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Handy & Harman to Commence Tender Offer for SL Industries Common Stock at $40.00 Per Share
Handy & Harman Ltd. (NASDAQ:HNH) (“HNH”), a diversified global industrial company, and SL Industries, Inc. (NYSE MKT:SLI) (the “Company” or “SLI”), a leading manufacturer of high-performance power solutions, announced today that they have entered into a definitive merger agreement pursuant to which HNH will acquire SLI.
Under the terms of the merger agreement, which has been unanimously approved by a special committee of the Board of Directors of SLI consisting of independent directors (the “Special Committee”), as well as the Boards of Directors of each of HNH and SLI, HNH, through a wholly owned subsidiary, will commence a tender offer to purchase up to all of the outstanding shares of SLI common stock at a purchase price of $40.00 per share in cash. The offer price represents a premium of 18.7% over the closing price of the SLI common stock on April 6, 2016, the last trading day prior to today’s announcement, and a premium of 38.2% over the closing price on February 8, 2016, the last full trading day prior to the announcement of HNH’s proposal to acquire SLI in an all-cash transaction.
Consummation of the offer is subject to certain conditions, including the tender of a number of shares that constitutes at least (1) a majority of SLI’s outstanding shares and (2) 60% of SLI’s outstanding shares not owned by HNH or any of its affiliates, as well as other customary conditions. The transaction is not subject to any financing contingencies. DGT Holdings Corp., an affiliate of HNH which owns approximately 25.1% of the outstanding shares of SLI common stock, has agreed to tender those shares in the offer.
Warren Lichtenstein, Chairman of HNH, said, “We believe this transaction exemplifies our strategy of profitably growing and building upon our core business units both internally and through strategic acquisitions. Affiliates of HNH first purchased shares in SLI almost 25 years ago when the stock was selling for around $3.50 per share. SLI is a company we know well and we expect it will be a great addition to the HNH / Steel family of businesses.”
William T. Fejes, Jr, President & CEO of SLI, stated, “Over the past several years, the SLI employees have done a fantastic job servicing our customers and improving financial results thereby significantly increasing shareholder value. We look forward to this new chapter in SLI’s history and continuing to contribute strong value to our customers and to our new shareholders.”
Olshan Frome Wolosky LLP served as legal counsel to HNH. Houlihan Lokey Capital Inc. acted as financial advisor to the Special Committee, and Gardere Wynne Sewell LLP served as legal counsel to the Special Committee.
Important Information
The tender offer described in this press release has not yet commenced. This press release is for informational purposes only and it is neither an offer to purchase nor a solicitation of an offer to sell shares of SLI’s common stock. At the time the tender offer is commenced, HNH will file a Tender Offer Statement on Schedule TO, containing an offer to purchase, a form of letter of transmittal and other related tender offer documents with the United States Securities and Exchange Commission (the “SEC”), and SLI will file a Solicitation/Recommendation Statement on Schedule 14D-9 and a Schedule 13E-3 Transaction Statement relating to such tender offer with the SEC. SLI’s stockholders are strongly advised to read these tender offer materials carefully and in their entirety when they become available, as they may be amended from time to time, because they will contain important information about such tender offer that SLI’s stockholders should consider prior to making any decisions with respect to such tender offer. Once filed, SLI’s stockholders will be able to obtain a free copy of these documents at the website maintained by the SEC at www.sec.gov.
Forward-Looking Statements
Statements in this press release regarding the proposed transaction between HNH and SLI, the expected timetable for completing the transaction, future financial and operating results, benefits of the transaction, future opportunities for HNH’s and SLI’s businesses and any other statements by management of HNH and SLI concerning future expectations, beliefs, goals, plans or prospects constitute forward-looking statements. Generally, forward-looking statements include expressed expectations, estimates and projections of future events and financial performance and the assumptions on which these expressed expectations, estimates and projections are based. Statements that are not historical facts, including statements about the beliefs and expectations of the parties and their management, are forward-looking statements. All forward-looking statements are inherently uncertain as they are based on various expectations and assumptions about future events, and they are subject to known and unknown risks and uncertainties and other factors that can cause actual events and results to differ materially from historical results and those projected. Risks and uncertainties include the satisfaction of closing conditions for the transaction; the possibility that the transaction will not be completed, or if completed, not completed on a timely basis; the ability of HNH to successfully integrate SLI’s business; and the risk that the expected benefits of the transaction may not be realized or maintained.
Neither HNH nor SLI can give any assurance that any of the transactions contemplated by the merger agreement will be completed or that the conditions to the tender offer will be satisfied. A further list and description of additional business risks, uncertainties and other factors can be found in HNH’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, SLI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, as well as other filings by HNH and SLI with the SEC. Copies of these filings, as well as subsequent filings, are available online at www.sec.gov. Many of the factors that will determine the outcome of the transaction are beyond HNH’s or SLI’s ability to control or predict. Neither HNH nor SLI undertakes to update any forward-looking statements as a result of new information or future events or developments.
About Handy & Harman Ltd.
Handy & Harman Ltd. is a diversified manufacturer of engineered niche industrial products with leading market positions in many of the markets it serves. Through its wholly-owned operating subsidiaries, HNH focuses on high margin products and innovative technology and serves customers across a wide range of end markets. HNH’s diverse product offerings are marketed throughout the United States and internationally.
HNH’s companies are organized into five businesses: Joining Materials, Tubing, Building Materials, Performance Materials, and Kasco.
HNH sells its products and services through direct sales forces, distributors, and manufacturer’s representatives. HNH serves a diverse customer base, including the construction, electrical, electronics, transportation, utility, medical, oil and gas exploration, aerospace and defense, and food industries.
HNH’s business strategy is to enhance the growth and profitability of the HNH business units and to build upon their strengths through internal growth, the Steel Business System and strategic acquisitions. Management expects HNH to continue to focus on high margin products and innovative technology. Management has evaluated and will continue to evaluate, from time to time, potential strategic and opportunistic acquisition opportunities, as well as the potential sale of certain businesses and assets.
HNH is based in White Plains, N.Y., and its common stock is listed on the NASDAQ Capital Market under the symbol HNH. Website: www.handyharman.com
About SL Industries
SL Industries, Inc. designs, manufactures and markets power electronics, motion control, power protection, power quality electromagnetic equipment, and custom gears and gearboxes that are used in a variety of medical, commercial and military aerospace, computer, datacom, industrial, architectural and entertainment lighting, and telecom applications. For more information about SL Industries, Inc. and its products, please visit the Company’s web site at www.slindustries.com.
Handy & Harman Ltd.
James F. McCabe, Jr., 212-520-2300
Senior Vice President and Chief Financial Officer
jmccabe@steelpartners.com
or
SL Industries, Inc.
Louis J. Belardi, 856-727-1500 x 5525
Chief Financial Officer
louis.belardi@slindustries.com
HOUSTON, April 7, 2016 — Lucas Energy, Inc. (NYSE MKT: LEI) (“Lucas” or the “Company”) announced today that it has entered into a series of agreements with an institutional investor whereby it will receive $10.0 million of equity capital, subject to meeting certain conditions. The initial investment is structured as a Redeemable Convertible Subordinated Debenture which will automatically convert into common stock at an initial conversion price of $3.25 per share upon certain of the conditions described below being met. At closing, this placement will provide $500,000 of funding immediately, and the balance of $4.5 million through the exercise of a Warrant upon (i) the closing of the announced transaction with Segundo, (ii) shareholder approval to issue the common shares for NYSE MKT purposes, (iii) registration of the underlying common stock and (iv) a dollar volume trading requirement of $5 million in the previous 20 trading days. Lucas also agreed to issue an additional $5.0 million of a newly designated Series C Redeemable Convertible Preferred Stock of which $500,000 will be funded upon closing of the announced Segundo Transaction, and the balance upon achieving certain milestones. The Series C Redeemable Convertible Preferred Stock will also be convertible into common stock at an initial conversion price of $3.25 per share.
Under the terms of the agreements with the investor, Lucas is to receive $10 million under current commitments while an additional $5 million is to be made available through the exercise of an additional Warrant upon mutual consent. See the Form 8-K filed on April 7, 2016 for the conditions and other material terms relating to this transaction and associated agreements.
“This placement demonstrates confidence in the future of Lucas Energy as we progress towards closing on the Segundo Resources asset purchase,” said Anthony C. Schnur, Chief Executive Officer of Lucas Energy who continued, “Having received this commitment establishes some certainty that we can initiate growth and development activities upon closing the acquisition.”
On December 31, 2015 the Company announced the signing of a purchase agreement to acquire, from 21 different entities and individuals, working interests in producing properties and undeveloped acreage. The assets being acquired include varied interests in two largely contiguous acreage blocks in the liquids-rich Mid-Continent region. The properties currently produce in excess of 1,200 net barrels of oil equivalent per day (BOE/d). At the closing of the transaction, Lucas will rebrand and change its name to Camber Energy, Inc.
ROTH Capital Partners acted as exclusive placement agent on this Transaction.
More information regarding the agreements referenced herein, including the terms and conditions have been disclosed in the Current Report on Form 8- K filed by Lucas today with the Securities and Exchange Commission.
About Lucas Energy, Inc.
Lucas Energy (NYSE MKT: LEI) is engaged in the production of crude oil and natural gas currently in the Austin Chalk and Eagle Ford formations in South Texas. Based in Houston, Lucas’s management team is committed to building a platform for growth and the development of its five million barrels of proved Eagle Ford and other oil reserves while continuing its focus on operating efficiencies and cost control.
Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements give our current expectations, opinions, beliefs or forecasts of future events and performance. A statement identified by the use of forward-looking words including “may,” “expects,” “projects,” “anticipates,” “plans,” “believes,” “estimate,” “should,” “progress,” and certain of the other foregoing statements may be deemed forward-looking statements. Although Lucas believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties that may cause actual future activities and results to be materially different from those suggested or described in this news release. These risks and uncertainties include, but are not limited to: the occurrence of any event, change or other circumstances that could give rise to the termination of the asset purchase agreement; the inability to complete the asset purchase transaction due to the failure to satisfy any of the conditions to complete the asset purchase transaction; or the occurrence of any event, change or other circumstances that would cause us not to meet the conditions required to receive the full amount of the proceeds from the $15 million financing. These also include risks inherent in natural gas and oil drilling and production activities, including risks of fire, explosion, blowouts, pipe failure, casing collapse, unusual or unexpected formation pressures, environmental hazards, and other operating and production risks, which may temporarily or permanently reduce production or cause initial production or test results to not be indicative of future well performance or delay the timing of sales or completion of drilling operations; delays in receipt of drilling permits; risks with respect to natural gas and oil prices, a material decline which could cause Lucas to delay or suspend planned drilling operations or reduce production levels; risks relating to the availability of capital to fund drilling operations that can be adversely affected by adverse drilling results, production declines and declines in natural gas and oil prices; risks relating to unexpected adverse developments in the status of properties; risks relating to the absence or delay in receipt of government approvals or fourth party consents; and other risks described in Lucas’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the SEC, available at the SEC’s website at www.sec.gov. Investors are cautioned that any forward-looking statements are not guarantees of future performance and actual results or developments may differ materially from those projected. The forward-looking statements in this press release are made as of the date hereof. The Company takes no obligation to update or correct its own forward-looking statements, except as required by law, or those prepared by third parties that are not paid for by the Company. The Company’s SEC filings are available at http://www.sec.gov.
Important Information
The securities described above have not been registered under the Securities Act of 1933, or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. In connection with the financing and planned acquisition described above, Lucas currently intends to file resale registration statements and a proxy statement with the Securities and Exchange Commission (the “SEC”). This communication is not a substitute for any proxy statement, registration statement, proxy statement/prospectus or other document Lucas may file with the SEC in connection with the proposed transactions. Prospective investors are urged to read the proxy statement, when filed as it will contain important information. Any definitive proxy statement(s) (if and when available) will be mailed to stockholders of Lucas. Prospective investors may obtain free copies of the proxy statement, when filed, as well as other filings containing information about Lucas, without charge, at the SEC’s website (www.sec.gov). Copies of Lucas’s SEC filings may also be obtained from Lucas without charge at Lucas’s website (www.lucasenergy.com) or by directing a request to Lucas at (713) 528-1881. This document does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
INVESTORS SHOULD READ THE PROXY STATEMENT AND OTHER DOCUMENTS TO BE FILED WITH THE SEC CAREFULLY BEFORE MAKING A DECISION CONCERNING THE TRANSACTION.
Participants in Solicitation
Lucas and its directors and executive officers and other members of management and employees are potential participants in the solicitation of proxies in respect of the proposed transaction. Information regarding Lucas’s directors and executive officers is available in Lucas’s Annual Report on Form 10-K for the year ended March 31, 2015, filed with the SEC on July 14, 2015 and Lucas’s definitive proxy statement on Schedule 14A, filed with the SEC on February 18, 2016. Additional information regarding the interests of such potential participants will be included in the registration statement and proxy statement to be filed with the SEC by Lucas in connection with the proposed transaction and in other relevant documents filed by Lucas with the SEC. These documents can be obtained free of charge from the sources indicated above. Additional information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available.
Contact:
Carol Coale / Ken Dennard
Dennard Lascar Associates, LLC
(713) 529-6600
ccoale@dennardlascar.com
ken@dennardlascar.com
http://www.dennardlascar.com
BELLINGHAM, WA–(April 07, 2016) – eXp Realty International Corporation (OTCQB: EXPI) announced today that it has changed its corporate name to eXp World Holdings, Inc. in order to reflect its broader commitment to utilizing cloud-based technologies in order to create opportunities for the most entrepreneurial professionals across a number of industries beyond real estate brokerage.
“Our achievements within our real estate brokerage division have demonstrated to us in a compelling way that entrepreneurial professionals are willing and eager to embrace the cloud to transform business, ownership, and collaboration and to avail themselves of new opportunities to earn, learn and grow that otherwise wouldn’t be feasible,” said Company Founder and CEO, Glenn Sanford. “This name change will allow us to continue to focus on the tremendous growth and achievements happening within our real estate brokerage division while delivering innovation and opportunity to other service industries without causing confusion among the investing public,” Sanford said.
The Company’s common stock trades under the symbol “EXPI” and the name change will have no impact on the Company’s trading symbol.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage™ as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
eXp World Holdings, Inc. also owns 90.5% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, New Mexico and Texas.
The corporate name change to “eXp World Holdings, Inc.” has been approved by our Board and stockholders but is not yet effective, pending the mailing of a definitive information statement to our stockholders in accordance with applicable rules and a 20-day notice period thereafter.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit investors.exprealty.com or www.exprealty.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426
Trade and Media Contact Information:
Jason Gesing
President
eXp Realty World Holdings, Inc.
jason@expworldholdings.com
617-970-8518
SPRINGFIELD, Va., April 6, 2016 — Versar, Inc. (NYSE MKT: VSR) announced today that it has been awarded a $47.8 million contract extension for its ongoing efforts to support the Federal Aviation Administration’s (FAA) Security System Design and Integration (SSDI) Program. The contract extension is for one two-year base period and two six-month option periods. This contract modification was awarded under the FAA’s contract with Johnson Controls Security Systems, which Versar purchased from Johnson Controls, Inc. in late 2015 and is now known as Versar Security Systems (VSS). Under this modification, VSS will continue to provide physical security design and implementation services and support the migration of physical security systems onto the FAA’s IT Enterprise.
Tony Otten, CEO of Versar said, “We are very pleased to continue our quality support of the Federal Aviation Administration, a long term client of VSS. This contract extension will enable VSS to continue to provide Security System Design and Integration services to FAA facilities throughout the United States. We’re confident that our capabilities are aligned with the requirements of the contract.”
VERSAR, INC., headquartered in Springfield, Virginia, is a publicly-traded global project management company providing sustainable value oriented solutions to government and commercial clients in the construction management, environmental services, and professional services market areas.
VERSAR operates the following websites: www.versar.com and www.versarpps.com.
This news release contains forward-looking information. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be significantly impacted by certain risks and uncertainties described herein and in Versar’s Annual Report on Form 10-K filed with the Securities and Exchange Commission for the fiscal year ended June 26, 2015, as updated from time to time in the Company’s periodic filings. The forward-looking statements are made as of the date hereof and Versar does not undertake to update its forward-looking statements.
NEW YORK, April 06, 2016 — Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced it delivered an oral presentation and presented several posters featuring data on ITI-007, the Company’s lead drug candidate at the 5th Biennial Schizophrenia International Research Society (SIRS) Conference being held in Florence, Italy.
The oral presentation and two poster presentations featured additional efficacy and safety data from ITI-007-301, the Company’s recently completed Phase 3 clinical trial in patients with schizophrenia. An additional poster presentation featured data from the ITI-007 Positron Emission Tomography (PET) study in patients with schizophrenia. Top-line data from both trials were announced in September 2015 and subsequently presented at the 54th annual meeting of the American College of Neuropsychopharmacology (ACNP) in December 2015.
Poster #S66 entitled “ITI-007 Exhibits Unique Pharmacology: Combined Results from Positron Emission Tomography (PET) Studies in Healthy Volunteers and Patients with Schizophrenia,” was presented on Sunday, April 3rd. This PET study highlights ITI-007’s unique pharmacological profile via serotonergic, dopaminergic, and glutamatergic pathways. ITI-007 was safe and well-tolerated and demonstrated dose-related occupancy of human brain dopamine D2 receptors, 5-HT2A receptors, and serotonin transporters. At a dose of 60 mg, ITI-007 demonstrated relatively low, about 40% mean peak striatal D2 receptor occupancy in patients with schizophrenia at plasma steady state. Taken into context with data from other clinical trials, ITI-007 60 mg was effective in reducing psychosis in patients with schizophrenia at relatively low striatal D2 receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs. This mechanism, along with ITI-007’s potent interactions at 5-HT2A receptors, serotonin transporters and D1 receptors, likely contributes to the efficacy of ITI-007 with improved psychosocial function and favorable motoric tolerability representing a potentially novel approach to the treatment of schizophrenia and other neuropsychiatric disorders. Additional data regarding receptor occupancy within specific brain regions such as the ventral striatum were presented.
Poster #M67 entitled “Positive Phase 3 Clinical Trial of ITI-007 for the Treatment of Schizophrenia: Secondary Endpoints and Subgroup Analyses from a Randomized, Double-Blind, Placebo-Controlled Trial,” was presented on Monday, April 4th. In this trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated efficacy with statistically significant superiority over placebo at Day 28 as measured by the Positive and Negative Syndrome Scale (PANSS) total score (p=0.022). Moreover, ITI-007 60 mg showed significant efficacy as early as week 1 on both the PANSS total score and PANSS Positive Symptom subscale score, which was maintained at every time point throughout the entire study. ITI-007 60 mg also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression of Severity of Illness (CGI-S) (p=0.003). Both doses (ITI-007 40 mg and 60 mg) improved global severity of illness, positive symptoms and prosocial behavior.
A high treatment completion rate was observed with ITI-007 (87% of patients completed treatment on ITI-007 60 mg, 82% completed on ITI-007 40 mg, and 75% completed on placebo). Patients randomized to ITI-007 60 mg demonstrated a statistically significant longer time to treatment discontinuation due to any reason compared to placebo (p=0.006) and a statistically significant longer time to treatment discontinuation due to lack of efficacy (p=0.01). Baseline characteristics of the studied patient population indicated a mean of 17 years since first diagnosis and markedly ill at baseline with a mean baseline PANSS total score of 89.8 and a mean baseline CGI-S score of 4.8.
Poster #T66 entitled “Positive Phase 3 Clinical Trial of ITI-007 for the Treatment of Schizophrenia: Safety Results from a Randomized, Double-Blind, Placebo-Controlled Trial,” was presented on Tuesday, April 5th. ITI-007 given once daily in the morning was well-tolerated with no dose titration and demonstrated a safety profile that did not differ from placebo in patients with acutely exacerbated schizophrenia. The number of patients who discontinued treatment in this trial due to an adverse event was low and the time to treatment discontinuation due to an adverse event was not statistically significantly different from placebo for either dose of ITI-007. Patients randomized in this trial included 77.1% males with a mean age of 42.4 years. Administered orally once daily in the morning, the only treatment-emergent adverse event considered at least possibly related to ITI-007 occurring in ≥5% of patients and at least twice the rate of placebo were somnolence, sedation and fatigue, all predominantly mild. ITI-007 showed a motoric profile similar to placebo according to adverse event reports or when objectively measured by the Simpson Angus Scale, the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale. There was no clinically meaningful increase in prolactin, rather ITI-007 (60 mg) significantly decreased prolactin (p=0.05), consistent with its mechanism of action as a dopamine D2 receptor partial agonist. ITI-007 also showed a metabolic profile similar to placebo.
The oral presentation at SIRS entitled “Positive Phase 3 Clinical Trial of ITI-007 for the Treatment of Schizophrenia: Efficacy Results from a Randomized, Double-Blind, Placebo-Controlled Trial,” was presented on Tuesday, April 5th and included an overview of the data presented in the posters.
“These data provide additional insights into the positive efficacy, safety and tolerability results seen in our ITI-007 studies in patients with schizophrenia, suggesting there is a broad beneficial effect with ITI-007 in schizophrenia and potentially across multiple indications,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe, if approved, ITI-007 may provide an advancement in the treatment of schizophrenia by offering patients an effective therapy and the possibility of achieving long-term benefits by staying on treatment.”
About ITI-007
ITI-007 is our lead drug development candidate with mechanisms of action that, we believe, have the potential to yield a first-in-class therapy for multiple therapeutic indications. In our pre-clinical and clinical trials to date, ITI-007 combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation (DPPM), glutamatergic modulation, and serotonin reuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia, as well as for the treatment of bipolar disorder, including bipolar depression. At dopamine D2 receptors, ITI-007 has been demonstrated to have dual properties and to act as both a post-synaptic antagonist and a pre-synaptic partial agonist. ITI-007 has also been demonstrated to stimulate phosphorylation of glutamatergic NMDA GluN2B receptors in a mesolimbic specific manner. We believe that this regional selectivity in brain areas thought to mediate the efficacy of antipsychotic drugs, together with serotonergic, glutamatergic, and dopaminergic interactions, may result in efficacy for a broad array of symptoms associated with schizophrenia and bipolar disorder with improved psychosocial function. The serotonin reuptake inhibition potentially allows for antidepressant activity in the treatment of schizoaffective disorder, co-morbid depression, and/or as a stand-alone treatment for major depressive disorder. We believe ITI-007 may also be useful for the treatment of other psychiatric and neurodegenerative disorders, particularly behavioral disturbances associated with dementia, autism, and other CNS diseases.
About Schizophrenia
Schizophrenia is a disabling and chronic mental illness affecting over 1% of the world’s population. Schizophrenia is characterized by multiple symptoms during an acute phase of the disorder that can include so-called “positive” symptoms, such as hearing voices, disorganized thinking, grandiose beliefs and suspiciousness or paranoia. These symptoms can be accompanied by additional, harder-to-treat symptoms, such as social withdrawal and blunted emotional response and expression, collectively referred to as “negative” symptoms, difficulty concentrating or cognitive impairment, depression, and insomnia. Such residual symptoms often persist even after the acute positive symptoms subside, and contribute substantially to the social and employment disability associated with schizophrenia. Current antipsychotic medications provide some relief for the symptoms associated with the acute phase of the disorder, but they do not effectively treat the residual phase symptoms and psychosocial impairment associated with chronic schizophrenia. Currently available medications used to treat acute schizophrenia are limited in their use due to side effects that can include movement disorders, weight gain, metabolic disturbances, and cardiovascular disorders. There is an unmet medical need for new therapies that have improved side effect and efficacy profiles.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson’s and Alzheimer’s disease. The Company is developing its lead drug candidate, ITI-007, for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in dementia, depression and other neuropsychiatric and neurological disorders. ITI-007, a first-in-class molecule, is in Phase 3 clinical development for the treatment of schizophrenia and bipolar depression. The Company is also utilizing its phosphodiesterase platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders.
Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our clinical and non-clinical development plans; the progress, timing and results of our clinical trials; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of ITI-007; and our research and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management’s present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: our current and planned clinical trials, other studies for ITI-007, and our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.

Contact:
Juan Sanchez, M.D.
Vice President
Corporate Communications and Investor Relations of Intra-Cellular Therapies, Inc.
Phone: 646-440-9333
Burns McClellan, Inc.
Lisa Burns
Justin Jackson (Media)
jjackson@burnsmc.com
212-213-0006
SAN DIEGO, April 6, 2016 — Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), a clinical-stage oncology company developing new treatments for cancer and associated pain, announced today that Gunnar F. Kaufmann, Ph.D., Senior Vice President, Immunotherapy, & Head of Research and Global Partnerships, will present at the Jefferies Immuno-Oncology Summit on Thursday, April 7, 2016 from 7:55 am to 8:20 am EDT. The conference will take place at the Boston Harbor Hotel in Boston, MA.
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for cancer, inflammation and autoimmune diseases. Sorrento’s lead products are multiple late-stage biosimilar and biobetter antibodies, as well as clinical CAR-T therapies targeting solid tumors.
Forward-Looking Statements
This press release and any statements made for and during any presentation or conference contain forward-looking statements related to Sorrento Therapeutics, Inc., and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Sorrento’s and its subsidiaries’ prospects, Sorrento’s expectations for adoptive cellular immunotherapies and Sorrento’s collaborations; Sorrento’s advances made in developing RTX, biosimilars/biobetters, cellular therapies, such as CAR-T, CAR.NK and CAR.TNK, cell-penetrant antibodies (LA Cell technology) as well as antibody immunotherapies using its proprietary G-MAB fully human antibody technology, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
All other trademarks and trade names are the property of their respective owners.
© 2016 Sorrento Therapeutics, Inc. All Rights Reserved.
SOUTH SAN FRANCISCO, Calif., April 06, 2016 — Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, today announced that Gad Soffer, the Company’s Chief Operating Officer, will present at the 15th Annual Needham Healthcare Conference on Wednesday, April 13, 2016 at 12:50 p.m. ET. The conference will be held at the Westin Grand Central Hotel in New York, NY.
A live webcast of the presentation will be available by visiting the Investors section of the Atara Bio website at www.atarabio.com. An archived replay of the webcast will be available on the Company’s website for 14 days following the presentation.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. is a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, with an initial focus on immunotherapy and oncology. Atara Bio’s programs include T-cell product candidates and molecularly targeted product candidates. The T-cell product candidates include EBV-CTL, CMV-CTL and WT1-CTL and harness the power of the immune system to recognize and attack cancer cells and cells infected with certain viruses. The molecularly targeted product candidates include STM 434. These product candidates target activin and myostatin, members of the TGF-beta family of proteins, and have demonstrated the potential to have therapeutic benefit in a number of clinical indications.

INVESTOR & MEDIA CONTACT:
Investors:
Steve Klass
212-213-0006 x331
sklass@burnsmc.com
Media:
Justin Jackson
212-213-0006 x327
jjackson@burnsmc.com
New Orders from Existing Customer
SANTA CLARA, Calif., April 6, 2016 — UniPixel, Inc. (NASDAQ: UNXL), a provider of advanced touch solutions to the touchscreen and flexible electronics markets, today announced that it has been awarded two new 2-in-1 convertible programs from a leading PC manufacturing customer. 2-in-1 convertible computers combine the best features of a laptop and a tablet in one device.
Both programs will utilize UniPixel’s XTouch™ highly responsive touchscreen sensors with its outstanding finger-touch and capacitive stylus performance, and the company’s Diamond Guard hardcoat technology to reduce the overall cost and the weight of the computing devices. Volume production for the two programs is expected to commence during the fourth quarter of 2016 and first quarter of 2017, respectively.
Jeff Hawthorne, president and chief executive officer of UniPixel, said, “We are pleased with the two design wins from this existing customer. Further orders from existing customers are an affirmation that not only does our technology resonate with customers, but our response time and service levels meet their requirements.
“Our XTouch copper metal mesh touch sensor product is increasingly gaining share in the market as an alternative to traditional ITO sensors due to the unique sensor design and significantly lower sheet resistance of our sensors, which allow for superior touch and stylus performance. As 2-in-1 computing devices with advanced stylus capabilities continue to gain market share, UniPixel is well positioned to benefit as the market more fully develops in the coming years.”
Mr. Hawthorne continued, “By adding our Diamond Guard hardcoat, this customer will be able to produce two new devices that are lighter, thinner, and faster with exceptional stylus performance. We believe this is a strong validation of our technologies and is indicative of the increased traction that we are now starting to gain with our highly differentiated products. We are pleased with the progress achieved thus far in 2016.”
About UniPixel
UniPixel, Inc. (NASDAQ: UNXL) develops and markets Performance Engineered Films for the touch screen and flexible electronics markets. The company’s roll-to-roll electronics manufacturing process patterns fine line conductive elements on thin films. The company markets its technologies for touch panel sensor, cover glass replacement, and protective cover film applications under the XTouch™ and Diamond Guard™ brands. For further information, visit www.unipixel.com.
Forward-looking Statements
All statements in this news release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended including the statement that UniPixel’s integrated technologies are expected to provide enhanced yields at a lower cost, thereby expanding UniPixel’s competitiveness in the touch screen market. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, which could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015. UniPixel operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the company’s Annual Report on Form 10-K, quarterly reports on Form 10-Q and Current Reports on Form 8-K.
Trademarks in this release are the property of their respective owners
Contact:
Joe Diaz, Robert Blum, Joe Dorame
Lytham Partners, LLC
602-889-9700
unxl@lythampartners.com
Tokai Pharmaceuticals Inc. (NASDAQ:TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, today announced that management will present at the 15th Annual Needham Healthcare Conference on Wednesday, April 13, 2016 at 1:40pm ET at The Westin Grand Central in New York City.
A live webcast of the presentation can be accessed under the “Calendar of Events” page within the Investors & Media section of the company’s website at www.tokaipharma.com. A replay of the webcast will be archived on the Tokai website for 90 days following the date of the presentation.
About Tokai Pharmaceuticals
Tokai Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases. The company’s lead drug candidate, galeterone, is an oral small molecule that utilizes the mechanistic pathways of current second-generation anti-androgens, while also introducing a unique third mechanism – androgen receptor degradation. Tokai is developing galeterone for the treatment of patients with metastatic castration-resistant prostate cancer. The company’s ARDA drug discovery program is focused on the identification and evaluation of compounds that are designed to disrupt androgen receptor signaling through enhanced androgen receptor degradation and are targeted to patients with androgen receptor signaling diseases, including prostate cancer. For more information on the company and galeterone, please visit www.tokaipharma.com.
DALLAS, April 5, 2016 — COPsync, Inc. (NASDAQ: COYN), which operates the nation’s only law enforcement in-car information sharing and data communication network and the COPsync911™ threat-alert service for schools, government buildings, hospitals and other potentially at-risk facilities, announced the launch of the Trust 2 Protect campaign in New York at the Grand Prospect Hall on April 4, 2016. The campaign is focused on engaging, empowering and promoting concrete solutions that help bridge the gap dividing law enforcement and citizens.
Supporters of the Trust 2 Protect Campaign include Founder and The Brewer Group CEO Jack Brewer, and Trust 2 Protect Partners COPsync CEO Ronald Woessner, and The Blue Alert Foundation Founder/Director Tom Berry. Trust 2 Protect Campaign Endorsers include former NFL running back and Founder of the Two 6 Foundation Clinton Portis, former NFL defensive tackle Tommie Harris, Jr., as well as other celebrity athletes.
COPsync CEO Ron Woessner stated, “I am grateful to Jack Brewer for organizing the Trust 2 Protect Campaign and for bringing much needed public focus to the safety needs of law enforcement. At COPsync, our goal is to protect officers with 21st-century technologies that arm them with information to help keep them safer and help interdict crime and criminals more effectively.”
The Trust 2 Protect campaign continues with an event in New Jersey at The Brownstone House on April 5, 2016. During the events leading up to National Police Week in Washington, D.C., the Trust 2 Protect Campaign will host a third launch on May 10, 2016, at the Washington, D.C. Rayburn House Office Building. Future launch locations will include Texas and Florida. The campaign will also be highlighted at the Brewer Sports Symposium VIII featuring the Sport 4 Development Summit on April 6, 2016, recognizing International Day for Sport for Development and Peace at the United Nations.
Become Involved with Trust 2 Protect
For more information or to bring Trust 2 Protect to your community, contact: trust2protect@thebrewergroup.com.
To make a financial contribution that will help communities obtain officer and community safety technologies like those provided by COPsync, visit www.trust2protect.org. All donations are tax-deductible.
About COPsync, Inc.
COPsync, Inc. (NASDAQ: COYN) is a technology company that improves law enforcement communication in a manner that saves officers’ lives and helps them prevent and respond more quickly to crime. Officers have instant access to actionable, mission-critical data, share information, and communicate in real-time with other officers and agencies, even those hundreds and thousands of miles away. The COPsync Network™ also eliminates manual processes and increases officer productivity by enabling officers to write electronic tickets, accident reports, DUI forms, arrest forms and incident and offense reports. COPsync’s threat-alert system, COPsync911™, enables schools, courts, hospitals, and other potentially at-risk facilities to automatically and silently send emergency alerts directly to local law enforcement officers in their patrol cars during a crisis, thereby speeding first responder response times and saving minutes when seconds count. The Company also sells VidTac®, a law enforcement software-driven in-vehicle video system. Visit www.copsync.com and www.copsync911.com for more information.
Contact:
For COPsync:
Ronald A. Woessner
Chief Executive Officer
972-865-6192
invest@copsync.com
Media:
Fred Sommer
Senior Consultant
Investor Relations
Ascendant Partners, LLC.
732-410-9810
fred@ascendantpartnersllc.com
EWING, N.J., April 5, 2016 — Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that Scott Jackson, Chief Executive Officer, will present an overview of the company at the 15th Annual Healthcare Conference in New York City, NY on Tuesday, April 12, 2016 at 11:20 a.m. Eastern Time.
A live webcast will be available on the investor section of Celator’s website at www.celatorpharma.com. An archived replay of the webcast will be available on the Company’s website for 30 days after the conference.
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 in Phase 3 clinical testing for the treatment of acute myeloid leukemia. We have 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. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and development programs, the efficacy and commercial potential of our drug candidates, and our performance and achievements to differ significantly from those expressed or implied by the forward-looking statements. 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 the company in general, see Celator’s Form 10-K for the year ended December 31, 2015, and other filings by the company with the U.S. Securities and Exchange Commission.
CONTACTS:
Media:
Sam Brown, Inc.
Mike Beyer, 312-961-9502
mikebeyer@sambrown.com
Investors:
The Trout Group
Adam Krop, 646-378-2963
akrop@troutgroup.com
CEO Sehat Sutardja and President Weili Dai Depart from Management Positions, Effective Immediately Board Forms Interim Office of the Chief Executive to Lead Company until Replacements are Appointed
SANTA CLARA, Calif., April 5, 2016 — Marvell Technology Group Ltd. (NASDAQ: MRVL), a global leader in integrated silicon solutions, today announced the departure of Chief Executive Officer Sehat Sutardja and President Weili Dai from their management positions, effective immediately. Dr. Sutardja and Ms. Dai will remain on the Board of Directors, with Dr. Sutardja continuing as Chairman. The Board, in conjunction with a leading executive search firm, will conduct a search for a new CEO and President.
The Board has formed an Interim Office of the Chief Executive to oversee day-to-day leadership of the Company’s operations. The Interim Office of the Chief Executive will be headed by Ms. Maya Strelar-Migotti, Executive Vice President, Smart Networked Devices and Solutions (SNDS) Business Group and Dr. Pantelis Alexopoulos, Executive Vice President of the Storage Business Group, as Interim Co-Chief Executive Officers. Each has the authority to exercise all powers of the Chief Executive Officer.
The other members of the Interim Office of the Chief Executive include Dr. Zining Wu, Chief Technology Officer; Mr. David Eichler, Interim Chief Financial Officer; Mr. Tom Savage, Senior Vice President and General Counsel; and Mr. William Valle, Vice President, Global Human Resources.
Arturo Krueger, Marvell’s lead outside director, said, “The Board would like to thank Sehat and Weili for their enormous contributions and service since they founded Marvell in 1995. Marvell has revolutionized the world through its innovative technology and breakthrough designs in the semiconductor industry. However, the Board believes that the time has come to move in a new leadership direction. The Company’s highest priority is to leverage Marvell’s strong core business and technology to drive the next stage of product innovation and profitable growth. The Board has full confidence in the proven ability of Maya and Pantelis, together with the other members of the Interim Office of the Chief Executive and all of Marvell’s employees, to continue providing world-class research and development and customer support during this time of transition. We look forward to demonstrating our continuing commitment to excellence in our products and service, as well as to creating value for our shareholders.”
On February 22, 2016, the Audit Committee approved the engagement of Deloitte & Touche LLP as the Company’s new independent public accounting firm. On March 1, 2016, the Company reported the results of the Audit Committee’s independent investigation of certain accounting and internal control matters. With these two key matters completed, the Company is working diligently to complete the preparation and filing of its Annual Report on Form 10-K for fiscal 2016 and its Quarterly Reports on Form 10-Q for the second and third quarters of fiscal 2016 as soon as practicable. As previously announced, a search for a permanent Chief Financial Officer and additional independent board members is underway with the assistance of an international executive search firm.
Forward-Looking Statements under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements within the meaning of the federal securities laws that involve risks and uncertainties. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “can,” “will” and similar expressions identify such forward-looking statements. These statements are not guarantees of results and should not be considered as an indication of future activity or future performance. Actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, including, among others: the interim performance of Interim Office of the Chief Executive; Marvell’s ability to recruit new executive leadership in a timely manner and, if they are recruited, their performance, the timing of Marvell’s regaining of compliance with its SEC reporting obligations, any matters arising out of the review and audit of Marvell’s financial statements by Marvell’s new independent registered public accounting firm, the results of further review by the Audit Committee of certain matters that came to the Audit Committee’s attention during the course of its now-completed investigation, adverse impact of litigation or regulatory activities, and other risks detailed in Marvell’s SEC filings from time to time. For other factors that could cause Marvell’s results to vary from expectations, please see the risk factors identified in the Marvell’s latest Annual Report on Form 10-K for the year ended January 31, 2015 and its latest Quarterly Report on Form 10-Q for the quarter ended May 2, 2015 as filed with the SEC, and other factors detailed from time to time in Marvell’s filings with the SEC. Marvell undertakes no obligation to revise or update publicly any forward-looking statements.
About Marvell
Marvell (NASDAQ: MRVL) is a global leader in providing complete silicon solutions and Kinoma software enabling the “Smart Life and Smart Lifestyle.” From storage to Internet of Things (IoT), cloud infrastructure, digital entertainment and in-home content delivery, Marvell’s diverse product portfolio aligns complete platform designs with industry-leading performance, security, reliability and efficiency. At the core of the world’s most powerful consumer, network and enterprise systems, Marvell empowers partners and their customers to always stand at the forefront of innovation, performance and mass appeal. By providing people around the world with mobility and ease of access to services adding value to their social, private and work lives, Marvell is committed to enhancing the human experience.
As used in this release, the term “Marvell” refers to Marvell Technology Group Ltd. and its subsidiaries. For more information, please visit www.Marvell.com.
Marvell, the M logo, ARMADA, Avastar and Kinoma are registered trademarks of Marvell and/or its affiliates. Other names and brands may be claimed as the property of others.
TIS Invents Unique Method for Mail Classification and Automatic Response Generation
TEL AVIV, Israel and PLANO, Texas, April 05, 2016 — Top Image Systems, Ltd. (NASDAQ:TISA), a global innovator of intelligent content processing solutions, announced today that the United States Patent and Trademark Office has examined the application filed by TIS in 2013 to protect our unique method for mail classification and automatic response generation and has allowed for its issuance as a patent.
This patent will protect TIS’ research and development in the area of automated document understanding, empowering eFLOW® software to more closely mimic human comprehension of content and context. These developments will advance future-forward technologies in the Digital Mailroom arena, enabling enhanced intelligent document recognition and extremely accurate classification capabilities that will improve automated customer communications management, contributing to enhanced customer engagement, satisfaction and retention.
In today’s expanding digital mailroom market, TIS collaborates with strategic partners to offer enterprises complete end-to-end Digital Mailroom solutions. These solutions effectively capture and process incoming documents, on the one hand enabling efficient, economic straight-through-processing of those documents that can be managed automatically, while on the other hand rapidly and accurately classifying, prioritizing and routing significant customer communications to the right processes and persons to facilitate customer-centric business operations.
“To maintain our technological edge, Top Image Systems continually invests in innovative R&D that lets us bring to market increasingly intelligent document automation capabilities,” remarked Carsten Nelk, CTO, Top Image Systems. “The issuance of this patent positions TIS far ahead of our competition in the automated mail management space. We are confident that advanced classification and response generation will be key in business process automation solutions going forward and expect TIS to continue to be an important player in this market.”
About Top Image Systems
Top Image Systems™ (TIS™) Ltd. is a leading innovator of enterprise solutions for capturing and validating structured and unstructured content entering organizations from various sources and managing content-driven business processes. Whether originating from mobile, electronic, paper or other sources, TIS solutions automatically capture, process and deliver content across enterprise applications. TIS’ flagship eFLOW platform and diverse business process and mobile image processing solutions are marketed in more than 40 countries through a multi-tier network of distributors, system integrators, value-added resellers and strategic partners. Visit the company’s website at http://www.TopImageSystems.com for more information.
Caution Concerning Forward-Looking Statements
Certain matters discussed in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results expressed or implied in those forward looking statements. Words such as “will,” “expects,” “anticipates,” “estimates,” and words and terms of similar substance in connection with any discussion of future operating or financial performance identify forward-looking statements. These statements are based on management’s current expectations or beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially including, but not limited to, risks in product development, approval and introduction plans and schedules, rapid technological change, customer acceptance of new products, the impact of competitive products and pricing, the lengthy sales cycle, proprietary rights of TIS and its competitors, risk of operations in Israel, government regulation, litigation, general economic conditions and other risk factors detailed in the Company’s most recent annual report on Form 20-F and other subsequent filings with the United States Securities and Exchange Commission. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact:
Shelli Zargary
Director of Corporate Marketing and Investor Relations
shelli.zargary@topimagesystems.com
+972 3 767 9114
Investors:
James Carbonara
Regional Vice President, Hayden IR
james@haydenir.com
+ 1 646 755 7412
The successful launch of Harmony Care includes five initial customer orders
OTTAWA, CANADA–(April 5, 2016) – DragonWave Inc. (TSX:DWI)(NASDAQ:DRWI) a global supplier of packet microwave radio systems, today announced the launch of its Harmony Care services offering. Harmony Care will provide legacy support to DragonWave’s installed base of over 400,000 units, including the product line acquired in the 2012 acquisition of Nokia’s Microwave unit.
Harmony Care allows our operator customers the ability to extend the lifecycle of their installed microwave base products, including FlexiPacket Radio, FlexiPacket MultiRadio, Hub800, FirstMile 200, FlexiTrunk, SRT1f, Horizon Compact, Horizon Compact+, Horizon Duo and Horizon Quantum. The Harmony Care service offering is an added option which includes hardware and software warranty, along with 24 hour help desk and level 2 support.
“Network Operators are trying to maximize the use of their equipment investment. Harmony Care allows this lifecycle extension, while at the same time establishing direct customer relationships, as the operators move towards a network upgrade,” said Greg Friesen, vice president, Product Management, DragonWave. “DragonWave has won five new direct customers with the Harmony Care offering, and we aspire to support many more of our 200 plus legacy radio customers, helping them extend their network investment.”
About DragonWave
DragonWave® is a leading provider of high-capacity packet microwave solutions that drive next-generation IP networks. DragonWave’s carrier-grade point-to-point packet microwave systems transmit broadband voice, video and data, enabling service providers, government agencies, enterprises and other organizations to meet their increasing bandwidth requirements rapidly and affordably. The principal application of DragonWave’s products is wireless network backhaul. Additional solutions include leased line replacement, last mile fiber extension and enterprise networks. DragonWave’s corporate headquarters is located in Ottawa, Ontario, with sales locations in Europe, Asia, the Middle East and North America. For more information, visit http://www.dragonwaveinc.com.
DragonWave® is a registered trademark of DragonWave Inc.
Forward-Looking Statements
Certain statements in this release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements as to DragonWave’s growth opportunities and the potential benefits of, and demand for, DragonWave’s products. These statements are subject to certain assumptions, risks and uncertainties, including our view of the relative position of DragonWave’s products compared to competitive offerings in the industry. Readers are cautioned not to place undue reliance on such statements. DragonWave’s actual results, performance, achievements and developments may differ materially from the results, performance, achievements or developments expressed or implied by such statements. Risk factors that may cause the actual results, performance, achievements or developments of DragonWave to differ materially from the results, performance, achievements or developments expressed or implied by such statements can be found in the public documents filed by DragonWave with U.S. and Canadian securities regulatory authorities. DragonWave assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Media Contact:
Nadine Kittle
Marketing Communications
DragonWave Inc.
613-599-9991 ext. 2262
nkittle@dragonwaveinc.com
Media Contact:
Becky Obbema
Interprose Public Relations
(for DragonWave)
(408) 778-2024
Becky.Obbema@interprosepr.com
Investor Contact:
Peter Allen
President & CEO
DragonWave Inc.
613-599-9991 ext. 2222
Investor@dragonwaveinc.com
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) announced today that based on its very recent meeting with the U.S. Food and Drug Administration (FDA), the Company will begin the clinical trial development process for its intravenous (IV) injection protocols for use of Lymphoseek® (technetium Tc 99m tilmanocept) injection in rheumatoid arthritis (RA) and other disease states. Lymphoseek is Navidea’s first commercial product from its Manocept™ platform.
“Our efforts to continue to unlock the significant value of the Manocept platform are well underway as we seek to expand Lymphoseek’s label so it can be used as an immunodiagnostic for additional diseases,” said Rick Gonzalez, President and CEO of Navidea. “This collaborative meeting with FDA has enabled us to continue to advance the regulatory process and begin to implement our clinical program in rheumatoid arthritis, an indication that has an addressable market that is substantially larger than the current Lymphoseek indications. We look forward to reporting our progress throughout the year.”
Over the past year Navidea conducted a series of meetings and communications with the FDA to gain clarity on a path to extend the current Lymphoseek IND to support IV administration of Lymphoseek. In parallel the Company initiated its clinical development efforts and has already completed six required non-clinical animal studies for this new route of administration, submitted the summary results in a briefing package to the FDA, and secured NIH grants in RA and Kaposi’s Sarcoma, worth up to $3.8 million to support further development through Phase 2 studies.
Based upon the feedback from the latest meeting, Navidea expects to submit an IND amendment to the FDA that will allow initiation of Phase 1/2 IV studies of Lymphoseek. The addition of this new route of administration would enable further development of Lymphoseek in broader immunodiagnostic disease applications including rheumatoid arthritis. The timing is expected to be consistent with Navidea’s previously disclosed development plans to initiate a multi-center Phase 1/2 registrational trial employing IV-administration to evaluate Lymphoseek for the primary diagnosis of rheumatoid arthritis and to aid in the differential diagnosis of rheumatoid arthritis from other types of inflammatory arthritis during the second half of 2016. In addition, we expect to begin the Phase 1 pilot trial evaluating subcutaneous injection of Lymphoseek in active RA subjects in the second quarter of 2016.
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.
Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
• Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
• Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. The development activities of the Manocept immunotherapeutic platform will be conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Navidea Biopharmaceuticals
Investors & Media
Sharon Correia, 978-655-2686
Senior Director, Corporate Communications
or
David Schull, 858-717-2310
david.schull@russopartnersllc.com
- Positive data from Zilretta Phase 2b and Phase 3 clinical trials demonstrate consistent efficacy across both studies with substantial and persistent pain relief
- In the Phase 3 trial Zilretta, in contrast to immediate-release triamcinolone acetonide (TCA), exceeds American Academy of Orthopedic Surgeons (AAOS) criteria for clinically important effects on pain and function
- Safety data from these studies are comparable to placebo and immediate-release TCA
- CONFERENCE CALL TODAY APRIL 4, 2016 AT 9:00 A.M. EDT
BURLINGTON, Mass., April 04, 2016 — Results from two Flexion Therapeutics, Inc. (Nasdaq:FLXN) sponsored pivotal clinical trials showed that its lead drug candidate Zilretta (also known as FX006) provided sustained and significant pain relief in patients with moderate to severe osteoarthritis (OA) knee pain. Professor Philip Conaghan, M.B., B.S., Ph.D., F.R.A.C.P., F.R.C.P., Chair of Musculoskeletal Medicine at the University of Leeds, presented the results at the OARSI 2016 World Congress in Amsterdam in a podium presentation that is available at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.
Following the presentation Professor Conaghan said, “Consistent results across two pivotal clinical trials with Zilretta suggest that, at last, we have a long-lasting intra-articular therapy that is highly effective and has the potential to change the treatment paradigm for osteoarthritis.”
“We are delighted to be able to now share the detailed data from these studies which clearly demonstrate clinically meaningful and statistically significant pain relief in patients with knee OA. In addition, we are especially gratified by the Phase 3 data that demonstrate clear differentiation of Zilretta from immediate-release TCA,” said Michael Clayman, M.D., Flexion Therapeutics’ President and CEO. “Based on these data we have scheduled a pre-New Drug Application (NDA) meeting in May with the U.S. Food and Drug Administration (FDA) with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.”
The Phase 3 trial was a randomized, double-blind, placebo-controlled, active-comparator trial that enrolled 486 patients at approximately 40 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single intra-articular injection of 40 mg of Zilretta, normal saline (placebo) or 40 mg of immediate-release TCA. Each patient was evaluated for efficacy and safety during seven outpatient visits over 24 weeks after receiving an injection. The primary objective of the study was to assess the magnitude of pain relief of Zilretta at 12 weeks against placebo as measured by the weekly mean of the average daily pain (ADP) score. The secondary objectives of the study assessed the magnitude and duration of pain relief and effect of Zilretta against placebo and immediate-release TCA in additional pre-specified measures.
Phase 3 study data from the OARSI podium presentation and from additional company analyses are summarized below and posted to the Flexion website at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.
In the Phase 3 study, Zilretta:
- Met its primary endpoint at week 12, demonstrating highly significant (p < 0.0001, 2-sided) and clinically meaningful pain relief against placebo as measured by the weekly mean of the ADP score.
- Achieved statistically significant pain relief against placebo as measured by the weekly mean of the ADP score at weeks 1 through 16 and demonstrated, on average, an approximately 50 percent reduction in pain from baseline over weeks 1 through 12.
- Achieved numerically superior pain relief against immediate-release TCA at weeks 2 through 12 as measured by the weekly mean of the ADP score, but did not achieve statistical significance in that measure.
- Achieved statistical significance against placebo and immediate-release TCA at each time point through 12 weeks on WOMAC A (pain), WOMAC B (stiffness) and WOMAC C (function) and the Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale.
- Demonstrated in a pre-specified subset analysis of patients with unilateral knee pain (35 percent of subjects in the study), substantially magnified effects in the weekly mean of the ADP score, WOMAC A, B and C and KOOS quality of life and significantly enhanced separation from placebo and immediate-release TCA in all of these measures.
- Demonstrated reduced rescue medicine consumption compared with placebo and immediate-release TCA.
The Phase 3 data were also evaluated for clinical relevance by applying established AAOS criteria. In its 2013 publication, “Evidence-Based Guideline: Treatment of Osteoarthritis of the Knee,” the AAOS comprehensively reviewed the available literature on existing treatments and determined a minimal relative improvement in WOMAC A, B and C measures that would be meaningful to patients. This is referred to as the Minimal Clinically Important Improvement (MCII). The Phase 3 data show that Zilretta exceeds the MCII in WOMAC A, B and C and thus demonstrates a clinically important effect, whereas immediate-release TCA in this study does not.
The Phase 2b trial enrolled 310 participants in a multi-center, randomized, double-blind study, in which the participants received an injection of either 40 mg or 20 mg of FX006, or a placebo (saline). The 40 mg arm of Zilretta, compared to placebo, demonstrated statistical significance in average pain relief over weeks 1 through 12 (p = 0.0012; 2-sided) and over weeks 1 through 24 (p = 0.0209; 2-sided). At weekly time points, 40 mg of Zilretta also demonstrated superiority to placebo in pain relief beginning at week 1, continuing to week 11 and also at week 13 (p < 0.05 at each time point; 2-sided). The primary endpoint of the trial, superiority in pain relief at 12 weeks, did not reach statistical significance (p = 0.0821; 2-sided). A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks (p = 0.042).
Across both the Phase 2b and Phase 3 studies, there were no drug related serious adverse events for Zilretta and the frequency of treatment-related side effects was comparable across all study arms.
Conference Call
Flexion’s management will host a conference call today at 9:00 a.m. EDT. The dial-in number for the conference call is (855) 770-0022 for domestic participants and (908) 982-4677 for international participants, with Conference ID # 84943960. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website. A webcast replay will be available online after the call.
About Osteoarthritis of the Knee
OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.
Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.
About Zilretta
Zilretta is being investigated as the first intra-articular (IA) sustained-release, non-opioid treatment for patients with moderate to severe 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, over 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. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.
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 and our other product candidates; 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; Zilretta’s market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, 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 and our other product candidates, which could delay or limit their 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 of our 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 and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; 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 Relations Contact
David Carey
Lazar Partners LTD
T: 212-867-1768
dcarey@lazarpartners.com
Media Relations 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
Unico American Corporation (NASDAQ: UNAM) (“Unico” or the “Company”) today announced its Board of Directors has authorized a review of strategic alternatives for the Company aimed at enhancing shareholder value. The Board of Directors has established a Special Committee consisting entirely of independent directors to oversee the review of strategic alternatives and potential opportunities. Willis Capital Markets & Advisory has been retained as exclusive financial advisor to the Special Committee. No assurance can be given as to whether, when or on what terms any possible transaction might occur. The Company does not intend to make any further statements regarding this process unless and until a definitive agreement has been reached, or until the process of exploring strategic alternatives has ended.
Headquartered in Calabasas, California, Unico is an insurance holding company that underwrites property and casualty insurance through its insurance company subsidiary; provides property, casualty, and health insurance through its agency subsidiaries; and through its other subsidiaries provides insurance premium financing and membership association services. Unico has conducted the majority of its operations through its subsidiary Crusader Insurance Company since 1985. For more information concerning Crusader Insurance Company, please visit the Crusader’s Web site at www.crusaderinsurance.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Certain statements contained herein that are not historical facts are forward-looking. These statements, which may be identified by forward-looking words or phrases such as “anticipate,” “appears,” “believe,” ”expect,” “intend,” “may,” “should,” and “would,” involve risks and uncertainties, many of which are beyond the control of the Company. Such risks and uncertainties could cause actual results to differ materially from these forward-looking statements. Factors which could cause actual results to differ materially include underwriting actions not being effective, rate increases for coverages not being sufficient, premium rate adequacy relating to competition or regulation, actual versus estimated claim experience, regulatory changes or developments, unforeseen calamities, general market conditions, and the Company’s ability to introduce new profitable products.
Lester A. Aaron
Chief Financial Officer
818-591-9800
ALAMEDA, Calif., April 04, 2016 — OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, and The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, today announced positive research results for a lung cancer diagnostic test being developed at Wistar. This study of 620 subjects replicates a previous study that was carried out at Wistar, which was presented at the American Thoracic Society conference in May 2015. The results of this study mark a successful transition of the assay platform from Illumina microarrays to a Nanostring nCounterTM machine, which is the platform that OncoCyte intends to use for commercialization.
OncoCyte must now independently validate these results in its own follow-up study based on the results of Wistar’s latest study. OncoCyte will attempt to finalize and lock down both the assay and the classifier or algorithm that interprets test results. If successful, OncoCyte will initiate an internal analytical validation study, a process to confirm whether the test results can be reproduced in its laboratory. OncoCyte’s validation study will examine samples that it collects and analyzes independently using its own facility and equipment. The Company anticipates that the validation study will begin in the third quarter of 2016 and will be completed during the fourth quarter. If the validation study is successful, OncoCyte will be ready to implement its commercialization plans, including hiring its sales force, building out its commercial infrastructure, moving towards completion and obtaining CLIA certification of a diagnostic laboratory and ultimately launching its lung cancer diagnostic test in the first half of 2017.
“This data confirms the findings of Wistar’s previous study on the effectiveness of this non-invasive diagnostic for the early detection of lung cancer and represents a significant milestone in OncoCyte’s plan to commercially launch the test in 2017,” commented William Annett, Chief Executive Officer of OncoCyte. “Lung cancer results in 160,000 deaths annually in the U.S., in part because there is no effective test to reliably diagnose lung cancer at an early enough stage to enable effective treatment. OncoCyte’s non-invasive lung cancer diagnostic could therefore represent an important improvement for patients, doctors and payors by improving outcomes and lowering costs. We look forward to continuing the next steps in the product development process and providing additional updates in the coming months.”
About OncoCyte Corporation
OncoCyte is primarily focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients. While current biopsy tests use invasive surgical procedures to provide tissue samples in order to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples. OncoCyte’s pipeline products are intended to be confirmatory diagnostics for detecting lung, bladder and breast cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer.
About The Wistar Institute
The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the country, Wistar has held the prestigious National Cancer Institute Cancer Center designation since 1972, and works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. Wistar’s Business Development team is dedicated to advancing Wistar Science and Technology Development through creative partnerships. www.wistar.org
Forward Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for OncoCyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of OncoCyte, particularly those mentioned in the cautionary statements found in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements.

Investor Contact:
EVC Group, Inc.
Michael Polyviou/Chris Dailey
646-445-4800
mpolyviou@evcgroup.com /cdailey@evcgroup.com
Media Contact:
EVC Group, Inc.
Dave Schemelia
646-445-4800
dave@evcgroup.com
Saint Francis Leads New England in Treatment with Remote Magnetic Navigation
ST. LOUIS, April 04, 2016 — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that the Hoffman Heart and Vascular Institute at Saint Francis Hospital and Medical Center in Hartford, CT has completed more than 1,000 cardiac ablation procedures using its Niobe® remote magnetic navigation system. Drs. Joseph Dell’Orfano and Aneesh Tolat, electrophysiologists with Arrhythmia Consultants of Connecticut, were among the early adopters of the Niobe system and each has surpassed 500 procedures on the system, making the hospital the leading site in New England to use Stereotaxis technology.
“Utilizing the Niobe ES system, we can navigate a catheter safely and accurately within any of the four chambers of the heart, with nearly no danger of perforation and more consistent contact between the catheter and heart wall, resulting in more effective ablations,” said Dr. Dell’Orfano.
“The benefits of Stereotaxis technology are far greater than conventional methods used to treat arrhythmias. The unique design of remote magnetic navigation has greatly advanced our capabilities and reputation as a best-in-class institution for cardiac electrophysiology,” added Dr. Tolat.
Saint Francis first installed the Niobe system in 2007 and then in early 2012 upgraded to the Niobe ES, the latest generation magnetic navigation platform. The hospital helped pioneer the practice of remote magnetic navigation for electrophysiology procedures in New England, providing feedback and expertise during early usage. Led by Drs. Tolat and Dell’Orfano, Saint Francis has performed more procedures with the Niobe system than any hospital in the region, primarily for complex left atrial and supraventricular tachycardia cases.
About Electrophysiology
Electrophysiology (EP) is often used to help correct heart arrhythmias through catheter ablation, which is a treatment that cauterizes (burns) cardiac tissue to eliminate rhythm abnormalities in patients. During an EP procedure, the electrophysiologist (a cardiologist with specialized training in the electrical system of the heart) threads special electrode catheters (long, thin, flexible wire assemblies) to the heart, normally gaining access to the vasculature through the groin area. Once the area of the heart responsible for the arrhythmia is identified, a special wire carrying radiofrequency energy is used to ablate the site.
About Saint Francis
Saint Francis Hospital and Medical Center has been an anchor institution in north central Connecticut since 1897. In 2015, Saint Francis became part of Trinity Health-New England, an integrated health care delivery system that is a member of Trinity Health, Livonia, MI, one of the largest multi-institutional Catholic health care delivery systems in the nation. Saint Francis Hospital is a major teaching hospital and the largest Catholic hospital in New England. Other Saint Francis entities include the Comprehensive Women’s Health Center, the Connecticut Joint Replacement Institute, the Hoffman Heart and Vascular Institute of Connecticut, Smilow Cancer Hospital Yale-New Haven at Saint Francis, and Saint Francis Medical Group.
About Stereotaxis
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® ES remote magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems, and the Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the United States, Canada, and the European Union. For more information, please visit www.stereotaxis.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its continued listing on the NASDAQ Capital Market, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

STXS Company Contact:
Martin Stammer
Chief Financial Officer
314-678-6155
STXS Investor Contact:
Todd Kehrli / Jim Byers
MKR Group, Inc.
323-468-2300
stxs@mkr-group.com
Saint Francis Contact:
Fiona Phelan
Media Relations Manager
860-714-1076
fphelan@stfranciscare.org
Oakridge Global Energy Solutions: A New Era In Battery Manufacturing
Oakridge Successful First Quarter
Q1, 2016 Revenues Exceed Guidance
FOR IMMEDIATE RELEASE
Oakridge Pro Series Battery Production
April 4, 2016 Palm Bay, Florida – Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited to announce the very successful completion of the first quarter of 2016 with the company now in commercial production of its game-changing lithium-ion battery products. In continuing with the many successes previously announced Oakridge had its highest quarterly revenues in the history of the company by closing out the first quarter 2016 with $263,427 in revenues.
During what will clearly be seen as one of the most significant quarters in company history to date, Oakridge was able to continue to build momentum off its previously announced successes by generating the company’s first commercial revenues.
Other previously announced milestones for the first quarter, 2016, were the successful launch of production operations; the signing of a Strategic Business Alliance Agreement with the major global Japanese company, Sojitz Machinery Corporation; the production release of the Liberty Series motorsports starter battery; the first regular commercial production shipments of the Pro Series golf car battery; the strategic business alliance with Maritime Tactical Systems, Inc.; and the start-up of second shift production operations at the Company’s new Palm Bay, Florida, manufacturing facility.
Each of these events is further demonstration of the successful business that has been created by the major restructuring process that the company undertook during the previous 18 months.
In mid-March Oakridge was able to provide the first revenue guidance in the company’s history to the markets. This will become a trend as the company will now regularly provide revenue guidance for each quarter, as the company continues to build commercial production momentum throughout the remainder of the year by virtue of its offering customer focused, market leading products and service on a global scale.
Oakridge also looks to begin production shipments on its powerful Freedom IV series of living space power products in Q2 as well as continue product development and refinements in its Pro Series, Liberty Series and Patriot Series of Golf Car, Power Sports, and Unmanned Vehicle battery product ranges..
“This is a very exciting time to be part of Oakridge,” said Oakridge Executive Chairman and CEO, Steve Barber. “We have, for the first time in company history (which dates back to the 1980’s), generated significant commercial revenues in Q1, 2016, and in doing so have exceeded our guidance of $250,000 in expected Q1 revenues. We have an amazing team and an amazing product line. Our team really pulled it all together in the first quarter and we are very proud of them. We have passed the turning point after our lengthy restructure and transition of the company from an R&D company to a fully-fledged commercial production and manufacturing business and are looking forward to a very successful year in 2016.”
The Oakridge product development team has been working diligently to develop additional products for release throughout the balance of 2016. Additional capacity has been added by nearly tripling the capacity in cell formation, and much more high speed automation equipment is on order for delivery before the end of 2016.
“We have some truly amazing products, powerful strategic alliances, and some highly synergistic acquisition opportunities in the queue to be announced in the very near future. We aren’t ready to announce these quite yet, but you will need to keep an eye on our near term announcements, as they are likely to be truly transformative for the company” adds Mr. Barber.
http://www.globenewswire.com/NewsRoom/AttachmentNg/8d665128-2bd1-4e44-aaa0-72d768155739
http://www.globenewswire.com/NewsRoom/AttachmentNg/1998371a-e4c7-4313-adf1-ecbc29a5cde1
Oakridge Pro Series Batteries on pallet being readied for shipment
http://www.globenewswire.com/NewsRoom/AttachmentNg/67155504-435e-49db-8b85-1c6103a9b304
The Final Shipment of product for the First Quarter leaving the plant enroute to customers
http://www.globenewswire.com/NewsRoom/AttachmentNg/ada55fb6-25b1-43bd-b9f8-854c81d0b121
Oakridge Production Team readying products for Shipment
About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com
Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.
Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net
Investor Inquiries:
Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com
And:
Dutch DeWaard
Business Development
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
480.734.5834 Mobile
Dutch@DTN.fm
And:
Mike King
Princeton Research
www.princetonresearch.com
702.650.3000
mike@princetonresearch.com
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”) announced today that it has entered into an At Market Issuance (“ATM”) Sales Agreement, dated April 1, 2016, with H.C. Wainwright & Co., LLC (the “Sales Agent”), under which the Company may, at its discretion, from time to time during the term of the ATM Sales Agreement, sell up to a maximum of 3,000,000 of its common shares through ATM issuances on the NASDAQ Stock Market, up to an aggregate amount of approximately $10 million. The Sales Agent will act as sales agent for any sales made under this new ATM program. The common shares will be sold at market prices prevailing at the time of the sale of the common shares and, as a result, sale prices may vary.
In connection with the execution of the ATM Sales Agreement with the Sales Agent, the Company has filed with the United States Securities and Exchange Commission (the “SEC”) a prospectus supplement to its shelf registration statement on Form F-3 (333-194547) filed with the SEC on March 14, 2014, which was declared effective by the SEC on March 28, 2014.
The shelf registration statement on Form F-3 and the prospectus supplement for this offering are available on the SEC’s website (www.sec.gov). Alternatively, the Sales Agent will provide copies of these documents upon request by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 4th Floor, New York, NY 10022 at placements@hcwco.com.
This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any of the common shares, nor shall there be any sale of the common shares 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.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
Aeterna Zentaris Inc.
Philip A. Theodore
Senior Vice President
843-900-3223
ir@aezsinc.com
SOUTH SAN FRANCISCO, Calif., April 1, 2016 — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced it has completed enrollment for both studies in the FIT Phase 3 clinical program of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, in immune thromboycytopenic purpura (ITP). The first study in this program completed enrollment at the end of January and the second study has now completed enrollment. The results from the first study are expected in the middle of 2016, with the results for the second study expected shortly thereafter.
Earlier this year Rigel initiated a Phase 2 clinical trial in a second autoimmune disorder of the blood, autoimmune hemolytic anemia (AIHA). The purpose of this clinical trial is to evaluate the safety and efficacy of fostamatinib in patients with chronic AIHA. This disorder affects an estimated 40,000 Americans, for whom no approved treatment options currently exist.
FIT Phase 3 Program of Fostamatinib in ITP
The FIT program consists of two identical studies of approximately 75 patients each. The patients have been diagnosed with persistent or chronic ITP, and have blood platelet counts consistently below 30,000 per microliter of blood. Study subjects remain on treatment for up to 24 weeks. The primary efficacy endpoint of this program is a stable platelet response by week 24 with platelet counts at or above 50,000 per microliter of blood for at least four of the final six qualifying blood draws.
Fostamatinib and ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. Rigel believes that fostamatinib may address the autoimmune basis of the disease.
Fostamatinib and AIHA
AIHA is a rare, serious blood disorder where the immune system produces antibodies that result in the destruction of the body’s own red blood cells. Symptoms can include fatigue, shortness of breath, rapid heartbeat, jaundice or enlarged spleen. While no medical treatments are currently approved for AIHA, physicians generally treat acute and chronic cases of the disorder with corticosteroids, other immuno-suppressants, or splenectomy. Research has shown that inhibiting SYK with fostamatinib may reduce the destruction of red blood cells.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current clinical programs include fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, which is in Phase 3 clinical trials for ITP; a Phase 2 clinical trial for autoimmune hemolytic anemia (AIHA); and a Phase 2 clinical trial for IgA nephropathy (IgAN). In addition, Rigel has two oncology product candidates in Phase 1 development with partners BerGenBio AS and Daiichi Sankyo.
This press release contains “forward-looking” statements, including, without limitation, statements related to Rigel’s clinical development plans, including the timing, design and nature of planned clinical trials and the timing and nature of results of those trials, as well as the potential activity of fostamatinib with respect to ITP. 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 “planned,” “will,” “may,” “expect,” and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the availability of resources to develop Rigel’s product candidates, Rigel’s need for additional capital in the future to sufficiently fund Rigel’s operations and research, the uncertain timing of completion of and the success of clinical trials, risks associated with and Rigel’s dependence on Rigel’s corporate partnerships, as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2015. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
Contact: Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com
Media Contact: Susan C. Rogers, Rivily, Inc.
Phone: 650.430.3777
Email: susan@rivily.com
– Data demonstrate that abaloparatide-SC reduced the risk of osteoporotic fractures and increased bone mineral density across a broad group of postmenopausal women with osteoporosis regardless of baseline characteristics –
WALTHAM, Mass., April 01, 2016 — Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced results from pre-specified subgroup analyses from its Phase 3 ACTIVE trial. The results demonstrate that Radius’ investigational drug, abaloparatide-SC injection, reduced the risk of vertebral and nonvertebral fractures and increased bone mineral density (BMD) consistently in postmenopausal women with osteoporosis regardless of baseline patient characteristics. These data were presented today at the Endocrine Society (ENDO) 2016 Annual Meeting in Boston. Radius will also present an update at the Meeting on investigational drug RAD1901, a novel oral estrogen receptor ligand being studied at low doses for potential treatment of moderate to severe hot flashes (vasomotor symptoms) associated with menopause.
“Results from the Phase 3 ACTIVE subgroup analyses suggest that the investigational drug abaloparatide-SC reduces the risk of both vertebral and nonvertebral fractures and improves BMD consistently across a range of baseline patient characteristics, including age, baseline bone mineral density, and prior fracture history,” said Felicia Cosman, M.D., osteoporosis specialist and Medical Director of the Clinical Research Center at Helen Hayes Hospital, Senior Clinical Director of the National Osteoporosis Foundation, Professor of Medicine at Columbia University and consultant to Radius. “The safety and efficacy clinical trial data shown to date demonstrate that, if approved, the novel investigational bone anabolic, abaloparatide-SC, has the potential to address the needs of many postmenopausal women with osteoporosis.”
The Phase 3 ACTIVE trial is a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of the investigational drug abaloparatide-SC 80 mcg in the reduction of risk of vertebral and nonvertebral fractures.
About Radius Health
Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius’ lead product candidate, the investigational drug abaloparatide-SC, has completed Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with osteoporosis. Radius’ Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe, and a New Drug Application (NDA) was submitted in the U.S. at the end of the first quarter of 2016. The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius’ preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in multiple applications including cancer. For more information, please visit www.radiuspharm.com.
About Abaloparatide
Abaloparatide is an investigational therapy for the potential treatment of postmenopausal women with osteoporosis. Abaloparatide is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for clinical development based on its favorable bone building activity.
Abaloparatide has completed Phase 3 development for potential use as a daily self-administered injection (abaloparatide-SC). At the end of the first quarter of 2016, Radius submitted an NDA for abaloparatide-SC to the US Food and Drug Administration for the treatment of postmenopausal women with osteoporosis. In the fourth quarter of 2015, Radius’ MAA for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA).
Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M’s patented Microstructured Transdermal System technology for potential use as a short wear-time transdermal patch.
About RAD1901
RAD1901 is a selective estrogen receptor down-regulator/degrader (SERD), which is being evaluated at high doses for potential use as an oral non-steroidal treatment for hormone-driven, or hormone-resistant, breast cancer. RAD1901 is currently being investigated for potential use in postmenopausal women with advanced estrogen receptor positive (ER+), HER2-negative breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies to overcome endocrine resistance in breast cancer.
RAD1901 also is being evaluated in a Phase 2b study at low doses for potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. Additional information on the clinical trial program of RAD1901 is available on www.clinicaltrials.gov.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations for abaloparatide-SC, including without limitation, expectations regarding the clinical significance of clinical trial data for abaloparatide-SC, including data from the subgroup analyses of the phase 3 ACTIVE trial, the potential medical benefit of treatment with abaloparatide-SC for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the FDA and the EMA, and the potential clinical uses for the abaloparatide transdermal patch, RAD1901 and RAD140.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risk that the results of clinical trials of abaloparatide-SC will not meet regulatory requirements for approval or that regulatory authorities may require additional data or further studies; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; the risk that results of clinical trials of abaloparatide-SC and of our other product candidates may not support product claims, even if approved; failure to achieve market acceptance of abaloparatide-SC, if approved; the availability of coverage and reimbursement for abaloparatide-SC, if approved; the risk that a regulatory or government official will determine that third-parties with a financial interest in the outcome of the Phase 3 study of abaloparatide-SC affected the reliability of the data from the study; failure to establish an effective process for distribution of abaloparatide-SC; and the other important factors discussed under the caption “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 25, 2016, and in our other reports filed with the SEC, that could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Media Contact:
Lori Gorski
Email: Lgorski@radiuspharm.com
Phone: 617-551-4096
Investor Relations Contact:
Barbara Ryan
Email: bryan@radiuspharm.com
Phone: 203-274-2825
Dupilumab is first systemic therapy to show positive Phase 3 results in patients with moderate-to-severe atopic dermatitis, a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities U.S. regulatory submission for dupilumab planned for Q3 of 2016
TARRYTOWN, N.Y and PARIS, April 1, 2016 — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that two placebo-controlled Phase 3 studies evaluating investigational dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD) met their primary endpoints. In the studies, known as LIBERTY AD SOLO 1 and SOLO 2, treatment with dupilumab as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, quality of life, and mental health.
“These are the first Phase 3 studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. “These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab is the first in a new class of immunotherapies – in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects. We continue to evaluate the role of IL-4 and IL-13 signaling in related inflammatory conditions, including asthma and nasal polyposis, where we have ongoing dupilumab clinical development.”
“There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need. These results may bring new hope to atopic dermatitis patients, many of whom have suffered for years,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “In the U.S., where dupilumab in AD has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible.”
A total of 1,379 adult patients with moderate-to-severe AD were enrolled in the identically-designed SOLO 1 and SOLO 2 trials. Patients were enrolled if they were not adequately controlled with topical medications, or if topical treatment was not medically advisable. All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe); entry criteria required a baseline score of 3 or 4. Patients were also assessed using the Eczema Area and Severity Index (EASI) and other measures. Patients were randomized into one of three treatment groups: dupilumab 300 mg subcutaneously once per week, dupilumab 300 mg subcutaneously every two weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo. Results at 16 weeks included the following:
- For SOLO 1 and SOLO 2, respectively, 37 and 36 percent of patients who received dupilumab 300 mg weekly, and 38 and 36 percent of patients who received dupilumab 300 mg every two weeks, achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10 and 8.5 percent with placebo (p less than 0.0001). This was the primary endpoint of the study in the U.S.
- For SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received dupilumab 300 mg every two weeks, compared to 38 and 31 percent for placebo (p less than 0.0001).
- For SOLO 1 and SOLO 2, respectively, 52.5 and 48 percent of patients who received dupilumab 300 mg weekly, and 51 and 44 percent of patients who received dupilumab 300 mg every two weeks, achieved EASI-75 compared to 15 and 12 percent with placebo (p less than 0.0001). This was the key secondary endpoint in the US and one of the primary endpoints in the EU.
For the 16-week treatment period, the overall rate of adverse events (65-73 percent dupilumab and 65-72 percent placebo) was comparable between the dupilumab groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for dupilumab and 80.5-82 percent for placebo. The rate of serious adverse events was 1-3 percent for dupilumab and 5-6 percent for placebo. Serious and severe infections were also numerically higher in the placebo groups in both studies (0.5-1 percent dupilumab and 2-3 percent placebo). Adverse events that were noted to have a higher rate with dupilumab treatment across both studies included injection site reactions (10-20 percent dupilumab; 7-8 percent placebo) and conjunctivitis (7-12 percent dupilumab; 2 percent placebo); approximately 26 percent of patients in both studies reported a history of allergic conjunctivitis at study entry. No patient discontinued therapy due to injection site reactions and only one patient discontinued therapy due to conjunctivitis.
More detailed results from SOLO 1 and SOLO 2 will be submitted for presentation at a future medical congress.
The U.S. Food and Drug Administration (FDA) granted dupilumab Breakthrough Therapy designation in AD in November 2014. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
The LIBERTY AD Phase 3 clinical program consists of five trials of patients with moderate-to-severe AD at sites worldwide.
About Atopic Dermatitis
Atopic dermatitis – a serious form of eczema – is a chronic inflammatory disease characterized by itchy, inflamed skin that can be present on any part of the body. Though symptoms appear externally, atopic dermatitis is characterized by underlying systemic inflammation. Atopic dermatitis affects approximately 7-8 million adults in the U.S. and 1-3 percent of adults worldwide. Based on a survey of 200 physicians, there are approximately 1.6 million moderate-to-severe diagnosed and treated patients in the U.S. with uncontrolled disease. About 70 percent of people with atopic dermatitis have a family history of other common atopic diseases, such as asthma or hay fever. The intense itching, scratching and skin damage associated with the disease can sometimes lead to infections, caused by bacteria, such as Staphylococcus aureus. In addition, the physical manifestations of the disease can lead to anxiety, depression, and feelings of social isolation.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Regeneron Forward-Looking Statements and Use of Digital Media
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s products, product candidates, and research and clinical programs now underway or planned, including without limitation dupilumab; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s product candidates in clinical trials, such as the clinical development programs evaluating dupilumab; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates, such as dupilumab for atopic dermatitis or other indications; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates, such as dupilumab; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products, research and clinical programs, and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron’s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron’s products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron’s agreements with Sanofi and Bayer HealthCare LLC, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2015. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
Rentech, Inc. (NASDAQ: RTK) announced today that the closing of the Rentech Nitrogen Partners, L.P.-CVR Partners, LP (CVR) merger (Transaction) has enabled it to retire approximately $142 million of senior obligations to GSO Capital Partners (GSO), improve its liquidity, reduce future interest expense, and better position itself to maximize the value of its investments in the wood fibre processing industry.
Transaction Proceeds
Rentech received $261.9 million in gross consideration for its approximately 59% interest in Rentech Nitrogen Partners following today’s closing of the Transaction. The consideration was comprised of $59.8 million in cash and 24.18 million units of CVR valued at $202.1 million based on CVR’s closing price yesterday of $8.36 per unit.
GSO Exchange
Rentech utilized a portion of the Transaction proceeds to retire all $100 million of its Series E Preferred Stock and to repay approximately $42 million of term debt held by GSO. Under newly modified terms of the GSO agreement, these repayments were accomplished by Rentech delivering to GSO 17.0 million CVR units and $10.0 million in cash. Rentech’s obligations to GSO have been reduced from $195 million to approximately $53 million. The remaining $53 million of term debt with GSO will bear an interest rate of LIBOR plus 700 basis points per annum, with a LIBOR floor of 1.00% and will mature on April 9, 2019.
Rentech will retain 7.18 million CVR units of the Transaction consideration. These units, along with other Rentech assets, are pledged to GSO as collateral for the term loan. Rentech will receive the cash distributions paid by CVR on the 7.18 million retained units.
The final exchange terms with GSO were different than originally agreed to last year and as amended on March 14, 2016. GSO and Rentech agreed to set the final exchange price of CVR units at $7.75 per unit in lieu of using the pricing mechanism in the prior agreement. The original pricing mechanism would have valued the exchanged CVR units at $5.62 per unit based on a 15% discount to CVR’s 60-day volume weighted average price two days prior to closing. The parties also agreed that Rentech would use cash to repay a portion of the obligations and to retire approximately $142 million instead of $140 million of the obligations. The revised exchange terms enabled Rentech to retain units equivalent to a 6.3% ownership interest in CVR and to minimize taxable gains associated with the Transaction and exchange of units. GSO eliminated the one-time option granted to Rentech under the original transaction which would have enabled Rentech to repurchase CVR units at a future date six to twelve months following the closing. Additional details about the terms of the agreements with GSO will be provided in a Form 8-K that Rentech will file with the Securities and Exchange Commission.
Net Proceeds Following GSO Exchange
As a result of the Transaction and GSO exchange, Rentech retained $109.8 million of the total pre-tax proceeds received in the Transaction, comprised of $49.8 million of cash and 7.18 million CVR units valued at $60.0 million based on yesterday’s closing price of $8.36 per unit.
Rentech expects to pay $5 – $15 million in estimated cash taxes related to the Transaction, GSO exchange and the earlier sale of the Pasadena facility. The estimated tax payments take into consideration existing net operating loss carryforwards, which were $196.1 million as of December 31, 2015, and an estimate of operating losses expected to accrue this year.
Keith Forman, Rentech’s President and CEO, stated, “The transactions announced today represent a milestone for Rentech. We say goodbye to a business that has served our shareholders well and to a team of dedicated professionals at our East Dubuque facility who have been conscientious guardians and operators of this asset. We thank them.”
“This transaction affords Rentech the opportunity to reposition and intensify the focus on our investments in the wood fibre processing industry. It does so by providing us the liquidity and strengthened balance sheet to complete the construction and ramp-up of our Canadian facilities. This outcome would not have been possible save for the active willingness of GSO Capital to work with us on the terms of the exchange; both at the inception, in allowing for repayment of senior obligations in exchange for equity, and today in further modifying the terms of our agreements to allow for an outcome of less debt, greater liquidity, and less dilution than originally called for. As a result, we retain a meaningful stake in the “new” CVR Partners. We wish CVR well and we are confident that they will be good stewards of this asset as we have tried to be,” added Mr. Forman.
Financials
The table below illustrates the pro forma impact as if the foregoing transactions were completed on December 31, 2015.
|
|
|
|
|
|
|
|
|
|
| Pro Forma Capitalization ($MM) |
|
|
|
|
|
|
|
|
|
|
|
|
Actual
12/31/15 |
|
|
Pro Forma
12/31/15 |
|
|
$ Change |
| Rentech Cash1 |
|
|
$ |
33 |
|
|
$ |
86 |
|
|
$ |
52 |
|
| Ownership in CVR Partners2 |
|
|
|
– |
|
|
$ |
60 |
|
|
$ |
60 |
|
| GSO Preferred Stock |
|
|
$ |
100 |
|
|
|
– |
|
|
$ |
(100 |
) |
| GSO Term Loans |
|
|
$ |
95 |
|
|
$ |
53 |
|
|
$ |
(42 |
) |
| Fulghum Fibres Debt |
|
|
$ |
47 |
|
|
$ |
47 |
|
|
|
– |
|
| NEWP Debt |
|
|
$ |
16 |
|
|
$ |
16 |
|
|
|
– |
|
| QSL Debt3 |
|
|
$ |
20 |
|
|
$ |
20 |
|
|
|
– |
|
| Total Obligations |
|
|
$ |
278 |
|
|
$ |
136 |
|
|
$ |
(142 |
) |
1 Increase in cash is pre-tax; includes initial proceeds from sale of Pasadena and excludes future working capital proceeds and potential milestone payments related to the sale.
2 As of March 31, 2016; cost basis of CVR units estimated to be $0 at time of transaction.
3 Cash amount owed under the obligation is $13.7MM; see Note 15 in our 2015 10-K.
The table below provides Rentech’s anticipated debt service for 2016.
|
|
|
|
| Debt Service for 2016 ($MM) |
|
|
|
|
|
|
|
| Interest & Dividends Paid to GSO YTD |
|
|
$ |
3.7 |
| Interest on Remaining GSO Debt for 2016 |
|
|
$ |
3.2 |
| Interest on Other Debt |
|
|
$ |
4.3 |
| Scheduled Amortization on Other Debt |
|
|
$ |
18.3 |
|
|
|
|
The table below provides Rentech’s estimated cash taxes and capital expenditures for 2016.
|
|
|
|
| Estimated Taxes & CapEx for 2016 ($MM) |
|
|
|
|
|
|
|
| State & Federal Taxes1 |
|
|
$ |
5 – $15 |
| Industrial Wood Pellets CapEx |
|
|
$ |
21 |
| Fulghum Fibres & NEWP CapEx |
|
|
$ |
5 |
1 Represents estimated taxes to be paid in 2016.
About Rentech, Inc.
Rentech, Inc. (NASDAQ: RTK) owns and operates wood fibre processing and wood pellet production businesses. Rentech offers a full range of integrated wood fibre services for commercial and industrial customers around the world, including wood chipping services, operations, marketing, trading and vessel loading, through its subsidiary, Fulghum Fibres. The Company’s New England Wood Pellet subsidiary is a leading producer of bagged wood pellets for the U.S. heating market. Rentech’s industrial wood pellet facilities supply wood pellets used as fuel for power generation in Canada and the United Kingdom. Please visit www.rentechinc.com for more information.
Safe Harbor Statement
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 about matters such as: our estimated debt service, taxes and capital expenditures; and our ability to maintain our market positions and complete ramp-up of the Canadian wood pellet plants to full capacity. These statements are based on management’s current expectations and actual results may differ materially as a result of various risks and uncertainties. Other factors that could cause actual results to differ from those reflected in the forward-looking statements are set forth in the Company’s prior press releases and periodic public filings with the Securities and Exchange Commission, which are available via Rentech’s website at www.rentechinc.com. The forward-looking statements in this press release are made as of the date of this press release and Rentech does not undertake to revise or update these forward-looking statements, except to the extent that it is required to do so under applicable law.
Rentech, Inc.
Julie Dawoodjee Cafarella, 310-571-9800
Vice president of Investor Relations and Communications
ir@rentk.com
OVERLAND PARK, Kan., March 31, 2016 — Parnell Pharmaceuticals Holdings Ltd (NASDAQ:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, today announced that Robert Joseph, President and Chief Executive Officer, will be presenting at the Jefferies Animal Health Summit in New York on Thursday, March 31, 2016 at 10:45 AM ET.
The corporate slide presentation will be available on the Investors/Events & Presentations section of Parnell’s website at http://investors.parnell.com at the conclusion of the event.
About Parnell
Parnell (PARN) is a fully integrated, veterinary pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions. Parnell currently markets five products for companion animals and production animals in 14 countries and augments its pharmaceutical products with proprietary digital technologies – FETCH™ and mySYNCH®. These innovative solutions are designed to enhance the quality of life and/or performance of animals and provide a differentiated value proposition to our customers. Parnell also has a pipeline of 7 drug products covering valuable therapeutic areas in orthopedics, dermatology, anesthesiology, nutraceuticals and metabolic disorders for companion animals as well as reproduction and mastitis for cattle.
For more information on the company and its products, please visit www.parnell.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of the U.S. Private Securities Reform Act of 1995. Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “develops,” “believes,” and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify forward-looking statements. Forward-looking statements represent management’s present judgment regarding future events and are subject to a number of risk and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding Parnell’s research and development activities, its ability to conduct clinical trials of product candidates and the results of such trials, as well as risks and uncertainties relating to litigation, government regulation, economic conditions, markets, products, competition, intellectual property, services and prices, key employees, future capital needs, dependence on third parties, and other factors, including those described in Parnell’s Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on March 4, 2016, along with its other reports filed with the SEC. In light of these assumptions, risks, and uncertainties, the results and events discussed in any forward-looking statements contained in this press release might not occur. Investors are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Parnell is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events, or otherwise.

Parnell Pharmaceuticals Holdings
Robert Joseph, 913-274-2100
Robert.joseph@parnell.com
Name Change is Capstone of Corporate Rebranding Initiative for the Bioengineered Organ Implant Developer (www.biostage.com) – Trading Under Nasdaq Symbol “BSTG” begins April 1, 2016
HOLLISTON, Mass., March 31, 2016 — Harvard Apparatus Regenerative Technology, Inc. (NASDAQ: HART) announced today it has changed its corporate name to Biostage, Inc. and will trade under the Nasdaq symbol “BSTG” effective April 1, 2016. Concurrently, the company has launched a new web site www.biostage.com to provide greater clarity and visibility for its technology.
The name change reflects the company’s broad commitment and expertise in pioneering the development of bioengineered organ implants for the esophagus, bronchus and trachea. It also eliminates market confusion with its former parent company from which it was spun-out in November 2013.
Jim McGorry, CEO, commented, “The Biostage™ name change reflects the evolution of our focus from commercializing bioreactors and research tools to the pioneering development of bioengineered organ implants for the esophagus, bronchus, and trachea. We have changed our company name to Biostage to better communicate and differentiate our new Cellframe™ technology and strategic direction.”
The Biostage name embodies the company’s “biotechnology” focus on bioengineered implants that provide critical “staging” for the body’s innate healing processes with its new Cellframe™ technology platform. Mr. McGorry added, “Cellframe employs a process in which the patient’s own stem cells are taken from a simple adipose/fat tissue biopsy, the cells are first isolated, expanded and then seeded onto a proprietary biocompatible scaffold that mimics the natural dimensions of the damaged organ. After incubation in our proprietary bioreactor, the Cellspan implant is ready to be implanted. Cellspan implants are designed to deliver the necessary cues for triggering, guiding, and modulating the regenerative process.
“Biostage is the result of a nearly two-year corporate transformation that centered on people, research, and technologies. We put in place a deeply experienced management team and board of directors to effectively lead our team of cell biology experts, materials scientists, and engineers to develop and pursue a clearly-defined set of research, regulatory, and commercialization goals. Biostage has also expanded its research partnership base to cost-effectively add technology resources critical to our success. Collectively, these efforts allow Biostage to pursue a new approach to restoring function to damaged organs for patients who deserve better clinical solutions and improved outcomes.”
Biostage’s Initial IND to Focus on Cellspan Esophageal Implant
Biostage’s Cellframe technology features a biocompatible scaffold seeded with a recipient’s own stem cells to create Cellspan™ implants for treatment of life-threatening conditions of the esophagus, trachea, and bronchus. Key large-animal data for Biostage’s Cellspan esophageal and other implants was first announced in November 2015.
Based on its preclinical data, Biostage identified life-threatening conditions of the esophagus as the initial clinical application to advance its Cellspan esophageal implant. Biostage plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (USFDA) in late 2016, seeking to initiate clinical trials in humans.
Biostage is currently expanding its preclinical testing of its Cellspan esophageal implants in collaboration with Mayo Clinic to support its planned IND application. The company anticipates providing an update on its preclinical research collaboration mid-second quarter 2016.
Biostage Introductory Video: Cellframe Technology Animation
About Biostage, Inc.: www.biostage.com
Biostage is a biotechnology company developing bioengineered organ implants based on the company’s new Cellframe ™ technology. Biostage’s Cellframe technology uniquely combines a proprietary biocompatible scaffold with a patient’s own stem cells to create Cellspan implants. These novel implants are being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its Cellframe technology.
Cellspan implants are being advanced and tested in a preclinical collaborative study with Mayo Clinic. This testing of Biostage’s Cellspan esophageal implants is intended to expand the company’s preclinical data in support of its goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in late 2016, seeking to initiate clinical trials in humans.
Forward-Looking Statements:
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the development expectations and regulatory approval of any Biostage products, including its Cellframe ™ technology, by the FDA, EMA, MHRA or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of Biostage products, including its Cellframe technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for the our Cellframe technology, bioreactors, scaffolds and other devices and product candidates we pursue; plus other factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
| Media/Investor Relations Contact: |
|
| Tom McNaughton |
David Collins, Bill Jones, Helen Sun |
| Chief Financial Officer |
Catalyst Global LLC |
| 774-233-7321 |
212-924-9800 w; 917 734-0339 m |
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bstg@catalyst-ir.com |
RIVER FALLS, Wis., March 31, 2016 — Sajan, Inc. (NASDAQ: SAJA), a leading provider of global language services and translation management system technology, appoints Brett Leagjeld as the new Strategic Alliance Manager for the advancement of the Strategic Alliance Program.
Sajan’s Strategic Alliance Program was developed to establish a strategic channel-selling approach for its translation services and technology solutions (i.e. SiteSync). The breadth of Sajan’s Strategic Alliance Program is enormous and the hire of Brett Leagjeld is a move to increase Sajan’s capacity to offer valuable collaboration and strengthen the program. The program’s goal is to allow Sajan’s proprietary technology to drive true value and efficiencies that impact the bottom line. Sajan’s alliance ecosystem will include traditional channel relationships as well as strategic partnerships with prebuilt integration. As a global company, Sajan’s alliances will span the globe.
Mr. Leagjeld’s role is to manage existing channel relationships, and to expand Sajan’s alliance ecosystem. He will continue to standardize the program management processes to ensure Sajan meets and exceeds expectations of those relationships. Leagjeld has nearly 20 years’ experience in the Information Services arena with a focus in finance and 10 years developing and managing Strategic Alliances and Channel Relationships.
Jeff Kent, Vice President of Professional Services at Sajan said, “We are excited to have Brett on board to cultivate and grow this program and these relationships. Technology in this space is key, and Sajan has this technology already. It’s the ability to provide a superior technology driven solution, coupled with a standardized yet flexible approach that will enable program growth. The expansion of this program allows Sajan to offer more to the evolving industry of language services.”
About Sajan
Sajan is a leading provider of global language translation and localization services, helping clients around the world expand seamlessly into any global market. The foundation of Sajan’s solution is its industry-leading language translation management system technology, Sajan Transplicity, which provides process automation and innovative multilingual content reuse to ensure schedule predictability, higher quality and cost efficiencies for its clients. By working closely with its clients, Sajan’s experienced team of localization professionals develops tailored solutions that lend flexibility to any large or small business that truly desires to “think globally but act locally.” Based in the United States, Sajan also has offices in Ireland, Spain and Singapore. Visit Sajan online at www.sajan.com.
Willdan Group, Inc. (“Willdan”)(NASDAQ: WLDN) today announced that it has executed a new six-year contract with San Diego Gas & Electric Company (SDG&E) for the delivery of electricity capacity savings. Through the delivery of the contracted capacity, Willdan estimates that approximately $90 million of revenue will be recognized in the program over the six-year contract term. The capacity reduction will be achieved by implementing energy efficiency conservation measures in existing commercial buildings throughout SDG&E’s service territory. The estimated value of the contract is based on the annual delivery of capacity reduction totaling 18.5 MW by the end of the six-year term in 2024. The contract between Willdan and SDG&E must be approved by the California Public Utilities Commission (CPUC) before work can commence. Based on the expected timeline for the contract approval process, the program is expected to begin in late 2016 or early 2017, with first deliveries under the contract in 2018.
Willdan’s energy efficiency Large Commercial Custom Program will help SDG&E meet its Local Capacity Requirements (LCR) as established by the CPUC’s landmark 2014 “Track 4 Decision.” Prompted by the permanent retirement of the San Onofre Nuclear Generation Station, the decision authorized SDG&E to procure between 500 MW and 800 MW of incremental replacement capacity by 2022. Of this amount, at least 200 MW must come from “preferred resources,” including cost-effective energy efficiency, demand response, renewable resources, distributed generation, and energy storage solutions.
“We are honored to have been awarded this contract for energy efficiency services by SDG&E,” commented Tom Brisbin, President/CEO of Willdan. “Through our existing SDG&E programs in the lodging, healthcare, biotech, and small commercial business sectors, Willdan has delivered 13 MW of electricity savings to date at over 500 large commercial customer sites and 3,000 small business sites in the utility’s service area. We look forward to building on our successful delivery of peak-load reduction and energy efficiency savings to SDG&E.”
Willdan’s program is designed to target and implement specific kW-rich HVAC-related energy efficiency measures in commercial buildings. While these measures are currently offered under SDG&E’s existing energy efficiency portfolio, they have experienced low implementation rates in commercial buildings in certain markets. Willdan’s approach to increasing these rates includes innovative strategies for outreach and enrollment, delivery of customized engineering solutions, flexible financing options, and personalized customer technical support. The energy savings achieved will be incremental to the existing portfolio, which is expected to facilitate the CPUC’s approval of the agreement later this year.
“Utilities are finding energy efficiency to be a reliable, cost effective, and environmentally friendly alternative to traditional capacity procurement,” added Brisbin. “It appears that this energy efficiency LCR, as well as other LCR contracts already released by SDG&E and Southern California Edison (SCE), signify a growing trend throughout California and nationwide.”
Willdan is well positioned to follow such a trend, having delivered energy efficiency savings totaling more than 125 MW of peak load capacity reduction for utilities nationwide, including NYSERDA, Con Edison, Bonneville Power Administration, and Puget Sound Energy.
About Willdan
Willdan provides professional consulting and technical services to utilities, public agencies and private industry throughout the United States. The Company’s service offerings span a broad set of complementary disciplines that include energy efficiency and sustainability, engineering and planning, financial and economic consulting, and national preparedness. Willdan provides integrated technical solutions to extend the reach and resources of its clients, and provides all services through its subsidiaries specialized in each segment. For additional information, visit Willdan’s website at www.willdan.com.
Forward Looking Statements
Statements in this press release that are not purely historical, including statements regarding Willdan’s intentions, hopes, beliefs, expectations, representations, projections, estimates, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that Willdan will not be able to expand its services or meet the needs of customers in markets in which it operates. It is important to note that Willdan’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, a slowdown in the local and regional economies of the states where Willdan conducts business and the loss of or inability to hire additional qualified professionals. Willdan’s business could be affected by a number of other factors, including the risk factors listed from time to time in Willdan’s SEC reports including, but not limited to, the Annual Report on Form 10-K filed for the year ended January 1, 2016. Willdan cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Willdan disclaims any obligation to, and does not undertake to, update or revise any forward looking statements in this press release.
– Consistent efficacy across potential Phase 3 clinical trial endpoints –
– Once-yearly or less frequent maintenance dosing expected –
– Company to host conference call at 9 a.m. ET today –
CAMBRIDGE, Mass., March 31, 2016 — Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial.
“We are very pleased with these data, which show that GEN-003 has strong and durable effects on both HSV-2 viral activity and genital herpes clinical disease, supporting our belief that GEN-003 could become a cornerstone treatment for patients affected by this serious disease. Specifically, a single course of treatment of GEN-003 may offer benefits similar to a full year of daily administration of oral antivirals – but with greatly improved convenience,” said Chip Clark, president and chief executive officer of Genocea. “We anticipate reporting virologic efficacy data for GEN-003 from our recently-initiated Phase 2b study in the third quarter of 2016, clinical efficacy data at 6 months post dosing around the end of 2016 and conducting our end of Phase 2 meeting with the FDA in the first quarter of 2017.”
”These 12 month data highlight the potential of GEN-003 to significantly enhance the genital herpes treatment landscape,” said Lori A. Panther, M.D., MPH, infectious diseases specialist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School. “Because of the physical and psychological impact of this disease, both patients and treating physicians would be eager to use an effective treatment that more conveniently improves control of outbreaks. The reduction in viral shedding, which is thought to cause the epidemic spread of genital herpes, is also encouraging.”
Genocea has already advanced the two most promising doses, 60 µg per protein combined with either 50 or 75 µg of Matrix-M2TM adjuvant, from this Phase 2 dose optimization study into an ongoing Phase 2b efficacy trial. The efficacy of GEN-003 at these two dose levels over the course of the Phase 2 dose optimization trial is as follows:
| |
60 µg per protein /
50 µg of Matrix-M2 |
60 µg per protein /
75 µg of Matrix-M2 |
| Endpoint |
Post
dose 3 |
6
months |
12
months |
Post dose
3 |
6
months |
12
months |
Viral shedding
rate reduction* |
41%
(p<0.0001) |
46%
(p<0.0001) |
64%
(p<0.0001) |
55%
(p<0.0001) |
58%
(p<0.0001) |
52%
(p<0.0001) |
% patients
lesion free |
|
68 |
% |
|
36 |
% |
|
30 |
% |
|
68 |
% |
|
30 |
% |
|
21 |
% |
| Genital lesion rate reduction* |
69%
(p<0.0001) |
50%
(p<0.0001) |
65%
(p<0.0001) |
60%
(p<0.0001) |
43%
(p<0.0001) |
47%
(p<0.0001) |
Notes:
* Rate reduction vs. pre-dosing baseline levels. Poisson mixed effect model analysis.
Genocea plans to present the full data from the Phase 2 dose optimization trial at an upcoming scientific meeting.
About the GEN-003 Phase 2 Clinical Trial
This Phase 2 study enrolled 310 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rates were established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day), which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period was repeated immediately after the completion of dosing and at six and, twelve months following dosing. No booster doses were given. After the 28-day observation period immediately after dosing, patients in the placebo arm were rolled over across the 6 active combinations of GEN-003 and Matrix-M2 under a separate protocol.
For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.
Conference Call
Genocea management will host a conference call and webcast today at 9 a.m. ET to describe the 12 month efficacy data from the trial across all dose groups. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 81824505). A live webcast of the conference call will be available online from the investor relations section of the Company’s website at http://ir.genocea.com. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.
About GEN-003
Inducing a T cell response against HSV-2 is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class T-cell directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea’s ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, to identify antigen targets that drive T cell response. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea licenses from Novavax, Inc. For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/.
About Genital Herpes
Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. It can be transmitted to sexual partners, even when the disease is asymptomatic. Current genital herpes therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. Incomplete control of genital lesions and transmission risk, expense and the perceived inconvenience of taking a daily medication are hurdles for long-term disease management. Immunity through T cells is believed to be particularly critical to the control and possible prevention of genital herpes infections.
About Genocea
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus (development suspended pending further data analysis and consultation with our advisers), and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.
Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the ability of ATLAS to identify promising oncology vaccine and immunotherapy product candidates; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.

For media:
Liz Bryan
Spectrum Science Communications
O: 202-587-2526
lbryan@spectrumscience.com
For investors:
Jonathan Poole
Genocea Biosciences
O: 617-876-8191
jonathan.poole@genocea.com