(AGEN) & (INCY) Global Alliance to Develop Novel Immuno-Oncology Antibodies

Incyte Corporation (Nasdaq:INCY) and Agenus Inc. (Nasdaq:AGEN) today announced a global license, development and commercialization agreement focused on novel immuno-therapeutics using Agenus’ proprietary Retrocyte Display™ antibody discovery platform.

The alliance will initially focus on the development of checkpoint modulator antibodies directed against GITR, OX40, LAG-3 and TIM-3. Agenus and Incyte will share all costs and profits for the GITR and OX40 antibody programs on a 50:50 basis, with Agenus eligible for potential milestones; TIM-3 and LAG-3 are royalty-bearing programs to be funded by Incyte, with Agenus eligible for potential milestones and royalties. The first clinical trials are expected to be initiated in 2016.

“This alliance with Agenus adds therapeutic antibody capabilities to our proven small molecule discovery expertise, significantly expands the landscape of potential immuno-oncology targets available to us, and strengthens our ability to identify and advance novel therapeutic combinations,” said Hervé Hoppenot, President and CEO of Incyte.

“Incyte’s track record of success in oncology development and commercialization, together with our therapeutic antibody expertise and the commonality of our objectives, speak to the compelling strategic rationale for this alliance,” said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. “Our Retrocyte Display™ technology has produced high quality antibody candidates and offers significant advantages over competing technologies. With Incyte, we believe we have an ideal partner to help define the evolving treatment paradigm of cancer immunotherapies.”

Under the terms of the agreements between the parties, Incyte will make upfront payments to Agenus totaling $25 million and invest $35 million by purchasing approximately 7.76 million newly issued shares of Agenus common stock at a price of $4.51 per share. In addition to the initial four target programs in the alliance, the parties have an option to jointly nominate and pursue additional targets within the framework of the multi-year collaboration. Terms also include:

• For each royalty-bearing product, Agenus will be eligible to receive up to $155 million in future contingent development, regulatory and commercialization milestones.
• Also for royalty-bearing products, Agenus will be eligible to receive tiered royalties on global net sales ranging from mid-single to low-double digit rates, and has reserved the right to elect to co-fund 30% of development costs for increased royalties.
• For products from any additional programs that the parties elect to bring into the collaboration, Agenus may opt to designate them as profit-share products.
• For each profit-share product, Agenus will be eligible to receive up to $20 million in future contingent development milestones.

Retrocyte Display™ is a proprietary retroviral technology that enables a highly diverse library (>1×10⁹) of human IgG molecules to be displayed on the surface of B-lineage cells. This innovative cell-displayed expression platform permits the rapid generation of fully human and humanized therapeutic antibodies with high affinity and target specificity.

The closing of the transaction is conditioned on the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs, primarily for oncology. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

About Agenus

Agenus is an immuno-oncology company developing a portfolio of checkpoint modulators (CPMs), heat shock protein peptide-based vaccines and adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery engine Retrocyte Display^TM is used to generate fully human and humanized therapeutic antibody drug candidates. The Retrocyte Display^TM platform uses a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat shock protein-based vaccines for cancer and infectious disease have completed Phase 2 studies in glioblastoma multiforme, and in the treatment of herpes simplex viral infection. The company’s QS-21 Stimulon^® adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen Sciences Ireland UC and includes several vaccine candidates in Phase 2, as well as shingles and malaria vaccines which have successfully completed Phase 3 clinical trials. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements with respect to the initial focus of the alliance, the potential benefits of the alliance and the expectation that the first clinical trials under the alliance will be initiated in 2016, contain predictions and estimates and are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development, results of further research and development, unanticipated delays, other market or economic factors and technological advances, regulatory approval of the transaction and other risks detailed from time to time in Incyte’s filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. Incyte disclaims any intent or obligation to update these forward-looking statements.

Agenus Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the initial focus of the alliance between Agenus and Incyte, the potential benefits of the alliance and the expectation that the first clinical trials under the alliance will be initiated in 2016. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others, regulatory approval of the transaction, unanticipated delays and other market or economic factors, as well as the factors described under the Risk Factors section of our most recently filed Quarterly Report on Form 10-Q with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

(RGLS) Announces Key Goals Under its ‘Clinical Map Initiative’ for 2015

Accelerates RG-101 for HCV with Dual-Track Clinical Development Strategy; Top-Line, Single Dose, 4 mg/kg Results as Well as 2mg/kg Extended Follow Up Results from Ongoing Study to be Reported in Early February 2015 Aims to Advance microRNA Therapeutics Portfolio and Regulus microMarkersSM Division

LA JOLLA, Calif., Jan. 8, 2015  — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced key goals for 2015 under its ‘Clinical Map Initiative’ to advance its microRNA therapeutics portfolio and biomarkers platform.

“Regulus enters 2015 with the scientific and financial strength to realize the transformative potential of microRNAs.  As such, we’ve set aggressive goals for the year focused on creating a clear path to value for what we believe to be our greatest opportunities,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus.  “Under our ‘Clinical Map Initiative’, we are focusing our near term efforts on accelerating RG-101 for HCV with a Phase II dual-track clinical development strategy, while advancing our overall therapeutics pipeline and aligning our biomarker efforts to streamline our clinical development decisions.”

Key Goals Under Regulus’ ‘Clinical Map Initiative’ for 2015

• ‘Clinical Map’ of RG-101 for HCV Defined: Dual-Track Strategy Accelerates Phase II Development; Multiple Data Read-Outs in 2015.  Following the favorable interim results reported in October 2014 from its ongoing clinical study, Regulus has accelerated development of RG-101, a wholly-owned, GalNAc-conjugated anti-miR targeting microRNA-122 (“miR-122”) for the treatment of HCV.  Regulus is pursuing a Phase II dual-track development strategy (i) to investigate RG-101 in combination with oral agents to potentially shorten treatment durations, optimize clinical outcomes and potentially improve responses in certain underserved HCV patient populations; and (ii) to investigate RG-101 further as a single agent to determine whether HCV viral cures are achievable with monotherapy treatment (single or multiple doses of RG-101).  In the near term, Regulus expects to file both a Clinical Trial Application and an Investigational New Drug application for RG-101 with the goal to initiate the above described studies in Europe and the United States in the second quarter of 2015.
  • Multiple Data Read-Outs for RG-101 in 2015.  In early February 2015, Regulus expects to report new results from part IV of its ongoing clinical study of RG-101: viral load reduction and interim safety from the 4 mg/kg dose cohort (16 total HCV patients; 14 receiving a single administration of RG-101, 2 receiving placebo), as well as extended follow up results from the 2 mg/kg cohort.  In the second quarter of 2015, Regulus expects to report full results from the ongoing study at a medical meeting. In the fourth quarter of 2015, Regulus plans to report viral load reduction and safety data from the Phase II program, as described above.

• ‘Clinical Map’ of RG-012 for Alport Syndrome Emerging; Near Term Focus on ATHENA Enrollment, Phase I Study to Initiate in 1H 2015. RG-012 is a single-stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 (“miR-21”) for the treatment of renal dysfunction in Alport syndrome patients.  Alport syndrome is a life-threatening, genetic kidney disease driven by mutations in specific collagen. By inhibiting miR-21, which is highly overexpressed in animal models of Alport syndrome, RG-012 is intended to act by reducing the severity of fibrosis, which then may reduce the rate of decline of renal function in Alport syndrome patients.
  • Near Term Efforts Focused on ATHENA.  Regulus plans to focus its near term efforts on enrolling up to 120 Alport syndrome patients in its global ATHENA natural history of disease study, which is designed to characterize the natural decline of renal function (as measured by established renal markers) in Alport syndrome patients over time. The data from ATHENA should provide the clinical basis for the design of a Phase II proof-of-concept study to monitor the therapeutic effect of RG-012 on the decline in renal function in patients with Alport syndrome. The ATHENA study is being conducted at thirteen clinical sites worldwide, with multiple active sites in the United States, France and Germany, and additional sites anticipated to be active in Australia, Canada and other countries in Europe.
  • In addition to enrolling patients in ATHENA, Regulus plans to initiate a Phase I study in the first half of 2015 to evaluate the safety and tolerability of RG-012 in healthy volunteers.

“2015 will be an important year for the advancement of our clinical portfolio, with key data read outs on the horizon for RG-101 and other programs,” said Paul Grint, M.D., Chief Medical Officer of Regulus.   “While aggressively moving forward with RG-101 this year, we also aim to expand our clinical pipeline to include opportunities in oncology and orphan diseases, such as Alport syndrome, where we believe we can build significant value for the portfolio.”

• microRNA Therapeutics Portfolio and Regulus microMarkers^SM Goals for 2015
  
  • Advance microRNA Therapeutics Pipeline; Nominate At Least One Candidate for Clinical Development in 2015. Regulus continues to pursue several undisclosed microRNA targets, namely for oncology and orphan disease indications.  In addition to its internal research efforts, Regulus aims to advance certain programs with its strategic alliance partners, microRNA-103/107 for the treatment of metabolic diseases and microRNA-19 for oncology indications with AstraZeneca, microRNA-221 and miR-21 for hepatocellular carcinoma and miR-21 for renal fibrosis (RG-012) with Sanofi. In 2015, Regulus expects to nominate at least one additional microRNA candidate for clinical development, either independently or with a partner.
  • Expand Regulus microMarkers^SM Work to Support ‘Clinical Map’ of RG-101, RG-012 and Partners’ Programs. Regulus’ microMarkers^SM division utilizes a highly reproducible, proprietary technology platform to extract, profile, and analyze microRNAs from small volumes of different bodily fluids to differentiate disease from healthy patient samples and to identify microRNAs as potential biomarkers for disease. Regulus microMarkers^SM has profiled over 3,000 clinical samples in a wide variety of disease states and has formed a research collaboration with Biogen Idec, an additional large pharmaceutical partner (undisclosed), and multiple academic research institutions.
    • To support the ‘Clinical Map’ of RG-101, Regulus microMarkers^SM plans to profile serum samples from the healthy volunteers and HCV patients in the ongoing clinical study of RG-101 to identify potential microRNA signatures, which may aide in accurately predicting a patient’s response to RG-101 therapy.
    • Regulus microMarkers^SM believes that it has identified a microRNA signature in urine that may discriminate mutant mice from wild type mice early in disease progression in a kidney fibrosis model.  These findings suggest that profiling microRNAs in urine may be a useful biomarker approach to support the ‘Clinical Map’ of RG-012. As part of the ongoing ATHENA study, Regulus microMarkers^SM plans to profile urine and blood samples from the Alport syndrome patients to potentially identify a clinically useful microRNA signature.
    • To support its collaborators and academic research partners, Regulus microMarkers^SM aims to utilize its robust technology platform to profile and analyze microRNAs in different bodily fluids including plasma, serum, whole blood, urine and cerebrospinal fluid.  As part of its ongoing collaboration with Biogen Idec, Regulus microMarkers^SM will profile whole blood samples of patients treated with a Biogen Idec multiple sclerosis therapy to identify potential microRNA signatures.

“Regulus aims to pursue opportunities both internally and with our strategic partners where we can apply our oligonucleotide drug discovery and development expertise to validated microRNA targets,” said Neil W. Gibson, Ph.D., Chief Scientific Officer of Regulus.  “Specifically in 2015, our goal is to nominate at least one additional microRNA candidate for clinical development and expand our biomarkers work to support our clinical pipeline and our collaborators’ programs.”

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.  Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkers^SM biomarkers platform and a rich intellectual property estate to retain its domain dominant leadership in the microRNA field.  Under its ‘Clinical Map Initiative’, Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy.  Regulus is also advancing several programs toward clinical development in orphan disease indications, oncology and fibrosis.  Regulus’ commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi and a research collaboration with Biogen Idec focused on microRNA biomarkers.  Regulus maintains its corporate headquarters in La Jolla, CA.  For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to its ‘Clinical Map Initiative’ goals, including development and other activities related to RG-101 and RG-012 and with respect to the nomination of at least one microRNA candidate for clinical development in 2015), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus’ business plans (including Regulus’ expected future activities in 2015), technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus’ current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  These and other risks concerning Regulus’ financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

(RVNC) Announces Publication of Positive Results From RT002 Phase 1/2 Study

RT002 Achieved Median Duration of 7 Months

Phase 2 Active Comparator Study Underway

NEWARK, Calif., Jan. 8, 2015  — Revance Therapeutics, Inc. (Nasdaq:RVNC), a specialty biopharmaceutical company developing botulinum toxin products for the use in aesthetic and therapeutic indications, today announced publication in the peer reviewed journal, Dermatologic Surgery of positive data from its Phase 1/2 study of RT002 injectable botulinum toxin type A for the treatment of moderate to severe glabellar (frown) lines. RT002 is Revance’s proprietary, injectable botulinum toxin investigational product that incorporates the patented TransMTS® technology and is designed to provide a longer lasting duration of effect. Initial results from the study were announced last April and showed RT002 met its efficacy and safety endpoints with an extended duration of action.

The open-label, dose escalating, Phase 1/2 study enrolled 48 adults in four cohorts. All subjects had Severe or Moderate wrinkles at baseline, measured using the 4-point Global Line Severity Scale (GLSS).

In summary, the results were as follows:

• Clinical investigators rated 96% of subjects with None or Mild wrinkle severity at maximum frown 4 weeks post-treatment using the GLSS. At the same time point, 83% of the subjects assessed themselves as achieving None or Mild wrinkles at maximum frown.
• In the final cohort, the only one where duration of effect was measured, RT002 achieved a median duration of 29.4 weeks, or 7 months, based on both investigator and subject assessments.
• In this final cohort, 60% of subjects maintained None or Mild wrinkle severity at 6 months.
• RT002 was well tolerated, and there was no evidence of spread beyond the treatment site at any dose; additionally, adverse event rates did not change in frequency, severity, or type with increasing doses.

Based on the results of this study and previous findings from pre-clinical data, Revance initiated BELMONT, a Phase 2 active comparator study. BELMONT is a double-blind, dose ranging, active and placebo controlled multi-center study. Top-line data is expected in late 2015.

“BELMONT compares injectable RT002 and placebo with the current industry standard and this makes it a unique study,” said Alastair Carruthers, MD, editor of the current special issue of Dermatologic Surgery focused on Botulinum Toxin. An investigator in the BELMONT trial, he added “In 2015 we will know how RT002 compares with BOTOX^® Cosmetic and a placebo control, especially with regard to duration of effect and complications. If results are in line with previous data, use of RT002 could extend well beyond aesthetic applications.”

“Publication of our RT002 data in this peer-reviewed journal is a significant contribution to the published literature on the use of botulinum toxin,” said Dan Browne, Revance co-founder, President and CEO. “The study showed that RT002 reduced glabellar lines in nearly all of the 48 patients treated. Even more significant, patients in the final cohort enjoyed benefit almost twice as long as what the literature has shown with conventional botulinum toxin injections. We believe that such duration of effect could have significant positive implications for the botulinum toxin market.”

About RT002

RT002, an investigational product, is a novel, injectable form of botulinum toxin type A. RT002 combines Revance’s proprietary, pure 150kD botulinum toxin type A molecule, without any accessory proteins or animal derived components, with Revance’s patented TransMTS® peptide technology. RT002 is designed to offer more targeted delivery to the intended treatment sites, while reducing its spread beyond the site of local injection. RT002 is in clinical development for the treatment of glabellar (frown) lines and has the potential to address additional therapeutic indications in movement disorders, pain, urology, ophthalmology and other potential uses where more targeted delivery is required or longer duration is desired.

About Revance Therapeutics, Inc.

Revance is a specialty biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic applications. Revance is leveraging its proprietary portfolio of botulinum toxin compounds combined with its patented TransMTS® peptide delivery system to address unmet needs in the large and growing aesthetic and therapeutic botulinum toxin market. Revance’s proprietary TransMTS® technology enables transcutaneous delivery of botulinum toxin A eliminating the need for injections. Revance’s lead product candidate, RT001, is a topical formulation of botulinum toxin type A, which has the potential to be the first commercially-available non-injectable dose form. RT001 is being evaluated in a broad clinical program that includes aesthetic indications such as crow’s feet lines (wrinkles around the eyes) and therapeutic indications such as hyperhidrosis (excessive sweating). Revance’s second product candidate is RT002, a novel injectable formulation of botulinum toxin type A designed to be more targeted and longer lasting than currently available botulinum toxin injectable products.

For more information, please visit: www.revance.com.

“Revance Therapeutics”, TransMTS® and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

*BOTOX ® is a registered trademark of Allergan, Inc.

Forward-Looking Statements

This press release contains forward-looking statements, including statements about our RT002 product candidate, including but not limited to statements regarding the process and timing of, and ability to complete, current clinical studies and anticipated future clinical development, the initiation and design of clinical studies for current and future indications, related results and reporting of such results; statements about our business strategy, goals, applications and market for our anticipated products, plans and prospects; statements about potential benefits of our product candidates and our technologies; and statements about future performance.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our product candidates; our ability to obtain funding for our operations; our plans to research, develop and commercialize our product candidates; our ability to achieve market acceptance of our product candidates; unanticipated costs or delays in research, development and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our product candidates; our ability to successfully commercialize our product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance’s periodic filings with the Securities and Exchange Commission (the “SEC”), including factors described in the section entitled described in the “Risk Factors” section of our quarterly report on Form 10-Q filed November 13, 2014. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

CONTACT: Investors:
         Westwicke Partners
         Leigh Salvo
         (415) 513-1281
         leigh.salvo@westwicke.com

         Media:
         Brewlife
         Kelli Kampanis
         (212-301-7172)
         kkampanis@w2ogroup.com

(ELOS) Announces Preliminary Fourth Quarter 2014 Revenue

Total revenue in the range of $72 to $74 million, up 20% to 24% y/y (pro-forma excluding Syneron Beauty), including approximately 50% product revenue growth in North America Strong UltraShape full commercial launch in U.S. with more than 50 systems sold Successful global launch of PicoWay with approximately $2.5 million in sales from mid-November through the end of the year

YOKNEAM, Israel, Jan. 8, 2015  — Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, today announced preliminary fourth quarter 2014 revenue results. The Company expects revenue for the fourth quarter 2014 to be in the range of $72 to $74 million, representing growth compared to the year-ago quarter of between 20% and 24% on a pro-forma basis (excluding Syneron Beauty). This includes strong growth in product revenue in North America of approximately 50%, in the EMEA region of approximately 15% and in the APAC region of approximately 30%.

In October, Syneron began the full commercial launch of the UltraShape system in the U.S., selling more than 50 systems in the fourth quarter. In mid-November, Syneron began the global launch of the PicoWay system, generating approximately $2.5 million in sales in the fourth quarter.

Amit Meridor, Chief Executive Officer of Syneron, said, “We delivered strong revenue growth in the fourth quarter 2014, gaining traction with the U.S. commercial launch of Ultrashape system and generating strong initial sales of our PicoWay product after the global launch during the quarter. The revenue growth also included solid performance in all geographies, with significant product revenue growth in North America, the EMEA region, and the APAC region. We ended the year with strong customer demand across our product portfolio and remain confident that we are well positioned for continued growth, particularly in North America, where we are beginning to see results from our sales and marketing investments and dedicated Body Shaping team.”

The financial estimates presented above are preliminary and remain subject to management’s final review as well as audit by the Company’s independent registered accounting firm. The Company intends to report complete fourth quarter and full year 2014 financial results in February. Details regarding the timing of the release of those results, as well as details of a conference call and publicly available webcast, will be announced in a subsequent press release.

About Syneron Medical Ltd.
Syneron Medical Ltd. (NASDAQ: ELOS) is the leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, rejuvenation of the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under two distinct brands, Syneron and Candela. Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. are located in Israel. Syneron also has R&D and manufacturing operations in the US. The Company markets and services and supports its products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.

(PSUN) Announces December Comparable Store Sales Increased 9%

ANAHEIM, Calif., Jan. 8, 2015  — Pacific Sunwear of California, Inc. (Nasdaq:PSUN) (the “Company”), announced today that its comparable store net sales during the month of December increased 9% compared to the same period a year ago.

“We have had an excellent Holiday season with strong sales performance in both men’s and women’s and an estimated 400-500 basis point improvement in gross margins,” said Gary H. Schoenfeld, President and Chief Executive Officer. “With what will be our 12th consecutive quarter of positive comparable store net sales, customers are embracing the new PacSun and our elevated brands and merchandising assortments.”

Based on December results, the Company has updated its financial outlook for the fourth quarter of fiscal 2014 and now expects comparable store net sales of approximately 6% and non-GAAP loss from continuing operations per diluted share to be in the range of $(0.12) to $(0.11), compared to its previous guidance range of $(0.17) to $(0.12). The Company reported a non-GAAP loss from continuing operations per diluted share of $(0.17) for the fourth quarter of fiscal 2013.

About Pacific Sunwear of California, Inc.

Pacific Sunwear of California, Inc. and its subsidiaries (collectively, “PacSun” or the “Company”) is a leading specialty retailer rooted in the action sports, fashion and music influences of the California lifestyle. The Company sells a combination of branded and proprietary casual apparel, accessories and footwear designed to appeal to teens and young adults. As of January 8, 2015, the Company operates 617 stores in all 50 states and Puerto Rico. PacSun’s website address is www.pacsun.com.

Pacific Sunwear Safe Harbor

This press release contains “forward-looking statements” including, without limitation, the statements made in the second and third paragraphs above. In each case, these statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company intends that these forward-looking statements be subject to the safe harbors created thereby. These statements are not historical facts and involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Uncertainties that could adversely affect the Company’s business and results include, among others, the following factors: increased sourcing and product costs; adverse changes in U.S. and world economic conditions generally; adverse changes in consumer spending; changes in consumer demands and preferences; adverse changes in same-store sales; higher than anticipated markdowns and/or higher than estimated selling, general and administrative costs; currency fluctuations; competition from other retailers and uncertainties generally associated with apparel retailing; merchandising/fashion risk; lower than expected sales from private label merchandise; reliance on key personnel; economic impact of natural disasters, terrorist attacks or war/threat of war; shortages of supplies and/or contractors as a result of natural disasters or terrorist acts, which could cause unexpected delays in store relocations, renovations or expansions; reliance on foreign sources of production; and other risks outlined in the Company’s filings with the Securities and Exchange Commission (“SEC”), including but not limited to the Company’s Annual Report on Form 10-K for the fiscal year ended February 1, 2014, and subsequent periodic reports filed with the SEC. Historical results achieved are not necessarily indicative of future prospects of the Company. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update or revise any such forward-looking statements to reflect events or circumstances that occur after such statements are made. Nonetheless, the Company reserves the right to make such updates from time to time by press release, periodic report or other method of public disclosure without the need for specific reference to this press release. No such update shall be deemed to indicate that other statements not addressed by such update remain correct or create an obligation to provide any other updates.

About non-GAAP Financial Measures

The accompanying press release dated January 8, 2015, contains a non-GAAP financial measure. This non-GAAP financial measure includes a forward-looking estimate of the Company’s non-GAAP loss from continuing operations per diluted share for the fourth quarter of fiscal 2014. Non-GAAP financial measures should not be considered as a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures do not reflect a comprehensive system of accounting, differ from GAAP measures with the same names and may differ from non-GAAP financial measures with the same or similar names that are used by other companies. The Company computes non-GAAP financial measures using the same consistent method from quarter to quarter and year to year. The Company may consider whether other significant items that arise in the future should be excluded from the non-GAAP financial measure. The Company believes that this non-GAAP financial measure provides meaningful supplemental information regarding the Company’s operating results primarily because it exclude amounts that are not considered part of ongoing operating results when planning and forecasting and when assessing the performance of the organization, individual operating segments or its senior management. In addition, the Company believes that non-GAAP financial information is used by analysts and others in the investment community to analyze the Company’s historical results and in providing estimates of future performance and that failure to report non-GAAP measures, could result in confusion among analysts and others and create a misplaced perception that the Company’s results have underperformed or exceeded expectations.

CONTACT: Michael W. Kaplan
         Chief Financial Officer
         (714) 414-4003

(RGEN) Receives Milestone Payment From Pfizer (PFE)

Company Reports Preliminary Revenue Results for 2014 and Provides Initial Revenue Guidance for 2015

WALTHAM, Mass., Jan. 8, 2015  — Repligen Corporation (Nasdaq:RGEN) announced today that on December 30, 2014, it received a $1 million milestone payment from Pfizer, Inc. under the terms of the companies’ exclusive worldwide licensing agreement (the “Agreement”) for the development of compounds to potentially treat spinal muscular atrophy (SMA), a neuromuscular disease that typically presents in children under age two. Since announcing the Agreement in January 2013, Repligen has received $7 million in upfront and milestone payments. Repligen remains eligible to receive up to $63 million in additional performance-based milestone payments, as well as royalties on any future sales of compounds developed under the Agreement.

2014 Revenue

Repligen also today reported preliminary, unaudited total revenue of $63-$63.5 million for the fiscal year ended December 31, 2014. This total revenue figure is comprised of approximately $3 million in revenue from out-licensed therapeutic programs and product revenue of $60-$60.5 million, an increase from our previous product revenue guidance of $58-$60 million. Product revenue reflects sales growth of 26%-27%, driven by strength in sales of products that we sell directly to end users including partial year sales of the Alternating Tangential Flow System (the “ATF System”), the most recent addition to Repligen’s proprietary product portfolio.

2015 Revenue Forecast

For 2015, Repligen currently projects product revenue in the range of $69-$72 million, reflecting 15%-20% sales growth compared to 2014, which included only partial year sales of the ATF System. Gross margin on product sales is expected to be greater than 55% in 2015. These projections do not include the impact on product revenue or gross margin of potential acquisitions and/or fluctuations in currency exchange rates during 2015.

2014 Earnings Call

Repligen plans to announce complete financial results for fourth quarter and year ended December 31, 2014 in early March, and will hold its earnings conference call at that time. The preliminary, unaudited results reported in this press release could change as a result of further review by Repligen and its independent auditors.

About Repligen Corporation

Repligen Corporation (Nasdaq:RGEN) is a life sciences company focused on the development and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide. We are the leading manufacturer of Protein A affinity ligands, a critical component of Protein A media that is used to separate and purify monoclonal antibody therapeutics. Our ATF (Alternating Tangential Flow) System and our growth factor products are used to increase product yield during the fermentation stage of biologic drug manufacturing. In addition, we developed and market an innovative line of “ready-to-use” chromatography columns under our OPUS^® brand that we deliver pre-packed with our customers’ choice of purification media. Repligen’s corporate headquarters are in Waltham, MA (USA) and our manufacturing facilities are located in Waltham, MA and Lund, Sweden.

This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that statements in this press release which are not strictly historical statements, constitute forward-looking statements, including, without limitation, express or implied statements or guidance regarding future financial performance and position, including cash and investment position, our strategic decision to focus on the growth of our bioprocessing business, the future demand for our bioprocessing, growth factor, ATF and chromatography products, plans and objectives for future operations, plans and objectives for product development and acquisitions, our market share and product sales and other statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our ability to successfully grow our bioprocessing business, including as a result of acquisition, commercialization or partnership opportunities; our ability to develop and commercialize products and the market acceptance of our products; reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; the impact of the expiration on December 31, 2013 of Bristol-Myers Squibb royalty payments from U.S. sales of Orencia^®, the success of current and future collaborative or supply relationships, including our agreements with Pfizer, BioMarin Pharmaceuticals Inc. [and Innovate Biopharmaceuticals Inc.]; our ability to compete with larger, better financed bioprocessing, pharmaceutical and biotechnology companies; our compliance with all Food and Drug Administration and EMEA regulations; our ability to obtain, maintain and protect intellectual property rights for our products; the risk of litigation regarding our intellectual property rights; our limited sales capabilities; our volatile stock price; and other risks detailed in Repligen’s Annual Report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and Repligen does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.

CONTACT: Sondra S. Newman
         Director Investor Relations
         Repligen Corporation
         (781) 419-1881
         snewman@repligen.com

(NBIX) Top-Line Results, Phase 3 Study of Elagolix in Endometriosis

– Study meets co-primary efficacy endpoints; results show treatment with elagolix reduces endometriosis-associated pain (dysmenorrhea and non-menstrual pelvic pain) compared to placebo – Results from the first of two six-month, Phase 3 studies – Full data to be presented at a future date

NORTH CHICAGO, Ill., Jan. 8, 2015  — AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced positive top-line results from the first of two ongoing Phase 3 clinical trials, designed to evaluate the efficacy and safety of elagolix in premenopausal women with endometriosis. Results from the trial show that after six months of treatment, both doses of elagolix (150 mg once daily and 200 mg twice daily) met the study’s co-primary endpoints (p<0.001) of reducing scores of non-menstrual pelvic pain (NMPP) and menstrual pain (or dysmenorrhea), associated with endometriosis, at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale.

Endometriosis is associated with a multitude of symptoms, some of the most common of which include pain related to menstruation as well as chronic pelvic pain throughout the menstrual cycle, and is a leading cause of infertility. The World Endometriosis Research Foundation estimates that endometriosis affects one in ten women during their reproductive years, representing approximately 176 million women worldwide.

“Endometriosis is a condition in which the tissue that normally lines the inside of a woman’s uterus grows outside the uterus, and is often associated with severe, and at times, debilitating pain,” said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. “The positive results from this trial represent a significant milestone in the development of elagolix as a potential new treatment option for patients suffering from endometriosis.”

The observed safety profile of elagolix in this Phase 3 trial was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache, nausea and fatigue.  While most AEs were similar across treatment groups, some, such as hot flush and bone mineral density (BMD) loss were dose-dependent. Overall discontinuation rates were similar across treatment groups and discontinuations specifically due to AEs were 5.9 percent, 6.4 percent, and 9.7 percent for placebo, 150 mg once daily and 200 mg twice daily, respectively.

The top-line results are from a six-month, group-level analysis. Patients in the trial will continue on in either post-treatment follow-up or a blinded six-month extension study. AbbVie intends to present detailed results from this trial at a future medical conference.

Trial Design
The Phase 3 trial (M12-665) is a 24-week, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 872 women, age 18 to 49, with moderate-to-severe endometriosis-associated pain. It is being conducted at approximately 160 sites in the United States, Puerto Rico and Canada.

A second Phase 3, randomized, multinational, double-blind, placebo-controlled trial (M12-671) evaluating elagolix in patients with moderate-to-severe endometriosis-related pain is ongoing and results are expected in late 2015.

About Elagolix
Elagolix, currently being investigated in patients with pain from endometriosis, inhibits gonadatropin releasing hormone (GnRH) receptors in the pituitary gland and ultimately reduces circulating sex hormone levels. To date, elagolix has been studied in over 40 clinical trials totaling more than 3,000 patients. A Phase 2b trial of elagolix for the treatment of uterine fibroids is also ongoing.

Elagolix is the proposed International Nonproprietary Name (INN).

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.

AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

(BIOC) Proprietary Oncology Diagnostics to be Offered on America’s Choice Provider Network

ACPN’s Approximately 19 Million Participants Now Have Access to Biocept’s Suite of Blood-Based Diagnostics

SAN DIEGO, Jan. 7, 2015  — Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) testing, today announced that its proprietary liquid biopsy testing that is performed at the Company’s CLIA-certified and CAP-accredited laboratory will be offered to participants in the America’s Choice Provider Network (ACPN), a Preferred Provider Organization (PPO).

Biocept offers a clinically valuable molecular analysis from a simple blood sample that aids physicians’ treatment decisions for a wide variety of recurrent and metastatic cancers. In a substantial number of cancer patients, extracting sufficient tissue for a biopsy, either at diagnosis or at the time of progression or recurrence, is not a viable option. Biocept’s ‘liquid biopsy’ technology gives clinicians an alternative for testing patients when a tumor biopsy is not adequate or practical. Biocept’s blood-based tests are also used by physicians to monitor patients’ treatment in a non-invasive manner.

“The healthcare community understands the importance of tracking and monitoring biomarker status in order to successfully treat cancer patients,” said Mike Nall, CEO of Biocept. “Now, Biocept’s tests are available to provide this molecular information when tissue biopsies are not adequate or when the risk to the patient is too great to attempt a surgical procedure.  We are happy to partner with America’s Choice Provider Network and others in the payor community to ensure that a liquid biopsy is a diagnostic option for more patients.”

“We are excited to have Biocept as a participating provider in our network and pleased to offer the Company’s unique services to our members. When a tissue biopsy is not an option, our members now have access to a validated test to aid in making the crucial decisions in the treatment of cancer,” said Todd Breeden, CEO and President, ACPN.

“Through this collaboration with ACPN, we have expanded access to liquid biopsy to 19 million Americans, giving them an option to avoid additional surgeries for a tissue biopsy – thus reducing costs while improving outcomes,” added Amy McNeal, Biocept senior director of strategic reimbursement.

About Biocept, Inc.

Biocept, Inc., headquartered in San Diego, California, is a commercial stage oncology diagnostics company focused on providing information on patients’ tumors to physicians using its proprietary technology platform to help improve individual patient treatment. Biocept has developed proprietary technology platforms for capture and analysis of circulating tumor DNA, both in circulating tumor cells (CTCs) and in plasma (cell free tumor DNA). A standard blood sample is utilized to provide physicians with important prognostic and predictive information to enhance individual treatment of their patients with cancer. Biocept currently offers testing for breast cancer, lung cancer and gastric cancer and plans to introduce additional CLIA validated tests for breast, lung, colorectal, melanoma, prostate and other solid tumors based on its proprietary technology platforms over the coming months. For more information about Biocept and liquid biopsy, please visit www.biocept.com.

About America’s Choice Provider Network

America’s Choice Provider Network (ACPN) is an independent, multi-specialty national provider network that offers providers, payers, and patients an out of network solution. Across the nation, greater than 19 million Americans and over 1,100 payers have access to ACPN’s proprietary national network through a client base consisting of Insurance Carriers, Third Party Administrators, Health and Welfare Funds, Employer Groups and Self-Insured Health Plans. The products covered include Individual and Group Health, Workers Compensation, Auto Liability and Medicare Advantage.

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 Company’s ability to partner with other payors, 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 SEC filings, including without limitation our need to grow our business and our operations, our need for capital, and the effects of reimbursement limitations and other health care statutory and regulatory initiatives. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. Readers are advised to review our filings with the Securities and Exchange Commission, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.

CONTACT: Investor Contact:
         The Ruth Group
         David Burke
         (646) 536-7009
         dburke@theruthgroup.com

         Media Contact:
         The Ruth Group
         Melanie Sollid-Penton
         (646) 536-7023
         msollid@theruthgroup.com

(ZFGN) Positive Phase 2 For Beloranib in Hypothalamic Injury Associated Obesity

BOSTON, Jan. 7, 2015  — Zafgen (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, announced today that ZAF-221, a randomized, double-blind, placebo-controlled Phase 2 clinical trial of beloranib, a MetAP2 inhibitor, in 14 adults with hypothalamic injury associated obesity, or HIAO, met the primary efficacy endpoint of weight reduction (p = 0.01). In addition, beloranib treatment was well-tolerated and improved cardiovascular disease risk factors.

HIAO is a rare form of medically induced obesity resulting from damage to the hypothalamus following resection of central nervous system tumors such as craniopharyngioma. The hypothalamus is a homeostatic control center in the brain that provides oversight of multiple hormonal systems, metabolic rate, hunger, and satiety. Patients affected by HIAO fail to regulate metabolism and food intake normally, resulting in rapid and intractable weight gain, treatment resistant severe obesity, and associated co-morbidities.

“We are extremely pleased with these results, which differentiate beloranib from other weight loss agents. Beloranib’s impact to restore balance to production and utilization of fat is further validated with these findings,” said Dennis Kim, M.D., Chief Medical Officer of Zafgen. “With these results in hand, we plan to pursue HIAO as an extension of our work in Prader-Willi syndrome, or PWS. We believe beloranib shows tremendous potential to improve the lives of those impacted by HIAO and PWS, and for whom there are limited effective pharmaceutical alternatives. In 2015, we aim to establish the regulatory path for a registration program with U.S. and EU regulatory authorities.”

“We are delighted by these clinical results that provide additional evidence for our hypothesis about beloranib’s mechanism and establish the drug’s unique extra-hypothalamic mode of action. Along with PWS and severe obesity in the general population, HIAO is the third indication for which we have established proof of concept for beloranib,” said Thomas Hughes, Ph.D., Chief Executive Officer of Zafgen. “We are enthusiastic to continue development of beloranib for the treatment of patients with severe and complex forms of obesity.”

Beloranib, a first-in-class MetAP2 inhibitor, that has demonstrated the potential to address weight loss and hunger reduction in patients with obesity, is being studied for the treatment of multiple indications. ZAF-221 was a randomized, double-blind, placebo controlled study of twice-weekly subcutaneous injections of 1.8 mg beloranib or placebo in patients with HIAO to evaluate weight reduction and safety over four weeks, followed by an optional four week open-label extension. Beloranib treatment resulted in mean weight loss of 3.4 kg and 6.2 kg in patients with HIAO after four and eight weeks of treatment with beloranib, respectively, in contrast to 0.3 kg mean weight loss in patients treated with placebo for four weeks (p = 0.01). Improvements in cardiovascular disease risk factors of lipids and inflammation (measured by C-reactive protein) were also observed. Beloranib 1.8 mg was well tolerated in this population, with no serious or severe adverse events reported. Safety measures such as laboratory, electrocardiogram, and vital sign measurements revealed no signals of concern, and all subjects randomized to beloranib completed the trial. This trial enrolled 14 obese patients (nine women and five men) who were confirmed by magnetic resonance imaging (MRI) to have had hypothalamic injury.

“These data represent a significant step forward in understanding the role of MetAP2 inhibition as a useful therapeutic approach to treating complex forms of obesity characterized by hypothalamic dysfunction,” said Professor Joseph Proietto, Head of Weight Control Clinic, Austin Health, Melbourne, Australia. “These results are innovative, as they represent an exceptional level of success in the pharmaceutical treatment of HIAO, and are very encouraging for our field, as well as for these patients who remain largely beyond the reach of currently marketed pharmaceutical agents.”

About Beloranib

Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating the use of stored fat as an energy source. Beloranib is a potent inhibitor of methionine aminopeptidase 2, or MetAP2, an enzyme that modulates the activity of key cellular processes that control metabolism. MetAP2 inhibitors work, at least in part, by directing MetAP2 binding to cellular stress mediators, and, thus, reducing the tone of signals that drive lipid synthesis by the liver and fat storage throughout the body. In this manner, MetAP2 inhibition increases metabolism of fat as an energy source. Zafgen holds exclusive worldwide rights (exclusive of South Korea) for the development and commercialization of beloranib. Zafgen exclusively licensed beloranib from Chong Kun Dang (CKD) Pharmaceutical Corp. of South Korea.

About Hypothalamic Injury-Associated Obesity (HIAO)

HIAO is most commonly caused by damage incurred during removal of a central nervous system tumor called craniopharyngioma but it can also result from less common types of hypothalamic injury such as strokes, brain trauma, or radiation therapy to the brain. Craniopharyngioma is a rare form of benign brain tumor that occurs most commonly during childhood and infiltrates near the optic nerve, pituitary gland and the hypothalamus. Treatment of these tumors commonly involves surgical removal of the tumor mass, followed by radiation treatment, which results in disruption or removal of neighboring structures including the hypothalamus. Post-treatment hypothalamic dysfunction results in hyperphagia and significant obesity in up to 50% of these patients, resulting in a variety of co-morbid conditions and a deteriorated quality of life. Craniopharyngioma-associated obesity occurs in males and females equally and in all races, with the same incidence around the world. The incidence estimates have ranged from 0.13 to 0.17 per 100,000 per year, or approximately 400 to 500 new cases per year in the United States and 650 to 850 new cases per year in the European Union.

About Zafgen

Zafgen (Nasdaq:ZFGN) is a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders. Zafgen is focused on developing novel therapeutics that treat the underlying biological mechanisms through the MetAP2 pathway. Beloranib, Zafgen’s lead product candidate, is a novel, first-in-class, twice-weekly subcutaneous injection being developed for the treatment of multiple indications, including severe obesity in two rare diseases, Prader-Willi syndrome and obesity caused by hypothalamic injury, including craniopharyngioma-associated obesity; and severe obesity in the general population. Zafgen aspires to improve the lives of patients through targeted treatments and has assembled a team accomplished in bringing therapies to patients with both rare and prevalent metabolic diseases.

Safe Harbor Statement

Various statements in this release concerning Zafgen’s future expectations, plans and prospects, including without limitation, Zafgen’s expectations regarding beloranib as a treatment for HIAO, Prader-Willi syndrome, and severe obesity in the general population, its expectations with respect to the timing and success of its clinical trials, the expected requirements and timing of additional clinical trials and pre-clinical studies, and its plans regarding commercialization of beloranib may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements can be identified by terminology such as “anticipate,” “believe,” “could,” “could increase the likelihood,” “estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,” “will enable,” “would be expected,” “look forward,” “may provide,” “would” or similar terms, variations of such terms or the negative of those terms. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Zafgen’s ability to successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not support further development, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting its intellectual property, Zafgen’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, Zafgen’s ability to manage operating expenses, Zafgen’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Zafgen’s dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in the final prospectus related to Zafgen’s initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act, as well as discussions of potential risks, uncertainties, and other important factors in Zafgen’s subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Zafgen’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Zafgen explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Media & Investor Relations Contact:
         Shauna Elkin
         (212) 850-5613
         Shauna.Elkin@fticonsulting.com

(HALO) Provides Agenda Highlights For Analyst And Investor Meeting

– Discuss interim results for Study 202 evaluating PEGPH20 with gemcitabine and ABRAXANE® in pancreatic cancer patients – – Review current clinical development plan to evaluate PEGPH20 in two Non-Small Cell Lung Cancer trials, in combination with chemotherapy and then with a PD-1 inhibitor – – Provide 2015 financial guidance –

SAN DIEGO, Jan. 7, 2015  — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today will review the PEGPH20 development program and provide 2015 financial guidance during a meeting for analysts and investors in New York at 10:00 a.m. ET/ 7:00 a.m. PT.

“We are committed to exploring the full potential of investigational new drug PEGPH20 which we believe may have utility in a range of solid tumors with accumulation of high levels of hyaluronan (HA). The interim analysis of Study 202 has provided insights into the potential clinical benefit of PEGPH20 in patients with metastatic pancreatic cancer with accumulation of high levels of HA. We plan to meet with regulatory authorities in the first half of 2015 to discuss these preliminary results and seek their feedback on our plans to initiate a registration study for PEGPH20 in metastatic pancreatic cancer,” stated Dr. Helen Torley, President and Chief Executive Officer.

“Additionally, we plan to further our clinical development plan for PEGPH20 by conducting two trials in non-small cell lung cancer (NSCLC). Patient screening for the first study (PRIMAL), designed to evaluate PEGPH20 in combination with docetaxel in second-line NSCLC patients, initiated in December 2014. The second study, which is in the planning phase, will examine PEGPH20 in combination with an immuno-oncology agent, specifically a PD-1 inhibitor. All of these efforts are being managed with a highly efficient infrastructure as evidenced by our projected 2015 net cash burn.”

Members of Halozyme’s senior management, members of the research team and a renowned physician expert in pancreatic cancer will discuss the following topics as part of today’s analyst and investor meeting:

PEGPH20 in Pancreatic Cancer

• Efficacy and safety data based on an interim analysis of HALO 109-202 (Study 202) will be presented. Study 202 is evaluating PEGPH20 in combination with gemcitabine and nab-paclitaxel (ABRAXANE^®) compared to gemcitabine and ABRAXANE alone in metastatic pancreatic cancer.
• The analysis is based on 146 patients who had been enrolled at the time of the temporary hold in April 2014 due to the observation of a potential imbalance in thromboembolic events between treatment arms.
• The interim analysis was conducted to evaluate the overall benefit:risk of adding PEGPH20 to standard chemotherapy, and to help identify the cut-off point for hyaluronan accumulation as we further the clinical development plan for PEGPH20 with a planned registration study in metastatic pancreatic cancer patients with high HA accumulation, and initiate two studies in NSCLC.
• The Company has requested a meeting with the FDA in 1H 2015 to discuss the current benefit:risk of PEGPH20 and the design of the registration study in metastatic pancreatic cancer.

PEGPH20 in Non-Small Cell Lung Cancer

• Management will review the PRIMAL study design, the ongoing global Phase 1b/2 randomized study evaluating PEGPH20 in combination with docetaxel as a second-line therapy for patients with locally advanced and metastatic NSCLC.
  • The Phase 1b portion includes both a dose escalation and dose expansion phase evaluating two different schedules and is projected to complete enrollment in the third quarter of 2015, pending the number of dose escalation cohorts of PEGPH20.
  • The Phase 2 randomized portion of the study will follow evaluation of the Phase 1b data.
• Management will also discuss the scientific rationale for combining PEGPH20 with immuno-oncology agents and plans to begin a study of PEGPH20 combined with a PD-1 inhibitor in patients with high-HA NSCLC tumors, in the second half of 2015.

Financial Guidance
The Company ended 2014 with approximately $135 million in cash, cash equivalents and marketable securities (these results are unaudited). For the full year 2015, the Company expects:

• Net revenues to be in the range of $85 million to $95 million.
• Operating expenses to be in the range of $145 million to $155 million.
• Net cash burn to be between $35 million and $45 million.

A webcast of the Analyst Day presentation can be accessed through the “Investors” section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast, please log on to Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the systemic treatment of tumors that accumulate hyaluronan.

About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme’s pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex^® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Janssen and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning future actions relating to product development and regulatory events and goals, anticipated clinical trial results and strategies, product collaborations, our business intentions and financial estimates and results) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including delays in completion of clinical trials and other development activities, the possibility of safety events, unexpected expenditures and costs, unexpected results or delays in regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2014.

Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com

Media Contact:
Susan Neath Francis
212-301-7182
sfrancis@w2ogroup.com

(GALT) Final Phase 1 Demonstrates GR-MD-02 Safe, Potential Therapeutic for Advanced Fibrosis

NORCROSS, Ga., Jan. 7, 2015  — Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces that final results from its Phase 1 trial show that GR-MD-02 had an effect on a serum biomarker (as assessed by FibroTest®) and liver stiffness (as assessed by FibroScan^®) that suggest a potential for therapeutic effect on fibrosis that warrants further exploration. This first-in-man study, which enrolled 30 patients in three cohorts, principally evaluated the safety, tolerability and pharmacokinetics for single and multiple doses of its galectin-inhibiting drug GR-MD-02 when administered intravenously to patients with fatty liver disease, or nonalcoholic steatohepatitis (NASH) with advanced fibrosis. The study also secondarily examined exploratory biomarkers as well as a newer non-invasive liver stiffness measure. Final Phase 1 data are included in a new corporate presentation which is available on the Company’s website (www.galectintherapeutics.com).

GR-MD-02 administered to patients in three cohorts in doses up to 8 mg/kg for a total of four doses was found to be safe and well-tolerated. There were no serious adverse events or treatment-emergent adverse events attributed to the study drug. Mild (grade 1) adverse events possibly attributable to drug were identified in more patients receiving placebo (4 patients) than those receiving active drug (2 patients). The pharmacokinetic analysis of GR-MD-02 plasma levels for the 8 mg/kg dose shows that plasma drug coverage was in the upper portion of the targeted therapeutic range derived from NASH animal model studies. Therefore, the highest dose in the third cohort suggested a desired dose for testing in Phase 2 clinical trials.

“The final conclusion of the Phase 1 trial is that GR-MD-02 is safe and well tolerated after multiple doses,” said Stephen A. Harrison, M.D., the lead investigator of the trial and Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston. “Additionally, the highest dose utilized is within the therapeutic range, and had significant effects on a relevant biomarker of fibrotic liver disease and a potential signal indicating a reduction in liver stiffness. These findings provide a firm foundation for a Phase 2 clinical trial program and I am enthusiastic about participating in these trials.” Dr. Harrison also presented interim results of the study at the 2014 AASLD annual meeting, where he represented a group of principal investigators from leading medical institutions in the U.S., many of whom have authored seminal publications on liver disease and NASH in particular.

Evaluation of FibroTest^®, a biomarker consisting of a composite score of five blood tests that correlates with the extent of liver fibrosis, showed a statistically significant reduction between patients administered 8 mg/kg GR-MD-02 and those administered placebo in cohort 3. In contrast, there was no evidence of a significant reduction with the doses administered in the first two cohorts (2 mg/kg and 4 mg/kg), thereby suggesting a dose-dependent pharmacodynamic effect of GR-MD-02, which will be further explored in Phase 2 studies. The decrease in FibroTest^® score was attributable to a marked, statistically significant reduction in serum alpha-2 macroglobulin (A2M), a component of the FibroTest^® score and a serum protein that has been associated with liver fibrosis. A2M is a relevant marker for liver fibrosis because it has been shown that serum levels correlate with liver fibrosis. Moreover, it may be involved in the pathogenesis of fibrosis because it is known to inhibit proteases such as collagenase, which may promote fibrosis, and is increased in fibrogenic stellate cells in liver fibrosis.

Patients in the third cohort were also evaluated for liver stiffness with FibroScan^®, an ultrasound-based instrument approved by the U.S. Food and Drug Administration (FDA) for use in non-invasive liver diagnosis. Liver stiffness as measured by FibroScan^® has been shown in multiple studies to correlate with the degree of liver fibrosis as assessed by liver biopsy. The area of the liver interrogated with this method is approximately 100-times larger than the size of a standard liver biopsy. Although not cleared by the FDA specifically to assess fibrosis, FibroScan^® is believed to represent a promising non-invasive, out-patient method for measuring changes in liver fibrosis over time without the need for invasive surgical liver biopsy.

While FibroScan^® analysis was added during cohort 2, too few scans were obtained among those patients for analysis. In cohort 3 there were technically adequate scans at baseline, Day 38 and Day 63 in 5 patients administered GR-MD-02 and 3 patients administered placebo. Five patients in cohort 3 were not available for FibroScan^® analysis (3 placebo and 2 active) because of unavailability of the instrument at the site (1 placebo and 1 active), unavailability of the appropriate instrument probe (1 active), a technically inadequate baseline scan (1 placebo) and the Day 63 scan not being performed (1 placebo). All 3 placebo patients showed no significant change in FibroScan^® scores from baseline to Day 63, defined as changes of ±20% from baseline. In contrast, 3 of the 5 patients administered GR-MD-02 showed a reduction in FibroScan^® scores at Day 63 with reductions of 25%, 49% and 53%. While the number of patients in this analysis is small, these findings suggest there may be a reduction in liver stiffness with GR-MD-02 in some patients, which may correlate with the state of fibrosis and warrants that these observations be further explored in Phase 2 studies.

“We are pleased that our Phase 1 trial of GR-MD-02 in NASH patients with advanced fibrosis was a success in all key measures of safety and pharmacokinetics, while the exploratory marker A2M and non-invasive liver stiffness measure via FibroScan^® are encouraging,” said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer of Galectin Therapeutics. “The additional finding in the third cohort that liver stiffness may be decreased following administration of GR-MD-02 is an exciting one that opens additional avenues for Phase 2 study designs. The results of the Phase 1 trial provide the basis for launching a Phase 2 program that will include several concurrent trials focused on NASH patients with advanced fibrosis and cirrhosis. We plan to announce details of the Phase 2 program in February 2015 and to initiate trials in the second quarter of 2015.”

Dr. Traber added, “I extend sincere thanks to three groups for their involvement in this study. First and most importantly, I thank the patients who donated time and effort to help promote a promising therapy – their dedication to our protocol is recognized as critical to progress. Second, I thank the world-class group of investigators and their support teams who worked on this trial. Lastly, I thank Clinical Trial and Consulting Services, who as our contract research partner worked tirelessly to accomplish these results.”

The Phase 1 multicenter, double-blind, placebo-controlled clinical trial was conducted in patients with NASH with advanced fibrosis (Brunt Stage 3) who received four doses of GR‑MD‑02 over a 35- to 42‑day period. Each of the three planned cohorts consisted of patients randomized to receive active drug or placebo. Trial design details can be found here.

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scaring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.

About Fatty Liver Disease with Advanced Fibrosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates. NASH is estimated to affect 9 to 15 million people in the U.S., including children. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who consume little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as 3 million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only treatment available. Approximately 6,300 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.

About Galectin Therapeutics

Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, key mediators of biologic function. Galectin is leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a clear development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for GR-MD-02 will lead to the first therapy for the treatment of fatty liver disease with fibrosis. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development. The Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies. Regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

CONTACT: Galectin Therapeutics Inc.
         Peter G. Traber, M.D.
         President, CEO & CMO
         (678) 620-3186
         ir@galectintherapeutics.com

         LHA
         Kim Golodetz
         (212) 838-3777
         kgolodetz@lhai.com

(BIOD) Concentrated Insulin BIOD-531 Demonstrates Superior Post-Meal Glucose Control

Phase 2a Clinical Trial Data Demonstrate That BIOD-531 Provides Superior Glucose Control Compared to Humalog(R) Mix 75/25 and Humulin(R) R U-500; Conference Call and Webcast Will Be Held Today, Wednesday, January 7, 2015, 5:00 PM Eastern Standard Time

(ARNA) Positive Results Phase 1b of APD334 in Autoimmune Diseases

– Trial results show novel S1P1 modulator produced strong, dose-dependent lymphocyte lowering – – No clinically significant safety findings relative to heart, liver or pulmonary function –

SAN DIEGO, Jan. 7, 2015  — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced top-line results from a Phase 1b multiple ascending dose clinical trial for APD334, an oral drug candidate that targets the sphingosine 1-phosphate subtype 1 (S1P₁) receptor for the potential treatment of autoimmune diseases.

In the Phase 1b clinical trial, APD334 demonstrated a dose-dependent effect on lymphocyte count lowering in blood, with mean decreases from baseline of up to 69%. Lymphocyte counts, on average, recovered to baseline within one week of conclusion of dosing. There were no clinically significant safety findings with respect to heart rate or rhythm or pulmonary function, and no clinically significant elevations in liver enzyme tests. The most common treatment-emergent adverse events were mild or moderate contact dermatitis, headache, constipation and diarrhea, with none being clearly drug related. There were no discontinuations for adverse events, and no serious adverse events were observed.

“Lymphocyte lowering at the level demonstrated in this trial has been shown to correlate with clinical efficacy in Phase 2 and Phase 3 trials of other S1P₁ modulators in multiple sclerosis, psoriasis and ulcerative colitis,” said William R. Shanahan, M.D., Arena’s Senior Vice President and Chief Medical Officer. “The results of this trial support investigation of the efficacy and safety of APD334 in patients with autoimmune diseases.”

The randomized, double-blind, placebo-controlled Phase 1b clinical trial evaluated the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple-ascending doses of APD334. In five different dosing cohorts, a total of 50 healthy volunteers received APD334 and 10 received placebo for 21 days.

“Based on these impressive results, we plan to expedite APD334 into Phase 2 clinical trials for ulcerative colitis and Crohn’s disease,” said Jack Lief, Arena’s President and Chief Executive Officer. “The advancement of this promising drug candidate further demonstrates Arena’s focused expertise in discovering and developing innovative drug candidates targeting G protein-coupled receptors that have the potential to improve health.”

About Autoimmune Diseases

Autoimmune diseases, such as multiple sclerosis, psoriasis, ulcerative colitis, Crohn’s disease and rheumatoid arthritis, are characterized by an inappropriate immune response against substances and tissues that are normally present in the body. In an autoimmune reaction, a person’s antibodies and immune cells target healthy tissue, triggering an inflammatory response. Reducing the immune and/or inflammatory response is an important goal in the treatment of autoimmune diseases.

About APD334

APD334 is a potent and selective, orally available investigational drug candidate that targets the S1P₁ receptor. Discovered by Arena, APD334 has therapeutic potential in autoimmune diseases. S1P₁ receptors have been demonstrated to be involved in the modulation of several biological responses, including lymphocyte trafficking from lymph nodes to the peripheral blood. By isolating lymphocytes in lymph nodes, fewer immune cells are available in the circulating blood to effect tissue damage.

About Arena Pharmaceuticals

Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena’s internally discovered drug, BELVIQ® (lorcaserin HCl), is approved in the United States, and Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. Arena’s US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena’s website at www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the advancement, investigation, therapeutic indication, use, safety, efficacy, mechanism of action, and potential of APD334, including as a potential treatment for one or more autoimmune diseases; the significance of the trial results for APD334, including with respect to lymphocyte lowering and safety; the significance of lymphocyte lowering and reducing the immune and/or inflammatory response; expediting the development of APD334, including future trials and investigated indications; Arena’s expertise in discovering and developing drug candidates that have the potential to improve health; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena’s focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: top-line results are not comprehensive and are based on a preliminary analysis of then available data, and findings and conclusions related to the trial are subject to change following a more comprehensive review of the data; APD334 may not be developed, approved for marketing or commercialized for any disease or condition; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; Arena’s revenues will be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena’s guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing when expected or ever in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena’s business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena’s research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arena’s and third parties’ intellectual property rights; the timing, success and cost of Arena’s research and development; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

(CUR) To Present At Biotech Showcase 2015

GERMANTOWN, Md., Jan. 6, 2015  — Neuralstem, Inc. (NYSE MKT: CUR) announced that the Company will present at the seventh annual Biotech Showcase in San Francisco on Tuesday, January 13, at 9:00 a.m. PST. Richard Garr, President and CEO, will present an overview on the company’s clinical advancements of 2014 for both the cell therapy and small molecule drug discovery pipeline platforms. This will include the status of the company’s lead cell therapy asset, NSI-566 for amyotrophic lateral sclerosis (ALS), and its lead neurogenic small molecule program, NSI-189, for the treatment of major depressive disorder.

A live audio webcast of the presentation will be available by visiting the Investor Center home page of Neuralstem’s website: investor.neuralstem.com.  An archive of the presentation will also be available for 30 days.

For more information on Biotech Showcase 2015, visit: http://www.ebdgroup.com/bts/index.php.

About Neuralstem

Neuralstem’s patented technology enables the production of multiple types of brain and spinal cord neural stem cells in commercial quantities for the potential treatment of central nervous system diseases and conditions. Neuralstem’s first stem cell product, NSI-566, a spinal cord-derived neural stem cell line, is in an ongoing clinical trial to treat amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease). Phase II surgeries were completed in July, 2014. A later stage trial is anticipated to commence in 2015 at multiple centers. Neuralstem received orphan status designation by the FDA for NSI-566 in ALS. In addition to ALS, NSI-566 is also in a Phase I trial in chronic spinal cord injury at UC San Diego School of Medicine. NSI-566 is also in clinical development to treat neurological diseases such as ischemic stroke and acute spinal cord injury.

Neuralstem’s second stem cell product, NSI-532.IGF, consists of human cortex-derived neural stem cells that have been engineered to secrete human insulin-like growth factor 1 (IGF-1). In animal data presented at the Congress of Neurological Surgeons 2014 Annual Meeting, the cells rescued spatial learning and memory deficits in an animal model of Alzheimer’s disease.

Additionally, Neuralstem’s ability to generate human neural stem cell lines for chemical screening has led to the discovery and patenting of compounds that may stimulate the brain’s capacity to generate neurons, possibly reversing pathologies associated with certain central nervous system (CNS) conditions. The company has completed Phase Ia and Ib trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder (MDD), and is expecting to launch a Phase II study for major depressive disorder (MDD) in 2015. Additional indications might include traumatic brain injury (TBI), Alzheimer’s disease, and post-traumatic stress disorder (PTSD).

For more information, please visit www.neuralstem.com or connect with us on Twitter, Facebook and LinkedIn

Cautionary Statement Regarding Forward Looking Information:
This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the annual report on Form 10-K for the year ended December 31, 2013 and Form 10Q, for the period ended September 30, 2014.

(GLBS) CEO Discusses Latest Company Developments and Future Plans

Capital Link Shipping Interview

(CYTR) Positive Interim Phase 2 Aldoxorubicin Results in Brain Cancer

Aldoxorubicin Shows a Complete Response, Tumor Shrinkage, Prolonged Stable Disease, and Favorable Tolerability in Patients Novel Albumin-Binding Drug Candidate Appears to Allow Doxorubicin to Cross the Tumor’s Blood-Brain Barrier in Humans

LOS ANGELES, Jan. 6, 2015  — CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.  The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.  Preliminary results in 12 patients show both prolonged stable disease and tumor shrinkage in several patients, including one patient who demonstrated no microscopic evidence of tumor when tissue was examined after resection, representing a complete response.  These observations suggest that aldoxorubicin allows doxorubicin to cross the tumor’s blood-brain barrier in humans.

“Aldoxorubicin appears to be the first anthracycline to cross the blood-brain barrier in GBM, potentially creating a new approach to attacking brain tumors,” said Steven Kriegsman, Chairman, President and CEO of CytRx.  “These findings are early but important, and suggest that binding to albumin may play a crucial role in transporting chemotherapies that normally cannot cross the tumor blood-brain barrier into the malignancy.  They indicate that aldoxorubicin has the potential to address the unmet therapeutic needs of patients suffering from brain cancer. We currently expect to have more definitive data in the first half of this year, which we intend to submit for possible presentation at ASCO 2015.”

The primary objective of this Phase 2 trial is to determine progression-free survival (PFS) at 6 months and overall survival (OS) in patients with recurrent glioblastoma multiforme.  The principal secondary objective is to evaluate the safety of aldoxorubicin in study patients as assessed by the frequency and severity of adverse events.  Only patients who have not received prior treatment with bevacizumab (Avastin®) are eligible to participate in the trial.  The clinical trial is expected to enroll up to 28 patients randomly assigned equally to receive either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent.  Tumor response is monitored every 6 weeks by MRI until disease progression occurs.  The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, CA, City of Hope in Duarte, CA, the Louisiana State University Health Sciences Center in New Orleans, LA, and Texas Oncology in Dallas, TX.

This Phase 2 study follows positive confirmatory results reported in 2013 from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals.  In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline.  In addition, because aldoxorubicin uptake was confined to the tumor in the brain rather than normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually.  Despite surgical resection, radiotherapy and chemotherapy, the median survival after diagnosis is approximately 14 months.  Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood-brain barrier.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology.  CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin.  CytRx has initiated under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial.  CytRx is currently evaluating aldoxorubicin in a global Phase 2b clinical trial in small cell lung cancer, a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma, a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer), a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors.  CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors.  CytRx plans to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, based on novel linker technologies that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites.  For more information about CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, risks related to the clinical hold placed by the FDA on aldoxorubicin clinical trials and their potential impact on the timing or resumption of those trials, the timing or FDA approval of projected commercial sales of aldoxorubicin, the risk that any ongoing or future human testing of aldoxorubicin, including the Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable GBM, might not produce results similar to those seen in past human or animal testing, including the preliminary results described in this press release, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations:
Argot Partners
Michelle Carroll
212.600.1902
michelle@argotpartners.com

Media:
Argot Partners
Eliza Schleifstein
973.361.1546
eliza@argotpartners.com

Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
310-826-5648, x304
dhaen@cytrx.com

(CBMX) Superior Court Issues Tentative Ruling and Proposed Statement of Decision in Favor

Parties Have 15 Days to File Objections

IRVINE, Calif., Jan. 6, 2015  — CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced that the Superior Court of the State of California, County of Orange (the “Court”), has issued a tentative ruling and proposed statement of decision (the “Proposed Statement of Decision”) in the matter of the People of the State of California and Relator Michael Strathmann (“Plaintiff”) vs. Acacia Research Corporation, CombiMatrix Corporation and Amit Kumar (“Defendants”). In its 27-page Proposed Statement of Decision, the Court has tentatively ruled in favor of the Defendants and against all claims of the Plaintiff. Specifically, the Court determined that Defendants had no fraudulent intent when they pursued insurance benefits under the National Union D&O Policy over a decade ago. Each party in this case now has up to fifteen days to file any objections it may have. The Court then has approximately 60 days to consider the objections and to hear additional arguments before the Court issues its final ruling and judgment.

“We are pleased with the Court’s Proposed Statement of Decision,” said Mark McDonough, President and Chief Executive Officer of CombiMatrix. “Though we understand that there may be future legal hurdles to overcome, based on the Court’s tentative decision, we are optimistic this matter will be resolved in favor of CombiMatrix in a timely fashion. We continue to focus on executing our business plan and driving toward commercial success in 2015 and beyond.”

About CombiMatrix Corporation

CombiMatrix Corporation provides valuable molecular diagnostic solutions and comprehensive clinical support for the highest quality of care – specializing in miscarriage analysis, prenatal and pediatric healthcare. CombiMatrix offers comprehensive testing services for the detection of abnormalities of genes at the DNA level beyond what can be identified through traditional technologies. The Company performs genetic testing utilizing microarray, FISH, PCR and G-Band chromosome analyses. Additional information about CombiMatrix is available at www.combimatrix.com or by calling 1-800-710-0624.

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

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations, speak only as of the date hereof and are subject to change. All statements, other than statements of historical fact included in this press release, are forward-looking statements. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “goal,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” “objective,” similar expressions, and variations or negatives of these words. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. The risks and uncertainties referred to above include, but are not limited to: the risk that the Court’s final ruling and statement of decision in the current litigation will be different than its tentative ruling and proposed statement of decision; the risk that a successful appeal will be taken from the Court’s decision in the current litigation; market acceptance of CMA as a preferred method over karyotyping; the rate of transition to CMA from karyotyping; our ability to successfully expand the base of our customers and strategic partners, add to the menu of our diagnostic tests in both of our primary markets, develop and introduce new tests and related reports, optimize the reimbursements received for our testing services, and increase operating margins by improving overall productivity and expanding sales volumes; our ability to successfully accelerate sales, allow access to samples earlier in the testing continuum, steadily increase the size of our customer rosters in both developmental medicine and oncology; our ability to attract and retain a qualified sales force; rapid technological change in our markets; changes in demand for our future products; legislative, regulatory and competitive developments; general economic conditions; and various other factors. Further information on potential factors that could affect our financial results is included in our Annual Report on Form 10-K, Quarterly Reports of Form 10-Q, and in other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

CONTACT: Company Contact:
         Mark McDonough
         President & CEO, CombiMatrix Corporation
         (949) 753-0624

         Investor Contact:
         Robert Flamm, Ph.D.
         Russo Partners, LLC
         (212) 845-4226
         robert.flamm@russopartnersllc.com

         Media Contact:
         David Schull or Lena Evans
         Russo Partners LLC
         (212) 845-4271
         david.schull@russopartnersllc.com
         lena.evans@russopartnersllc.com

(MOC) Two Contracts w/ USPS Valued at $250M Over Ten Years

HERNDON, Va., Jan. 6, 2015  — Command Security Corporation (NYSE MKT:MOC) announced today the award of two United States Postal Service (USPS) contracts valued at approximately $250 million over a ten year term of service.

On December 31, 2014, Command Security Corporation received notification of the award of an approximate $20 million per year contract to provide security services at 50 USPS locations in 18 states, Puerto Rico and the District of Columbia. The award includes a four year base contract and three two-year options. The Company has commenced a one month transition period and will assume operational responsibility on February 1, 2015.

In addition, the USPS awarded the Company an approximate $5 million per year contract to operate the two USPS National Law Enforcement Communication Centers (NLECC) at Dulles International Airport, VA and in Ft. Worth, TX. The Company will commence a one month transition period for this contract on February 1, 2015, and will assume operational responsibility on March 1, 2015.

Todd Pratt, Vice President, Sales and Marketing said, “This is a major success for our team and represents the largest single contract ever awarded to the Company. It represents an affirmation of our strategic plan and positions the Company to compete for other major contracts.”

“We are honored to have been selected by the USPS for this important contract to provide for their security needs across the country,” said Craig P. Coy, Chief Executive Officer. “Our operational and support staff teams have worked very hard to enable the Company to secure this opportunity and we look forward to a long and successful relationship with the USPS.”

About Command Security Corporation

Command Security Corporation and its Aviation Safeguards division provides uniformed security officers, aviation security services and support security services to commercial, financial, industrial, aviation and governmental customers throughout the United States. We safeguard against theft, fraud, fire, intrusion, vandalism and the many other threats that our customers are facing today. By partnering with each customer, we design programs customized to meet their specific security needs and address their particular concerns. We bring years of expertise, including sophisticated systems for hiring, training, supervision and oversight, backed by cutting-edge technology, to every situation that our customers face involving security. Our mission is to enable our customers to operate their businesses without disruption or loss, and to create safe environments for their employees. For more information concerning our company, please refer to our website at www.commandsecurity.com.

Forward-Looking Statements

This announcement by Command Security Corporation (referred to herein as the “Company”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and within the meaning of the Private Securities Litigation Reform Act of 1995 about the Company that are based on management’s assumptions, expectations and projections about the Company.  Such forward-looking statements by their nature involve a degree of risk and uncertainty. The Company cautions that actual results of the Company could differ materially from those projected in the forward-looking statements as a result of various factors, including but not limited to the factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2014, filed with the Securities and Exchange Commission, and such other risks disclosed from time to time in the Company’s periodic and other reports filed with the Securities and Exchange Commission. You should consider the areas of risk described above in connection with any forward-looking statements that may be made by the Company. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosures the Company makes in proxy statements, quarterly reports on Form 10-Q, annual reports on Form 10-K and current reports on Form 8-K filed with the Securities and Exchange Commission, which are publicly available at the Securities and Exchange Commission’s website at www.sec.gov/edgar.shtml.

CONTACT: COMPANY CONTACT:
         N. Paul Brost, Chief Financial Officer
         Command Security Corporation
         Ph. 703-464-4735

(TNXP) Clinical, Regulatory Update on TNX-102 SL in Fibromyalgia

Phase 3 Program to Begin in the Second Quarter of 2015

NEW YORK, Jan. 6, 2015  — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) has received written guidance from the U.S. Food and Drug Administration (FDA) on its Phase 3 clinical study design for TNX-102 SL in fibromyalgia.

“Getting this confirmation from the FDA – particularly its acceptance of the 30 percent responder analysis as the primary outcome measure – represents a clear step forward in our ongoing development of TNX-102 SL in fibromyalgia,” said Seth Lederman, M.D., president and chief executive officer of Tonix.

The 30 percent responder analysis is defined as an improvement in pain, as measured by the number of subjects who achieve at least a 30 percent improvement in their pain scores. In the Phase 2b BESTFIT study, TNX-102 SL demonstrated a statistically significant improvement in the 30 percent responder analysis, which was a pre-specified secondary outcome measure.

Dr. Lederman added, “Our proposed Phase 3 study design is based on our analysis and learnings from the BESTFIT trial results. We are on track to begin the Phase 3 clinical study in this debilitating condition in the second quarter of this year.”

About Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals is a clinical-stage company developing first-in-class medicines for common disorders of the central nervous system, including fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headache. These disorders are characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. Tonix’s lead candidate, TNX-102 SL, is intended to be a first-line treatment for fibromyalgia and for PTSD. A Phase 2b trial of TNX-102 SL in fibromyalgia (BESTFIT) has been completed, and Tonix is preparing to initiate a Phase 3 program to support registration. A Phase 2 trial of TNX-102 SL in PTSD (AtEase) is recruiting. TNX-201 is in clinical development for episodic tension-type headache and recently completed a Phase 1 comparative pharmacokinetic and safety study. To learn more, please visit www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K filed with the SEC on March 28, 2014 and future periodic reports filed with the Securities and Exchange Commission. All of the Company’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

CONTACT: Tonix Pharmaceuticals Holding Corp:

         Leland Gershell, M.D., Ph.D.
         Chief Financial Officer
         (212) 980-9155 x104
         leland.gershell@tonixpharma.com

         Investor Relations:
         Martini Communications
         Amy Martini
         amartini@martinicommunications.com

         Public Relations:
         Dian Griesel Intl.
         Susan Forman / Laura Radocaj
         (212) 825-3210
         sforman@dgicomm.com
         lradocaj@dgicomm.com

(CISG) Announces Management’s Purchase of Shares From CDH Inservice Limited

GUANGZHOU, China, Jan. 5, 2015  — CNinsure Inc. (“CNinsure” or the “Company”) (Nasdaq:CISG), a leading independent insurance intermediary company and an online insurance service provider in China, today announced that Kingsford Resources Limited (“Kingsford”), a company owned by certain members of management of CNinsure (“Management”), has entered into a share purchase and sale agreement (the “Agreement”) with CDH Inservice Limited (“CDH Inservice”), an affiliate of CDH Investments (“CDH”), one of the largest private equity fund in China, in a privately negotiated transaction. Pursuant to the Agreement, Management has agreed to purchase from CDH Inservice 7,731,149 American Depositary Shares (“ADSs”, each representing 20 ordinary shares of the Company) or its equivalent in ordinary shares of the Company, at a price of US$7 per ADS or US$0.35 per ordinary share, totaling US$54.1 million. The 7,731,149 ADSs represent the entire interests in the Company held by CDH Inservice as of the date of the Agreement.

Upon completion of the transaction, Management’s stake in the Company will increase from approximately 3.1% to 16.6%, which will make it the second largest shareholder of the Company, only after Mr. Yinan Hu, Chairman of the board of directors of the Company, who beneficially owns approximately 16.8% of the shares of the Company. Completion of the transaction is subject to satisfaction of the closing conditions contained in the Agreement.

Mr. Chunlin Wang, chief executive officer of CNinsure commented: “CDH has been our major shareholder since December 2005. I would like to, on behalf of the management, extend our deep gratitude to CDH for their support and trust in the Company in the past decade, which has contributed significantly to the growth of CNinsure from a regional insurance agency to become a leading insurance intermediary in China.”

“Our decision to significantly increase our stake in the Company demonstrates our strong confidence in the Company’s growth strategies and prospects. It is also a reflection of our continued commitment to enhancing shareholder value.”

About CNinsure Inc.

CNinsure is a leading independent intermediary company and an online insurance service provider operating in China. CNinsure’s distribution network reaches many of China’s most economically developed regions and affluent cities. The Company distributes a wide variety of individual and commercial lines of property and casualty and life insurance products underwritten by domestic and foreign insurance companies operating in China, and provides insurance claims adjusting as well as other insurance-related services.

Forward-looking Statements

This press release contains statements of a forward-looking nature. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward- looking statements by terminology such as “will,” “expects,” “believes,” “anticipates,” “intends,” “estimates” and similar statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about CNinsure and the industry. Potential risks and uncertainties include, but are not limited to, those relating to CNinsure’s limited operating history, especially its limited experience in selling life insurance products, its ability to attract and retain productive agents, especially entrepreneurial agents, its ability to maintain existing and develop new business relationships with insurance companies, its ability to execute its growth strategy, its ability to adapt to the evolving regulatory environment in the Chinese insurance industry, its ability to compete effectively against its competitors, and macroeconomic conditions in China and their potential impact on the sales of insurance products. All information provided in this press release is as of the date hereof, and CNinsure undertakes no obligation to update any forward-looking statements. Although CNinsure believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results. Further information regarding risks and uncertainties faced by CNinsure is included in CNinsure’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F.

CONTACT: For more information, please contact:
         Oasis Qiu
         Investor Relations Manager
         Tel: +86 (20) 6122-2731
         Email: qiusr@cninsure.net

(KITE) & (AMGN) Announce Strategic Cancer Immunotherapy Collaboration

Alliance Combines Amgen’s Oncology Targets and Kite’s Leading CAR T Cell Therapy Platform to Develop new Therapeutic Candidates Kite to Receive a $60 Million Upfront Payment From Amgen and Eligible for up to $525 Million in Regulatory and Sales Milestone Payments per Amgen Program; Plus, Tiered High Single- to Double-Digit Royalties for Sales and License of Kite’s Intellectual Property for CAR T Cell Products Amgen Eligible to Receive up to $525 Million in Milestone Payments per Kite Program; Plus, Tiered Single-Digit Sales Royalties Kite to Host Conference Call Today at 4:00 PM Eastern Time

THOUSAND OAKS, Calif. and SANTA MONICA, Calif., Jan. 5, 2015  — Amgen (NASDAQ:AMGN) and Kite Pharma (NASDAQ:KITE) announced today that the two companies have entered into a strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite’s engineered autologous cell therapy (eACT™) platform and Amgen’s extensive array of cancer targets. The collaboration brings together Amgen’s commitment to and capabilities in advancing new approaches in immuno-oncology and Kite’s industry-leading presence in CAR T cell therapy.

Under the terms of the agreement, Amgen will contribute cancer targets, and Kite will leverage its proprietary CAR platform, research and development (R&D) and manufacturing capabilities, and expertise. Kite will be responsible for conducting all preclinical research and cell manufacturing and processing through Investigational New Drug (IND) filing. Each company will then be responsible for clinical development and commercialization of their respective CAR therapeutic candidates, including all related expenses. Kite will receive from Amgen an upfront payment of $60 million, as well as funding for R&D costs through IND filing. Kite will be eligible to receive up to $525 million in milestone payments per Amgen program based on the successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and the license of Kite’s intellectual property for CAR T cell products. Amgen is eligible to receive up to $525 million in milestone payments per Kite program, plus tiered single-digit sales royalties.  Further terms of the agreement are not being disclosed.

“The intersection of immunology and oncology represents one of the most promising approaches to delivering significant impact for patients with cancer,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “With our existing immuno-oncology portfolio of cutting-edge technologies and expertise, we believe joining forces with Kite Pharma will leverage our targets and their leading CAR T cell platform to advance another new promising therapeutic approach to fight cancer.”

“Amgen is an ideal partner for us, based on their strong presence in oncology and the company’s broad array of cancer targets optimally suited for combining with our CAR technologies. We are proud to announce this unique collaboration and its validation of our R&D expertise, intellectual property position, and therapeutic manufacturing and processing capabilities,” stated Arie Belldegrun, M.D., FACS, Kite Pharma’s president and chief executive officer. “We believe that the therapeutic candidates resulting from the collaboration will have the potential to dramatically transform CAR approaches and to become some of the most powerful therapies for the treatment of cancer.”

Conference Call / Webcast Information
Kite Pharma will host a live conference call and webcast today at 4 p.m. ET to discuss the transaction. To access the live webcast or replay, please visit Kite Pharma’s Investor Relations website at http://ir.kitepharma.com. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

Alternatively, the dial-in number to access the conference call is (844) 856-8656, or from international locations dial (443) 877-4062. The conference ID number for the live call is 59012654. Telephone replay will be available approximately three hours following the call. To access the replay, please dial (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 59012654. The telephone replay will remain available until 11:59 p.m. ET, Jan. 12, 2015.

About CAR T Immunotherapies
Kite Pharma’s broadly enabling eACT™ technology platform allows a patient’s T cells to be genetically modified to express cancer-targeting receptors. Engineered CAR T cells contain a single chain antibody domain, which recognizes and binds to a cell surface tumor antigen, as well as intracellular T cell-activating domains. CAR T cells are designed to traffic directly to tumor sites and become activated upon engagement with the target tumor antigen, selectively eradicating the tumor cells.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s largest independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on eACT™ designed to restore the immune system’s ability to recognize and eradicate tumors. In partnership with the NCI Surgery Branch through a Cooperative Research and Development Agreement (CRADA), Kite is advancing a pipeline of proprietary eACT™ product candidates, both CAR (chimeric antigen receptor) and TCR (T cell receptor) products, directed to a wide range of cancer indications. Kite is based in Santa Monica, Calif. For more information on Kite Pharma, please visit www.kitepharma.com.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen, we or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Jan. 5, 2015, and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we and our partners routinely obtain patents for our and their products and technology, the protection of our products offered by patents and patent applications may be challenged, invalidated or circumvented by our or our partners’ competitors and there can be no guarantee of our or our partners’ ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. Cost savings initiatives may result in us incurring impairment or other related charges on our assets. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our recently announced restructuring plans. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase common stock.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Kite Pharma Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our ability to research and develop new therapeutic candidates; our expectations regarding the clinical effectiveness and safety of CAR T cell therapies; our ability to manufacture and process CAR T cell therapies; and our ability to protect our proprietary technology and enforce our intellectual property rights. Various factors may cause differences between Kite’s expectations and actual results as discussed in greater detail in Kite’s filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended Sept. 30, 2014. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CONTACT:
Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

Kite Pharma
Cynthia M. Butitta
Chief Financial Officer and Chief Operating Officer
310-824-9999

For Media: Justin Jackson
For Investor Inquiries: Nancy Yu
Burns McClellan
212-213-0006
jjackson@burnsmc.com
nyu@burnsmc.com

(AMDA) Spinal Interbody Spacers Show Equivalent Fusion to PEEK

SALT LAKE CITY, Jan. 5, 2015  — Amedica Corporation (Nasdaq:AMDA), a biomaterial company that develops and commercializes silicon nitride ceramics, today released the results of its CASCADE study, a blinded, randomized clinical trial that compared outcomes of spinal fusion surgery between its composite silicon nitride spacers manufactured with a central core of cancellous structured ceramic (CsC), to the gold standard, i.e., PEEK (polyether ether ketone plastic) spacers filled with bone autograft.

“Surgeons have long known that autograft is the holy grail of bone healing,” said Mark P. Arts, M.D., Ph.D., Neurosurgeon at the Medical Center Haaglanden, The Hague, Netherlands. “All osteoinductive and osteoconductive formulations on the market today aspire to show healing rates that are comparable to autograft bone. Hollow-body PEEK spacers used in cervical and lumbar spinal fusion must be filled with osteoconductive materials, such as allograft, bone autograft, or synthetic biologic formulations. The CASCADE study is the first to show that a synthetic material can heal and fuse as well as the patient’s own bone. We have shown that it is no longer necessary to use hollow interbody spacers filled with bone or bone void fillers to achieve optimal fusion results.”

The CASCADE study enrolled 104 patients in a prospective clinical trial that independently scored fusion rates and clinical outcomes at 12 months follow-up. Neck Disability Index scores decreased similarly in both patient groups, consistent with clinical improvements reported in the literature. Importantly, the incidence of cervical spine fusion was statistically identical between study groups, and consistent with figures reported in other studies.

“The significance of the CASCADE data cannot be overstated,” said Dr. Sonny Bal, Chairman and CEO of Amedica Corporation. “For the first time, a porous synthetic interbody spacer with no bone or bone fillers has shown fusion rates that are equivalent to the gold standard. Previously we have demonstrated that the surface topography and chemistry of our current Valeo silicon nitride spacers – sales of which were up 50% through the third quarter of 2014 as compared to the same period for 2013 – are uniquely conducive to bone ongrowth and bacterial resistance. In fact, many manufacturers are trying to overcome the limitations of PEEK spacers, and replicate our superior bone ongrowth properties by enhancing PEEK with costly porous metal coatings, or hydroxyapatite and related materials. Now, Amedica is leap-frogging the competition yet again with our composite, solid-and-porous CsC spacers to deliver equivalent fusion without the use of any bone, bone void fillers, or expensive biologics.”

“In addition to the superior bone ongrowth, strength, biocompatibility, favorable radiographic imaging and antibacterial properties of silicon nitride, we have now shown that the cancellous formulation of our material enables bone ingrowth and spinal fusion by itself, i.e., without relying on additives,” continued Dr. Bal. “We expect this advantage will translate into decreased cost and complexity of surgical procedures, and support our efforts to receive 510(k) clearance from the FDA for the CsC product used in the CASCADE study, which is already approved for use in Europe.”

Amedica is preparing a scientific paper describing the CASCADE study for publication in a peer-reviewed journal. The Company will also submit an application during January 2015 in the 510(k) regulatory track based on the final clinical data. The Food and Drug Administration will examine all the data presented as part of a complete application for 510(k) clearance of the composite silicon nitride interbody system.

More information about the trial can be found at www.ClinicalTrials.gov using NCT01511445 as the identifier.

About Amedica Corporation

Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world’s largest ceramic manufacturer. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include statements that the cancellous formulation of our material will translate into decreased cost and complexity of surgical procedures and that the CASCADE study results will support our efforts to receive 510(k) clearance from the FDA. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, including those described in the “Risk Factors” disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 31, 2014, and in our other filings with the SEC. Amedica undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

CONTACT: Mike Houston
         Director of Investor Relations
         801-839-3534
         mhouston@amedica.com

(GLMD) Announces the Appointment of Josh Blacher as Chief Financial Officer

TEL AVIV, Israel, Jan. 5, 2015  — Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed”), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, today announced that it has appointed Josh Blacher as Chief Financial Officer, effective as of January 1, 2015.  Mr. Blacher replaces Mr. Ray Morris, who previously served Galmed in such capacity through December 31, 2014.

Mr. Blacher joins Galmed with six years of experience in biotech-related business development, investing and operations, as well as 14 years in capital markets in the United States.  Prior to joining Galmed, among other things, Mr. Blacher served as Director of Business Development at Teva Innovative Ventures, Teva Pharmaceuticals’ early- and mid-stage investment and in-licensing arm.  In that capacity, Mr. Blacher helped build and manage Teva’s portfolio of approximately 20 equity investments in biotech companies, spanning a wide range of development stage companies from pre-clinical through Phase III projects, as well as various therapeutic areas.  Previously, Mr. Blacher also held positions in portfolio management at Deutsche Asset Management and equity research at Morgan Stanley, as well as in mergers & acquisitions at Lehman Brothers.  Mr. Blacher holds an MBA in Finance from Columbia Business School.

“Josh brings to Galmed strong financial and analytical skills, together with extensive experience working in the U.S. capital markets,” commented Allen Baharaff, Galmed’s Chief Executive Officer.  Mr. Baharaff continued, “we expect Josh to devote substantial efforts assisting the company in developing and maintaining key relationships with the investment community.  In addition, we believe that Josh’s expertise in biotech transactions may help the company achieve its objectives of maximizing shareholder value over time.  We’re delighted to welcome Josh to the company.”

Mr. Blacher added “I am very happy to become a part of Galmed’s talented team.  I am excited to join such a dynamic company that is seeking to develop a treatment for a large unmet need.  I look forward to helping the company achieve its clinical and financial goals.”

About Galmed Pharmaceuticals Ltd.
Galmed is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel, once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed believes that its product candidate, aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need.

Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading “Risk Factors” included in the registration statement on Form F-1 (File No. 333 -193792), initially filed with the Securities and Exchange Commission, or the SEC, on February 6, 2014 and declared effective by the SEC on March 12, 2014, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release reflect Galmed’s current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update any forward-looking statements.

(STXS) Receives FDA Clearance of Vdrive(R) With V-CAS(TM) System

ST. LOUIS, Jan. 5, 2015  — Stereotaxis, Inc. (Nasdaq:STXS) announced today that it has received 510(k) clearance by the Food and Drug Administration (FDA) for its Vdrive® with V-CAS™ Catheter Advancement System in the U.S., representing the Company’s third Vdrive system product to be cleared for market entry. The Company also announced that it has received regulatory approval of its Odyssey® product line by the Japan Pharmaceuticals and Medical Devices Agency, the country’s equivalent to the U.S. FDA.

Stereotaxis’ Vdrive with V-Loop™ Variable Loop Catheter Manipulator received U.S. clearance in September 2014 and its Vdrive with V-Sono™ Intracardiac Echocardiography Catheter Manipulator has been available since 2013.

“The Vdrive system and disposable suite provides flexibility in robotic catheter and sheath control, adaptable to a physician’s individual workflow and product preferences,” said William C. Mills, Stereotaxis Chief Executive Officer. “As additional Vdrive system accessories gain market approval in the U.S., we move closer to our vision of a fully remote electrophysiology procedure environment.”

The Vdrive with V-CAS system, which was first released in Europe in 2011, allows physicians to remotely control the advancement, retraction and rotation of a compatible fixed curve transseptal sheath, in conjunction with a magnetic ablation catheter. Utilized in the majority of ablation procedures, the fixed curve transseptal sheath provides stability and support to the ablation catheter during therapy delivery.

Bruno Schwagten, M.D., Ph.D. at ZNA Middelheim Hospital in Belgium, who has performed Stereotaxis magnetic navigation procedures since 2008 and started using the Vdrive with V-CAS system in 2012, said, “The addition of robotic sheath control to a magnetic procedure has simplified the therapy process and enhanced patient safety, allowing me to efficiently access even the most challenging areas of the heart chambers.”

In Japan, approval of the Stereotaxis Odyssey Vision™ system for use in conjunction with the Niobe® ES remote magnetic navigation system comes three months after the Company’s first commercial order in that country. The Odyssey Vision system, together with the Odyssey Cinema™ solutions, provides a consolidated user interface of all lab information during a Niobe procedure, as well as real-time or recorded viewing of procedures across networks and institutions. The Company expects to submit its Vdrive system for regulatory review in Japan during the first quarter of 2015.

About Stereotaxis

Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch™ Solution includes the Niobe® ES remote magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems and the Vdrive™ robotic navigation system and consumables.

The core components of Stereotaxis systems have received regulatory clearance in the U.S., European Union, Canada, China, Japan and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator and V-CAS™ catheter advancement system have received U.S. clearance. For more information, please visit www.stereotaxis.com.

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

CONTACT: Investor Contact:
         Martin Stammer
         Chief Financial Officer
         314-678-6155

         Investor Contact:
         Todd Kehrli / Jim Byers
         MKR Group, Inc.
         323-468-2300
         stxs@mkr-group.com

(CNAT) Emricasan Top-line Results ACLF and Organ Impairment Clinical Trials

SAN DIEGO, Jan. 5, 2015  — Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that it will report top-line results from three clinical trials in subjects with varying degrees of organ impairment – the company’s Phase 2 trial in patients with acute-on-chronic liver failure (ACLF), Phase 1 trial in patients with mild, moderate and severe hepatic impairment, and Phase 1 trial in patients with severe renal impairment – after the market close on Thursday, January 8, 2015. Conatus will host a conference call and webcast with an associated presentation at 4:30 p.m. Eastern Time on Thursday, January 8, 2015, to discuss the trial results.

To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 58431482. A live and archived audio webcast of the call will also be available in the Investor Center of the company’s website at http://ir.conatuspharma.com/events.cfm.

About Conatus Pharmaceuticals

Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease and acute exacerbations of chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding emricasan’s potential to interrupt the disease progression across the spectrum of liver disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those risks described in the company’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

CONTACT: Alan Engbring
         (858) 376-2637
         aengbring@conatuspharma.com

(NERV) Positive Data on Analog of MIN-301 In Parkinson’s

Results provide further support for research involving use of neuregulin-1 compounds in treatment of Parkinson’s and other neurodegenerative disorders

WALTHAM, Mass., Jan. 5, 2015  — Minerva Neurosciences, Inc. (Nasdaq:NERV) today announced that results from a Primomed (use of PRIMate MOdels to support translational MEDicine) non-human primate study showed that treatment with an analog of MIN-301, the company’s investigational neuregulin-1 compound, resulted in improvements in a range of symptoms associated with Parkinson’s disease in primates. MIN-301 is a recombinant form of the neuregulin-1β1 extracellular domain. The analog used in the Primomed study differs from MIN-301 by a single amino acid.

“We believe that MIN-301 and its analog are functionally identical and that this data provides further support for advancing MIN-301 into clinical trials for the treatment of Parkinson’s disease in humans,” stated Dr. Rémy Luthringer, Ph.D., president and CEO of Minerva. “We believe MIN-301 and other peptides from our neuregulin platform may represent the next generation of therapies with neuroprotective activities in Parkinson’s and other neurodegenerative disorders.”

In the pre-clinical study, Parkinson’s disease symptoms were induced in marmosets by a standard protocol using subcutaneous injections of MPTP neurotoxin. Daily treatment with either the analog or saline vehicle was initiated one week prior to Parkinson’s induction with MPTP and continued for eight weeks. In both treatment groups, disease-modifying efficacy was measured as it related to changes in clinical signs, motor symptoms and motor function. Clinical signs were scored on a semi-quantitative scale of clinical Parkinsonian symptoms. Motor symptoms were assessed using the abnormal involuntary movements scale (AIMS), which includes assessments of extremity and trunk movements, facial expressions, and movements of the lips, peri-oral area, tongue and jaw. Motor function was evaluated using the Bungalow test, which records the number of compartment changes as a measure of locomotor activity.

Subjects treated with a daily subcutaneous injection of the MIN-301 analog showed greater improvements in Parkinsonian clinical score, AIMS and locomotor activity (Bungalow test) compared to vehicle. The strongest improvements in the analog-treated population were obtained during periods of slower disease progression. Previous research in rodent models of Parkinson’s disease has shown that MIN-301 has the potential to restore motor function. Results from the Primomed study involving an analog of MIN-301 were consistent with these previous results.

Neuregulins play key roles in myelination, neuronal integrity and cognition-related signaling. Neuregulin-1 has been shown to have neurotrophic and neuroprotective effects on dopaminergic neurons. A number of studies have also demonstrated the association of neuregulin-1 with brain pathologies including schizophrenia, Alzheimer’s disease and Parkinson’s disease. These features, combined with the ability to cross the blood-brain barrier, make neuregulin-1 and its variants attractive for therapeutic purposes in Parkinson’s.

In previous research both MIN-301 and its analog have been found to have the same level of activity in vitro in phosphorylation of ErBB3 receptors. Research involving multiple pre-clinical models mimicking Parkinson’s symptoms has been carried out with MIN-301. The non-human primate MPTP model used in the Primomed study is the only animal model of early Parkinson’s that replicates the progressive development of symptoms alongside progressive neurodegeneration.

About the Primomed Project

Primomed, sponsored by the European Union, is a research project involving the use of PRIMate MOdels to support translational MEDicine and advance disease modifying therapies to address a range of unmet medical needs in the treatment of chronic inflammatory and degenerative disorders. The project works to provide clinically relevant proof of concept regarding efficacy for drug candidates and to characterize the immune responses in biological samples generated by research activities, when appropriate. Further details are available at: http://primomed.fp7sme.eu/

About Parkinson’s disease

Parkinson’s disease is a widespread and progressive neurodegenerative disorder resulting in disabling motor impairment. Parkinson’s is the most common neurodegenerative disease after Alzheimer’s disease, and currently has no cure. The average age at which symptoms begin to develop is 55–60 years. While a range of medications and surgical interventions is available to treat some of the symptoms of Parkinson’s disease, no therapy has been shown to either prevent or cure the disease. Parkinson’s disease is associated with a range of medical and societal costs, including frequent medical interventions and hospitalizations, loss of productivity, inability to work, and diminished quality of life for patients and care partners.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat central nervous system (CNS) diseases. Minerva is developing first-in-class proprietary compounds, including MIN-301, which is in preclinical development for the treatment of Parkinson’s disease, and additional candidates targeting major depressive disorder, insomnia and other CNS disorders. Minerva’s common stock is listed on the NASDAQ Global Market where it trades under the symbol “NERV.” For more information, please visit : www.minervaneurosciences.com/.

Forward-Looking Safe-Harbor Statement:

This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to whether the results of the study of the analog of MIN-301 are applicable to MIN-301; the timing and results of future clinical milestones; the timing of future clinical trials and results of clinical trials regarding MIN-301; clinical and therapeutic potential of MIN-301; our ability to successfully develop and commercialize MIN-301; and management’s ability to successfully achieve its goals. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors including, without limitation, whether the analog of MIN-301 is a good predictor of clinical efficacy of MIN-301; whether MIN-301 or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether MIN-301 and our other therapeutic products will be successfully marketed if approved; whether any of our other therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the Securities and Exchange Commission on November 6, 2014. Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

CONTACT: Media contact:
         Bill Berry
         Berry & Company Public Relations
         212-253-8881
         bberry@berrypr.com

         Investor contact:
         Renee Leck
         Stern Investor Relations
         212-362-1200
         renee@sternir.com

(BTN) Samuel C. Freitag Elected Chairman of the Board of Ballantyne Strong

William F. Welsh, II to step down as Chairman and remain as a Director

Ballantyne Strong, Inc. (NYSE MKT: BTN), a diversified provider of digital technology services, products and solutions, today announced that its board of directors has elected Samuel C. Freitag to serve as chairman of the board, effective January 1, 2015. Mr. Freitag succeeds William F. Welsh, II, who has chosen to step down as chairman while remaining as a member of the board of directors. Mr. Welsh, age 73, has served as chairman of the board of Ballantyne Strong since 2000.

“Since joining the board of Ballantyne Strong in 2011, Sam has demonstrated exceptional leadership capabilities and the skill set required to be an effective chairman of the board,” said Mr. Welsh. “We determined that it’s a good time to transition to new leadership at the board level and we have great confidence in Sam to help guide the continued transition of Ballantyne to a more diversified business model and oversee the growth of our digital media business. It will be my privilege to continue serving as a member of the board and working with the other directors to guide the execution of our strategic plan for enhancing shareholder value.”

“We would like to thank Bill Welsh for his many years of distinguished service as Ballantyne’s chairman and we are very pleased that he will continue to be a valuable member of the board,” said Mr. Freitag. “I am excited to assume the role of chairman at such an important time in Ballantyne’s history. We have made a great deal of progress in positioning the company for long-term success by entering new markets with strong opportunities for future growth. I look forward to working with my fellow board members and the management team to execute on our vision for Ballantyne and creating value for shareholders in the future.”

Samuel C. Freitag, age 58, has been an independent private investor since January 2004. From July 2002 to December 2003, he was President of McCarthy Capital Corporation, a private equity fund manager with approximately $300 million in capital. From 1986 until 1997, he held various positions with George K. Baum Merchant Bank, LLC, including serving as Senior Managing Director and Director, Investment Banking. Mr. Freitag has served as a director of Ballantyne since June 2011 and has been a member of the Audit, Compensation, and Nominating and Corporate Governance committees.

About Ballantyne Strong, Inc. (www.strong-world.com)

Ballantyne Strong designs, integrates, and installs technology solutions for a broad range of applications; develops and delivers out-of-home messaging, advertising and communications; manufactures projection screens and lighting products; and provides managed services including monitoring of networked equipment. The Company focuses on serving the retail, financial, government and cinema markets.

Forward-Looking Statements

Except for the historical information in this press release, it includes forward-looking statements that involve risks and uncertainties, including but not limited to, quarterly fluctuations in results; customer demand for the Company’s products; the development of new technology for alternate means of motion picture presentation; domestic and international economic conditions; the management of growth; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings. Actual results may differ materially from management’s expectations.

(RGLD) Announces Fiscal 2015 Second Quarter Earnings Call

Royal Gold, Inc. (NASDAQ: RGLD)(TSX: RGL) today announced that its second quarter fiscal 2015 results will be released before the market opens for trading on Thursday, January 29, 2015, followed by a conference call that day at noon Eastern Time (10:00 a.m. Mountain Time). The call will be webcast and archived on the Company’s website for a limited time.

Fiscal 2015 Second Quarter Earnings Call Information:

About Royal Gold

Royal Gold is a precious metals royalty and stream company engaged in the acquisition and management of precious metal royalties, streams and similar production based interests. The Company owns interests on 198 properties on six continents, including interests on 37 producing mines and 24 development stage projects. Royal Gold is publicly traded on the NASDAQ Global Select Market under the symbol “RGLD,” and on the Toronto Stock Exchange under the symbol “RGL.” The Company’s website is located at www.royalgold.com.

Royal Gold
Karli Anderson, 303-575-6517
Vice President Investor Relations

(WLB) Completes Oxford Transactions and Acquires Buckingham Coal Company

Transactions pave the way for Westmoreland to unlock value through MLP drop-down strategy and complement stable cash flow-generating business model

Westmoreland Coal Company (NasdaqGM: WLB, “Westmoreland”), Oxford Resource Partners, LP (NYSE: OXF, the “MLP”) and Oxford Resources GP, LLC, the general partner of Oxford (the “GP”), today announced the completion of Westmoreland’s acquisition of the GP and Westmoreland’s contribution of certain royalty-bearing coal reserves to the MLP in return for MLP common units (the “Contribution”), as well as Westmoreland’s acquisition of Buckingham Coal Company, LLC.

The completion of the GP acquisition and the Contribution provide Westmoreland with a platform to implement a value-creating drop-down strategy, pursuant to which it intends to periodically contribute certain U.S. and Canadian coal assets to the MLP in exchange for a combination of cash and additional limited partner interests. Westmoreland expects these transactions to unlock value that is inherent in Westmoreland’s stable cash flow-generating business model, to the benefit of both its stakeholders and the MLP’s unitholders. The MLP will continue to operate as a stand-alone, publicly traded master limited partnership, with Westmoreland owning 77% of the fully diluted limited partner interests.

“We are pleased that these strategic transactions have come to a successful close and excited for Westmoreland to enter the MLP space,” stated Keith E. Alessi, Westmoreland’s Chief Executive Officer. “We believe our strategy with respect to the MLP will help ensure our continued long-term growth.”

“Oxford is very pleased that it has been able to join with Westmoreland,” said Oxford’s President and Chief Executive Officer, Charles C. Ungurean. “This is the culmination of our efforts to bring increased value to our unitholders. We believe that this represents a great opportunity for our company, unitholders, employees and customers, as well as providing a MLP vehicle for Westmoreland and its shareholders. This represents a win for all stakeholders.”

Westmoreland paid a total of $30.0 million in cash to acquire the GP, and received 4,512,500 common units of the MLP (on a post-split basis following the previously disclosed 12-to-1 reverse split of the MLP’s common and general partner units) as consideration for the Contribution. The closing of these transactions followed the successful restructuring of both Westmoreland’s and the MLP’s debt arrangements, as well as the approval by the MLP’s public unitholders of the Contribution and the MLP’s equity restructuring through certain previously announced amendments to its partnership agreement.

In connection with the closing, the MLP’s name was changed to Westmoreland Resource Partners, LP (“Westmoreland LP”) and the name of the GP was changed to Westmoreland Resources GP, LLC. The common units of Westmoreland LP will trade on the NYSE under the symbol “WMLP”.

On January 1, 2015, Westmoreland also completed its acquisition of Buckingham Coal Company, LLC, an Ohio-based coal supplier, for a total cash purchase price of $34.0 million, subject to customary post-closing adjustments. Separately, an affiliate of Westmoreland entered into a five-year coal supply agreement with AEP Generation Resources Inc. (“AEP”), which includes an obligation to purchase a minimum of 5.5 million tons of coal.

“Westmoreland is happy to implement a long-term supply relationship with AEP,” said Mr. Alessi. “We were able to realize significant cost savings through this acquisition and we expect our supply agreement will provide additional value to our shareholders,” he added.

About Westmoreland Coal Company

Westmoreland Coal Company is the oldest independent coal company in the United States. Westmoreland’s coal operations include sub-bituminous and lignite coal mining in the Western United States and Canada, a char production facility, and a 50% interest in an activated carbon plant. Its power operations include ownership of the two-unit ROVA coal-fired power plant in North Carolina. For more information, visit www.westmoreland.com.

About Oxford Resource Partners, LP

Oxford Resource Partners, LP is a low-cost producer of high-value steam coal in Northern Appalachia. Oxford markets its coal primarily to large electric utilities with coal-fired, base-load scrubbed power plants under long-term coal sales contracts. For more information, visit www.oxfordresources.com.

Cautionary Note Regarding Forward-Looking Statements

This release may contain “forward-looking statements.” Forward-looking statements can be identified by words such as “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects” and similar references to future periods. These statements involve known and unknown risks, which may cause actual results to differ materially from results expressed or implied by the forward-looking statements. These risks include factors such as the uncertainty of negotiations to result in agreements or completed transactions, the uncertain nature of the expected benefits from the actual or expected transactions, the uncertain nature of the announced transactions, the ability to complete such transactions, risks associated with the integration of acquired assets, risks associated with the coal industry or the economy generally, and other such matters discussed in the “Risk Factors” sections of both Westmoreland’s and Oxford’s 2013 annual reports on Form 10-K and their subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. The forward-looking statements in this release speak only as of the date of this release. Although either or both of Westmoreland and Oxford may from time to time voluntarily update their prior forward-looking statements, they disclaim any commitment to do so except as required by securities laws.

(OCUL) to Present at Oppenheimer 25th Annual Healthcare Conference

Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Amar Sawhney, Ph.D., President and Chief Executive Officer, will present a corporate overview at the Oppenheimer 25th Annual Healthcare Conference on Thursday, December 11, 2014 at 3:20 p.m. Eastern Time at the Crowne Plaza Hotel in New York City.

The audio-only presentation will be accessible live on Ocular Therapeutix’s website at investors.ocutx.com under Investor Events and will be available for 90 days following the presentation. A copy of the investor presentation will also be made available upon written request.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidates are in Phase 3 clinical development for post-surgical ocular inflammation and pain, and Phase 2 clinical development for glaucoma and allergic conjunctivitis. The Company is also evaluating sustained-release injectable anti-VEGF drug depots for back-of-the-eye diseases. Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.