(PAVMU) to Present at 2016 Marcum MicroCap Conference on June 2, 2016

PAVmed Inc. (Nasdaq:PAVMU), an innovative, multi-product medical device company developing and commercializing a diversified pipeline of innovative products utilizing a groundbreaking business model focused on capital efficiency and speed to market, today announced that Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer, will present at the 2016 Marcum MicroCap Conference on Thursday, June 2, 2016, at 3:30pm ET taking place in New York City. Dr. Aklog will provide a corporate overview, discuss the company’s innovative business model and review PAVmed’s five lead products.

To access the live webcast of the presentation, please click here. A replay will be available following the presentation.

About PAVmed

PAVmed Inc. is an innovative, multi-product medical device company developing and commercializing a diversified pipeline of innovative products which address unmet clinical needs. The Company’s goal is to enhance and accelerate value creation by employing a business model focused on capital efficiency and speed to market. PAVmed is building a deep development product pipeline with attractive regulatory pathways and market opportunities encompassing a broad spectrum of clinical areas including carpal tunnel syndrome, medical infusions, interventional radiology, tissue ablation, and cardiovascular intervention. The Company is further expanding its pipeline through engagements with clinician innovators and leading academic medical centers.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of the Company’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements.

For PAVmed:
Investors:
Matthew Ventimiglia, 212-599-1265
mventimiglia@lazarpartners.com
or
Media:
Erich Sandoval, 213-908-6226
esandoval@lazarpartners.com

(ERN) Announces Results of Annual Meeting of Shareholders

Erin Energy Corporation (“Erin Energy” or the “Company”) (NYSE MKT:ERN) (JSE:ERN) announced today the results of the Company’s Annual Meeting of Shareholders held on May 25, 2016 and changes to its board of directors (Board) and management team.

• John Hofmeister named Chairman of the Board
• Segun Omidele named CEO
• Pannell Kerr Foster of Texas, P.C. appointed as the Company’s auditors for 2016

Chairman of Erin Energy, John Hofmeister commented: “It is an honor to inherit the determined leadership of our former Chairman, Kase Lawal. Despite challenging market conditions we will pursue both near and longer term opportunities to strengthen and grow the Company and to reward shareholders with sustained value creating initiatives. Our Board, new Chief Executive, Segun Omidele, other executive leaders, Erin Energy people, plans, and assets are aligned, organized and focused on the tasks at hand to do just that.”

Mr. Segun Omidele has been with Erin Energy since 2011 and previously served as its COO. He will now assume the role of CEO and serve as an executive director on the Company’s Board. Prior to Erin Energy, Mr. Omidele worked for 28 years with Shell in various leadership roles.

Mr. Michael Stinson and Mr. Omidele were elected to fill vacancies resulting from the retirement of Dr. Kase Lawal and Ms. Hazel O’Leary. Mr. Stinson gained more than 37 years of multi-national E&P experience from a career at ConocoPhillips and its predecessor company, Conoco, Inc. Mr. Stinson’s operational experience is substantial in the fields of exploration and production, pipelines and storage, natural gas, gas liquids processing and commercial operations, and marine scheduling. He has extensive capabilities in new business development, mergers and acquisitions, corporate planning, and corporate communications. He will serve on the Company’s Board as an independent director.

About Erin Energy

Erin Energy Corporation is an independent oil and gas exploration and production company focused on energy resources in sub-Saharan Africa. Its asset portfolio consists of 9 licenses across 4 countries covering an area of 40,000 square kilometers (10 million acres), including current production and other exploration projects offshore Nigeria, as well as exploration licenses offshore Ghana, Kenya and Gambia, and onshore Kenya. Erin Energy is headquartered in Houston, Texas, and is listed on the New York and Johannesburg Stock Exchanges under the ticker symbol ERN.

(FLXN) Positive Guidance from FDA on Zilretta™ for Osteoarthritis NDA

BURLINGTON, Mass., May 26, 2016  — Flexion Therapeutics, Inc. (Nasdaq:FLXN) announces that yesterday it received written responses from the U.S. Food & Drug Administration (FDA) to questions the company had submitted in advance of a pre-NDA meeting regarding Flexion’s lead product candidate, Zilretta (also known as FX006). The FDA clearly indicates in its responses that the safety and efficacy data from the registration program for Zilretta are “acceptable to support filing of an NDA submission.” Based on this positive FDA feedback, the in-person pre-NDA meeting has become unnecessary and the FDA responses will serve as the official meeting minutes.

Michael Clayman, M.D., President and Chief Executive Officer of Flexion, stated, “The endorsement from the FDA for the Zilretta NDA submission represents a major milestone in the development of this drug candidate and brings us one step closer to making it available to the many millions of knee osteoarthritis (OA) patients who lack good pain-relief options. We intend to submit the NDA in the fourth quarter of this year.”

About Zilretta

Zilretta is being investigated as the first intra-articular sustained-release, non-opioid treatment for patients with moderate to severe knee OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.

To date, more than 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta and its market potential; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

Media Contact
Mariann Caprino
TogoRun
T: 917.242.1087  
M.Caprino@togorun.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com

(NERV) Positive Results, Phase IIB Trial of MIN-101, Phase IIA Trial of MIN-117

Positive Results From Phase IIB Trial of MIN-101 Monotherapy in Schizophrenia

MIN-101 meets primary and secondary endpoints

• Statistically significant improvement in PANSS negative symptoms and total PANSS scores observed
• MIN-101 shown to be statistically superior on key secondary endpoints
• Effect of MIN-101 demonstrated to be specific for negative symptoms and not secondary to improvement in other symptoms

WALTHAM, Mass., May 26, 2016  — Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced positive top line results from a prospective Phase IIb, 12-week, randomized, double-blind, placebo-controlled parallel clinical trial evaluating the efficacy, safety and tolerability of MIN-101 in patients with negative symptoms of schizophrenia.  These negative symptoms, for which no approved treatment is currently available, affect the majority of schizophrenic patients and can persist over their lifetimes.

The study successfully achieved its primary endpoint, demonstrating the statistically significant benefit of MIN-101 over placebo in improving negative symptoms as measured by the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS). The effect was shown for both doses tested: 32 mg: p less than or equal to 0.022 with an effect size of 0.45, and 64 mg: p less than or equal to 0.003 with effect size of 0.58.

The study also demonstrated statistically significant benefit of MIN-101 over placebo on the PANSS three factors negative symptoms subscale for both doses tested: 32 mg: p less than or equal to 0.006, with an effect size of 0.55, and 64 mg: p less than or equal to 0.001 with an effect size of 0.70. Furthermore, the statistically significant benefit of MIN-101 over placebo was demonstrated on the PANSS total score (not significant for the 32 mg dose; p less than or equal to 0.003 for the 64 mg dose), with effect sizes of 0.35 and 0.59, respectively.

The consistency and robustness of the effect was also supported by the demonstrated statistically significant benefit of MIN-101 over placebo in multiple secondary endpoints as measured by the following: the PANSS general psychopathology subscale, Brief Negative Symptoms Scale (BNSS) total score, Clinical Global Impression of Severity (CGI-S), Clinical Global Impression of Improvement (CGI-I), Personal and Social Performance (PSP) total score and Brief Assessment of Cognition in Schizophrenia (BACS). Positive symptoms were observed to remain stable, and the absence of extra-pyramidal symptoms throughout the three month trial is consistent with the hypothesis that MIN-101 has a direct and specific effect on negative symptoms rather than an indirect effect mediated by improvements of positive symptoms.

MIN-101 was generally reported to be well tolerated, and the incidence and types of side effects did not differ significantly between the MIN-101 group and the placebo group. Based upon previous non-clinical and clinical experience, QTcF, a measurement of cardiac function, was closely monitored. Discontinuation criteria based on QTcF prolongation were incorporated in the protocol. Two patients out of 162 who received MIN-101 were discontinued based upon these criteria; both of these patients received the higher dose (64 mg). Unlike many currently marketed antipsychotic drugs, no metabolic adverse effects, no weight gain and no extra-pyramidal symptoms were observed.

“We believe the results from this trial constitute a key step forward in the development of a novel treatment for schizophrenia and specifically the negative symptoms of the disease, which represent a significant unmet medical need,” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “Negative symptoms contribute substantially to poor quality of life and functional outcomes of schizophrenic patients.

“We also observed consistent improvements in multiple secondary endpoints,” said Dr. Luthringer.  “This broad impact underscores the potential of MIN-101, a molecule that combines sigma2 antagonism and 5-HT2a antagonism, as a promising differentiated treatment for a debilitating disease affecting large numbers of underserved patients worldwide.  Because negative symptoms are not only present in schizophrenia but also in brain degenerative disorders and other mental illnesses, we believe that MIN-101 may be a candidate for the potential treatment of other indications.”

About this study (https://www.clinicaltrialsregister.eu, EudraCT Number: 2014-004878-42)

This was a prospective trial designed to evaluate the efficacy of MIN-101 monotherapy on negative symptoms using the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS) as the primary endpoint. A total of 244 patients were randomized in equal groups to receive daily doses of MIN-101 32 mg, MIN-101 64 mg or placebo at 32 clinical sites in Russia and five European countries. To participate in the trial, patients were required to have stable positive and negative symptoms for three months prior to entry, a PANSS negative sub-score greater than or equal to 20, and scores < 4 on the following PANSS items: excitement, hyperactivity, hostility, suspiciousness, uncooperativeness and poor impulse control.  All three cohorts were balanced with respect to demographic and baseline disease characteristics.

Secondary and exploratory outcomes included PANSS total and subscale scores, the Brief Assessment of Cognition in Schizophrenia (BACS), Brief Negative Symptoms Scale (BNSS), Clinical Global Impression of Severity (CGI-S), Clinical Global Impression of Improvement (CGI-I), the Calgary Depression Scale for Schizophrenia (CDSS), the Personal and Social Performance (PSP), and the Pittsburgh Sleep Quality Index (PSQI).

Patients who completed the 12-week double-blind core phase of this study were provided the opportunity to enter into the ongoing 24-week, open-label extension phase, which will provide additional long term safety and efficacy data.  During the extension phase, all patients are receiving either 32 mg or 64 mg of MIN-101.  Patients who received placebo in the core study were randomized to one of these two doses.   The extension phase is expected to be completed during the third quarter of 2016.

About schizophrenia and the impact of negative symptoms

Schizophrenia remains among the top ten disabling conditions worldwide for young adults and affects more than 21 million people worldwide.  According to Datamonitor, an independent market research firm, in 2015 approximately 3.2 million people suffered from schizophrenia in the United States, Japan and the five major European Union markets of France, Germany, Italy, Spain and the United Kingdom.

Although positive psychotic symptoms are characteristic of schizophrenia, negative symptoms constitute the main burden of illness, represent an important treatment target and are responsible for the poor vocational and social capabilities of these patients.  These symptoms, which include a-motivation, avolition, lack of initiative, and restricted personal interaction, are associated with poor psychosocial functioning.

Most current pharmacological therapies ameliorate positive, psychotic symptoms in most but not all schizophrenic patients.  However, there currently exists no effective treatment for negative symptoms.

About MIN-101

MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5-hydroxytryptamine-2A (5-HT_2A) and lower affinity at alpha 1-adrenergic receptors. In preclinical studies and in a phase IIa trial, MIN-101 showed significant efficacy against negative symptoms.

Positive Results in Phase IIA Trial of MIN-117 in Major Depressive Disorder

MIN-117 meets primary and secondary endpoints

• Reduction in depressive symptoms demonstrated
  
• Good tolerability and safety profile observed
• Positive effect on sleep architecture shown
• Differentiated mechanism of action

WALTHAM, Mass., May 26, 2016  — Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced positive top line results from a Phase IIa clinical trial in major depressive disorder (MDD) with MIN-117, an antidepressant drug candidate with a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine transporter.

Results demonstrated dose-dependent superiority of MIN-117 over placebo as measured by change in the Montgomery-Asberg Depression Rating Scale (MADRS).  Data show that MIN-117 at the 0.5 milligrams (mg) daily dose had an effect size (magnitude of difference) as compared to the placebo group of 0.23 while the 2.5 mg daily dose had an effect size of 0.33.  This magnitude of effect size is similar to those observed with currently marketed antidepressants.  Improvement in MADRS with MIN-117 against placebo was observed at two weeks. Furthermore, data also show that 24 percent of the patients treated with 2.5 mg of MIN-117 achieved remission as prospectively defined.

Both doses of MIN-117 demonstrated a favorable tolerability profile, and the incidence and types of side effects did not differ significantly between the MIN-117 group and the placebo group.  No unexpected adverse events were reported. Preliminary analysis shows that treatment with MIN-117 is not associated with cognitive impairment, sexual dysfunction, suicidal ideation or weight gain.

Pharmacodynamic measurements based on sleep recordings show that MIN-117 preserved sleep continuity and architecture and therefore is not expected to have detrimental effects on rapid eye movement (REM) sleep distribution and duration unlike most marketed antidepressants.

“We believe these results show a meaningful clinical benefit and support further development of MIN-117, an antidepressant with a differentiated mechanism of action and a favorable tolerability profile,” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “These promising results, combined with the drug’s distinctive pharmacology, lay the foundation to potentially address unmet needs not currently served by existing therapies in the treatment of mood disorders and other central nervous system indications.”

About this study (https://www.clinicaltrials register.eu, EudraCT Number: 2015-000306-18)

This study was a four-arm, parallel-group, randomized double-blind, placebo- and positive-control trial which tested two daily administered doses of MIN-117: 0.5 mg and 2.5 mg. The study included 84 patients (21 per arm) with moderate to severe MDD in four European countries. The goals of the trial were to test efficacy, safety and tolerability of MIN-117 over six weeks of treatment. The antidepressant paroxetine was used as an active control and confirmed assay sensitivity. Change on the MADRS, a scale measuring severity of depression, was used as the main outcome measurement. As established prospectively in the statistical analysis plan, this trial was designed for signal detection and effect size estimation.  As such, the study was not powered to demonstrate statistically significant differences between MIN-117 and placebo.

About Major Depressive Disorder

Major depressive disorder (also referred to as major depression) is one of the most common mental disorders worldwide, with an estimated 350 million people affected. According to the World Health Organization, it is the leading cause of disability worldwide and a major contributor to the overall global disease burden. In the U.S. in 2014, an estimated 15.7 million adults aged 18 or older, representing 6.7 percent of all adults, had at least one major depressive in the past. Shortcomings of many current antidepressant therapies include a large number of treatment non-responders, delayed onset of action, sexual dysfunction and weight gain, all potentially leading to poor compliance with therapy.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of products to treat CNS diseases.  Minerva’s proprietary compounds include: MIN-101, in Phase IIb development for schizophrenia; MIN-202 (JNJ-42847922), which has completed Phase IIa and Phase Ib clinical trials in insomnia and the adjunctive treatment of major depressive disorder (MDD), respectively; MIN-117, in Phase IIa development for MDD; and MIN-301, in pre-clinical development for Parkinson’s disease.  Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.”  For more information, please visitwww.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 the timing and results of future clinical milestones with MIN-117; the clinical and therapeutic potential of MIN-117; our ability to successfully develop and commercialize MIN-117; and management’s ability to successfully achieve its goals.  These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether MIN-117 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN-117, if any, will be consistent with the results of past clinical trials; whether MIN-117 will be successfully marketed if approved; whether our therapeutic product discovery and development efforts with MIN-117 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 March 31, 2016, filed with the Securities and Exchange Commission on May 3, 2016.  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:

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376

(AXAS) Exercise of Over-Allotment Option and Closing of Public Offering

Abraxas Petroleum Corporation (“Abraxas” or the “Company”) (NASDAQ:AXAS) today announced the closing of its public offering of 28,750,000 shares of common stock including 3,750,000 shares sold pursuant to the full exercise of the underwriters option to purchase additional shares at a price of $1.00 per share, less applicable underwriting discounts.

The offering was made pursuant to an effective shelf registration statement on Form S-3 previously filed by the Company with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. This offering was made by means of a prospectus supplement and related base prospectus.

Johnson Rice & Company L.L.C., Canaccord Genuity Inc. and Stephens Inc. are acting as joint book-running managers for the offering. Copies of the preliminary prospectus supplement for the offering may be obtained on the website of the Securities and Exchange Commission, www.sec.gov, or by contacting Johnson Rice & Company L.L.C., ATTN: Syndicate Department, 639 Loyola Avenue, Suite 2775, New Orleans, LA 70113, or by telephone at (800) 443-5924; Canaccord Genuity Inc., ATTN: Syndicate Department, 99 High Street, 12th Floor, Boston, MA 02110, or by telephone at (617) 371-3900; or Stephens Inc.’s Prospectus Department at Stephens Inc., 111 Center Street, Little Rock, AR 72201, ATTN: Prospectus Department (prospectus@stephens.com) or by telephone at (501) 377-2131.

The common stock will be issued and sold pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. This offering may only be made by means of a prospectus supplement and related base prospectus.

Abraxas Petroleum Corporation is a San Antonio based crude oil and natural gas exploration and production company with operations across the Rocky Mountain, Permian Basin and onshore Gulf Coast regions of the United States.

Safe Harbor for forward-looking statements: Statements in this release looking forward in time involve known and unknown risks and uncertainties, which may cause Abraxas’ actual results in future periods to be materially different from any future performance suggested in this release. Such factors may include, but may not be necessarily limited to, changes in the prices received by Abraxas for crude oil and natural gas. In addition, Abraxas’ future crude oil and natural gas production is highly dependent upon Abraxas’ level of success in acquiring or finding additional reserves. Further, Abraxas operates in an industry sector where the value of securities is highly volatile and may be influenced by economic and other factors beyond Abraxas’ control. In the context of forward-looking information provided for in this release, reference is made to the discussion of risk factors detailed in Abraxas’ filings with the Securities and Exchange Commission during the past 12 months.

(CLRB) USPTO Issues Patent for New Phospholipid Drug Conjugate (PDC) with Paclitaxel

Patent Covers Paclitaxel  Drug Conjugate for Targeted Delivery of Paclitaxel to Cancer Cells

MADISON, Wis., May 25, 2016  — Cellectar Biosciences, Inc. (Nasdaq:CLRB) (“the Company”), an oncology-focused biotechnology company, today announces that the United States Patent and Trademark Office has issued U.S. Patent No. 9,345,718 on May 24, 2016, which covers CLR 1603, a phospholipid ether-paclitaxel conjugate.

This specific PDC product patent is based on one of a series of patent applications designed to protect both composition of matter and method of use for phospholipid drug conjugates, or PDCs, developed with Cellectar’s proprietary phospholipid-ether delivery vehicle conjugated with any existing or future cytotoxic agents, including chemotherapeutics such as paclitaxel, for targeted delivery to cancer cells and cancer stem cells.  Phospholipid ethers act as a cancer targeting drug vehicle delivering cytotoxic compounds like paclitaxel directly to cancer cells, thus limiting the drug’s exposure to healthy cells and increasing the potency of the drug at lower concentrations.

“This first issued patent under our CLR CTX Chemotherapeutic program provides Cellectar and any future partners intellectual property (IP) protection through at least November 2035, allowing significant runway for product development and commercialization,” said Jim Caruso, president and CEO of Cellectar.  “Importantly, this IP protection further validates our delivery platform and strengthens the value-optimizing potential of our CLR CTX chemotherapeutic conjugate R&D program.”

The objective of the CLR CTX franchise is to develop PDC chemotherapeutics through conjugation of non-targeted anti-cancer agents with the Company’s novel delivery vehicle with the goal of improving therapeutic indices, enhancing product profiles and expanding potential indications through targeted cancer cell delivery of chemotherapeutic payloads.

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s PDC platform has demonstrated highly selective cancer targeting both preclinically in over 60 in vivo cancer models, and subsequently confirmed clinically in over 10 cancer types. The platform’s payload diversity has been validated using cytotoxic radioisotopes for cancer therapy; PET imaging isotopes for cancer imaging; fluorophores for image-guided surgery, and the company has recently expanded its payload portfolio to chemotherapeutics with further research of paclitaxel and other non-targeted anti-cancer agents through both in-house and collaborative R&D efforts.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

INVESTOR AND MEDIA CONTACT:

Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

(NNDM) and Accellta Joined Forces to Successfully BioPrint Stem Cell-Derived Tissues

By Combining high speed, high precision inkjet with massive stem cell production and differentiation technologies the companies plan to enable high volume advanced 3D bioprinting

NESS ZIONA, Israel, May 25, 2016  — Nano Dimension Ltd. (NASDAQ, TASE: NNDM), a leader in the area of 3D Printed Electronics, today announced it has successfully lab-tested a proof of concept 3D Bioprinter for stem cells. The trial was conducted in collaboration with Accellta Ltd., a company headquartered in Haifa, Israel, that has developed proprietary technologies for the unique production of high quality media, stem cells, progenitors and differentiated cells for drug discovery, regenerative medicine and research.

The feasibility study, conducted in Q2 2016, confirmed that the combined know-how and technologies of the companies enabled printing of viable stem cells using an adapted 3D printer.

“3D printing of living cells is a technology that is already playing a significant role in medical research, but in order to reach its full potential, for the field to evolve further, there is a need to improve printing speeds, print resolution, cell control and viability as well as cell availability and bio-ink technologies,” said Amit Dror, CEO of Nano Dimension. “By combining our high speed, high precision inkjet capabilities with Accellta’s stem cell suspension technologies and induced differentiation capabilities led by a world-renown group of experienced engineers and scientists, we can enable 3D printing at high resolution and high volumes.”

The companies will consider the formation of a new entity for these future solutions and do not intend to invest significant capital directly to expand this activity. Such funds would be raised by and for the use of the joint entity.

3D bioprinting enabled by the two companies’ technologies, means that Nano Dimension and Accellta have the potential to accelerate high fidelity and high viability manufacturing of living cellular products. Accellta’s unique, robust and reproducible suspension-based cell culturing systems produce billions of high quality stem cells per batch and represent a transformative step in terms of stem cell production. Accellta’s technology can deliver large quantities of high quality cells which can be an enabler for printing even large and complex tissues and organs.

“Accellta and Nano Dimension have joined forces in this initial trial to evaluate and adapt the joint potential of our technologies. We hope and believe that this will bring the mutual capabilities and know-how of both companies to create 3D bioprinting solutions that combine a high precision, high-throughput printer with dedicated bio-ink technologies, derived from stem cells,” said Dr. Itzchak Angel, Chairman and CEO of Accellta. “By enabling high precision 3D bioprinting and differentiation of stem cells into required tissues, our combined technologies have the potential to enable vast areas of development. We are very excited about these initial results and what the future holds.”

IDTechEx forecasts the market for 3D bioprinting to grow rapidly over the next decade from a market size of USD $481 million in 2014 to as much as USD $6 billion in 2024. Developments in these emerging fields are progressing at a swift pace, and the healthcare industry is clamoring to participate. The technology has tremendous value for areas such as pre-clinical drug discovery and testing, cosmetics safety testing, toxicology assays, tissue printing and ‘organs on chips’.

Advanced 3D inkjet technology, the core competence of Nano Dimension, enables rapid printing of complex multi-material objects such as those needed for next generation bioprinting. Nano Dimension’s novel capabilities, developed for its state-of-the-art 3D printed electronics technology for printed circuit boards (PCBs) may pave the way to other advanced multi-material printing domains such as 3D bioprinting. This latest development is consistent with Nano Dimension’s strategy of offering commercial solutions to help companies and partners develop innovative products through advanced 3D printing and multi-material technology.

About Nano Dimension Ltd.

Nano Dimension, founded in 2012, focuses on development of advanced 3D printed electronics systems and advanced additive manufacturing. Nano Dimension’s unique products combine three advanced technologies: 3D inkjet, 3D software and nanomaterials. The company’s primary products include the first 3D printer dedicated to printing multi-layer PCBs (printed circuit boards) and advanced nanotechnology-based conductive and dielectric inks.

In addition to the trading of the company’s American Depositary Shares on NASDAQ, the company’s ordinary shares are also traded on the TASE in Israel. The Bank of New York Mellon serves as the depositary for Nano Dimension.

About Accellta

The company was founded in 2012 by the Alfred Mann Institute at Technion (AMIT) on the basis of two decades of research at the Stem Cell Center in the Technion’s Rappaport Faculty of Medicine. Amongst its shareholders are the Technion Fund, the AMIT and Horizons Ventures. Accellta specializes in innovative, high quality and cost-effective media and custom-made technologies for culturing and differentiation of human stem cells in unique 3D suspension culture systems, using bioreactors, with no animal products, no feeder cells or micro-carriers and serum-free. The company presently sells and markets several media formulations, through several agreements with major companies, as based on their proprietary patents. The potential uses of culturing and differentiation of very high quantities and densities of consistent, well-defined and homogeneous cell population are numerous, and include the development of cell-based medical therapies, research tools and methods, drug screening and development (as an alternative for animal-based assays), bio-fabrication and tissue engineering.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Because such statements deal with future events and are based on Nano Dimension’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Nano Dimension could differ materially from those described in or implied by the statements in this press release.

For example, Nano Dimension is using forward-looking statements when it discusses collaboration with Accellta, the potential of such collaboration, the formation of a new entity for future solutions and funding for such entity. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Nano Dimension’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 8, 2016, and in any subsequent filings with the SEC. Except as otherwise required by law, Nano Dimension undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

CONTACT INVESTOR RELATIONS:
Miri Segal-Scharia
Hayden/ MS-IR LLC
917-607-8654
msegal@ms-ir.com

(PEIX) to Participate in the 13th Annual Craig-Hallum Institutional Investor Conference

SACRAMENTO, Calif., May 25, 2016  — Pacific Ethanol, Inc. (NASDAQ:PEIX), a leading producer and marketer of low-carbon renewable fuels in the United States, announced it will participate in the 13^th Annual Craig-Hallum Institutional Investor Conference on June 1^st in Minneapolis, MN.

CFO Bryon McGregor will host one-on-one meetings throughout the day. To schedule a meeting, please contact your Craig-Hallum representative or call Becky Herrick of LHA at (415) 433-3777. A copy of management’s most recent investor presentation will be available online in the investor section of Pacific Ethanol’s website at www.pacificethanol.com.

About Pacific Ethanol, Inc.
Pacific Ethanol, Inc. (PEIX) is the leading producer and marketer of low-carbon renewable fuels in the Western United States. With the addition of four Midwestern ethanol plants in July 2015, Pacific Ethanol more than doubled the scale of its operations, entered new markets, and expanded its mission to advance its position as an industry leader in the production and marketing of low carbon renewable fuels. Pacific Ethanol owns and operates eight ethanol production facilities, four in the Western states of California, Oregon and Idaho, and four in the Midwestern states of Illinois and Nebraska. The plants have a combined production capacity of 515 million gallons per year, produce over one million tons per year of ethanol co-products such as wet and dry distillers grains, wet and dry corn gluten feed, condensed distillers solubles, corn gluten meal, corn germ, corn oil, distillers yeast and CO₂. Pacific Ethanol markets and distributes ethanol and co-products domestically and internationally. Pacific Ethanol’s subsidiary, Kinergy Marketing LLC, markets all ethanol for Pacific Ethanol’s plants as well as for third parties, with over 800 million gallons of ethanol marketed annually based on historical volumes. Pacific Ethanol’s subsidiary, Pacific Ag. Products LLC, markets wet and dry distillers grains. For more information please visit www.pacificethanol.com.

Company IR Contact:
Pacific Ethanol, Inc.
916-403-2755
866-508-4969
Investorrelations@pacificethanol.com

IR Agency Contact:
Becky Herrick
LHA
415-433-3777

Media Contact:
Paul Koehler
Pacific Ethanol, Inc.
916-403-2790
paulk@pacificethanol.com

(SRPT) Announces FDA Will Not Complete Review of Eteplirsen NDA

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they are continuing their review and internal discussions related to our pending NDA for eteplirsen and will not be able to complete their work by the Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016. The FDA has communicated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.

About Sarepta Therapeutics

Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of rare, infectious and other diseases. For more information, please visit us at www.sarepta.com.

About Eteplirsen

Eteplirsen is designed to address the underlying cause of DMD by restoring the dystrophin messenger RNA (mRNA) reading frame, thus enabling the production of a shorter, functional form of the dystrophin protein. Eteplirsen uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. Approximately 13 percent of the DMD population is amenable to exon 51 skipping. Data from clinical studies of eteplirsen in DMD patients have demonstrated a consistent safety and tolerability profile and have also shown measurable dystrophin protein expression. Promoting the synthesis of a shorter dystrophin protein is intended to slow the decline of ambulation and mobility seen in DMD patients. There currently is no approved treatment in the United States for DMD and eteplirsen has not been approved by the FDA or any regulatory authority for the treatment of DMD.

About Duchenne Muscular Dystrophy

DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500-5,000 males worldwide. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and death usually occurs before the age of 30.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the FDA not completing its review of the eteplirsen NDA by the PDUFA date of May 26, 2016, additional review and internal FDA discussions relating to the NDA, and the timing for the FDA completing its work and reaching a decision with respect to the Company’s eteplirsen NDA. Forward-looking statements also include those regarding Sarepta’s future business developments and actions and the timing of the same.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the FDA may further delay its decision on the eteplirsen NDA or may not provide marketing approval for eteplirsen; we may not be able to comply with all FDA requests, including with respect to our eteplirsen NDA submission and the addendums we have submitted to the FDA or with respect to our ongoing or planned clinical trials, in a timely manner or at all; we may not be able to complete clinical trials required by the FDA for approval of our products or any submissions made in connection with our pipeline of product candidates; the results of our ongoing research and development efforts and clinical trials for our product candidates including eteplirsen and our technologies may not be positive or consistent with prior results or demonstrate a safe treatment benefit or support an NDA filing, positive advisory committee recommendation or marketing approval by the FDA or other regulatory authority; we may not be able to execute on our business plans including meeting our expected or planned regulatory milestones and timelines, clinical development plans and bringing our product candidates to market, including the planned commercialization of eteplirsen, for various reasons, including factors outside of the Company’s control, including possible limitations of Company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner or at all, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K for the year ended December 31, 2015 or Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the Company’s filings with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Internet Posting of Information

We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

(INNL) Announces XARACOLL® Meets Primary Endpoint in Both Pivotal Phase 3 Trials

• First long-acting, opioid-sparing, local analgesic to meet primary endpoints of Phase 3 clinical trials in hernia repair
• Data supports on-schedule NDA filing this year
• Results validate the Innocoll technology platform
• Conference call and webcast on top-line results scheduled for today at 8:30 a.m. Eastern Daylight Time

ATHLONE, Ireland, May 25, 2016  —  Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine-collagen bioresorbable implant) each achieved the primary endpoint as a postoperative pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction.

The primary efficacy endpoint, the sum of pain intensity over 24 hours (SPI24) comparing XARACOLL to placebo, met statistical significance in both the MATRIX-1 (p=0.0004) and MATRIX-2 (p<0.0001) studies. These highly statistically significant results make XARACOLL the first long-acting, opioid-sparing, local analgesic to meet primary endpoints of Phase 3 clinical trials in hernia repair, a highly painful and commonly performed surgery.

A key secondary endpoint in the MATRIX trials was the sum of pain intensity over 48 hours (SPI48). The pooled data of the two MATRIX studies were statistically significant for this endpoint (p=0.0033). MATRIX-2 achieved a statistically significant result (p=0.0270), and MATRIX-1 trended toward, but did not achieve statistical significance (p=0.0568).

Another key secondary endpoint was the sum of pain intensity over 72 hours (SPI72). The pooled data of the two MATRIX studies for this endpoint were statistically significant, although neither individual study achieved statistical significance for SPI72.

The MATRIX studies also looked at multiple opioid-sparing secondary endpoints. Both trials demonstrated that XARACOLL significantly reduces total opioid consumption and significantly increases the time prior to the first use of opioids. To preserve the company’s plan to publish the full analysis of the Phase 3 MATRIX studies at future medical meetings and in peer-reviewed publications, further details regarding secondary endpoints will not be released at this time.

XARACOLL was well tolerated in both studies. Incidence of overall adverse events was similar to the placebo arm of each study. There were no XARACOLL-related serious adverse events. Opioid-related adverse events were higher in the placebo arms of both studies.

Based on these results, Innocoll plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) this year.

“We are very pleased by these positive top-line results for XARACOLL,” said Innocoll CEO Tony Zook. “These two successful postoperative pain studies validate our proprietary collagen-based technology platform. We are committed to filing our NDA this year and bringing this innovative new treatment to market. Our manufacturing expansion and commercial readiness activities are on-track to support an anticipated launch in 2017.”

XARACOLL, a surgically implantable and bioresorbable bupivacaine-collagen matrix, is applied through a simple insertion into the incision and is being developed to provide sustained pain relief by delivering bupivacaine HCl directly at the site of surgical trauma. Bupivacaine HCl is a local anesthetic with a well-characterized safety and efficacy profile. The data collected on the MATRIX-1 and MATRIX-2 studies show that the use of our XARACOLL proprietary collagen implant as a delivery vehicle for bupivacaine HCl appeared to be safe.

“Available therapies for postoperative pain relief are heavily reliant on opioids, which may cause costly and problematic side effects, and further subject patients to long-term opioid use and abuse,” said Harold S. Minkowitz, MD, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, TX. “XARACOLL’s success in a commonly performed and highly painful surgery suggests that XARACOLL could become an important option for the surgical and anesthesia communities in addressing patient satisfaction with pain management options and the need for opioid-sparing approaches to pain reduction.”

Webcast and Conference Call Today, May 25, 2016, at 8:30 a.m. Eastern Daylight Time
The Innocoll management team will host a webcast and conference call to discuss the top-line results at 8:30 a.m. ET on May 25, 2016. Interested parties may access the webcast through the Investors section of our website, direct through the registration link, or by dialing 1-877-407-4018 (toll-free); 1-201-689-8471 (international); 1-800-904-100 (Ireland toll-free) and referencing the confirmation number 13638130. A replay of the call will be available on the Innocoll website later in the day, and the replay will be available for approximately one month following the call.

About XARACOLL®
XARACOLL® is a surgically implantable and bioresorbable bupivacaine-collagen matrix that utilizes our CollaRx® proprietary collagen-based delivery technology and is being developed to provide sustained postoperative pain relief directly into the surgical site. XARACOLL is also designed to reduce the need for systemic opioids and their associated risks.

About Postoperative Pain
Postoperative pain is a complex response to tissue trauma during surgery that stimulates hypersensitivity of the central nervous system, resulting in pain within the surgical cavity and in other areas directly affected by the surgical procedure (incision site). The current standard of care relies heavily on the use of opioids supplemented by other classes of pain medications, the combination of which is known as multi-modal pain therapy. However, according to a survey published in the journal of Anesthesia & Analgesia and a 2014 Decision Resources Postoperative Pain Survey, 75 percent of patients receiving standard treatments still report inadequate postoperative pain relief and 79 percent of patients report adverse events from these medications. Given the negative side effects of opioids in particular, there is increasing focus on treatments that reduce opioid use in the treatment of postoperative pain.

About MATRIX-1 and MATRIX-2
MATRIX-1 and MATRIX-2 Phase 3 studies are two identical, randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and bioresorbable bupivacaine-collagen matrix in treating acute postoperative pain associated with hernia repair. Each study enrolled over 300 patients aged 18 and older in the United States (U.S.). Patients with a unilateral inguinal hernia undergoing open hernioplasty were randomized in a 2:1 ratio to one of two treatment groups per study: three 100 mg XARACOLL matrices for a total dose of 300 mg of bupivacaine HCl or three placebo matrices. The matrices were placed at multiple layers within the hernia repair site in order to provide local levels of bupivacaine HCl directly at the location of surgical trauma. All patients received 650 mg of acetaminophen three times a day and could receive rescue opioids as needed. The primary efficacy endpoint was the sum of pain intensity (SPI) over 24 hours comparing the XARACOLL matrix to placebo. Safety was evaluated through the collection of adverse events through 30 days postoperatively.

About Innocoll
Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. The company’s late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain; INL-002, a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Pioneer, Biomet 3i and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

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

Ongoing Pipeline Studies
Innocoll is also conducting two identical Phase 3 trials, one in the U.S. (COACT-1) and the second in the U.S., Europe and Australia (COACT-2), to evaluate the safety and efficacy of INL-002, a topical gentamicin administered via our proprietary collagen matrix, in patients with diabetic foot infections. The primary endpoint is the percent of patients achieving resolution of all clinical signs and symptoms of infection, evaluated by the clinician 10 to 14 days after completion of treatment, compared to placebo arms. Top-line data from these studies are anticipated to be available later in 2016.

INL-002 received QIPD designation for the adjunctive treatment of moderate and severe diabetic foot infection from the FDA.

Additionally, a clinical program is under development for INL-003, a collagen barrier for the prevention of post-surgical adhesions, to support approval in the U.S. The nonclinical program is ongoing and will be completed and reported prior to the filing of an IDE application planned for second half of 2016, with the Pilot (Feasibility) Clinical Study to be initiated immediately thereafter, upon availability of financial resources. For more information on our pipeline studies, please visit www.innocoll.com/products.aspx.

Forward-looking Statements
Any statements in this press release about our ongoing development of XARACOLL and our other product candidates; our interpretation of the data and results from our MATRIX-1 and MATRIX-2 clinical trials; our plans for, and the expected timing of, our XARACOLL NDA submission with the FDA; our plans to develop and commercialize XARACOLL and its market potential; the potential therapeutic and other benefits of XARACOLL and our other product candidates; Innocoll’s current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of XARACOLL, plans and objectives for present and future clinical trials and results of such trials, the risk that the FDA may not accept pooled data, plans and objectives for regulatory approval and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties including, but not limited to, the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of XARACOLL and may require us to conduct additional clinical trials; XARACOLL may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; our plans to develop and manufacture XARACOLL; the size and growth of the potential markets for XARACOLL and our ability to serve those markets; our manufacturing and marketing capabilities; or other actions and factors discussed in the “Risk Factors” section of our Annual Report on Form 20-F for the year ended December 31, 2015, which is on file with the Securities and Exchange Commission. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, the forward-looking statements included in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

The scientific information discussed in this news release related to Innocoll’s 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.

Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com  

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com   

Media Contact:
Shelly Orlacchio
(215) 564-3200, ext 118
Sorlacchio@Gobraithwaite.com

(TBBK) Board of Directors Announces Damian Kozlowski as New CEO and President

The Board of Directors of The Bancorp, Inc. (NASDAQ: TBBK), and The Bancorp Bank, today announced that Damian Kozlowski has been appointed Chief Executive Officer of The Bancorp, Inc., President of The Bancorp Bank and a Director of the company and the bank, effective June 1, 2016. Mr. Kozlowski succeeds Interim Chief Executive Officer John C. Chrystal, who will work with Mr. Kozlowski to ensure a smooth transition. Mr. Chrystal will remain a Director of both the company and the bank.

Daniel Cohen, The Bancorp’s Chairman of the Board and Executive Vice President, commented, “Damian brings to The Bancorp well-rounded knowledge of the business of banking and deep understanding of its regulatory complexities. His experience in both smaller and larger financial institutions has given him the unique perspective that’s required of The Bancorp’s business model within the financial services and technology sectors.”

According to Mr. Kozlowski, “I am eager to become part of The Bancorp, a widely recognized leader in financial services and technology solutions. The experience and knowledge that I bring, combined with the expertise of the outstanding executive leadership team currently in place, will help drive the company to achieve its fullest potential, both fiscally and operationally.”

Mr. Kozlowski joins The Bancorp after having served, since 2010, as Chief Executive Officer, President, and Director of Modern Bank, N.A. Previously, Mr. Kozlowski served as Chairman and Chief Executive Officer of Alpha Capital Financial Group, Inc. (2007-2010). From 2000 to 2007, Mr. Kozlowski was responsible for developing The Citigroup Private Bank’s global growth strategy to significantly build position in the high net worth wealth management market. At Citigroup Private Bank, Mr. Kozlowski managed 4500 employees in 98 offices in 31 countries; he served as Chief Executive Officer, Global Private Bank (2005-2007); President, US Private Bank (2002-2005); Chief Operating Officer and Chief Financial Officer (2001-2002); and Global Head of Business Development and Strategy (2000-2001). Mr. Kozlowski served as a member of Citigroup’s Operating and Management Committees, and was the ranking business leader on the Global Anti-Money Laundering Council. His prior experience includes positions held at Banc of America Securities, Marakon Associates, Rostra Holdings and US Trust, which have equipped him with deep expertise in private equity, wealth management, and investment banking.

As Managing Director of Payment Solutions, The Bancorp’s largest division, Jeremy Kuiper commented, “The Bancorp is on an exciting trajectory that will now be further fueled by Damian’s exceptional track record. We welcome his leadership in shaping and bringing The Bancorp’s strategic vision to fruition.”

The Bancorp is widely recognized for its dedication to serving the needs of non-bank financial service companies, ranging from entrepreneurial start-ups to those on the Fortune 500. With total assets of $4.379 billion, the company has over recent years strategically refocused its services to the payments industry as well as to a handful of highly specialized, lower-risk lending categories, including: Institutional Banking, Government Guaranteed Lending, Commercial Fleet Leasing and Commercial Mortgage-Backed Securitization. During this same time, the company has made significant capital investments in fortifying its operational infrastructure.

About The Bancorp

With operations in the US and Europe, The Bancorp, Inc. (NASDAQ: TBBK) is dedicated to serving the unique needs of non-bank financial service companies, ranging from entrepreneurial start-ups to those on the Fortune 500. The company’s chief financial institution, The Bancorp Bank (Member FDIC, Equal Housing Lender), has been repeatedly recognized in the payments industry as the Top Issuer of Prepaid Cards (US), a top merchant sponsor bank, and a top ACH originator. Specialized lending distinctions include National Preferred SBA Lender, a leading provider of securities-backed lines of credit, and one of the few bank-owned commercial leasing groups in the nation. For more information, please visit www.thebancorp.com.

The Bancorp, Inc.
Andres Viroslav, 215-861-7990
aviroslav@thebancorp.com

(CDZI) to Present at 17th Annual B. Riley & Co. Investor Conference

LOS ANGELES, May 24, 2016  — Cadiz Inc. (NASDAQ:CDZI) (“Cadiz”, the “Company”), a California land and water resources development company, announced today that Timothy J. Shaheen, the Company’s Chief Financial Officer, will make a presentation at the 17th Annual B. Riley & Co. Investor Conference on Wednesday, May 25^th at 3:00pm PT.  The conference is being held May 25 & 26, 2016 at the Loews Hollywood Hotel in Hollywood, California.

A live webcast of the presentation will be available from the Cadiz Inc. Investor Relations website page at  http://cadizinc.com/investor-relations/. A copy of Mr. Shaheen’s presentation will also be posted on the Company website.

For more information about the conference or to schedule a one-on-one meeting with management, investors can contact B. Riley at conference@brileyco.com.

About Cadiz
Founded in 1983, Cadiz Inc. is a publicly-held renewable resources company that owns 70 square miles of property with significant water resources in Southern California. The Company is engaged in a combination of organic farming and water supply and storage projects at its properties and abides by a wide-ranging “Green Compact” focused on environmental conservation and sustainable practices to manage its land, water and agricultural resources. For more information about Cadiz, visit http://www.cadizinc.com/.

FORWARD LOOKING STATEMENT: This release contains forward-looking statements that are subject to significant risks and uncertainties, including statements related to the future operating and financial performance of the Company and the financing activities of the Company.  Although the Company believes that the expectations reflected in our forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct.  Factors that could cause actual results or events to differ materially from those reflected in the Company’s forward-looking statements include the Company’s ability to maximize value for Cadiz land and water resources, the Company’s ability to obtain new financing as needed, the receipt of additional permits for the water project and other factors and considerations detailed in the Company’s Securities and Exchange Commission filings.

CONTACT:
Courtney Degener
213-271-1600

(KOOL) to Exhibit at the 2016 International Society for Cellular Therapy

RANCHO CORDOVA, Calif., May 24, 2016  — Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that the Company will be exhibiting at the 2016 International Society for Cellular Therapy (ISCT) Annual Meeting in Booth B06 on May 25-28, 2016 at the Suntec Convention and Exhibition Center in Suntec City, Singapore.

“We are very pleased to be exhibiting at the ISCT 2016 Annual Meeting, which showcases many of the latest developments in the field of cell therapy,” stated Dalip Sethi, Ph.D., Director of Clinical Research at Cesca Therapeutics “It is an opportune time to introduce our SurgWerks™ and CellWerks™ systems to other experts in the field and to forge new collaborative relationships with pioneering organizations.”

ISCT is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective therapies to improve patients’ lives. ISCT members gain access to an influential global community of peers, experts, and organizations invested in cell therapy. ISCT offers a unique collaboration between academia, regulatory bodies, and industry partners in cell therapy translation.

About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics.  These include:

• The SurgWerks™ System (in development) – a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure  Kits  for use in regenerative stem cell therapy at the point-of-care for  vascular and orthopedic diseases.
• The CellWerks™ System (in development) – a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
• The AutoXpress® System (AXP^®) – a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
• The MarrowXpress™ System (MXP™) – a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
• The BioArchive® System – an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
• Manual bag sets for use in the processing and cryogenic storage of cord blood.

Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change.  Forward-looking statements can often be identified by words such as “may,” “could,” “potential,” “continue,” and similar expressions and include, but are not limited to, statements regarding research and product commercialization.  These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption “Risk Factors” in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.  We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

Company Contact: Cesca Therapeutics Inc.
ir@cescatherapeutics.com

Investor Contact: The Ruth Group
Lee Roth / Tram Bui
646-536-7012 / 7035 
lroth@theruthgroup.com / tbui@theruthgroup.com

(APHB) Announces Start of First Phage Therapy Trial in U.S. Under IND

AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced it has dosed the first patient in its Phase 1 clinical trial to evaluate the safety of AB-SA01, AmpliPhi’s proprietary phage cocktail targeting Staphylococcus aureus (S. aureus) infections, administered topically to the intact skin of healthy adults. The trial is being conducted under a Collaborative Research and Development Agreement with the U.S. Army and at the Walter Reed Army Institute of Research Clinical Trials Center in Silver Spring, Maryland.

S. aureus is a leading cause of skin and soft tissue infections, especially among individuals with underlying health conditions. Despite vigorous eradication efforts, S. aureus is common in hospitals where it can plague patients with weakened immune systems, burns and surgical wounds.

The double-blind, ascending dose study is designed to evaluate the safety of AB-SA01 administered topically to the skin of up to six healthy adult volunteers between the ages of 18 and 60 years in each of two dose cohorts. Participants in the low- and high-dose cohorts will receive either 1 x 10⁸ or 1 x 10⁹ PFU/mL of AB-SA01, respectively, administered topically to the forearm with an occlusive bandage. Placebo will be administered to the opposite forearm, allowing each participant to serve as his or her own control. Participants will receive AB-SA01 and placebo daily for three consecutive days and will be followed for 10-14 days after the final treatment.

“This trial is the important first step in the clinical development of AB-SA01, which we we feel has the potential to be an important weapon against antibiotic-resistant S. aureus infections,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “Harnessing the natural predators of bacteria to conquer infections is a radically new therapeutic strategy that has the potential to deliver a new generation of medicines to treat antibiotic-resistant infections, and to do so without destroying a patient’s microbiome, or the trillions of beneficial bacteria critical to good health. Our preclinical data demonstrate that AB-SA01 effectively kills a variety of S. aureus strains, including those resistant to methicillin. I would like to thank Jeffrey Livezey, MD, MSc, MAJ, MC, Deputy Director, Clinical Pharmacology at Walter Reed Army Institute of Research and the Principal Investigator of this study, along with his entire team for their support and hard work. I am extremely proud of the AmpliPhi team and our partners for the accomplishment of starting two clinical trials during the first half of 2016, putting us on track to announce data from both trials later this year.”

For more information, visit www.ampliphibio.com.

About AmpliPhi Biosciences

AmpliPhi Biosciences Corporation (NYSEMKT: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi’s product development programs target infections that are often resistant to existing antibiotic treatments. In addition to its AB-SA01 trial to evaluate S. aureus infections, AmpliPhi is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and expects to report final data for both trials in the second half of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa and Clostridium difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.

About Bacteriophage

Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects.

Forward Looking Statements

Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the expected timing of reporting data from AmpliPhi’s two AB-SA01 trials, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

Company and Investor Relations:
AmpliPhi Biosciences
Matt Dansey, +1 858-800-4869
md@ampliphibio.com
or
Media Relations (USA):
Lazar Partners
Danielle Lewis/Glenn Silver, + 1 212-867-1762
ampliphi@lazarpartners.com
or
Media Relations (Europe and ROW):
Instinctif Partners
Gemma Howe/Sue Charles, +44 (0)20 7866 7860
ampliphi@instinctif.com

(SPEX) Executes Second License Agreement with (RPXC)

NEW YORK, May 24, 2016  — Spherix Incorporated (NASDAQ: SPEX) – an intellectual property development company committed to the fostering and monetization of intellectual property, today announced a second licensing agreement with RPX Corporation (NASDAQ: RPXC).

Under the new agreement, Spherix receives a cash payment and return of all of the Series H preferred stock of Spherix presently held by RPX, representing the entire class of Series H shares outstanding. In exchange, Spherix granted RPX a portfolio license, which RPX can then use to grant sublicenses to its clients.

In unrelated matters, Spherix’s litigations against L3 Communications Inc., TW Telecommunications Inc., Fairpoint Communications Inc., and Uniden will continue.

Anthony Hayes, Chief Executive Officer of Spherix, stated, “We are pleased to have reached this second license agreement with RPX.  We continue to seek long-term, mutually beneficial license agreements that represent a positive outcome for our shareholders.”

About Spherix

Spherix is committed to advancing innovation by active participation in all areas of the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation. Spherix has acquired over 100 patents from Rockstar Consortium Inc., and several hundred patents issued to Harris Corporation, covering a variety of methods and components involved in switching, routing, networking, optical and telephone technologies, as well as in the wireless communications and telecommunication sectors.

Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:
Investor Relations Contact:
Hayden IR, LLC
Brett Mass
Phone: (646) 536-7331
Email: brett@haydenir.com
www.haydenir.com

Spherix Contact:
Phone: (703) 992-9325
Email: info@spherix.com
www.spherix.com

(CLRB) to Present at the 2016 Marcum MicroCap Conference

MADISON, Wis., May 23, 2016  — Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused biotechnology company, announces today its CEO, Jim Caruso, will be presenting at the 2016 Marcum MicroCap Conference at the Grand Hyatt in New York City on June 2, 2016 at 3:30 PM ET in the Julliard Room.

“Interest in Cellectar’s Phospholipid Drug Conjugate (PDC) delivery platform and pipeline assets such as CLR 131, a one dose treatment for multiple myeloma continues to increase.” said Mr. Caruso. “The Marcum MicroCap conference provides a meaningful opportunity to further expand awareness of our novel technology and to update the investment community on our continued performance.”

Following the presentation, a link to the latest presentation, including both slides and audio, will be posted on the company’s website.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1602-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

INVESTOR AND MEDIA CONTACT:

Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

(ACTS) Special Committee Appoints Counsel

ZHUHAI, China, May 23, 2016  — Actions Semiconductor Co., Ltd. (ACTS) (“Actions Semiconductor” or the “Company”), one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics, today announced that the independent special committee of the Company’s Board of Directors (the “Special Committee”), formed to evaluate the previously announced preliminary non-binding “going-private” proposal received on May 19, 2016, has retained Jones Day as its U.S. counsel and Maples and Calders as its Cayman Islands counsel.

The Special Committee cautions the Company’s shareholders and others considering trading in the Company’s securities that no decision has been made on the response to the proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated. The Special Committee does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law.

About Actions Semiconductor

Actions Semiconductor is one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics. Actions Semiconductor products include SoCs, firmware, software, solution development kits, as well as detailed specifications of other required components. Actions Semiconductor also provides total product and technology solutions that allow customers to quickly introduce new portable consumer electronics to the mass market in a cost effective way. The Company is headquartered in Zhuhai, China, with offices in Shanghai, Shenzhen, Hong Kong and Taipei. For more information, please visit the Actions Semiconductor website at http://www.actions-semi.com.

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

Statements contained in this release that are not historical facts are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning the preliminary, non-binding going private proposal.  Actions Semiconductor uses words like “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project” and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are estimates reflecting current assumptions, expectations and projections about future events and involve significant risks, both known and unknown, uncertainties and other factors that may cause Actions Semiconductor’s actual performance, financial condition or results of operations to be materially different from those suggested by the forward-looking statements including, among others, customers’ cancellation or modification of their orders; our failure to accurately forecast demand for our products; the loss of, or a significant reduction in orders from, any of our significant customers; fluctuations in our operating results; our inability to develop and sell new products; defects in or failures of our products; the expense and uncertainty involved in our customer design-win efforts; the financial viability of the distributors of our products; consumer demand; worldwide economic and political conditions; fluctuations in our costs to manufacture our products; our reliance on third parties to manufacture, test, assemble and ship our products; our ability to retain and attract key personnel; our ability to compete with our competitors; and our ability to protect our intellectual property rights and not infringe the intellectual property rights of others. Other factors that may cause our actual results to differ from those set forth in the forward-looking statements contained in this press release and that may affect our prospects in general are described in our filings with the Securities and Exchange Commission, including our most recently filed Forms F-1, 20-F and 6-Ks. Other unknown or unpredictable factors also could have material adverse effects on Actions Semiconductor’s future results, performance or achievements. In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed in this press release may not occur. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date stated, or if no date is stated, as of the date of this press release. Except as required by law, Actions Semiconductor undertakes no obligation and does not intend to update or revise any forward-looking statement to reflect subsequent events or changed assumptions or circumstances.

(NSPH) & (LMNX) Provide Update on Acquisition Agreement

AUSTIN, Texas and NORTHBROOK, Ill., May 23, 2016  — Luminex Corporation (NASDAQ: LMNX) and Nanosphere, Inc. (NASDAQ: NSPH) announced today that they have entered into an amendment to the definitive agreement under which Luminex will acquire Nanosphere, a leader in the molecular microbiology and molecular diagnostic market.  The purchase price has been increased to $1.70 per share from $1.35 per share in an all cash transaction valued at approximately $77 million. This increase was in response to an unsolicited third party offer for Nanosphere at $1.50 per share.

About Luminex Corporation

Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP^® open-architecture multi-analyte platform, MultiCode^® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex’s technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award winning technology, please visit http://www.luminexcorp.com/.

About Nanosphere, Inc.

Nanosphere is enhancing medicine through targeted molecular diagnostics that result in earlier disease detection, optimal patient treatment and improved healthcare economics. The Company’s versatile technology platform, the Verigene^® System, enables clinicians to rapidly detect the most complex, costly and deadly infectious diseases through a low cost and simple-to-use multiplexed diagnostic test. The combination of this innovative technology and Nanosphere’s customer-driven solutions keeps commitment to the patient at the forefront of its business. Nanosphere is based in Northbrook, IL. Additional information is available at http://www.nanosphere.us.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this press release, including statements regarding the proposed transaction between Luminex and Nanosphere, Luminex’s and Nanosphere’ financial results and estimates and/or business prospects, the combined company’s plans, objectives, expectations and intentions, leadership in biological testing technologies in the clinical diagnostic and life science industries and the expected size, scope and growth of the combined company’s operations and the markets in which it will operate, expected synergies, as well as the expected timing and benefits of the transaction, may contain words such as “expects,” “may,” “potential,” “upside,” “approximately,” “project,” “would,” “could,” “should,” “will,” “anticipates,” “believes,” “intends,” “estimates,” “targets,” “plans,” “envisions,” “seeks” and other similar language and are considered forward-looking statements or information under applicable securities laws. These statements are based on Luminex’s current expectations, estimates, forecasts and projections about the proposed transaction and the operating environment, economies and markets in which Luminex and Nanosphere operate, are subject to important risks and uncertainties that are difficult to predict and the actual outcome may be materially different. These statements reflect beliefs and assumptions that are based on Luminex’s and Nanosphere’ perception of historical trends, current conditions and expected future developments as well as other factors management believes are appropriate in the circumstances. In making these statements, Luminex and Nanosphere have made assumptions with respect to the ability of Luminex and Nanosphere to achieve expected synergies and the timing of same, the ability of Luminex and Nanosphere to predict and adapt to changing customer requirements, preferences and spending patterns, the ability of Luminex and Nanosphere to protect their intellectual property, future capital expenditures, including the amount and nature thereof, trends and developments in the clinical diagnostic and life science industries, business strategy and outlook, expansion and growth of business and operations, credit risks, anticipated acquisitions, future results for Luminex being similar to historical results, expectations related to future general economic and market conditions and other matters. Luminex’s and Nanosphere’ beliefs and assumptions are inherently subject to significant business, economic, competitive and other uncertainties and contingencies regarding future events and as such, are subject to change. Luminex’s beliefs and assumptions may prove to be inaccurate and consequently Luminex’s actual results could differ materially from the expectations set out herein.

Actual results or events could differ materially from those contemplated in the forward-looking statements as a result of the following:

Contacts
Luminex Investor Contact
Harriss Currie
Sr. Vice President of Finance and CFO
512.219.8020
hcurrie@luminexcorp.com

Matthew Scalo
Sr. Director, Investor Relations
512.219.8020
mscalo@luminexcorp.com

(REXI) Signs Definitive Agreement to Be Acquired by C-III Capital Partners LLC

(XNPT) to be Acquired by Arbor Pharmaceuticals

Arbor Pharmaceuticals, LLC (Arbor) and XenoPort, Inc. (XenoPort) (NASDAQ:XNPT) announced today that they have signed a definitive agreement under which Arbor will acquire XenoPort for $7.03 per share in cash, or a total equity value of approximately $467 million. The purchase price per share represents a 60 percent premium to the closing price of XenoPort shares on May 20, 2016.

“We are pleased to be adding HORIZANT and the XenoPort pipeline to the growing portfolio of Arbor products,” said Ed Schutter, President and Chief Executive Officer of Arbor. “We believe that XenoPort’s lead product HORIZANT offers patients and physicians a valuable treatment option for moderate-to-severe primary restless legs syndrome and postherpetic neuralgia. The XenoPort sales team has done an excellent job of growing HORIZANT, and we look forward to supporting them to continue this significant momentum.”

Vincent J. Angotti, Chief Executive Officer of XenoPort, stated, “This transaction provides immediate and substantial value to our stockholders, and we believe that Arbor is well positioned to provide the proper resources for a more expanded commercialization effort of HORIZANT. We evaluated many potential options to maximize the value for stockholders and believe this transaction represents a great outcome for XenoPort stockholders.”

Under the terms of the agreement, Arbor will commence a tender offer to purchase all of the outstanding shares of XenoPort for $7.03 per share. Following the closing of the tender offer, the agreement provides for the parties to effect, as promptly as practicable, a merger that would result in all shares not tendered in the tender offer being converted into the right to receive $7.03 per share in cash. The transaction, which has been unanimously approved by both the Arbor Board of Directors and the XenoPort Board of Directors, is expected to close in the third quarter of 2016.

Closing of the tender offer and merger is subject to certain customary conditions, including the tender of more than 50 percent of all outstanding shares of XenoPort. The transaction is also subject to review by the U.S. Government under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, as amended, and other customary closing conditions.

Centerview Partners is serving as exclusive financial advisor to XenoPort, and Weil, Gotshal & Manges LLP is serving as legal advisor to XenoPort. Deutsche Bank has provided sole committed debt financing to Arbor in support of the transaction. Alston & Bird, LLP and Simpson, Thacher & Bartlett LLP acted as legal advisors to Arbor.

About Arbor Pharmaceuticals

Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets. The company has over 600 employees including 500 sales professionals promoting its products to physicians, hospitals and pharmacists. Arbor currently markets twenty NDA or ANDA approved products with over 35 more in development.

For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to info@arborpharma.com.

About XenoPort

XenoPort, Inc. is a biopharmaceutical company focused on commercializing HORIZANT in the United States. XenoPort has entered into a clinical trial agreement with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) under which the NIAAA has initiated a clinical trial evaluating HORIZANT as a potential treatment for patients with alcohol use disorder. REGNITE^® (gabapentin enacarbil) Extended-Release Tablets is being marketed in Japan by Astellas Pharma Inc. XenoPort has granted exclusive world-wide rights for the development and commercialization of its clinical-stage oral product candidate, arbaclofen placarbil, to Indivior PLC for all indications. It has granted exclusive U.S. rights for the development and commercialization of its clinical-stage oral product candidate, XP23829, to Dr. Reddy’s Laboratories. XenoPort’s other clinical-stage product candidate, XP21279, is a prodrug of levodopa that is a potential treatment for patients with idiopathic Parkinson’s disease.

To learn more about XenoPort, please visit the website at www.XenoPort.com.

HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort, Inc.

Important Additional Information

The tender offer for the outstanding shares of XenoPort, referenced in this press release has not yet commenced. This announcement is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of XenoPort, nor is it a substitute for the tender offer materials that Arbor and its acquisition subsidiary will file with the U.S. Securities and Exchange Commission (the “SEC”) upon commencement of the tender offer. At the time the tender offer is commenced, Arbor and its acquisition subsidiary will file tender offer materials on Schedule TO, and XenoPort will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement will contain important information. Holders of shares of XenoPort are urged to read these documents when they become available because they will contain important information that holders of XenoPort shares should consider before making any decision regarding tendering their shares. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of XenoPort at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Arbor media relations at the phone number or e-mail address below or XenoPort investor relations at the phone number or e-mail address below.

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, XenoPort files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Arbor or XenoPort at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Arbor’s and XenoPort’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

XenoPort Forward-Looking Statements

This press release contains “forward-looking” statements, including, without limitation, all statements about the proposed acquisition of XenoPort by Arbor, the commencement of a tender offer for shares of XenoPort common stock, and benefits from the proposed acquisition, business strategies, market potential, future financial prospects and other matters that are not historical facts. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “could,” “intend,” “may,” “plans,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort’s current expectations. Forward-looking statements involve risks and uncertainties. XenoPort’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions set forth in the merger agreement between the parties, the possibility of any termination of the merger agreement between the parties, and the parties’ ability to obtain regulatory approval in a timely manner. These and other risk factors are discussed under the heading “Risk Factors” in XenoPort’s Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 5, 2016. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

HORIZANT^® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS

HORIZANT^® (gabapentin enacarbil) is a prescription medicine used to:

• treat adults with moderate-to-severe primary Restless Legs Syndrome (RLS). HORIZANT is not for people who need to sleep during the daytime and stay awake at night.
• manage pain from damaged nerves (postherpetic neuralgia) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.

IMPORTANT SAFETY INFORMATION

• Do not drive after taking your dose of HORIZANT until you know how it affects you, including the morning after you take it. Do not operate heavy machinery or do other dangerous activities until you know how HORIZANT affects you. HORIZANT can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it is okay to do these activities.
• Do not take other medicines that make you sleepy or dizzy while taking HORIZANT without talking to your healthcare provider. Taking HORIZANT with these other medicines may make your sleepiness or dizziness worse.
• HORIZANT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • thoughts or actions about suicide, self-harm, or dying; attempt to commit suicide
  • new or worsening depression or anxiety; or feeling agitated
  • new or worse restlessness or panic attacks
  • new or worse trouble sleeping (insomnia); or irritability
  • acting aggressive, being angry, or violent; acting on dangerous impulses
  • an extreme increase in activity or talking (mania); other unusual changes in mood or behavior
• Do not stop taking HORIZANT without first talking to your healthcare provider. Suicidal thoughts or actions can be caused by things other than medicines. If you have these thoughts or actions, your healthcare provider may check for other causes.

• HORIZANT may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash with these types of reactions. Call a healthcare provider right away if you have any of the following symptoms: skin rash, hives, fever, swollen glands that do not go away, swelling of your lips or tongue, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, unexpected severe muscle pain, or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking HORIZANT.
• HORIZANT is not the same medicine as gabapentin (for example, Neurontin^® and Gralise^®). HORIZANT should not be used in their place. Do not take these or other gabapentin products while taking HORIZANT.
• Before taking HORIZANT, tell your healthcare provider if you:
  • have or have had kidney problems or are on hemodialysis
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have or have had seizures
  • have a history of drug abuse
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if HORIZANT will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant while taking HORIZANT. You and your healthcare provider will decide if you should take HORIZANT while you are pregnant
  • are breastfeeding or plan to breastfeed. Your body turns HORIZANT into another drug (gabapentin) that passes into your milk. It is not known if this can harm your baby. You and your healthcare provider should decide if you will take HORIZANT or breastfeed
  • drink alcohol

• Do not drink alcohol while taking HORIZANT because it may increase the risk of side effects.
• Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking HORIZANT with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
• Do not stop taking HORIZANT without talking to your healthcare provider first. If you stop taking HORIZANT suddenly, you may develop side effects.
• The most common side effects of HORIZANT include dizziness, sleepiness, and headache. Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of HORIZANT. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. See Medication Guide.

XNPT2G

Arbor Media Contact
Brian Adams, 404-496-5915
brian.adams@arborpharma.com
or
XenoPort IR and Media Contact
Jackie Cossmon, 408-616-7220
ir@XenoPort.com

(ISCO) Cryoport to Provide Cold Chain Logistics Support

IRVINE, Calif., May 23, 2016  — Cryoport, Inc. (NASDAQ: CYRX) (“Company”), the world’s leading cryogenic logistics company for the life sciences industry, today announced that it will provide global logistics support to International Stem Cell Corporation’s (OTCQB: ISCO) (“ISCO”) for its Phase I clinical trial in Australia for the treatment of moderate to severe Parkinson’s disease. ISCO commenced patient enrollment for the study earlier this month.

Two of Cryoport’s strategically located depots, in southern California and Singapore, will provide logistics support for the clinical study from ISCO’s research facility in California to the study site in Australia. As the premier cryogenic logistics provider, Cryoport’s extensive experience with the movement of high-value biologic material for clinical trials and commercialization programs globally gives ISCO’s team assurance that its shipment will arrive with fully documented chain of custody and chain of condition data.

“This trial will take place across the globe and it is imperative that our cell therapy maintains integrity. We are pleased to have Cryoport handle our global logistics requirements,” said Russell Kern, PhD, Executive Vice President and Chief Scientific Officer of ISCO.

Jerrell Shelton, Chief Executive Officer of Cryoport, commented, “Cryoport is proud to work with ISCO and support its efforts. We are fully confident in our ability to manage the logistics of the therapies as specified – and with certainty. We look forward to furthering our relationship with ISCO as we move forward.”

About Cryoport, Inc.

Cryoport is the premier provider of cryogenic logistics solutions to the life sciences industry through its purpose-built proprietary packaging, information technology and specialized cold chain logistics expertise. Supporting the entire lifecycle of therapies from clinical trials to approval and commercialization, the Company provides leading edge logistics solutions for biologic materials, such as immunotherapies, stem cells, CAR-T cells and reproductive cells for clients worldwide. Cryoport actively supports points-of-care, CRO’s, central laboratories, pharmaceutical companies, contract manufacturers and university researchers. For more information, visit www.cryoport.com.

To download Cryoport’s investor relations app, which offers access to SEC documents, press releases, videos, audiocasts and more, please click to download from your iPhone and iPad or Android mobile device.

Forward Looking Statements
Statements in this news release which are not purely historical, including statements regarding Cryoport, Inc.’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, trends in the products markets, variations in the company’s cash flow, market acceptance risks, and technical development risks. The company’s business could be affected by a number of other factors, including the risk factors listed from time to time in the company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended March 31, 2015. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Cryoport, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

(MDGN) to Present at the UBS Global Healthcare Conference

PHILADELPHIA, PA–(May 20, 2016) – Medgenics, Inc. (NYSE MKT: MDGN) today announced that Michael F. Cola, President and Chief Executive Officer, will present at the annual UBS Global Healthcare Conference in New York, NY on Wednesday May 25, 2016 at 8:00 a.m. EDT at the Grand Hyatt New York.

A live webcast of the presentation can be accessed under “Presentations” in the Investors section of the Company’s website at www.medgenics.com or you may use the link: https://cc.talkpoint.com/ubsx001/052316a_ae/?entity=111_2U887X7

About Medgenics, Inc.

Medgenics is dedicated to unlocking the potential of genomic medicine to identify and treat patients with life-altering conditions. Its efforts, including its internal research and development and ongoing sponsored research and licensing agreements with a well-respected pediatric academic medical center, give Medgenics the ability to focus on the underlying genetic pathway of pediatric diseases with the goal of finding therapeutic solutions for subpopulations of both children and adults living with rare and other difficult-to-treat diseases. Medgenics is also the developer of TARGT™ (Transduced Autologous Restorative Gene Therapy. For more information, visit the Company’s website at www.medgenics.com.

Forward-looking Statements
This release 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 as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

CONTACT:

Medgenics
Brian Piper
240-899-5554
Email Contact

Westwicke Partners
Chris Brinzey
339-970-2843
Email Contact

(AVXL) FDA Orphan Drug Designation to ANAVEX 2-73

NEW YORK, May 20, 2016  — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reports the U.S. Food and Drug Administration’s (FDA) Office of Orphan Product Development (OOPD) has granted Orphan Drug Designation (ODD) to ANAVEX 2-73 for the treatment of Rett syndrome.

“The Orphan Drug Designation marks the first U.S. movement for ANAVEX 2-73.  Rett syndrome is a devastating disease occurring in early childhood and almost exclusively in girls.  As there is currently no cure and limited treatment, Rett syndrome represents a clear unmet clinical need,” commented Christopher U. Missling, PhD, President and Chief Executive Officer.  “The acknowledgement from the Agency for this orphan designation allows us to formally move forward with the planned human clinical study in this disease indication, thereby potentially expanding the reach for ANAVEX 2-73 in addition to Alzheimer’s disease.”

The FDA’s Office of Orphan Products Development advances the evaluation of drugs that show promise for the safe treatment of rare diseases, defined as those affecting fewer than 200,000 people in the United States.  The designation provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by FDA on clinical studies and certain exemptions from or reductions in regulatory fees.

About Rett Syndrome
Rett syndrome is rare non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat, and even breathe easily. The hallmark of Rett syndrome is near constant repetitive hand movements while awake. It is characterized by normal early growth and development (6 to 18 months) followed by a slowing of development, loss of purposeful use of the hands, distinctive hand movements, slowed brain and head growth, problems with walking, seizures, and intellectual disability. There is currently no cure for Rett syndrome and treatment of the disorder is symptomatic. Management of the symptoms is done through a multidisciplinary approach utilizing medication for motor difficulties, breathing irregularities, and control of seizures through anticonvulsant drugs. Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups and occurs worldwide in approximately 1 in every 10,000-15,000 live female births.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email:  info@anavex.com

Investors:
866-505-2895
Email: ir@anavex.com

Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

(TGTX) Presentations at the Upcoming 21st European Hematology Assoc. Congress

Presentations demonstrate the safety and efficacy of TGR-1202 in combination with ublituximab as well as in combination with ibrutinib in patients with CLL and NHL

NEW YORK, May 20, 2016  — TG Therapeutics, Inc. (Nasdaq:TGTX), today announced that updated data has been selected for presentation at the upcoming 21^st European Hematology Association (EHA) Annual Congress, to be held from June 9 – 12, 2016 in Copenhagen, Denmark.

Presentations Include:

• Title: Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
  • Abstract Number: P207
  • Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
  • Location: Poster Hall H
  • Presenter: Anthony Mato, MD, University of Pennsylvania, Philadelphia, PA
• Title: Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
  • Abstract Number: P315
  • Presentation Date & Time: Friday, June 10, 2016 5:15PM – 6:45PM CEST
  • Location: Poster Hall H
  • Presenter: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, NY, NY
• Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL
  • Abstract Number: E1053
  • E-poster Presentation
  • Presenter: Matthew S. Davids MD, Dana-Farber Cancer Institute, Boston, MA

A copy of the EHA abstracts were made available yesterday, May 19, 2016 through the EHA meeting website at www.ehaweb.org.   Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TGTX – G

CONTACT:

Jenna Bosco
Vice President- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com

(OTIC) Assignment of C Code and Pass-Through Payment Status for OTIPRIO™

SAN DIEGO, May 20, 2016  — Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and established a new billing code for OTIPRIO™ (ciprofloxacin otic suspension). The code, C9479, will become effective July 1, 2016.

“We welcome CMS’s decision to grant pass-through status and assign a new C code for OTIPRIO which can be used for billing in the hospital outpatient and ambulatory surgery center (ASC) settings,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, the timing of this assignment early in the launch of OTIPRIO will, we believe, be very helpful in our ongoing efforts to facilitate patient access.”

According to a CMS reference article, “C codes are unique temporary pricing codes that were initially established by CMS for the Hospital Outpatient Prospective Payment System (OPPS). The C codes are used on Medicare OPPS claims but may also be recognized on claims from other providers or by other payment systems.” Hospital outpatient departments and ASCs billing for drugs assigned a C code are eligible for payment by Medicare for the pass-through drug in addition to the fee received by the facility for the related procedure. Pass-through payment is typically available for two to three years and Otonomy believes, based on long-standing CMS policy, that pass-through payment for OTIPRIO will be effective through the end of 2018. Coverage and payment by non-Medicare payors including Medicaid and commercial insurers is determined by each payor’s policies and individual provider contracts.

About OTIPRIO

OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two Phase 3 trials, a single intraoperative administration of OTIPRIO demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).

Important Safety Information for OTIPRIO

Contraindications: OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

Warnings and Precautions – Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.

Adverse Reactions: Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).

Use in Specific Populations – Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.

Full prescribing information can be found at www.OTIPRIO.com.

About Otonomy

Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, and commercial launch commenced in March 2016. OTO-104 is a steroid in development for the treatment of Ménière’s disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière’s disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, whether payors will provide reimbursement according to the C code, the timing of any such reimbursement, how long pass-through payments and the C code will remain effective, and the timing of results for the two OTO-104 Phase 3 clinical trials in Ménière’s disease. Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTO-104 and OTO-311; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy’s product candidates; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct preclinical studies and clinical trials; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy’s dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to OTIPRIO and its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 9, 2016, and Otonomy’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:

Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com

Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

(CLRB) Patent App for Phospholipid-Ether Analogs as Cancer Targeting Drug

Patent Further Supports the Company’s Phospholipid Drug Conjugate (PDC) Platform and Provides Intellectual Property Protection for Chemotherapeutic Drug Conjugates to November 2036

MADISON, Wis., May 20, 2016  — Cellectar Biosciences, Inc. (NASDAQ:CLRB) (the Company), an oncology-focused biotechnology company, today announces that its previously filed non-provisional US and International (PCT) patent applications for Phospholipid-Ether Analogs as Cancer Targeting Drug Vehicles have received their US Patent and Trademark Office (USPTO) identification numbers and have been published by the USPTO, which marks the next step in the application process for approval and issuance of these patents.

As previously stated, these patents will protect both composition of matter and method of use for those phospholipid drug conjugates, or PDCs, developed with Cellectar’s proprietary phospholipid-ether delivery vehicle conjugated with any existing or future cytotoxic agents, including chemotherapeutics such as paclitaxel, for targeted delivery to cancer cells and cancer stem cells.

“When issued, these patents will provide Cellectar and potential partners with intellectual property (IP) protection through approximately November 2036, providing significant runway for product development and commercialization,” said Jim Caruso, president and CEO of Cellectar. “This expanded IP protection supports the value-optimizing potential of our CLR CTX chemotherapeutic program and we look forward to providing ongoing updates as we continue to advance this R&D program.”

The objective of the CLR CTX program is to develop PDC chemotherapeutics through conjugation of the Company’s delivery vehicle and non-targeted anti-cancer agents to improve therapeutic indices and expand potential indications through targeted cancer cell delivery of chemotherapeutic payloads.

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s PDC platform has demonstrated highly selective cancer targeting both preclinically in over 60 in vivo cancer models, and subsequently confirmed clinically in over 10 cancer types. The platform’s payload diversity has been validated using cytotoxic radioisotopes for cancer therapy; PET imaging isotopes for cancer imaging; fluorophores for image-guided surgery, and now the company plans to expand its payload portfolio to chemotherapeutics with further preclinical study of paclitaxel and other non-targeted anti-cancer agents with both in-house and collaborative R&D efforts.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1602-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

INVESTOR AND MEDIA CONTACT:

Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

(CPXX) Announces VYXEOS™ Granted Breakthrough Therapy Designation

FDA awards designation for treatment of adults with therapy-related AML or AML with myelodysplasia-related changes – – VYXEOS significantly improved overall survival in a Phase 3 clinical trial

EWING, N.J., May 19, 2016  — Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy designation to VYXEOS (also known as CPX-351). VYXEOS is an investigational product in development as a treatment for AML and other blood cancers.

The Breakthrough Therapy designation is primarily based upon the positive results from the pivotal Phase 3 clinical trial in older patients with previously untreated high-risk (secondary) AML.  The designation is for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).  This designation includes the patient populations enrolled in the Phase 3 clinical trial.

The Phase 3 trial met its primary endpoint demonstrating a statistically significant improvement in overall survival.  Data will be presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting on Saturday, June 4^th.

The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS.  The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3.   The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm.  The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS.

No substantial difference in Grade 3-5 adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.

“We are very happy the FDA granted Breakthrough Therapy designation for VYXEOS,” said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals.  “The breadth of the designation, which includes all adults with t-AML and AML-MRC, is encouraging as AML patients are in need of advancements in treatment.  We look forward to working with the FDA to bring VYXEOS to patients as quickly as possible.”

FDA awards Breakthrough Therapy designation in order to expedite the development and review of new medicines that are intended to treat serious or life-threatening diseases when the therapy has demonstrated substantial improvement over available therapies on at least one clinically significant endpoint or when there is significant unmet medical need.

Celator plans to submit a New Drug Application (NDA) to the FDA by the end of the third quarter of 2016.

About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator’s proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations of anti-cancer drugs, incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor. Celator’s lead product is VYXEOS™ (also known as CPX-351), a nano-scale liposomal formulation of cytarabine:daunorubicin that has completed a Phase 3 trial for the treatment of acute myeloid leukemia. Celator has also conducted clinical development on CPX-1, a nano-scale liposomal formulation of irinotecan:floxuridine studied in colorectal cancer; and have a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation. More recently, the company has advanced its CombiPlex platform and broadened its application to include molecularly targeted therapies. For more information, please visit Celator’s website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.

Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the safety, potential efficacy, therapeutic potential, our expectations regarding the timing of our regulatory filings and the timing of regulatory approvals, and commercial potential of VYXEOS, our expectations regarding our research and development programs, expanding our pipeline and advancing our CombiPlex platform, our ability to pursue R&D collaborations with pharmaceutical companies and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, working capital, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the regulatory process, whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS and other matters that could affect the commercial potential of our drug candidates, the uncertainties inherent in the conduct of future clinical studies, enrollment in clinical studies and whether clinical trial results obtained to date will be predictive of future results. Celator undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Celator in general, see Celator’s Form 10-K for the year ended December 31, 2015 and other filings by Celator with the U.S. Securities and Exchange Commission.

CONTACTS:
Media:

Sam Brown, Inc.
Mike Beyer, 312-961-2502
mikebeyer@sambrown.com

Investors:

The Trout Group
Peter Rahmer, 646-378-2973
prahmer@troutgroup.com

(ONCE) & (PFE) Announce Data from Initial Subjects in Hemophilia B Trial

Subjects received one-time administration of a highly optimized gene therapy at initial low dose without the need for immunosuppression

Therapeutic Factor IX activity sustained at levels exceeding those considered sufficient to reduce the risk of joint bleeds and need for prophylactic clotting Factor infusions

Expanded dataset on first cohort to be presented June 11 at European Hematology Association meeting

PHILADELPHIA and NEW YORK CITY, May 19, 2016  — Spark Therapeutics (NASDAQ:ONCE) and Pfizer Inc. (NYSE:PFE) announced today that new data will be presented on June 11 at the European Hematology Association’s (EHA) 21^st Congress. These data will show encouraging initial observations for the first subjects dosed in the Phase 1/2 clinical trial of SPK-9001, the lead investigational compound in the SPK-FIX program, which is being studied for the treatment of Hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized high-activity human Factor IX variant, was developed using Spark’s proprietary technology platform for selecting, designing, manufacturing and formulating highly optimized gene therapies. The conference abstract, including a figure demonstrating Factor IX activity levels (as % of normal) expressed by subject over time, was made available today: http://www.ehaweb.org/congress-and-events/21st-congress/key-information-3/

Data available today demonstrate that the first three subjects enrolled in the study experienced AAV-mediated Factor IX activity levels following one administration of SPK-9001 at the initial dose level (5 x 10¹¹ vg/kg) studied in the trial. Factor IX activity levels in the first two subjects, without prior history of liver disease, rose consistently through the first four weeks post-administration.  At the time of abstract submission, the first subject stabilized at 28% of normal at eighteen weeks, and the second subject at 30% of normal at seven weeks post-administration. Factor IX activity level in the third subject, with a history of liver disease, also rose consistently and was at 16% of normal at three weeks post–administration. Data from a natural history of patients with hemophilia suggest that circulating factor activity levels sustained at a threshold of greater than or equal to 12% of normal generally are considered to be sufficient to reduce the risk of joint bleeds and the need for prophylactic clotting factor infusions.

Over the combined 28 weeks of observation reported in the abstract, none of the three subjects received regular infusions of Factor IX concentrates to prevent bleeding events. Only one precautionary infusion has taken place due to a suspected ankle bleed in one subject two days after administration of vector. SPK-9001 has been well-tolerated and no subjects have needed, or received, immunosuppression.

“We are highly encouraged by these initial data, which are supportive of the target profile of a potential gene therapy product capable of eliminating the need for regular infusions to control and prevent bleeding episodes through a one-time, intravenous administration,” said Katherine A. High, MD, co-founder, president and chief scientific officer of Spark. “Our hypothesis had been that delivery of a highly optimized gene therapy at low doses could allow expression of therapeutic levels of FIX while avoiding the need for immunosuppression. The data summarized in the abstract of SPK-9001 appear to support this hypothesis, although we will continue to monitor and investigate the validity of the hypothesis as well as assess long-term efficacy and safety of the product candidate.”

Spark and Pfizer entered into a collaboration in 2014, under which Spark will be responsible for conducting all Phase 1/2 studies for any product candidates that may be developed under the SPK-FIX program, while Pfizer will assume responsibility for pivotal studies, any regulatory activities and potential global commercialization of any products that may result from the collaboration.

“Although these results are early, we believe that the initial SPK-9001 data are promising,” said Greg LaRosa, Chief Scientific Officer, Rare Disease Research Unit, Pfizer. “Pfizer has a longstanding commitment to the hemophilia community and strong history of providing hemophilia products to patients for nearly two decades. We look forward to our continued collaboration with Spark as we work toward our shared goal of bringing to market a novel potential therapy for hemophilia patients around the world.”

Up-to-date results from the trial will be presented at the EHA Congress on June 11 by Dr. Spencer Sullivan, an Assistant Professor of Pediatrics and Medicine at the University of Mississippi Medical Center, one of the trial investigators. The trial is led by Dr. Lindsey George of the Children’s Hospital of Philadelphia.  In addition, the work has been selected by the EHA for press briefing at the Congress scheduled for June 11, 8:30 am CET.

About Hemophilia B and the SPK-FIX Program
Hemophilia B is a rare genetic blood disorder that affects approximately 4,000 males in the U.S. and 26,000 males worldwide. Current treatment requires recurrent intravenous infusions of either plasma-derived or recombinant Factor IX to control and prevent bleeding episodes. Spark’s proprietary technology platform for selecting, designing, manufacturing and formulating highly optimized gene therapies was applied to developing SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized high-activity human Factor IX variant enabling endogenous production of Factor IX, with the potential to be a one-time therapy. The SPK-FIX program leverages a long track record of hemophilia B gene therapy research and clinical development conducted by Spark and its founding scientific team over nearly three decades. SPK-9001 is being developed under a partnership with Pfizer.

About Spark Therapeutics
Spark is a gene therapy leader seeking to transform the lives of patients with debilitating genetic diseases by developing one-time, life-altering treatments. Spark’s validated gene therapy platform is being applied to a range of clinical and preclinical programs addressing serious genetic diseases, including inherited retinal dystrophies, hematologic disorders and neurodegenerative diseases. Spark’s most advanced product candidate, SPK-RPE65 (voretigene neparvovec), which has received both breakthrough therapy and orphan product designation, reported positive top-line results from a pivotal Phase 3 clinical trial for the treatment of rare blinding conditions. Spark builds on two decades of research, development and manufacturing at The Children’s Hospital of Philadelphia, including human trials conducted across diverse therapeutic areas and routes of administration. To learn more, please visit www.sparktx.com.

Spark Cautionary Note on Forward-looking Statements:
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s SPK-FIX program. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that: (i) our lead SPK-FIX product candidate may not produce sufficient data in our Phase 1/2 clinical trial to warrant further development; and (ii) our overall collaboration with Pfizer may not be successful. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Spark undertakes no duty to update this information unless required by law.

Pfizer and Rare Diseases
Rare diseases are among the most serious of all illnesses and impact millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact in addressing unmet medical needs. The Pfizer focus on rare diseases builds on more than two decades of experience, a dedicated research unit focusing on rare diseases, and a global portfolio of more than 20 medicines approved worldwide that treat rare diseases in the areas of hematology, neuroscience, inherited metabolic disorders, pulmonology, and oncology.

Pfizer Inc: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of May 19, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about SPK-9001, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with initial data, including the risk that the final results of the Phase I/2 study for SPK-9001 and/or additional clinical trials may be different from (including less favorable than) the initial data results and may not support further clinical development;  whether and when any applications may be filed with regulatory authorities for SPK-9001; whether and when regulatory authorities may approve any such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of SPK-9001; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Contacts

Investor Relations
Spark Therapeutics, Inc.
Stephen W. Webster
Chief Financial Officer
(855) SPARKTX (1-855-772-7589)

Media
Ten Bridge Communications
Dan Quinn
(781) 475-7974
dan@tenbridgecommunications.com

(AQMS) & Interstate Batteries Form Strategic Partnership

Interstate Invests in Aqua Metals, Has Agreed to Provide Millions of Pounds Of Used Batteries to Recycle at World’s First AquaRefinery

ALAMEDA, Calif., May 19, 2016  — Aqua Metals, Inc. (NASDAQ:AQMS) (Aqua Metals), which is commercializing a non-polluting electrochemical lead recycling technology called AquaRefining™, today announced the signing of definitive agreements with Interstate Batteries. Interstate Batteries is the No. 1 replacement battery brand, the largest independent battery distribution system in North America and the country’s leading battery recycler.

Upon the closing of these agreements, Interstate Batteries has agreed to supply more than a million automotive and other lead-acid batteries as feedstock for Aqua Metals’ AquaRefineries. This partnership will start with Aqua Metals’ first AquaRefinery, which will be located in Nevada’s Tahoe-Reno Industrial Complex (TRIC) and is set to open in July 2016. Interstate Batteries will also make a strategic investment of approximately $10 million into Aqua Metals.

With a nationwide network of more than 200,000 dealers returning battery cores, Interstate Batteries recycled more than 24.9 million automotive batteries in 2015, which is more than it sells. In the automotive industry alone, Interstate Batteries sells more than 17 million automotive batteries annually in addition to powering everything including marine and heavy equipment, golf carts, lawn and garden care equipment, data center cloud infrastructure and security systems.

“Interstate Batteries seeks out innovation, pursues opportunities and invests in the technology we need to succeed not just today, but also tomorrow,” said Scott Miller, president and CEO of Interstate Batteries. “Our focus is on the future of our industry and continued growth. Aqua Metals’ breakthrough technology is a promising new way for recycling lead-acid batteries.”

Aqua Metals’ patent-pending AquaRefining process is an environmentally friendly electrochemical process for recycling lead-acid batteries. AquaRefining is a closed-loop, room temperature, water-based recycling method that is fundamentally non-polluting, yet able to yield nearly 100 percent lead recovery.

“With its forward-thinking environmental goals, broad distribution network and strong brand name, Interstate Batteries is an ideal partner for us as we scale our business,” said Dr. Stephen Clarke, chairman and CEO of Aqua Metals. “As we grow, we are able to create a more sustainable ecosystem for lead as a power source. We look forward to growing our partnership with Interstate Batteries.”

Interstate Batteries’ $10 million strategic investment into Aqua Metals will be in the form of common stock, a fixed-price note that converts into common stock, and two cash warrants to purchase common stock over the next three years.

Concurrent with all of these agreements with Interstate Batteries, Aqua Metals signed definitive agreements with various institutional and individual accredited investors to raise additional gross proceeds of approximately $5.1 million in a private placement of common stock. National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ:NHLD), acted as sole placement agent for the additional $5.1 million investment. The Liquid Venture Partners group at National Securities Corporation was primarily responsible for the sourcing and execution of that portion of the investment.

All of these agreements are expected to close on or before May 23, 2016, subject to customary closing conditions. Additional details of all of the agreements are included in the Aqua Metals’ recently filed Quarterly Report on Form 10-Q.

About Interstate Batteries
Interstate’s starting, lighting, ignition (SLI) batteries have been under millions of car hoods since 1952, each one backed by Outrageously Dependable^® service, quality and value. Interstate PowerCare offers premier products, technical expertise and reliable service for critical and motive power needs, and Interstate All Battery Centers meet the growing demand for portable power in both retail and commercial markets. Today, Interstate sells more than 17 million batteries in North, Central and South America and China – and they recycle more than they sell. With a nationwide network of more than 200,000 dealers returning battery cores, they’ve turned batteries into one of America’s greatest recycling successes. For more information, please visit www.interstatebatteries.com.

About Aqua Metals
Aqua Metals (NASDAQ:AQMS) is reinventing lead recycling with its patent-pending  AquaRefining^TM technology. Unlike smelting, AquaRefining is a room temperature, water-based process that is fundamentally non-polluting. These modular systems are expected to  allow the lead-acid battery industry to simultaneously improve environmental impact and scale production to meet rapidly growing demand. Aqua Metals is based in Alameda, California, and is building its first recycling facility in Nevada’s Tahoe Reno Industrial Complex. To learn more, please visit www.aquametals.com.

Safe Harbor
This press release contains forward-looking statements concerning Aqua Metals, Inc., the lead-acid battery recycling industry, the intended benefits of its agreements with Interstate Batteries, the future of lead-acid battery recycling via traditional smelters, the Company’s development of its commercial lead-acid battery recycling facilities and the quality, efficiency and profitability of Aqua Metals’ proposed lead-acid battery recycling operations. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (1) the fact that Company has not yet commenced revenue producing operations or developed its initial commercial recycling facility, thus subjecting the Company to all of the risks inherent in a pre-revenue start-up; (2) the uncertainties involved in any new commercial relationship and the risk that Aqua Metals will not receive the intended benefits of its agreements with Interstate Batteries; (3) risks related to Aqua Metals’ ability to raise sufficient capital, as and when needed, to develop and operate its recycling facilities; (4) changes in the federal, state and foreign laws regulating the recycling of lead-acid batteries; (5) the Company’s ability to protect its proprietary technology, trade secrets and know-how and (6) those other risks disclosed in the section “Risk Factors” included in the Annual Report on Form 10-K  filed with the SEC on March 28, 2016. Aqua Metals cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur.

Aqua Metals Media Relations:
Antenna
Sharon Golubchik
Director
609-418-0058
aquametals@antennagroup.com

Aqua Metals Investor Relations:
MZ North America
Greg Falesnik
Senior Vice President
Main: 949-385-6449
greg.falesnik@mzgroup.us 
www.mzgroup.us

Interstate Batteries Media Relations:
Jackson Spalding
Patrick Hill
404-724-2506  
phill@jacksonspalding.com 	

John Tucker
917-576-2813
jtucker@jacksonspalding.com

(KOOL) Publication of a Case Report on AMIRST in AMI

Data highlights promising results obtained from the AMIRST pilot study.

RANCHO CORDOVA, Calif., May 19, 2016  — Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced publication of data from a pilot study utilizing the company’s innovative technology for treatment of Acute Myocardial Infarction. The report was published in the “International Journal of the Cardiovascular Academy”, currently online*.

Results from the single-patient study titled, “Autologous bone marrow concentrate enriched in progenitor cells – an adjuvant in the treatment of acute myocardial infarction” were obtained using Cesca’s integrated point-of-care technology, Acute Myocardial Infarction Rapid Stem cell Therapy (AMIRST).

The patient was able to return to normal life two weeks after the AMIRST procedure, and the main findings of the study showed a significant improvement in the Left Ventricular Ejection Fraction (LVEF) from 35% at patient’s initial assessment to 60.3% at 24 months post-AMIRST intervention. LVEF is a key indicator of cardiac function, and reduced LVEF levels are considered risk factors for cardiovascular morbidity and mortality. In the publication, the authors note that, “This degree of improvement is considered atypical for a patient having suffered an ST elevated myocardial infarction (STEMI) with an ejection fraction below 40% post reperfusion (stenting).” No major adverse events were observed during the procedure and throughout the 24 month follow-up period. Additionally, data from the study demonstrated that Cesca’s AMIRST integrated technology provided all the components necessary for collection, processing and intracoronary delivery of concentrated stem cells from a patient’s own bone marrow directly into the target artery of the heart. The Company’s patented cell processing technology and proprietary protocol was developed to optimize the quality and quantity of the cells being administered to patients.

Dr. Venkatesh Ponemone, the Study Director and Executive Director of TotipotentRX, a subsidiary of Cesca Therapeutics Inc., commented, “The current standard of care treatment for cardiac regenerative medicine can benefit from improved technology. Cesca’s point-of-care technology overcomes some of the present challenges while also offering a clinical alternative for AMI patients and their physicians. The results from this case encourage our efforts to continue the AMIRST Phase II trial.”

“Cardiovascular morbidity and mortality are a significant economic burden on society, and it is encouraging to see Cesca’s innovative approach with the AMIRST protocol,” added Dr. Vinay Sanghi, MD, Principal Investigator and Associate Director, Interventional Cardiology, Fortis Hospital, Shalimarbagh, India.

*The full report is available online here: http://www.sciencedirect.com/science/article/pii/S2405818116300095

About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics.  These include:

• The SurgWerks™ System (in development) – a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure  Kits  for use in regenerative stem cell therapy at the point-of-care for  vascular and orthopedic diseases.
• The CellWerks™ System (in development) – a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
• The AutoXpress® System (AXP^®) – a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
• The MarrowXpress™ System (MXP™) – a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
• The BioArchive® System – an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
• Manual bag sets for use in the processing and cryogenic storage of cord blood.

Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change.  Forward-looking statements can often be identified by words such as “may,” “could,” “potential,” “continue,” and similar expressions and include, but are not limited to, statements regarding research and product commercialization.  These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption “Risk Factors” in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.  We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

Company Contact: Cesca Therapeutics Inc. 
ir@cescatherapeutics.com

Investor Contact: The Ruth Group 
Lee Roth / Tram Bui 
646-536-7012 / 7035 
lroth@theruthgroup.com / tbui@theruthgroup.com