmaceuticals™ is a trademark of Juniper Pharmaceuticals, Inc., in the U.S. and EU.

CRINONE^® is a registered trademark of Allergan, Inc. in the U.S. and of Merck KGaA, Darmstadt, Germany, outside the U.S.

Forward Looking Statements

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are usually indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” “should,” or similar expressions, and which are generally not historical in nature. These include all statements relating to expected product development and the timing thereof; potential benefits of Juniper’s product candidates; and.  Management believes that these forward-looking statements are reasonable as and when made.  However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.  Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management’s current expectations and Juniper Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.  For a discussion of certain risks and uncertainties associated with Juniper Pharmaceuticals’ forward-looking statements, please review the Company’s reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2014 and 10-Q for the period ended September 30, 2015.

Contact

Amy Raskopf
Director, Corporate Communications
Juniper Pharmaceuticals
(917) 673-5775
ir@juniperpharma.com

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¹ Milsom I, et al., How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001; 87(9): 760-6.
² Stewart WF, et al., Prevalence and burden of overactive bladder in the United States. World J Urol. 2003; 20(6): 327-36.
³ Griebling, TL, et al., Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJUI. 2011; 108(7): 1132-8.
⁴ Technavio Insights, 2014. Global Overactive Bladder Therapeutics Market Report.  Available from http://www.technavio.com/report/global-overactive-bladder-therapeutics-market-2014-2018
⁵ Yu YF, et al., Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid program. Value Health. 2005; 8: 495–505.
⁶ Shaya FT, et al., Persistence with overactive bladder pharmacotherapy in a Medicaid population. Am J Manag Care. 2005; 11(4 Suppl): S121–9.
⁷ Gopal M, et al., Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms. Obstet Gynecol. 2008; 112: 1311–8.
⁸ Krhut J, et al., Persistence with first line anticholinergic medication in treatment-naïve overactive bladder patients. Scand J Urol. 2014; 48: 79–83.
⁹ U.S. Census Bureau, Population Division. Table 2. Projections of the Population by Selected Age Groups and Sex for the United States: 2015 to 2060 (NP2012-T2). Release date: December 2012.
¹⁰ Symphony Health Solutions Report.
¹¹ Estimated based on Iams JD et al. N Engl J Med. 1996;334(9): 567-572
¹² Fonseca EB et al., Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9.
¹³ Hassan SS et al., Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
¹⁴ Maher MA et al., Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone. Acta Obstet Gynecol Scand 2012; 91:DOI: 10.1111/aogs.12017.

(GDEF) & National Security Systems, Adjournment of Special Meeting

RESTON, Va., Nov. 12, 2015  — Global Defense & National Security Systems, Inc. (“GDEF” or the “Company“) (NASDAQ:GDEF) today announced that it convened and adjourned, without conducting any business, its special meeting in lieu of the 2015 annual meeting of stockholders (the “Special Meeting“), held on November 12, 2015, at 11:00 a.m. Eastern Time until Friday, November 13, 2015 at 9:00 a.m. Eastern Time, at which time GDEF’s stockholders will vote on the proposals to be considered at the Special Meeting, including a proposal to approve GDEF’s business combination with STG Group, Inc. (the “Business Combination Proposal“) as described on the proxy statement (the “Proxy Statement“) that GDEF filed with the Securities and Exchange Commission on October 22, 2015. The Special Meeting will still be held at 2000 Pennsylvania Avenue, N.W. Suite 6000, Washington, D.C. 20006.

Stockholders of record at the close of business on October 21, 2015 are entitled to receive notice of the special meeting and to vote the shares of common stock of GDEF owned by them at the Special Meeting. If you have already returned a validly executed proxy card, your shares will remain voted unless you revoke your prior proxy before the Special Meeting. You may change your vote by submitting a subsequent proxy. You may change your vote by submitting a later-dated, executed proxy card by mail or following the voting instructions (including any telephone or Internet voting instructions) provided by your broker or bank if your shares are held in ”street name,” in each case in accordance with the instructions provided under ”Special Meeting in Lieu of 2015 Annual Meeting of GDEF Stockholders” in the Proxy Statement prior to the special meeting or attending the special meeting in person and voting. You also may revoke your proxy by sending a notice of revocation to our secretary, which must be received by our secretary prior to the special meeting.

As more fully described in the Proxy Statement, the stockholders who intend to exercise their redemption rights must check the box on the proxy card provided for that purpose and return the proxy card in accordance with the instructions provided. In connection with tendering your shares for redemption, you must elect either to physically tender your stock certificates to American Stock Transfer & Trust Company, LLC, our transfer agent, at American Stock Transfer & Trust Company, LLC, 6201 15th Avenue, Brooklyn, New York 11219, Attn: AST Proxy Department, by two business days prior to the special meeting or to deliver your shares to the transfer agent electronically using The Depository Trust Company’s DWAC (Deposit/Withdrawal At Custodian) System, which election would likely be determined based on the manner in which you hold your shares. Certificates that have not been tendered in accordance with these procedures by two business days prior to the special meeting will not be redeemed for cash. In the event that you tender your shares and decide prior to the special meeting that you do not want to redeem your shares, you may withdraw the tender at any time prior to the time that the Business Combination Proposal is approved.

Additional Information About the Transaction and Where to Find It

In connection with the transaction between the Company and STG pursuant to the Stock Purchase Agreement, dated as of June 8, 2015, by and among the Company, STG, the stockholders of STG, and Simon Lee as Stockholders’ Representative, the Company filed a definitive proxy statement with the Securities and Exchange Commission (the “SEC”) on October 22, 2015. The Company also filed a preliminary proxy statement with the SEC on November 2, 2015 for its proposal to amend and restate its amended and restated certificate of incorporation to extend the amount of time it has to complete the business combination from 25 months to 26 months (the “Extension Proposal”) and will file a definitive proxy statement. Investors are urged to read the preliminary proxy statement for the Extension Proposal and the definitive proxy statement for the proposed transaction and the Extension Proposal when it becomes available (including all amendments and supplements), because they contain important information. Investors may obtain free copies of these proxy statements, as well as other filings containing information about the Company, without charge, at the SEC’s Internet site (http://www.sec.gov). The definitive proxy statement for the proposed transaction has been, and the definitive proxy statement for the Extension Proposal will be, mailed to stockholders of the Company after a record date to be established for voting upon the proposed transaction and Extension Proposal, respectively. These documents may also be obtained for free from the Company’s Investor Relations web site (http://investor.gdef.com/) or by directing a request to the Company at: Global Defense & National Security Systems, Inc., 11921 Freedom Drive, Suite 550, Two Fountain Square, Reston, VA 20190.

The Company and its officers and directors may be deemed to be participants in the solicitation of proxies from the Company’s stockholders. Information about the Company’s executive officers and directors is set forth in its Annual Report on Form 10-K, which was filed with the SEC on March 25, 2015. Investors may obtain more detailed information regarding the direct and indirect interests of the Company and its respective executive officers and directors in the transaction by reading the preliminary proxy statement regarding the transaction, which has been filed with the SEC, and the definitive proxy statement regarding the transaction, which will be filed with the SEC.

Forward Looking Statements

This written communication contains forward-looking statements that involve risks and uncertainties, including risks and uncertainties concerning the Company’s proposed Business Combination, STG’s expected financial performance, as well as STG’s strategic and operational plans. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Actual events or results may differ materially from those described in this written communication due to a number of risks and uncertainties. The potential risks and uncertainties include, among others, the possibility that the proposed business combination transaction will not close or that the closing may be delayed; the reaction of customers to the transaction; general economic conditions; the possibility that the Company may be unable to obtain stockholder approval as required for the transaction or that the other conditions to the closing of the transaction may not be satisfied; the transaction may involve unexpected costs, liabilities or delays; the outcome of any legal proceedings related to the transaction; the occurrence of any event, change or other circumstances that could give rise to the termination of the transaction agreement. In addition, please refer to the documents that the Company files with the SEC on Forms 10-K, 10-Q and 8-K. The filings by the Company identify and address other important factors that could cause its financial and operational results to differ materially from those contained in the forward-looking statements set forth in this written communication. The Company is under no duty to update any of the forward-looking statements after the date of this written communication to conform to actual results.

CONTACT: Joele Frank, Wilkinson Brimmer Katcher
         Jamie Moser / Andrew Siegel / Leigh Parrish
         212-355-4449

(EDAP) Records First Three U.S. Orders for Ablatherm HIFU

First HIFU Devices to be Shipped to the U.S. Next Week

LYON, France, Nov. 12, 2015  — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it signed contracts for the sale of three Ablatherm® HIFU devices to prominent U.S. urology groups.

The Company expects to start shipping systems from its manufacturing facility in France to U.S. locations within the next ten days.

Marc Oczachowski, Chief Executive Officer of EDAP commented: “We are extremely pleased to announce that we have in-hand our first orders in the U.S., with three sales contracts signed and being executed. Since FDA clearance of our Ablatherm Robotic HIFU device, we have been receiving a significant number of queries from urologists and other stakeholders in the urology community. Thanks to our established sales and services network in the U.S., we are diligently responding to this strong demand.”

Oczachowski concluded: “We are very excited to see that our commercialization plans are showing immediate results and that our technology is generating such positive feedback from the U.S. market.”

About EDAP TMS SA

EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters’ range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.

Forward-Looking Statements

In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission and in particular, in the sections “Cautionary Statement on Forward-Looking Information” and “Risk Factors” in the Company’s Annual Report on Form 20-F.

CONTACT: Blandine Confort
         Investor Relations / Legal Affairs
         EDAP TMS SA
         +33 4 72 15 31 72
         bconfort@edap-tms.com

         Investors:
         Lee Roth
         The Ruth Group
         646-536-7012
         lroth@theruthgroup.com

(LPCN) Adopts Stockholder Rights Plan

SALT LAKE CITY, Nov. 13, 2015  — Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that on November 12, 2015 its board of directors adopted a stockholder rights plan designed to deter coercive takeover tactics, including the accumulation of shares in the open market or through private transactions and to prevent an acquirer from gaining control of without offering a fair price to all of the its stockholders.

The plan, similar to plans adopted by many other companies, was not adopted in response to any current hostile takeover attempt.

“The rights plan is designed to ensure that our stockholders realize the long-term value of their investment in the company and is similar to those adopted by many other companies,” commented Lipocine Chief Executive Officer Mahesh V. Patel.  “The plan will not prevent a takeover attempt, but should encourage anyone seeking to acquire the company to negotiate fair value directly with the board of directors.”

Under the terms of the rights plan, preferred stock purchase rights will be distributed as a dividend at the rate of one Right for each share of Lipocine’s common stock held by stockholders of record as of the close of business on November 30, 2015.  The plan would be triggered if a person or group acquires beneficial ownership of 15% or more of the Company’s common stock other than pursuant to a board-approved tender or exchange offer or commences, or publicly announces an intention to commence, a tender or exchange offer upon consummation of which such person or group would beneficially own 15% or more of the Company’s common stock.

Details of the stockholder rights plan are outlined in a letter that will be mailed to all Company stockholders as of the record date.  In addition, a copy of the rights plan will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing, is targeted for testosterone replacement therapy and has a NDA under review with the FDA.  Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth with orphan drug designation, that is currently in Phase 1 testing.

Forward-Looking Statements

This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts relating to the Lipocine’s common stock and preferred stock, the FDA review process relating to our product candidates and the outcome of such process, clinical trials, the potential uses and benefits of the Lipocine’s product candidates, product development and commercialization efforts and the projected timing and outcome of regulatory filings and actions. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the FDA’s review of our NDA for LPCN 1021, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, the risks related to market conditions for Lipocine’s common stock and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

Contact:

Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Email: mb@lipocine.com

John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com

(SYPR) Awarded Long-Term Contract with Volvo Group North America

Sypris Technologies, Inc. (Sypris), a subsidiary of Sypris Solutions, Inc. (Nasdaq/GM: SYPR), announced today that it has been awarded a long-term contract with Volvo Group North America LLC and Mack Trucks, Inc. for the supply of axle shafts for use on Volvo’s Mack branded axle through 2018.

Commenting on the announcement, Paul Larochelle, Vice President of Sales and Strategic Initiatives, stated, “Sypris has been providing axle shafts to Volvo for over a decade as a tier two supplier. We are pleased to continue the supply of these components now directly to Volvo as a tier one supplier. We are excited for the opportunity to expand and extend our strategic relationship with Volvo and collaborate on other products where we can bring value to their supply chain.”

Sypris Technologies is a premier manufacturer and supplier of drivetrain and other critical components for the commercial vehicle, automotive, recreational vehicle, mining, agriculture and energy markets. Sypris is headquartered in Louisville, Kentucky. With facilities located throughout North America, Sypris continues to meet the needs of the industry after more than 80 years of service.

Mack Trucks, Inc. is part of the Volvo Group, one of the world’s leading manufacturers of trucks, buses, construction equipment and marine and industrial engines. The Group also provides complete solutions for financing and service. The Volvo Group, which employs about 100,000 people, has production facilities in 19 countries and sells its products in more than 190 markets. In 2014, the Volvo Group’s sales amounted to about $38.2 billion. The Volvo Group is a publicly-held company headquartered in Gothenburg, Sweden. Volvo shares are listed on Nasdaq Stockholm and are traded OTC in the U.S.

This press release contains “forward-looking” statements within the meaning of federal securities laws. Actual results could differ materially from those projected in such forward-looking statements as a result of certain risk factors, including but not limited to: any early termination of the supply contract or any of those risk factors set forth in the Annual Report on Form 10-K, dated and filed March 31, 2015 with the Securities and Exchange Commission (SEC) by our parent company, Sypris Solutions, Inc. and other filings that Sypris makes with the SEC from time to time.

(YOD) & CNTV to Partner Exclusively for IPTV SVOD/TVOD

NEW YORK, Nov. 12, 2015  — YOU On Demand Holdings, Inc. (NASDAQ: YOD) (“YOU On Demand” or “YOD”), a leading Video On Demand (“VOD”) service provider in China delivering Hollywood movies and premium content to TV and mobile screens, announced today an exclusive distribution and service partnership agreement with China Network Television’s (“CNTV”) IPTV operating entity Ai Shang Media (“CHINA IPTV”).

Under existing government regulations, CNTV is the sole national broadcast controller of all of the country’s IPTV platforms across all 31 provinces.  In each region, the local telecom operators provide 2-tiered service of bundled broadband and IPTV services, which carry both live TV and on demand content from CNTV and local provincial TV stations.  For example, over the last several years, China Telecom, one of the big 3 telecom operators in China, has expanded to 40 million IPTV subscriber homes in southern China.

CHINA IPTV, created as a joint venture by CNTV and Shanghai Media Group, is the only integrated for-profit IPTV platform operating nationwide under CNTV’s authorization.   As of today, CHINA IPTV has consolidated more than a dozen local IPTV platforms covering 15 million subscriber homes and aims to accomplish its mission of covering all IPTV users, existing and new, by the end of 2017.

Under the terms of the agreement, CHINA IPTV and YOD will work exclusively to provide Hollywood movie content to all IPTV users in China. YOD will have the first right of refusal on all movie content distribution, so that any content that CHINA IPTV looks to distribute will always be sourced first from YOU On Demand.

“CHINA IPTV selected YOU On Demand as one of our most favored content partners based on the fact that YOD is already a recognized name with established service partnerships with some of the leading IPTV and OTT operators in China,” stated Ms. Jing Jing He, the Chief Editor and Executive Vice President of CHINA IPTV, “We also believe that YOD can help, with its rich experience in both content distribution operations and marketing, to expedite our integration with local IPTV platforms.”

CEO Weicheng Liu, commenting on the partnership, stated, “Aligning YOD’s content alongside such a strong, centralized national platform, will help strengthen both the YOD brand as well as its reach. This deal is particularly significant to YOD on multiple levels.  First, it makes YOU On Demand the exclusive gatekeeper of Hollywood movie content to potentially 40+ million IPTV users.  Second, it provides YOD, in addition to the typical SVOD and TVOD revenue split, a separate and additional recurring revenue that will be tied to its heavy involvement in CHINA IPTV operations and marketing and how those engines drive CHINA IPTV growth and expansion.”

About YOU On Demand Holdings, Inc. (http://corporate.yod.com)

YOU On Demand (NASDAQ: YOD), is a leading multi-platform entertainment service company delivering premium content, including leading Hollywood movie titles, to customers across China via Subscription Video On Demand and Transactional Video On Demand. The Company has secured alliances with leading global media operators and content developers.  YOU On Demand has content distribution agreements in place with many of Hollywood’s top studios including Disney Media Distribution, Paramount Pictures, NBC Universal and Twentieth Century Fox Television Distribution, Miramax, as well as a broad selection of the best content from Chinese filmmakers. The Company has a comprehensive end-to-end secure delivery system, governmental partnerships and approvals and offers additional value-added services. YOU On Demand has strategic partnerships with the largest media entities in China, a highly experienced management team with international background and expertise in Cable, Television, Film, Digital Media, Internet and Telecom. YOU On Demand is headquartered in both New York, NY and Beijing, China.

Safe Harbor Statement

This press release contains certain statements that may include “forward looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

CONTACT:
Jason Finkelstein
YOU On Demand
212-206-1216
jason.finkelstein@yod.com
@youondemand
corporate.yod.com

(HOTR) Announces Grand Opening of BGR the Burger Joint in Springfield, VA

(LPCN) Announces PDUFA Goal Date for LPCN 1021 NDA

SALT LAKE CITY, Nov. 12, 2015  — Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of June 28, 2016 for completion of the review of the New Drug Application (“NDA”) for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (“hypogonadism”). Additionally, the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021 and we confirmed in subsequent communication with the FDA that an Advisory Committee is not planned.

About LPCN 1021

LPCN 1021 is a novel twice-a-day, oral testosterone replacement therapy product candidate with three simple oral dosing options that Lipocine expects will overcome the major shortcomings of existing products. The current testosterone market is dominated by topical products that carry FDA “black box” warnings related to inadvertent transfer of testosterone and by injectable products. The IMS Health database shows that an average of half a million prescriptions a month has been dispensed so far in 2015 for TRT.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing, is targeted for testosterone replacement therapy and has a NDA under review with the FDA. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth with orphan drug designation, that is currently in Phase 1 testing.

Forward-Looking Statements

This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts relating to expectations regarding the FDA review process relating to our NDA for LPCN 1021 and the outcome of such process, clinical trials, the potential uses and benefits of Lipocine’s product candidates, product development and commercialization efforts and the projected timing and outcome of regulatory filings and actions. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the FDA’s review of our NDA for LPCN 1021, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the Company’s website at www.lipocine.com or on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

CONTACT:                                                                                 
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383 
Email: mb@lipocine.com

John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com

(MNKD) Announces Pricing of Registered Direct Offering

VALENCIA, Calif., Nov. 12, 2015  — MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today announced the pricing of its previously announced registered direct offering of its common stock to selected investment funds in Israel, as well as the total number of shares to be purchased in the offering. The purchasers in the offering have committed to purchase an aggregate of 13,852,435 shares of common stock at a price per share equal to $2.61 (based upon the exchange rate between the New Israeli Shekel and the U.S. Dollar on November 12, 2015). The gross proceeds from this offering are expected to be $36.2 million, before deducting placement agent fees, escrow agent fees and other estimated offering expenses payable by MannKind. The offering is expected to close on or about November 12, 2015, subject to customary closing conditions.

“We are very pleased with the dual listing in the Tel Aviv Stock Exchange. This listing offers a great opportunity for MannKind, allowing it to continue to leverage its business and clinical operations together with expanding its current investor base and creating opportunities for corporations with the local biomed industry. We would like to thank the Tel Aviv Stock Exchange for the opportunity to be listed for trade. We are committed to creating value for the current and new investors as one,” stated MannKind’s Chief Financial Officer, Matthew Pfeffer. Mr. Pfeffer went on to note, “A portion of the index funds’ required holdings have now been purchased directly from the company. These transactions provide MannKind with needed near term liquidity to support Afrezza operations and Technosphere developments, while minimizing shareholder dilution. Remaining demand from the TASE index funds’ long-term holding requirements are expected to be satisfied through open market purchases, which must be completed before Sunday, November 15, 2015.”

Sunrise Securities Corp. acted as MannKind’s exclusive placement agent in connection with the offering.  The shares were offered pursuant to MannKind’s effective registration statement on Form S-3 (File No. 333-333-206778) and a related prospectus supplement filed with the Securities and Exchange Commission (SEC) on November 9, 2015. Copies of the prospectus supplement and accompanying prospectus are available on the SEC’s website located at http://www.sec.gov and may also be obtained by contacting MannKind at 25134 Rye Canyon Loop, Suite 300, Valencia, CA 91355, Attn: Investor Relations, or by telephone at (661) 775-5300. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction 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.

Stock Exchange Listings 

MannKind’s common stock is listed on The Nasdaq Global Market and the Tel Aviv Stock Exchange (TASE). Investors should note that trading on The Nasdaq Global Market occurs Monday through Friday, 9:30 am to 4:00 pm Eastern Time, except on Nasdaq trading holidays, and trading on the TASE occurs Sunday from 8:30 am to 4:30 pm Israel time and Monday to Thursday from 8:30 am to 5:30 Israel time, except on TASE trading holidays. The TASE Clearing House is electronically linked to the Depository Trust Company, a subsidiary of the Depository Trust & Clearing Corporation, to automate the cross-border settlement of shares listed on both the TASE and a U.S. Exchange.

About MannKind Corporation

MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the SEC or posts certain other information to the website.

Forward-Looking Statements

Statements contained in this press release that are not strictly historical in nature are forward-looking statements that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind’s current expectations. 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 satisfaction of customary closing conditions, fluctuations in the New Israeli Shekel-to-U.S. Dollar exchange rate, MannKind’s dependency on Sanofi for commercialization of Afrezza, MannKind’s need and ability to raise additional capital and other risks detailed in MannKind’s filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2014, subsequently filed periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

CONTACT: Company Contact:
         Matthew J. Pfeffer
         Chief Financial Officer
         661-775-5300
         mpfeffer@mannkindcorp.com

(HART) Reports Significant Confirmatory Results for its 2nd Gen Implants

HOLLISTON, Mass., Nov. 12, 2015  — Harvard Apparatus Regenerative Technology, Inc. (HART) (Nasdaq: HART), a biotechnology company developing bioengineered implants for life-threatening conditions, today announced significant results – including clear evidence of complete esophageal tissue regeneration – from recently conducted animal research on HART’s 2^nd Generation (Gen2) bioengineered implant platform. HART will hold a conference call at 5:00 p.m. ET today to discuss these results.

Jim McGorry, HART CEO, commented: “We pursued these animal studies to test the design and technology enhancements we have made to our second generation technology and to prepare us for our upcoming studies with the Mayo Clinic. We are very encouraged by the results of these studies and by the significant advancements we have made across all three indications. In particular, results for the Gen2 implant in the esophagus far exceeded our expectations, particularly given the study’s brief duration. Over a two-week period, all layers of the esophagus, most notably the epithelial and muscle layers, were fully regenerated, and components of esophageal nerves were present. Such nerves are fundamental to the proper contraction of the muscles that move food along the esophagus.”

Mr. McGorry continued, “Based on the strong performance of our Gen2 implants in all three indications, we are well-positioned as we move forward with confirmatory longer-term large-animal studies with Mayo Clinic in December.”

Research and Development Highlights:

• HART’s Gen2 technology reflects design enhancements to improve the body’s response to the implant and to better guide the repair of tissue in the healing process.
• HART’s recent animal studies tested all three of its Gen2 implants – esophagus, trachea, and bronchus – demonstrating resolution of the negative inflammatory response observed with the prior generation of the technology.
• Clinically significant evidence of tissue and nerve regeneration was observed in the esophageal implant, positioning the esophageal implant as the current lead development priority.
• HART is initiating confirmatory and longer-term large-animal studies with Mayo Clinic in December.
• HART remains on track to conduct human compassionate use surgeries and to file an initial IND application with U.S. FDA in 2016.

Research Findings
Saverio La Francesca, M.D., HART’s CMO, added, “We have demonstrated a very significant improvement in the body’s response to the implant in the tracheal position, and we have observed initial engraftment of the implant into the surrounding tissues. Similar positive findings were noted in the main bronchus position.”

He continued, “We are very encouraged by the anatomical and histological data from our esophageal implant study. Based on these data, we believe that our second generation implant possesses all the necessary cues to elicit full regeneration of the esophagus. Importantly, our esophageal implant addresses a very significant need as a potentially life-saving treatment for patients with esophageal cancer. Each year in the U.S. approximately 17,000 new cases of esophageal cancer are diagnosed, and more than 4,000 are addressed by surgery. Our results underscore the value and potential of our platform technology to treat these patients and pave the way for further studies and our regulatory pathway for human clinical trials.”

Teleconference
A conference call to discuss the company’s animal studies described above, its third quarter results, and business outlook is scheduled today at 5:00 PM (Eastern Time). On that call, management may respond to questions from the audience on any of a number of topics related to the business, including clinical and preclinical research, operations, plans and outlook.

Participating in the call will be Jim McGorry, Chief Executive Officer, Saverio La Francesca, M.D., Executive Vice President and Chief Medical Officer and Tom McNaughton, Chief Financial Officer, of HART.

Investors can access the live conference call by dialing the following phone numbers: toll-free 877-407-8293, or international: 201-689-8349, and referencing Harvard Apparatus Regenerative Technology, Inc. An audio webcast will also be available at http://public.viavid.com/index.php?id=117087

If you are unable to listen to the live conference call, a replay will be available within approximately 3 hours from the end of the call through 11:59pm ET on November 19, 2015 and will be accessible by dialing toll-free 877-660-6853, or toll/international 201-612-7415, and referencing conference ID “13624147”. The replay will also be made available at the web link above and on the company’s web site, www.harvardapparatusregen.com.

About HART: (www.hartregen.com)
Harvard Apparatus Regenerative Technology (HART) makes bioengineered implants for life-threatening conditions. Our technology platform is to be used to restore function in the esophagus and the trachea and bronchus airways. Our first generation tracheal implant has been used successfully in five human implant procedures approved under compassionate use exemptions, but none of our products are yet approved for marketing by a government regulatory authority. HART is completing further large-animal studies to refine our technology platform with the goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to initiate clinical trials for one of our three indications in 2016.

Forward-Looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the regulatory approval of any HART products by the FDA, EMA, MHRA or otherwise, which approvals may not be obtained on a timely basis or at all, success with respect to any collaborations, clinical trials and other development and commercialization efforts of HART products pertaining to the airway or esophagus, which such success may not be achieved or obtained on a timely basis or at all; anticipated future earnings or other financial measures, and the continued availability of a market for HART securities. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for the bioreactors, scaffolds and other devices and product candidates we pursue; the success of our clinical trials and devices; our inability to operate effectively as a stand-alone, publicly traded company; plus other factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Harvard Apparatus Regenerative Technology expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor and Media Contact:
David Collins, Tanya Kamatu
Catalyst Global
212 924 9800
hart@catalyst-ir.com

(MOXC) Engagement of DreamTeamNetwork Corporate Communications Service Suite

(EVOL) 4th African Operator This Year Selects Dynamic SIM Allocation Solution

Extending the Number of Operators in a Major Wireless Multinational Group to Six

(AETI) Appoints Energy Industry Veteran Mark Haubert

Former Express Energy Services Executive Brings Significant Sales Leadership Experience to Newly Created Role

HOUSTON, Nov. 11, 2015  — American Electric Technologies, Inc. (NASDAQ:AETI), a leading provider of power delivery solutions for the global energy industry, announced today that Mark Haubert has joined the company as Senior Vice President, Sales and Marketing for its flagship M&I Electric business.

Mr. Haubert brings with him more than 25 years of sales, marketing, engineering, operations and executive leadership experience in the energy industry.

In this role, Mr. Haubert will have global responsibility for leading the company’s strategic and tactical sales and marketing initiatives targeting the oil & gas, power generation and distribution, marine and industrial segments.

Mr. Haubert was most recently Senior Vice President of Sales and Marketing for EMS USA, Inc., a privately held firm offering pipeline and facility construction, pipeline integrity maintenance, production measurement and automation services to the midstream, upstream and downstream markets. Prior to EMS, Mr. Haubert was Executive Vice President of Sales, Marketing and Engineering at Express Energy Services where he led significant revenue growth and market penetration with a blue chip customer base. Mr. Haubert has also held a variety of roles at Baker Hughes, Cameron, and Schlumberger.

Mr. Haubert will report directly to AETI’s President and CEO, Charles Dauber and will be located in the AETI office in the Houston Energy Corridor.

“We are excited to bring Mark on board to help the company take our revenues to the next level,” said Charles Dauber, AETI President and CEO. “Mark brings more than 25 years of energy industry sales leadership experience to his new role at M&I and we look forward to working with him to achieve the next phase of our company’s growth objectives.”

Mr. Haubert received a Bachelor of Science degree in Petroleum Engineering from Louisiana State University and an executive Master of Business Administration from Houston Baptist University.

“I am thrilled to join the M&I Electric team and I look forward to leveraging the quality products and services, customer-centric approach, industry-leading delivery and other value drivers to grow our customer base and to delight our clients,” said Mark Haubert.

American Electric Technologies, Inc. (NASDAQ:AETI) is a leading supplier of power delivery solutions for the global energy industry. AETI offers M&I Electric™ power distribution and control products, electrical services, and E&I construction services. South Coast Electric Systems L.L.C., a subsidiary, services Gulf Coast marine and vessel customers.

AETI is headquartered in Houston and has global operations in Beaumont, Texas; Bay St. Louis, Mississippi, and Rio de Janeiro and Macae, Brazil. In addition, AETI has minority interests in two joint ventures, which have facilities located in Xian, China and Singapore. AETI’s SEC filings, news and product/service information are available at www.aeti.com.

Investor Contacts:
American Electric Technologies, Inc.
713-644-8182
investorrelations@aeti.com

(BIOC) Expands Patent Protection in Europe

European patent covers the use of antibodies in the capture and detection of rare cells from biological fluids used in the company’s liquid biopsy, or blood-based, molecular diagnostic assays

SAN DIEGO, Nov. 11, 2015  — Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the diagnosis and treatment of cancer, announces that the European Patent Office has awarded the patent, “DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS,” as announced in the European Bulletin dated November 11, 2015. The patent covers the use of antibodies in the capture of rare cells, such as circulating tumor cells (CTCs), from blood as well as other biological fluids using the company’s patented microchannel capture device.

Biocept’s antibody capture cocktail along with the microchannel are key components of the company’s Cell Enrichment and Extraction (CEE™) platform, providing for the high-efficiency capture, visualization and microscopic analysis of targeted cancer cells obtained from a patient blood sample and used by physicians for medical decision-making.

Lyle Arnold, Ph.D., Chief Scientific Officer at Biocept, said, “The issuance of this patent further expands our international patent portfolio to include the use of antibodies in the capture of cancer cells in combination with our microchannel for which multiple U.S. and international patents have been granted. Our antibody cocktail is a key part of our patented, proprietary method to capture and analyze cells from a wide variety of tumor types. In addition, this patent expands our IP protection for the use of a simple blood sample and other biological sample types in obtaining valuable biomarker information that can be used by physicians to personalize the treatment of patients with cancer.”

“We have been aggressively broadening IP protection for our unique methods of capturing and analyzing cancer cells in blood and other biological fluids,” said Biocept’s President and Chief Executive Officer Michael Nall. “Our expanding patent portfolio better positions Biocept to capitalize on the growing movement toward the use of liquid biopsy, which we believe can reduce healthcare costs and improve outcomes by identifying patients who can qualify for targeted treatments that physicians can utilize to treat their cancer.”

About Biocept

Biocept, Inc. is a commercial-stage molecular diagnostics company that utilizes a proprietary technology platform and a standard blood sample to provide physicians with important prognostic and predictive information to enhance individual treatment of patients with cancer. Biocept’s patented technology platform captures and analyzes circulating tumor DNA, both in CTCs and in plasma (ctDNA). Biocept currently offers assays for gastric cancer, breast cancer, lung cancer, colorectal cancer and melanoma, and plans to introduce CLIA-validated assays for prostate cancer and other solid tumors in the near term. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including, without limitation, statements as to the ability of physicians to use our liquid biopsy technology to personalize treatment for individual patients with cancer, our ability to expand the clinical utility and adoption of our liquid biopsy assays, improvement of patient outcomes and our impact on diagnostic strategies and healthcare costs, and our ability to expand  into new cancer indications and grow our portfolio of biomarker assays, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.

(HSKA) Enters International Imaging Expansion With Acquisition Of Cuattro Veterinary

LOVELAND, Colo., Nov. 11, 2015  — Heska Corporation (NASDAQ: HSKA “Heska” or the “Company”), a leading provider of advanced veterinary diagnostic and specialty products, announced today the acquisition of Cuattro Veterinary, LLC (“Cuattro International”) a global leader in digital radiography, PACS, and other imaging technologies for veterinarians.

Kevin Wilson, Heska’s Chief Executive Officer and President, commented that, “We are excited to combine Cuattro International’s global reach with Heska’s success in the United States. This international expansion provides Heska with a strong and established platform for launching Heska’s blood diagnostics platforms and programs to international markets. With established sales throughout Canada, Mexico, Continental Europe, the United Kingdom, Australia, the Middle East, Singapore, Latin America, and elsewhere, Cuattro International’s imaging products continue to delight global veterinary customers. Now, Heska can leverage our domestic success in the imaging and blood diagnostics space on a worldwide stage. International markets represent a significant portion of worldwide veterinary revenues for which Heska intends to compete. Today, Heska begins to aggressively pursue those markets with advanced blood diagnostics and imaging bundles, a proven go-to-market model, and an expert and expanding team.”

Heska agreed to deliver $6.0 million in stock for 100% ownership of Cuattro International, subject to a minimum of 175,000 shares and a maximum of 200,000 shares. Heska will assume approximately $2.1 million in debt as part of the acquisition. Cuattro International generated approximately $6 million in revenue for the twelve months ended September 30, 2015 and was profitable during this period.  The acquisition is subject to closing conditions and is targeted to close January 1, 2016. The Company expects the acquisition to be neutral to slightly accretive to earnings per share in 2016.

Management will conduct a conference call on Wednesday, November 11, 2015 at 9 a.m. MST (11 a.m. EST) to discuss recent financial results and this transaction. To participate, dial 888‑438‑5491 (domestic) or 719-325-2455 (international) and reference conference call access number: 239441. The call will also be broadcast live over the Internet at http://www.heska.com. To listen, simply log on to the web address at least ten minutes prior to the start of the call to register, download and install any necessary audio software. Telephone replays of the conference call will be available for playback on Heska’s home page at www.heska.com until November 25, 2015. The telephone replay may be accessed by dialing 888-203-1112 (domestic) or 719-457-0820 (international). The replay access number is 239441.

Forward-Looking Statements
This announcement contains forward-looking statements regarding Heska’s future financial and operating results. These statements are based on current expectations and are subject to a number of risks and uncertainties. Investors should note that there is an inherent risk in using past results, including trends, to predict future outcomes, including using customer trends to predict future success with customers. Factors that could affect the business and financial results of Heska generally include,but are not limited to, the following: uncertainties related to Heska’s ability to sell different product categories through an existing sales channel; uncertainties related to acquisitions, including the potential that the acquired entity’s financial performance will not meet expectations; risks related to relying on third-party distributors; risks related to personnel; competition; and the risks set forth in Heska’s filings and future filings with the Securities and Exchange Commission, including those set forth in Heska’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015.

(DISCB) President & CEO to Present at UBS Global Conference

SILVER SPRING, Md., Nov. 11, 2015  — Discovery Communications (Nasdaq: DISCA, DISCB, DISCK) today announced that President and CEO David Zaslav will present at the 2015 UBS Global Media and Communications Conference at 2:30 p.m. ET on Monday, December 7, 2015, at the New York Hilton Midtown in New York, NY.

A link to a live audio webcast of the presentation will be available in the “Investor Relations” section of Discovery Communications’ website at www.discoverycommunications.com.  A replay of the webcast will be available on the company’s website for 180 days following the presentation.

About Discovery Communications
Discovery Communications (Nasdaq: DISCA, DISCB, DISCK) is the world’s #1 pay-TV programmer reaching 3 billion cumulative subscribers in more than 220 countries and territories. For 30 years Discovery has been satisfying curiosity and entertaining viewers with high-quality content through its global brands, led by Discovery Channel, TLC, Animal Planet, Investigation Discovery, Science and Turbo/Velocity, as well as U.S. joint venture network OWN: Oprah Winfrey Network, and through the Discovery Digital Networks portfolio, including TestTube, Seeker and SourceFed. Discovery owns Eurosport, the leading pan-regional sports entertainment destination across Europe and Asia-Pacific. Discovery also is a leading provider of educational products and services to schools, including an award-winning series of K-12 digital textbooks, through Discovery Education. For more information, please visit www.discoverycommunications.com.

(ANGI) Proposes To Acquire Angie’s List For $8.75 Per Share

– Proposal represents a premium of 50% over the unaffected Angie’s List share price and trailing 90 day average trading price – Proposal contemplates either an all cash offer or a stock-for-stock transaction that combines IAC’s HomeAdvisor business with Angie’s List – IAC expects that a transaction could be consummated expeditiously, with no financing condition

NEW YORK, Nov. 11, 2015  — IAC/InterActiveCorp (Nasdaq: IACI) today announced that it has proposed to acquire all of the outstanding shares of Angie’s List, Inc. (Nasdaq: ANGI) common stock for $8.75 per share. The transaction proposed to the Angie’s List Board of Directors would be structured as an all-cash deal; however, IAC has indicated its willingness to consider a combination of Angie’s List with IAC’s HomeAdvisor business through a tax-free stock-for-stock exchange.

The IAC all-cash proposal represents a premium of greater than 50% over the unaffected price of Angie’s List common stock as of October 12, 2015, the day immediately preceding disclosure of TCS Capital’s letter to the Angie’s List Board of Directors advocating pursuit of a strategic transaction between Angie’s List and HomeAdvisor and over the trailing 90 day average trading price for the stock.

“The combination of the Angie’s List brand, highly trafficked website and its network of paying service professionals with our HomeAdvisor business, the category leader which has seen eight consecutive quarters of accelerating growth in its core U.S. business, would cement our position as the premier home services platform,” said Joey Levin, CEO of IAC/InterActiveCorp.  “We are fully committed to this transaction and are confident that both Angie’s List stockholders and our stockholders will recognize the value of our proposal.”

Financial and Strategic Benefits of the Proposal

• The all-cash offer represents a compelling premium of 50% over the Angie’s List unaffected share price, as well as the trailing 90-day average trading price for the stock.
• The combination of Angie’s List with HomeAdvisor would create the premier platform in the home services market with over $700 million of revenue and an unparalleled network of active and high quality service professionals capable of delivering consumers a best-in-class experience.
• The combined company would have more than $35 billion in gross transaction value and over an estimated 15 million unique visitors per month.
• The combination of Angie’s List’s nationally recognized brand and directory monetization model with HomeAdvisor’s performance based on demand monetization (including Instant Booking, Instant Connect and Market Matching products) will provide the best experience to the largest number of consumers and service providers alike.

IAC delivered its proposal to the Angie’s List Board of Directors today.  Below is the text of the letter that was sent to the Angie’s List Board of Directors:

November 11, 2015

Board of Directors
Angie’s List, Inc.
1030 E. Washington Street
Indianapolis, IN 46202

Dear Ladies and Gentlemen:

We very much appreciated Scott Durchslag and Thomas Fox taking the time to meet with us on October 23.  We were disappointed to hear that the Board is not interested in further engaging with us regarding a strategic transaction involving Angie’s List.  We continue to believe a transaction involving our companies has a compelling strategic rationale, and we are confident we are well-positioned to swiftly consummate a transaction that will be in the best interests of Angie’s List stockholders.  In an effort to demonstrate our strong commitment to bringing our two companies together, outlined below is an updated proposal for the Board’s consideration.

We propose to acquire 100% of the outstanding capital stock of Angie’s List for a price of $8.75 per share in cash, representing a compelling premium of greater than 50% over the unaffected price of Angie’s List common stock as of October 12, 2015, the day immediately preceding disclosure of TCS Capital’s letter to the Angie’s List Board advocating pursuit of a strategic transaction, and over the trailing 90 day average trading price for the stock.  Our price represents a greater than 18x multiple of the midpoint of your forecasted EBITDA range for this year – a very rich multiple for a business currently growing revenue at 7% year over year on a standalone basis.

While we see many benefits of a clear, high-premium, all-cash offer that would deliver immediate liquidity and certain value to your stockholders, we are also prepared to discuss a combination of Angie’s List with our HomeAdvisor business.  This could be structured as a tax-free exchange for Angie’s List stockholders and would allow Angie’s List stockholders to participate in the upside resulting from the opportunities available to the combined company.

A combined HomeAdvisor-Angie’s List would have unparalleled consumer reach and an incomparable network of paid service professionals.  It would have the ability to deploy technological innovations across an enormous footprint, creating an unmatched ability to deliver the best experience to the largest number of consumers and service providers alike.  We are confident that the operating outlook for Angie’s List in a combination scenario would be substantially improved over its standalone prospects.

We believe the work required to finalize a mutually agreeable transaction would be quick, and we can manage it efficiently so as not to disrupt the Angie’s List day-to-day operations.  The definitive terms of our proposal could be agreed in the course of a week and completed within a few months, as promptly as the regulatory processes permit.  Our proposal is not conditioned on the receipt of financing.

Our strong preference would have been to work with you on a confidential and cooperative basis.  However, we have been unable to develop any meaningful dialogue with you for many months now and were disappointed by your unwillingness to continue discussions with us following our meeting.  Further, in light of the increase in the Angie’s List share price during the days that followed our October 5 letter to the Board expressing an interest in discussions, and further increases following our October 23 meeting and acquisition proposal, we determined it was advisable to publicly release the text of this letter concurrent with its delivery to the Board to ensure that your stockholders are fully apprised of the significant value afforded by our proposed transaction.

This letter does not represent or create any legally binding or enforceable obligations.  No such obligations will be imposed on any party unless and until a definitive agreement is executed.

I assure you that this transaction has the highest priority for IAC.  We look forward to working towards a transaction that creates value for all of our stockholders and, as we have indicated previously, we are prepared to meet with you immediately to discuss the same.

Sincerely,

Joey Levin
Chief Executive Officer

About IAC/InterActiveCorp

IAC (NASDAQ: IACI) is a leading media and Internet company. It is organized into four segments: Match Group, which includes dating and education businesses with brands such as Match, OkCupid, Tinder and The Princeton Review; Search & Applications, which includes brands such as About.com, Ask.com, Dictionary.com and Investopedia; Media, which consists of businesses such as Vimeo, Electus, The Daily Beast and CollegeHumor; and eCommerce, which includes HomeAdvisor and ShoeBuy. IAC’s brands and products are among the most recognized in the world reaching users in over 200 countries. IAC is headquartered in New York City and has offices worldwide.

About HomeAdvisor

HomeAdvisor.com is a local home services marketplace providing homeowners the tools and resources for home repair, maintenance, and improvement projects. HomeAdvisor’s marketplace lets homeowners view average project costs coast-to-coast, find local pre-screened home professionals, and instantly book appointments online. Access to all of HomeAdvisor’s resources is free for homeowners, with no membership or fees required. HomeAdvisor is based in Golden, Colo., and is an operating business of IAC (NASDAQ: IACI)

Important Additional Information

This communication does not constitute an offer to buy or solicitation of an offer to sell any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Subject to future developments, IAC may file a registration statement and/or tender offer documents with the SEC in connection with a possible transaction with Angie’s List. IAC and Angie’s List stockholders should read those filings, and any other filings made by IAC with the SEC in connection with a possible transaction, as they will contain important information. Those documents, if and when filed, as well as IAC’s other public filings with the SEC, may be obtained without charge at the SEC’s website at www.sec.gov and at IAC’s website at www.iac.com/investor-relations.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995

This communication contains “forward‑looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as “anticipates,” “expects,” “intends,” “plans” and “believes,” among others, generally identify forward-looking statements.  These forward-looking statements include statements relating to: future financial performance, business prospects and strategy, anticipated trends, prospects in the industries in which our businesses operate and other similar matters. These forward‑looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. Actual results could differ materially from those contained in these forward‑looking statements for a variety of reasons, including, among others: changes in senior management at IAC or its businesses, adverse changes in economic conditions, adverse trends in the online advertising industry, our ability to convert visitors to our websites into users, risks relating to acquisitions, technology changes, our ability to expand successfully into international markets and regulatory changes. These statements also include assumptions about our offer to acquire Angie’s List (including its benefits, results, effects and timing) that may not be realized.  Risks and uncertainties related to the proposed transaction include, among others: the possibility that a possible transaction will not be pursued or will be pursued on different terms or conditions; adverse effects on the market price of IAC’s common stock and on IAC’s operating results because of a failure to agree to or complete a possible combination; in the event a definitive transaction agreement is executed, the risk that Angie’s List stockholders do not approve the transaction; uncertainties as to the timing of the transaction; the risk that regulatory or other approvals required for the transaction are not obtained,  the risk that the other conditions to the closing of the transaction are not satisfied; and, in the event a transaction combining the Angie’s List and HomeAdvisor businesses is consummated, risks related to the costs and difficulties related to the integration of Angie’s List businesses and operations with HomeAdvisor and IAC’s businesses and operations; the inability to obtain, or delays in obtaining, cost savings and synergies from the transaction; unexpected costs, charges or expenses resulting from the transaction; litigation relating to the transaction; and the inability to retain key personnel. Certain of these and other risks and uncertainties are discussed in IAC’s filings with the Securities and Exchange Commission. Other unknown or unpredictable factors that could also adversely affect our business, financial condition and results of operations may arise from time to time. In light of these risks and uncertainties, these forward‑looking statements may not prove to be accurate. Accordingly, you should not place undue reliance on these forward‑looking statements, which only reflect the views of our management as of the date of this press release. We do not undertake to update these forward-looking statements.

Contact Us

IAC Investor Relations
Mark Schneider / Alexandra Caffrey
(212) 314-7400

IAC Corporate Communications
Isabelle Weisman
(212) 314-7361

(APTO) Collaborations for New Multi-Targeting Epigenetic Therapeutics

Moffitt Cancer Center Grants Aptose Exclusive Global Rights to Highly Potent Multi-Targeting Epigenetic Inhibitors

Exclusive Agreement with Laxai Avanti Life Sciences to Design Next Generation Epigenetic Therapeutics

REDWOOD CITY, Calif., TORONTO, TAMPA, Fla. and HYDERABAD, India, Nov. 10, 2015  — Aptose Biosciences Inc. (Nasdaq:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced two collaborations that will provide exclusive access to new epigenetic therapeutics for the Company’s oncology pipeline. These partnerships have been strategically formed to leverage Aptose’s scientific and clinical expertise in cancer and hematologic diseases to develop mechanistically differentiated and high-value epigenetic drug candidates.

Strategic Collaboration with Moffitt Cancer Center

Aptose has entered into a definitive agreement with Moffitt Cancer Center for exclusive global rights to potent, multi-targeting, single-agent inhibitors for the treatment of hematologic and solid tumor cancers. These small molecule agents are highly differentiated inhibitors of the Bromodomain and Extra-Terminal motif (BET) protein family members, which simultaneously target specific kinase enzymes. The molecules developed by Moffitt exhibit single-digit nanomolar potency against the BET family members and specific oncogenic kinases which, when inhibited, are synergistic with BET inhibition. Under the agreement, Aptose will gain access to the drug candidates developed by Moffitt and the underlying intellectual property covering the chemical modifications enabling potent bromodomain (BRD) inhibition on the chemical backbone of a kinase inhibitor. Aptose expects lead clinical candidates to emerge from the collaboration by late 2016.

Transcriptional dysregulation in cancer cells may occur through various means, including chromatin remodeling, histone modification and super-enhancer formation. The bromodomain proteins play a critical role in this dysregulation, and hence targeting specific bromodomains represents a validated treatment approach for various cancers. Aptose is committed to developing a pipeline of molecules that inhibit key epigenetic targets with the potential to intervene in oncogenesis and induce remission.

“We’ve built an oncology drug development organization with valuable ties to leading clinical centers and thought leaders,” said William G. Rice, Ph.D., Chairman, President and CEO, “and we are exceptionally pleased to partner with Moffitt on advancing new epigenetic inhibitors, specifically bromodomain inhibitors that simultaneously inhibit specific kinases in key regulatory pathways.”

“Aptose views a multi-targeting approach, which incorporates bromodomain inhibition, as an exciting means to enhance efficacy and diminish therapeutic resistance relative to the current landscape in cancer treatment. This is even more beneficial when inhibition of the pathways is highly synergistic. The researchers at Moffitt have made unprecedented progress in this field,” continued Dr. Rice.

“We view the advancement of epigenetic multi-inhibitors as a highly promising strategy in the treatment of cancer,” said the principal investigators Ernst Schonbrunn, Ph.D. and Nicholas Lawrence, Ph.D., members of the Drug Discovery Program at Moffitt, “and targeting broad-acting epigenetic regulators of transcription like bromodomain proteins is needed to suppress the induction of gene expression that results when cancer cells respond to kinase inhibitors.”

“We are excited to work with an organization as scientifically driven to develop novel therapeutics as Aptose,” said Haskell Adler, Ph.D., MBA, Senior Licensing Manager at Moffitt.

Exclusive Agreement with Laxai Avanti Life Sciences

Aptose today also announced an exclusive drug discovery partnership with Laxai Avanti Life Sciences (LALS) for their expertise in next generation epigenetic-based therapies. Under the agreement, LALS will be responsible for developing multiple clinical candidates, including optimizing candidates derived from Aptose’s relationship with the Moffitt Cancer Center. Aptose will own global rights to all newly discovered candidates characterized and optimized under the collaboration, including all generated intellectual property.

“We have identified LALS as an organization with high-caliber medicinal chemistry and with robust, and highly efficient drug discovery capabilities that complement our capabilities at Aptose,” said Dr. Rice. “These collaborations are designed to build upon insights into the epigenetic field that were informed by the mechanism of APTO-253. As we continue to advance APTO-253 into late-stage clinical development, we are committed to creating and acquiring additional differentiated agents and building a staged oncology pipeline behind APTO-253.”

About APTO-253

Epigenetic suppression of the KLF4 gene has been reported in the scientific literature as a key transforming event in AML and high-risk myelodysplastic syndromes. APTO-253, Aptose’s lead drug candidate, is a first-in-class inducer of the Krüppel-like factor 4 (KLF4) tumor suppressor gene, and the only clinical-stage compound targeted for patients with suppressed KLF4 levels. APTO-253 has demonstrated a favorable safety profile with no evidence of bone marrow suppression. Preclinical studies have shown potent single-agent activity and an opportunity for combination therapy with a variety of anti-cancer therapeutics. The drug candidate is in a Phase 1b clinical study in patients with relapsed or refractory hematologic malignancies.

About Moffitt Cancer Center

Located in Tampa, Moffitt is one of only 45 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the top-ranked cancer hospital in Florida and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. With more than 4,600 team members, Moffitt has an economic impact in the state of $1.9 billion. For more information, visit MOFFITT.org, and follow the Moffitt momentum on Facebook, Twitter and YouTube.

About Laxai Avanti Life Sciences

Laxai Avanti Life Sciences (LALS) was established in 2007 with a vision to innovate and accelerate the drug discovery campaigns of global pharmaceutical companies. The goal of LALS is to provide intelligent solutions to global pharmaceutical and biotechnological companies by providing high quality services with accelerated timelines. LALS provides a one-stop service for pharmaceutical and biotechnology companies around the globe to accelerate drug discovery programs. LALS current client base includes Biopharmaceutical, Agrochemical and Specialty Chemical Companies in Europe and the US.

About Aptose Biosciences

Aptose Biosciences is a clinical-stage biotechnology company committed to discovering and developing personalized therapies addressing unmet medical needs in oncology. Aptose is advancing new therapeutics focused on novel cellular targets on the leading edge of cancer research, coupled with companion diagnostics to identify the optimal patient population for our products. The Company’s small molecule cancer therapeutics pipeline includes products designed to provide enhanced efficacy with existing anti-cancer therapies and regimens without overlapping toxicities. Aptose Biosciences Inc. is listed on NASDAQ under the symbol APTO and on the TSX under the symbol APS.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws. Such statements include, but are not limited to, the ability of the company to develop mechanistically differentiated and high-value epigenetic drug candidates; that the licensed molecules will be potent, multi-targeting, single-agent inhibitors for the treatment of hematologic and solid tumor cancers; that the small molecule agents are highly differentiated inhibitors of the Bromodomain and Extra-Terminal motif (BET) protein family members, which simultaneously target specific kinase enzymes; that lead clinical candidates may emerge from the collaboration by late 2016; that future bromodomain inhibitors will simultaneously inhibit specific kinases in key regulatory pathways; that we will be able to enhance efficacy and diminish therapeutic resistance relative to the current landscape in cancer; that the researchers at Moffitt Cancer Center have made unprecedented progress in this field; that we will continue to advance APTO-253 into late-stage clinical development and statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “should”, “would”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such expressed or implied forward looking statements could include, among others: our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.

Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.

CONTACT: For further information, please contact:

         Aptose Biosciences
         Avanish Vellanki
         SVP, Chief Business Officer
         650-718-5021
         avellanki@aptose.com

         BCC Partners
         Karen L. Bergman or Susan Pietropaolo
         650-323-1717 or 845-638-6290
         kbergman@bccpartners.com or spietropaolo@bccpartners.com

         Moffitt Cancer Center
         Kim Polacek
         Public Relations Account Services Coordinator
         Moffitt Cancer Center
         Kim.Polacek@Moffitt.org
         813-745-7408

(NCMI) to Present at the MKM Partners Entertainment, Leisure & Internet Conference

National CineMedia, Inc. (NASDAQ: NCMI) (the Company), the managing member and owner of 45.2% of National CineMedia, LLC (NCM LLC), the operator of the largest digital in-theatre network in North America, today announced that the Company will participate at the MKM Partners Entertainment, Leisure & Internet Conference on Thursday, November 19, 2015 at The New York Palace in New York, NY. The Company’s CEO Kurt Hall will present at 08:00 AM EST.

Investors and interested parties may listen to a webcast of the event by visiting the investor relations section of the Company’s website at www.ncm.com.

About National CineMedia, Inc.

National CineMedia (NCM) is America’s Movie Network. As the #1 weekend network in the U.S., NCM helps brands get in front of the movies that shape the national conversation. More than 700 million moviegoers annually attend theatres that are currently under contract to present NCM’s FirstLook pre-show in over 40 leading national and regional theatre circuits including AMC Entertainment Inc. (NYSE:AMC), Cinemark Holdings, Inc. (NYSE:CNK) and Regal Entertainment Group (NYSE: RGC). NCM’s cinema advertising network offers broad reach and unparalleled audience engagement with approximately 20,050 screens in approximately 1,600 theaters in 187 Designated Market Areas® (49 of the top 50). NCM Digital goes beyond the big screen, extending in-theatre campaigns into online and mobile marketing programs to reach entertainment audiences. National CineMedia, Inc. (NASDAQ:NCMI) owns a 45.2% interest in, and is the managing member of, National CineMedia, LLC. For more information, visit www.ncm.com.

National CineMedia, Inc.
Investor Contact:
David Oddo, 800-844-0935
investors@ncm.com

(JIVE) Appoints (EA) Executive Gabrielle Toledano To Board Of Directors

Senior Human Resources Leader Brings More Than 25 Years of Experience from Oracle, Microsoft, Siebel Systems and Electronic Arts

PALO ALTO, Calif., Nov. 9, 2015  — Jive Software, Inc. (Nasdaq: JIVE) today announced that Gabrielle Toledano has been appointed to its board of directors. Ms. Toledano joins the Jive board with a distinguished 25-year career in technology industry human relations, including her current role as executive vice president and chief talent officer at Electronic Arts.

“Gabrielle brings a wealth of experience managing human resources and cultural innovation at some of the biggest companies in the industry, and she will be an incredible addition to the board,” said Elisa Steele, chief executive officer at Jive Software. “She will help us push the boundaries of what’s possible across all aspects of our business.”

At Electronic Arts, Ms. Toledano is responsible for the company’s organization and leadership capability development, global staffing and resourcing, benefits and compensation, rewards and recognition, facilities, and corporate social responsibility. Previously, she served as chief human resources officer for Siebel Systems and has held strategic human resources positions with Microsoft and Oracle.

“People are at the center of every organization, and in today’s competitive talent landscape it’s imperative for companies to foster meaningful relationships with their employees, customers and partners,” said Gabrielle Toledano. “Jive lives and breathes this belief every day — delivering solutions that directly impact how millions of people around the world connect, communicate and collaborate. I’m honored to join Jive’s team and support its mission to help people work better together.”

Ms. Toledano will replace Jonathan Heiliger, who is resigning to focus full time on his role as partner at Vertex Ventures. “As we welcome Gabrielle, I want to also recognize the dedication and impact that Jonathan has made as a member of Jive’s board,” added Steele. “We’re thankful for his contributions to Jive’s business over the years.”

About Jive Software
Jive (Nasdaq: JIVE) is the leading provider of modern communication and collaboration solutions for business. Recognized as a leader by the industry’s top analyst firms in multiple categories, Jive enables employees, partners and customers to work better together. More information can be found at www.jivesoftware.com or the Jive News Blog.

(OESX) Awarded National Contract with One of the World’s Largest Retailers

One of the premier supermarket chains and top ten global retailers has awarded its national LED lighting contract for distribution centers to Orion Energy Systems, Inc. (NASDAQ: OESX), a leading designer and manufacturer of high-performance, energy-efficient retrofit lighting platforms.

The contract continues Orion’s long history of successful partnerships with over fifty of the best-known cold storage, food distribution and warehousing facilities. In this market, Orion has completed nearly $60 million in installations at over 650 sites.

Orion is now the specified supplier of all interior LED lighting for the company. The total value of upgrading 29 distribution and cold storage centers from fluorescent to LED technology is expected to be $12-15 million over the next three years, with projects ranging from $150,000 to over $1 million depending on the size of the facility.

“Because we understand the unique requirements and incredible margin pressure these clients face, we’ve become the go to company in the cold storage and food distribution industry,” said John Scribante, Chief Executive Officer of Orion Energy Systems. “Orion creates unique LED lighting retrofit products specifically designed to not only reduce their utility bill, but also install and ship faster, perform better, and provide long-lasting, no-maintenance and green solutions for their facilities and communities.”

The global retailer had previously selected Orion for its initial lighting retrofit from metal halide to a combination of Orion Compact Modular High Bay four lamp T8 fluorescent fixtures and ENCF Freezer Enclosed fixtures with dual switch motion sensors. For this new contract, Orion beat out eight other companies, including all of the largest lighting manufacturers in the US. Orion stood out as the clear winner in the final competitive demonstration because it set a new standard for shipment and installation, and used fewer LED fixtures to deliver more light for less energy.

In the typical 12-fixture aisle, Orion was able to reduce the amount of fixtures by 50 percent while improving light levels due to superior LED optics. The fixtures with dimming smart motion controls were also delivered and installed within two weeks vs. a more than 12-week ship time for the runner-up.

Under the contract, Orion products will be installed for a variety of interior lighting applications, including the Orion ISON™ Open LED High Bay, Apollo® LED High Bay (ALHB), Apollo® LED Strip Retrofit (OLSR), Apollo® LED Troffer Retrofit (LDR) and Harris Exit Signs. For freezer applications, the newest generation of LED technology provides additional functionality and controls that were not available before with fluorescent fixtures, including the ability to completely power off the LED fixtures without affecting lifetime performance or output. Over the life of these new Orion LED fixtures, the retailer expects to save over $94,000 for the average facility.

About Orion Energy Systems

Orion is leading the transformation of commercial and industrial buildings with state-of-the-art energy efficient lighting systems and retrofit lighting solutions. Orion manufactures and markets a cutting edge portfolio of products encompassing LED Solid-State Lighting and high intensity fluorescent lighting. Many of Orion’s 100+ granted patents and pending patent applications relate to lighting systems that provide exceptional optical and thermal performance, which drive financial, environmental, and work-space benefits for a wide variety of customers in the retrofit markets.

Investor Relations Contact:
Orion Energy Systems, Inc.
Bill Hull
Chief Financial Officer
(920) 482-0520
or
Media Relations Contact:
Orion Energy Systems, Inc.
Erica St. Angel
SVP Marketing
(920) 892-5653

(SPHS) Phase 3 BPH Study Successfully Meets Primary Endpoint

A single treatment with PRX302 (topsalysin) demonstrated a statistically significant improvement in BPH symptoms over a 12 month period

SAN DIEGO and VANCOUVER, British Columbia, Nov. 10, 2015 — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, today announced final results from its Phase 3 “PLUS-1” study of PRX302 as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH, enlarged prostate).  PRX302 demonstrated a statistically significant improvement in International Prostate Symptom Score (IPSS) total score from baseline over 12 months compared to the vehicle-only control group (7.60 vs. 6.58 point overall improvement; p = 0.043), the primary endpoint of the study. PRX302 continues to demonstrate a favorable safety profile, with no evidence of any treatment related sexual or cardiovascular side effects.

“A 7.60 point improvement in IPSS total score over 12 months indicates that patients are experiencing a significant relief of their BPH symptoms and improvement in their quality of life following a single treatment with PRX302,” said Dr. Allison Hulme, chief operating officer and head of research and development at Sophiris Bio. “Oral medications such as alpha blockers and 5-alpha reductase inhibitors typically demonstrate a 3-6 point improvement in IPSS total score. We believe that a statistically significant improvement in IPSS, if replicated in a second Phase 3 trial, may be sufficient for registration with the FDA.”

Efficacy Analysis

The primary efficacy endpoint of the IPSS total score change from baseline over 52 weeks was analyzed, per guidance from the FDA, using the repeated measures linear mixed model applied to the modified intent-to-treat population of every patient randomized and dosed with study drug.  The 7.60-point overall improvement for the PRX302 group was statistically significantly superior to the 6.58 point improvement in the vehicle-only group (p = 0.043).

In a secondary efficacy analysis of IPSS total score using an ANCOVA model and LOCF (Last Observation Carried Forward) to impute missing post-baseline data, the improvement in IPSS for PRX302 was well sustained over the 52 weeks following the single administration. The maximal effect of 8.31 points improvement in IPSS  vs vehicle 6.89 points (p = 0.012)  was achieved at Week 18 with 8.04 points of improvement for PRX302 still remaining at Week 52 vs 6.64 points for patients treated with vehicle only (p = 0.022) representing an end-of-study preservation of 97% of the peak benefit.

“The combination of the efficacy and safety profile makes PRX302 a particularly compelling potential option for men suffering from BPH and may help men avoid more invasive, surgical procedures,” said Randall Woods, President and CEO of Sophiris. “PRX302 is the only single-administration investigational treatment for BPH that has demonstrated a statistically significant improvement in symptoms of BPH, is well-tolerated, and has a favorable safety profile. The results of the study demonstrate clear biological activity of PRX302 and increase our confidence in the mechanism of action.”

Secondary efficacy endpoints included analysis of Qmax (maximum urine flow) change from baseline over 52 weeks by the repeated measures linear mixed model, which showed overall improvement of 1.77 mL/sec for PRX302, representing a statistical trend that narrowly missed statistical significance (p = 0.055) compared to the vehicle group.

An additional efficacy endpoint was the patient self-assessment of disease specific Quality of Life. On the 0 to 6 point Quality of Life (QOL) from the IPSS questionnaire, the PRX302 average change from the 4.5 point baseline was a sustained 1.6 to 1.7 points improvement from Weeks 18 through 52, which was statistically significantly superior to vehicle for every post-baseline visit beginning at Week 18 (reaching p = 0.004).

Safety Analysis

PRX302 treatment was generally well-tolerated, and no patient was withdrawn from the study or had their study drug injection altered because of an adverse event (AE).  The safety profile was consistent with that reported in the TRIUMPH Phase 2 trial published in the Journal of Urology in April 2013. Adverse events occurring in >5% of patients treated with PRX302 regardless of assessed relatedness to study treatment are set forth in the table below. These adverse events are not unexpected manifestations of the intraprostatic cellular destruction and resultant inflammation integral to the PRX302 mechanism of action. The median duration for each of these adverse events was typically less than one day. In general, these adverse events were mild or moderate, transient, began within the first few days after treatment (primarily on the same day as the study drug injection) and were resolved without consequences.

Adverse Events Occurring in >5% of Patients Treated with PRX302 (Safety Population)

Reported Any Time over the Entire 52 Weeks of Study and Regardless of Assessed Relatedness to Study Treatment:

¹(MedDRA Dictionary Preferred Terms)

The incidence of serious AEs (SAEs) was similar in both treatment groups.  There were two SAEs assessed by the Investigator as at least possibly related to treatment for PRX302 and one such SAE for vehicle.  The PRX302-related SAEs were moderate events of “acute non-infectious prostatitis” and “fever following prostate procedure” not unexpected manifestations of the intraprostatic cellular destruction and resultant inflammation integral to the PRX302 mechanism of action.  The vehicle-related SAE was a mild event of “urinary tract infection.”

PLUS-1 Study Background

The Phase 3 “PLUS-1” study is an international, multicenter, randomized, double-blind, and vehicle-controlled trial to assess the efficacy and safety of a single intraprostatic administration of PRX302 (0.6 mg/g prostate) for the treatment of BPH.  Patients were randomized in a 1:1 ratio to either PRX302 or vehicle-only injection, and then monitored for 1 year.  A total of 479 patients with moderate to severe BPH were enrolled and dosed by September 2014.  The 52-week completion rate was 91.9%, with a similar number of premature withdrawals from study for the PRX302 group (8.8%) vs. the vehicle group (7.5%). On average, the injection itself was completed in less than 4 minutes.

Treatment groups were well balanced at baseline, including average IPSS total score (21.2 points both groups), Qmax (maximum urine flow) (9.5 mL/sec both groups), total prostate volume (49.8 mL for PRX302 vs. 48.1 mL vehicle), prior BPH treatment (55.2% PRX302 vs. 55.1% vehicle), and quality of life (4.5 points both groups, “mostly dissatisfied” to “unhappy” with current urinary condition).

About PRX302

PRX302 (topsalysin) is a modified recombinant protein that has been engineered to be selectively activated by an enzyme in the prostate, leading to localized cell death and tissue disruption without damaging neighboring tissue and nerves. PRX302 binds to the GPI-anchored receptors on the cell surface of prostate cells. Once activated by PSA, PRX302 combines with other activated PRX302 molecules, forming stable transmembrane pores that induce cell death. The prostate specific activation of PRX302 by enzymatically active PSA thus limits exposure of non-prostate tissues to the drug’s activity, contributing to the safety of the therapy.

About BPH Market Opportunity

Our market research suggests that as many as 36 million men in the United States are affected by BPH with approximately 5 million of these men suffering from bothersome symptoms. While 3 million men are prescribed pharmaceuticals for BPH in the US each year, these treatments lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. With current pharmaceutical treatments, symptoms will usually return if medication is discontinued. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH. However, any type of prostate surgery can cause side effects, such as semen flowing backward into the bladder (retrograde ejaculation), loss of bladder control (incontinence) and impotence (erectile dysfunction). There is a demand for better balance between efficacy, safety and quality of life.

About Sophiris

Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of urological diseases. PRX302 is in Phase 3 clinical development for the treatment of the symptoms of BPH and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. PRX302 is also currently in a Phase 2a proof of concept study for the treatment of localized low to intermediate risk prostate cancer. For more information, please visit www.sophiris.com.

Certain statements included in this press release may be considered forward-looking, including the quotes of Sophiris’ President and CEO and our COO and head of research and development and any expectations relating to future development of PRX302 for the treatment of symptoms of BPH, including a second Phase 3 clinical trial necessary to pursue registration of PRX302, the results of the Phase 2a proof of concept trial for the treatment of localized low to intermediate risk prostate cancer l or Sophiris’ capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Some of the risks and uncertainties that could cause actual results, performance or achievements to differ include without limitation, risks associated with the process of developing, manufacturing commercial scale drug products, obtaining regulatory approval of and commercializing treatments that are safe and effective and risks relating to raising sufficient capital to fund development and commercialization of drug products. All forward-looking statements are based on Sophiris’ current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, clinical trial results, market acceptance, ability to raise capital and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

(ETAK) Expands Presence in Latin America via Partnership with EUTV Brazil