Archive for December, 2016
$BCLI #ALS #MND Data BUllish for #NurOwn
HACKENSACK, N.J. and PETACH TIKVAH, Israel, Dec. 14, 2016 — BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that new data from the Company’s Phase 2 study of NurOwn® in ALS were presented by lead investigator Dr. James Berry at the 27th International Symposium on ALS/MND in Dublin, Ireland.
In the Phase 2 trial, levels of neurotrophic factors and inflammatory markers were measured in cerebral-spinal fluid (CSF) samples collected from patients. In the samples of those patients treated with NurOwn, a statistically significant increase in levels of neurotrophic factors VEGF, HGF and LIF was observed from pre- to post-transplantation. There was also a statistically significant reduction in inflammatory markers (MCP-1 and SDF-1) over this period, in patients treated with NurOwn® and this was not observed in the placebo group.
Dr. Berry also presented the pre-specified responder analyses from the Phase 2 trial which examined percentage improvements in post treatment of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope compared to pre-treatment slope. These analyses showed that, in the NurOwn® treated group, a greater number of patients achieved the high threshold of 100% improvement in the post-treatment vs. pre-treatment slope, compared with the placebo group. The definition of these responders is that their disease symptoms were essentially halted for the period of the treatment effect or they achieved a positive improvement on their ALSFRS-R score. Moreover, in the pre-specified subgroup that was defined in order to exclude subjects whose disease was progressing slowly, this effect was even more pronounced.
“This Phase 2 trial demonstrated clinical meaningful improvements in disease symptoms as measured by the well-established ALSFRS-R scale”, stated Dr. James Berry, Unit Chief of the Mass. General ALS Multidisciplinary Clinic. “Importantly, there is evidence that NurOwn® may be halting disease progression or improving symptoms in some patients. The CSF biomarker profiles were also encouraging. The significant increases in neurotrophic factors and decrease in inflammatory markers observed in the treated group post-transplant provide a biological mechanism supporting the observed clinical effect.”
The Phase 2 trial was a randomized, double-blind, placebo-controlled multi-center study designed to evaluate the safety and efficacy of NurOwn® in 48 ALS patients. It was conducted at three sites in the U.S: Massachusetts General Hospital, UMass Medical School and the Mayo Clinic. Patients were randomized to receive NurOwn cells administered via combined intramuscular and intrathecal injection (n= 36), or placebo (n=12). The primary objective of the study was safety and tolerability. The pre-specified efficacy analyses were: change in the ALSFRS-R slope, change in Slow Vital Capacity (SVC) and muscle strength, responder analysis (the percentage of subjects who improved post-treatment compared with pre-treatment), and a subgroup analysis excluding slowly progressing patients who are less likely to have a detectable benefit from NurOwn.
Dr. Berry’s presentation is posted on the “Events and Presentations” page of the Brainstorm company website (www.brainstorm-cell.com).
About the International Symposium on ALS/MND
The MND Association organizes the International Symposium on ALS/MND. This International Symposium is the largest medical and scientific conference on Motor Neuron Disease, also known as Amyotrophic Lateral Sclerosis. It is the premier event in the MND research calendar, attracting over 800 delegates, representing the energy and dynamism of the global MND research community. For more information, refer to http://www.mndassociation.org/research/international-symposium/
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company’s website at www.brainstorm-cell.com.
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as “may”, “should”, “would”, “could”, “will”, “expect”, “likely”, “believe”, “plan”, “estimate”, “predict”, “potential”, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm’s limited operating history, history of losses; minimal working capital, dependence on its license to Ramot’s technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
CONTACTS
Media:
Uri Yablonka, COO
Brainstorm Cell Therapeutics Inc.
Phone: (646) 666-3188
uri@brainstorm-cell.com
Investors:
Michael Rice
LifeSci Advisors, LLC
Phone: 646-597-6979
mrice@lifesciadvisors.com
$EPIX Provides Business Update, #Q$ #Financials
ESSA Pharma Provides Business Update and Announces Fourth Quarter and Year Ended September 30, 2016 Financial Results
Canada NewsWire
HOUSTON and VANCOUVER, Dec. 14, 2016
HOUSTON and VANCOUVER, Dec. 14, 2016 – ESSA Pharma Inc. (“ESSA” or the “Company”) (NASDAQ: EPIX, TSX: EPI), a clinical stage pharmaceutical company focused on developing novel therapies for prostate cancer, today reported financial results for the year ended September 30, 2016 and progress on its clinical development program.
2016 Business Highlights
Clinical Development
“We continue to advance our lead clinical product candidate, EPI-506, in our Phase 1/2 clinical trial in men with metastatic castrate-resistant prostate cancer (“mCRPC”). This drug, which we believe works in a novel manner to inhibit androgen-driven pathways in prostate cancer, is being tested initially in men who have progressed after therapy with current generation anti-androgens,” said David R. Parkinson, MD, President and Chief Executive Officer. “We are encouraged by the fact that the drug has been shown to be well-tolerated with a predictable pharmacokinetic profile to-date. We look forward to reporting the clinical results from the study following establishment of a Phase 2 dose.”
The clinical trial continues to enroll patients in both the United States and Canada. Dose escalations have been informed by assessments of patients safety and a pharmacokinetic assessment of drug exposure.
- The study drug has been well tolerated in the clinical trial with a favorable safety profile to date.
- Patients are currently being dosed in the fifth cohort of the clinical trial. Initial dose selection in the clinical trial was estimated using allometric scaling from animal studies. Pharmacokinetic data from the clinical trial revealed lower study drug exposures than initially projected. As a result, more aggressive dose escalations were required.
- Pharmacokinetic assessments indicate dose-proportional exposure of study drug across all cohorts. The Company believes that the current dosing cohort may achieve study drug exposures similar to exposures associated with the minimally efficacious dose seen in prosate tumor animal models.
- ESSA hopes to establish a Phase 2 dose during calendar Q1 2017 and to commence the Phase 2 portion of the clinical trial thereafter.
- The Company has received regulatory clearance from the UK and French authorities to begin the Phase 2 portion of the clinical trial, pending review of the Phase 1 data.
About the clinical trial: The Company initiated the Phase 1/2 clinical trial of EPI-506 in late 2015. The clinical trial is designed to demonstrate the safety, tolerability, maximum tolerated-dose, pharmacokinetics and efficacy of EPI-506 in the treatment of prostate cancer patients who have failed treatments using abiraterone or enzalutamide or both, the current standard-of-care drugs in mCRPC.
The Phase 1 portion of the clinical trial is an open-label, adaptive 3 + 3 design, dose-escalation study. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial 12 weeks. In addition to clinical, radiological and biochemical assessments including prostate specific antigen measurements, patients are being characterized biologically with respect to characteristics known to be associated with resistance to currently used anti-androgens. These assessments include expression of androgen receptor (“AR”) splice variants in circulating tumor cells, assessment of AR copy number, and mutations in circulating free DNA. The Phase 1 portion of the clinical trial is being conducted in 5 institutions in the United States and Canada.
The Phase 2 portion of the clinical trial will begin following the establishment of a Phase 2 dose and will be conducted in the United States, Canada, the UK, and France, in patients with prostate cancer resistant to the newer generation anti-androgens. It is a single-arm, open-label study, with a primary endpoint of number of patients demonstrating a 50% decline in prostate specific antigen (“PSA”), as well as radiographic progression.
Additional data about the study can be found at ClinicalTrials.gov.
Recent Scientific Publications Regarding EPI- Compounds: In 2016, several important publications were published concerning the biochemical and biological effects of the EPI- series of compounds, adding to our understanding of their mechanism of action. Published studies have decribed how the EPI compounds specifically bind to the Tau5 region of the androgen receptor N-terminal domain, thereby uniquely and selectively inhibiting AR-driven gene transcription, and forming the basis for active inhibition of the AR pathway in men with castrate-resistant prostate cancer, even in the setting of resistance to currently-used anti-androgens. Further details regarding the publications discussed herein can be found on the Company’s website.
2016 Year Financial Highlights
Amounts disclosed herein, unless specified otherwise, are expressed in United States dollars and in accordance with International Financial Reporting Standards (“IFRS”). References to “$” are to United States dollars and references to “C$” are to Canadian dollars.
- Receipt of $3.8 million from the Cancer Prevention and Research Institute of Texas. The approval of the Investigational New Drug (“IND”) application in September 2015 triggered the receipt of an additional $3.8 million of funding from the Cancer Prevention and Research Institute of Texas (“CPRIT”). Under ESSA’s agreement with CPRIT, a total of $12.0 million of grant funding (repayable out of potential product revenues) will be made available to the Company, of which $2.8 million had previously been received.
- Closed $20.0 million in Private Placements. On January 14, 2016 the Company completed a private placement for aggregate gross proceeds of approximately $15.0 million led by Clarus Lifesciences (the “January 2016 Financing”; see news release dated January 14, 2016). On March 21, 2016, the Company closed a private placement to Eventide Funds for gross proceeds of $5.0 million (the “March 2016 Financing”; see news release dated March 21, 2016).
- Receipt of $10.0 million term loan from Silicon Valley Bank. On November 18, 2016, the Company entered into a term loan agreement with Silicon Valley Bank, pursuant to which the Company has drawn down $8.0 million, with an option for an additional $2.0 million by April 30, 2017, conditional on positive data from the ongoing Phase 1 clinical trial and receipt of the $5.4 million balance of the grant from CPRIT.
Summary Financial Results
- Net Income (Loss). ESSA recorded a net loss of $13.1 million ($0.49 per common share) for the year ended September 30, 2016, compared to a net loss of $9.7 million ($0.53 per common share) for the year ended September 30, 2015. The net loss for the fourth quarter of 2016 was $4.2 million compared to a net income of $0.5 million for the fourth quarter of 2015.
- Research and Development (“R&D”) expenditures. R&D expenditures for the year were $13.6 million compared to $5.0 million, net of grants ($10.4 million gross), for the year ended September 30, 2015. For the fourth quarter ended September 30, 2016, R&D expenditures were $3.9 million compared to a recovery of $0.8 million, net of grants ($3.1 million gross), for the fourth quarter ended September 30, 2015. Increases in R&D expenditures for the full year and fourth quarter were primarily related to manufacturing and clinical costs as the Company continues its clinical development of EPI-506. In the quarter ended December 31, 2015, the Company commenced enrolling patients into its Phase 1/2 clinical trial. The composition of R&D costs has therefore evolved from preclinical and IND application work in the year ended September 30, 2015 to include clinical, manufacturing and additional staff salaries in the year ended September 30, 2016.
- General and administration (“G&A”) expenditures. G&A for the year ended September 30, 2016 were $5.6 million compared to $5.3 million for the year ended September 30, 2015. The increase was primarily due to increased activity as a public corporate entity, and additional general and administrative expenditures to support the clinical development of EPI-506. For the fourth quarter ended September 30, 2016, G&A was $1.2 million compared to $2.2 million for the fourth quarter ended September 30, 2015. The decrease for the fourth quarter was primarily due to decreased professional, regulatory, and listing fees, which in the prior quarter were incurred in relation to the Company’s initial listings on the NASDAQ and TSX.
Liquidity and Outstanding Share Capital
Working capital as at September 30, 2016 was $6.4 million. In November 2016, the Company secured a $10.0 million term loan (see news release dated November 21, 2016). Management believes, assuming completion of the Phase 1 clinical trial in the first quarter of calendar 2017, that the term loan, together with the Company’s existing capital, will provide the Company with sufficient funds to (i) complete EPI-506’s Phase 1 clinical trial, (ii) trigger a $5.4 million grant under the CPRIT program at completion of the Phase 1 clinical trial and (iii) commence EPI-506’s Phase 2 portion of the clinical trial. The Phase 1 portion is anticipated to complete in the first quarter of calendar 2017, depending on the enrollment rate and number of dose escalation steps. Management continues to consider sources of additional financing which would assure continuation of the Company’s operations and research programs.
As of September 30, 2016, the Company had 29,096,889 common shares issued and outstanding, 4,062,519 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of C$2.76 per common share, and 7,099,541 common shares issuable upon the exercise of outstanding warrants at a weighted-average exercise price of $3.28 per common share.
About ESSA Pharma Inc.
ESSA Pharma is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration resistant prostate cancer (“CRPC”) in patients whose disease is progressing despite treatment with current therapies. ESSA believes that its product candidate, EPI-506, can significantly expand the interval of time in which patients suffering from CRPC can benefit from hormone-based therapies. EPI-506 acts by disrupting the AR signaling pathway, which is the primary pathway that drives prostate cancer growth. EPI-002, the primary metabolite of EPI-506, prevents AR activation by binding selectively to the N-terminal domain (“NTD”) of the AR. A functional NTD is essential for activation of the AR. Blocking the NTD prevents activation of the AR by all of the three known mechanisms of activation. In pre-clinical studies, blocking the NTD has demonstrated the capability to overcome the known AR-dependent mechanisms of CRPC. ESSA was founded in 2009.
About Prostate Cancer
Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2012). Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone (for example, ADT), disease progression despite castrate levels of testosterone generally represents a transition to the lethal variant of the disease (mCRPC) and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years; despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those that have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo studies, ESSA’s novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and/or Canadian securities laws that may not be based on historical fact, including without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward-looking statements in this news release include, but are not limited to, statements regarding the Phase 1 clinical trial, including the drug exposures of the current dosing cohort, the anticipated results and the completion thereof, the Phase 2 clinical trial, including details and anticipated timing thereof, and the expected location and number of Phase 2 clinical trial centres, the sufficiency of ESSA’s funds to execute the Phase 1 portion of the Phase 1/2 clinical trial and possible future financings by ESSA.
Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA’s actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward-looking statements, ESSA may make various material assumptions, including but not limited to the accuracy of ESSA’s financial projections and the Phase 1 portion of the Phase 1/2 clinical trial proceeding as expected.
Forward-looking information is developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA’s Annual Report on Form 20-F dated December 14, 2016 under the heading “Risk Factors”, a copy of which is available on ESSA’s profile on the SEDAR website at www.sedar.com, ESSA’s profile on EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA’s SEDAR profile. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable Canadian and United States securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements.
ESSA PHARMA INC.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Unaudited (Amounts in thousands)
As at September 30, | |||||
2016 | 2015 | ||||
Cash | $ | 8,985 | $ | 1,579 | |
Prepaid and other assets | 1,417 | 5,961 | |||
Total assets | $ | 10,402 | $ | 7,540 | |
Current liabilities | 3,630 | 2,091 | |||
Derivative liability | 7,309 | 993 | |||
Shareholders’ equity (deficiency) | (537) | 4,456 | |||
Total liabilities and shareholders’ equity (deficiency) | $ | 10,402 | $ | 7,540 |
ESSA PHARMA INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Amounts in thousands, except share and per share data
Three months ended September 30, 2016 |
Three months ended September 30, 2015 |
Year ended September 30, 2016 |
Year ended September 30, 2015 |
||||||||||
OPERATING EXPENSES | |||||||||||||
Research and development | $ | 3,952 | $ | (792) | $ | 13,060 | $ | 4,976 | |||||
Financing costs | – | 31 | 938 | 94 | |||||||||
General and administration | 1,237 | 2,178 | 5,644 | 5,259 | |||||||||
Total operating expenses | (5,189) | (1,417) | (19,642) | (10,329) | |||||||||
Gain (loss) on derivative liability | 1,041 | 1,124 | 6,574 | (908) | |||||||||
Other items | 2 | 781 | 79 | 1,560 | |||||||||
Net income (loss) for the year before taxes | (4,146) | 488 | (12,989) | (9,677) | |||||||||
Income tax expense | (91) | – | (151) | – | |||||||||
Net income (loss) for the year | $ | (4,237) | $ | 488 | $ | (13,140) | $ | (9,677) | |||||
Basic and diluted loss per common share | $ | (0.15) | $ | 0.03 | $ | (0.49) | $ | (0.53) | |||||
Weighted average number of common shares outstanding | 26,903,834 | 18,353,018 | 26,903,834 | 18,353,018 |
$VCEL Receives #FDA #Approval for #MACI
Shares of Vericel Corp. (NASDAQ: VCEL) are up more than 60% mid-day after the company broke news of the approval of MACI® (autologous cultured chondrocytes on porcine collagen membrane) by the U.S. Food and Drug Administration (FDA) for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. MACI is the first FDA-approved cellularized scaffold product that applies tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee. “We believe that the introduction of MACI, along with investments to expand our commercial organization and implement new patient support programs, positions Vericel to generate significant growth in 2017 and beyond,” Nick Colangelo, Vericel president and CEO stated in the news release.
To view the full press release, visit: http://nnw.fm/rgz5O
About Vericel Corporation
Vericel develops, manufactures, and markets expanded autologous cell therapies for the treatment of patients with serious diseases and conditions. The company currently markets two cell therapy products in the United States. Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant for the treatment of cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also plans to market MACI® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults, which has just been approved by the FDA. Vericel is also developing ixmyelocel‑T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM). For more information, please visit the company’s website at www.vcel.com
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$AKAO Announces Proposed #PublicOffering of Common #Stock
SOUTH SAN FRANCISCO, Calif., Dec. 12, 2016 — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has commenced an underwritten public offering of up to 5,750,000 shares of its common stock. All of the shares to be sold in the offering will be offered by Achaogen. In addition, Achaogen expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 862,500 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Achaogen intends to use the net proceeds of the offering to fund the ongoing development and preparation for potential commercialization of plazomicin, including the preparation and submission of Achaogen’s New Drug Application with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application with the European Medicines Agency (EMA) for plazomicin, to support its activities during the FDA’s and the EMA’s review and approval process and pre-commercialization marketing activities for plazomicin, and any remaining proceeds for working capital and general corporate purposes, including research and development of additional product candidates.
Leerink Partners LLC, Stifel and Guggenheim Securities, LLC are acting as joint book-running managers for the offering. SunTrust Robinson Humphrey, Inc. is acting as lead manager for the offering.
A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on April 21, 2015. This offering is being made solely by means of such registration statement, including a prospectus supplement and the accompanying prospectus forming a part of the registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may be obtained from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by email at syndicate@leerink.com, or by phone at 800-808-7525, ext. 6142; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, California 94104, Attn: Syndicate, by phone at 415-364-2720 or by email at syndprospectus@stifel.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by email at GSEquityProspectusDelivery@guggenheimpartners.com, or by phone at 212-518-9658.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Achaogen
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein 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, including, but not limited to, Achaogen’s statements regarding the completion, timing, size and use of proceeds of the proposed public offering. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, market conditions and the satisfaction of closing conditions related to the proposed public offering, the uncertainties inherent in the drug development and commercialization process, including regulatory requirements, the timing of Achaogen’s regulatory filings, Achaogen’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of plazomicin, Achaogen’s reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof, Achaogen’s dependence on its President and Chief Executive Officer and risks and uncertainties related to the acceptance of government funding for certain of Achaogen’s programs, including the risk that the Biomedical Advanced Research and Development Authority (BARDA) could terminate Achaogen’s contract for the funding of the plazomicin development program. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. 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 Achaogen’s business in general, see Achaogen’s prospectus supplement to be filed with the SEC on December 12, 2016, including the documents incorporated by reference therein, which includes Achaogen’s current and future reports filed with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015.
Media Contact: Denise Powell 510.703.9491 denise@redhousecomms.com
$CETX Outlines Opportunities in the #Automotive #Electronics Space
FARMINGDALE, N.Y., Dec. 13, 2016 — Cemtrex Inc. (Nasdaq: CETX), a world-leading industrial and manufacturing solutions company, commented today on the outlook for the Automotive Electronics industry and potential opportunities for the Company, as automobiles add more electronic components and as they become more connected. A recent report by Mckinsey indicates, “the dramatic increase in vehicle connectivity will increase the value of the global market for connectivity components and services to €170 billion by 2020 from just €30 billion today.”
As the automotive industry also moves toward self-driving technology and connected intelligent cars, it is expected to generate new opportunities for Cemtrex. Companies like Hyundai and Volkswagen are working on connected car technologies and related services such as smartphone and smart home connected services, intelligent remote support, fully autonomous driving, smart traffic functionality and mobility hubs as part of their effort to establish a presence in the market. Technology companies such as Alphabet and Apple and automobile manufacturers including Ford, Volvo, Tesla, and BMW are investing in autonomous driving technology which requires the integration of many electronic components and assemblies. According to a recent report from PwC, autonomous vehicles could come to full fruition in ten years which will enable new levels of connectivity and services both inside and outside the car. They estimate connected car revenues to increase from approximately $50 billion to $155.9 billion by 2022.
Cemtrex’s chairman and CEO, Saagar Govil, commented: “Samsung Electronics recently acquired Harman International Industries, one of our largest customers, in an effort to accelerate its growth in the automotive connected space, which we believe is further validation of our strategy in this sector. We are extremely optimistic about the opportunities in front of us and our ability to leverage them with our growing organization.”
About Cemtrex
Cemtrex, Inc. (NASDAQ:CETX) is a global, diversified industrial and manufacturing company that provides a wide array of solutions to meet today’s technology challenges and is rapidly growing through acquisitions. Cemtrex provides manufacturing services of advanced custom-engineered electronics, industrial contracting services, monitoring instruments for industrial processes and environmental compliance, and equipment for controlling particulates, hazardous pollutants, and Greenhouse gases used in carbon trading globally.
www.cemtrex.com
Safe Harbor Statement
This press release contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. This release may contain Non-GAAP financial information and is not presented in accordance with US GAAP. The Company believes that the presentation of non-GAAP financial measures provides useful information to management and investors regarding underlying trends in its consolidated financial condition and results of operations. The Company’s management regularly uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate the Company’s business and make operating decisions.
For further information, please contact:
Investor Relations
Cemtrex, Inc.
Phone: 631-756-9116
137623@email4pr.com
$IDXG Announces Launch of Combination #Thyroid #Test #Study; #ThyGenX #ThyramiR
Patient Registry of ThyGenX and ThyramiR Designed to Further Validate Combination Test’s Clinical Utility
PARSIPPANY, N.J., Dec. 13, 2016 — Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides clinically useful molecular diagnostic tests and pathology services, announced today that the Company has launched a multi-site study to provide further evidence of the Clinical Utility of the ThyGenX/ThyramiR tests in accurately identifying malignancy or benign status in indeterminate thyroid nodules. The primary objective of the study is to demonstrate the real world clinical utility of the test, i.e. the degree to which the tests impact physician decision-making and positively affect patient outcomes. To date, the Company has performed the combination assay on over 5,000 patients on behalf of over 200 physicians and hospitals nationwide.
Participating institutions, which were selected based on their specific expertise in diagnosing and treating thyroid cancer, include sites from the New York metropolitan region. In September 2016, the Company announced that the New York State Department of Health approved ThyGenX™, the Company’s Next Generation Sequencing oncogene panel for indeterminate thyroid nodules, allowing Interpace Diagnostics to offer both ThyGenX and ThyramiR in New York State. According to Thyroid Disease Manager, New York State accounts for nearly 5% of the approximately 600,000 annual Thyroid FNA biopsies performed in the US.
According to Syd Finkelstein MD, Chief Scientific Officer of Interpace Diagnostics, “The role of the participating institutions will be to work with the Company in tracking patients’ treatments and other key outcomes data following molecular testing with ThyGenX and ThyramiR. We expect to be able to report the results of the study sometime during the second half of 2017.”
ThyGenX – ThyramiR represents the only test in the market that combines the rule-in properties of next-generation sequencing of a patient’s DNA and RNA, with rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, over 80% of the Company’s total cases are reflexed to ThyramiR for additional assessment. The Company first launched ThyGenX in October, 2014 and ThyramiR on April 15, 2015 making the combination test available to Endocrinologists and Pathologists throughout the country.
According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign or malignant following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign. Molecular testing using ThyGenX – ThyramiR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased to be able to collaborate with this group of top tier health care institutions and physicians in the New York market place. We believe in continuing to invest in studies that provide further evidence that our molecular tests for thyroid cancer provide physicians and their patients critical insights. We expect that the data from this initiative will add to the already compelling evidence supporting the superior performance of ThyGenX and ThyramiR.”
About Thyroid Nodules, ThyGenX and ThyramiR testing
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyramiR.
ThyGenX and ThyramiR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyramiR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyramiR measures the expression of 10 microRNAs. Both ThyGenX and ThyramiR are covered by both Medicare and Commercial insurers.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics is a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGen® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyramiR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics’ mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. The company has attempted to identify forward looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause company’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, our ability to adequately finance the business, our ability to restructure our debt and other obligations, our ability to find a buyer of our assets, the market’s acceptance of our molecular diagnostic tests; our ability to secure additional business and generate higher profit margins through sales of our molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company’s periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 30, 2016 as amended on April 29, 2016 and June 14, 2016, and the Quarterly Report on Form 10-Q filed with the SEC on November 17, 2016. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
CONTACTS:
Victor Roberts
RedChip Companies
407.644.4256, ext. 111
victor@redchip.com
$SRTS Receives #BioFlorida #CompanyoftheYear #Award
BOCA RATON, Fla., Dec. 13, 2016 — Sensus Healthcare, Inc. (NASDAQ: SRTS), a medical device company specializing in the treatment of non-melanoma skin cancers (NMSC) and other skin conditions such as keloids with superficial radiation therapy (SRT), announced today that it has been named the winner of the BioFlorida Company of the Year Award at the 2016 BioFlorida Annual Conference in Jacksonville, Florida.
“We are honored to receive the BioFlorida Company of the Year Award,” said Joe Sardano, Chief Executive Officer of Sensus Healthcare. “2016 has been especially exciting for us as a company. To name a few milestones, we successfully completed our initial public offering in June, more than doubled our salesforce, expanded our global reach and increased sales 54 percent year-over-year all in the first nine months of the year.”
“We launched Sensus Healthcare in 2010 with the goal to develop and market advanced medical devices that would allow the company to achieve two goals: address large and underserved market opportunities within the medical device arena and offer a disruptive and compelling value proposition to physicians and patients alike. Our SRT therapy treatment devices are virtually painless; do not require anesthesia, cutting, or stitching; do not result in bleeding or scarring; and are cost effective. We are committed to bringing innovative solutions to the State of Florida and globally,” concluded Mr. Sardano.
The BioFlorida Annual Conference brings together hundreds of life science professionals and showcases recent scientific advancements, business achievements and public policy issues. Attendees gather to hear about the industry’s significant growth across the state of Florida. Prominent keynote speakers at the 2016 conference included: Jason Altmire, SVP of Public Policy and Community Engagement, Florida Blue; Peter Menziuso, President, North America, Johnson & Johnson Vision Care; James A. Rogers III, J.D., Chair, Mayo Clinic Ventures, Deputy Director, Center for Regenerative Medicine.
“As the voice of Florida’s life sciences industry, we are proud to award Sensus Healthcare with the BioFlorida Company of the Year. As the only Florida based company to complete an initial public offering in 2016, the unique technology that Sensus brings to the market could not be a better representation of the innovation we recognize and foster in Florida,” said Nancy Bryan, President and CEO of BioFlorida.
About BioFlorida
BioFlorida is the voice of Florida’s life sciences industry, representing nearly 6,000 establishments and research organizations in the biotechnology, pharmaceuticals, medical technology (devices and diagnostics) and bioagriculture sectors that collectively employ nearly 83,000 Floridians (Source: The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life, TEConomy/BIO, 2016). Members of the BioFlorida network include emerging and established life science companies, universities, research institutions, hospitals, medical centers, incubators, economic development agencies, investors and service providers.
About Sensus
Sensus Healthcare, Inc. is a medical device company that is committed to enabling non-invasive and cost-effective treatment of non-melanoma skin cancers and keloids. Sensus uses a proprietary low energy x-ray radiation technology known as superficial radiation therapy (SRT), which is a result of over a decade of dedicated research and development activities. Sensus has successfully incorporated the SRT therapy into its portfolio of treatment devices, the SRT-100™ and SRT-100 Vision™. To date, the SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in thousands of patients. For more information, visit http://www.sensushealthcare.com.
Investor Relations:
Jeffrey Goldberger / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1249 / 212-896-1267
Email: jgoldberger@kcsa.com / asoss@kcsa.com
$AKRX Completion of #FDA Re-inspection of #Decatur Facility
LAKE FOREST, Ill., Dec. 12, 2016 — Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) conducted a re-inspection of its Decatur, Illinois manufacturing facility from December 5, 2016 to December 9, 2016, with no Form 483 observations.
The re-inspection was conducted to verify the implementation and effectiveness of Akorn’s responses to the observations from the June 2016 FDA inspection.
About Akorn
Akorn, Inc. is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India that manufacture ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on Akorn’s website at www.akorn.com.
Investors/Media: Stephanie Carrington ICR, Inc. (646) 277-1282 Stephanie.carrington@icrinc.com
$AIQ Controlling Shareholder Expression of Interest to Acquire All Outstanding Shares
Acquire All Outstanding Shares
Alliance HealthCare Services, Inc. (NASDAQ: AIQ) (the “Company”, “Alliance”, “we” or “our”), a leading national provider of outsourced radiology, oncology and interventional services, announced today that it has received a letter (the “Expression of Interest”) describing a non-binding proposal from Tahoe Investment Group Co., Ltd. (“Tahoe”), formerly known as Fujian Thai Hot Investment Co., Ltd, to acquire all of the outstanding common shares of Alliance that are not currently owned by THAIHOT Investment Company Limited (“THAIHOT”), an indirect wholly owned subsidiary of Tahoe. Tahoe has proposed a purchase price of $9.60 per share in cash.
As previously disclosed on March 29, 2016, Tahoe, through its subsidiary, completed the purchase of the majority interest in Alliance, owning an aggregate of approximately 52% of outstanding common stock, and entered into a Governance, Voting and Standstill Agreement (the “Governance Agreement”) with the Company.
The Board of Directors of the Company has authorized a Special Committee, comprised solely of directors not affiliated with Tahoe, to evaluate the Expression of Interest. The Special Committee has engaged independent legal counsel and intends to engage an independent financial advisor to assist in its evaluation of the Expression of Interest. In connection with the Expression of Interest, the Special Committee has agreed to waive the provision of the Governance Agreement prohibiting THAIHOT and its affiliates, including Tahoe, from proposing to acquire additional shares of the Company’s common stock. The waiver is for the limited purpose of submitting the Expression of Interest to the Special Committee.
The Expression of Interest indicated that any transaction with Tahoe would be subject to approval by the Special Committee and a non-waiveable condition requiring approval of a majority of the shares of Alliance not owned by Tahoe or is affiliates. Tahoe also indicated that the proposed transaction would not be subject to a financing condition.
About Alliance HealthCare Services
Alliance HealthCare Services (NASDAQ: AIQ) is a leading national provider of outsourced healthcare services to hospitals and providers. We also operate freestanding outpatient radiology, oncology and interventional services clinics, and Ambulatory Surgical Centers (“ASC”) that are not owned by hospitals or providers. Diagnostic radiology services are delivered through the Radiology Division (Alliance HealthCare Radiology), radiation oncology services are delivered through the Oncology Division (Alliance Oncology), and interventional and pain management services are delivered through the Interventional Division (Alliance Interventional). Alliance is the nation’s largest provider of advanced diagnostic mobile imaging services, an industry-leading operator of fixed-site imaging centers, and a leading provider of stereotactic radiosurgery nationwide. As of September 30, 2016, Alliance operated 619 diagnostic radiology and radiation therapy systems, including 112 fixed-site radiology centers across the country, and 32 radiation therapy centers and SRS facilities. With a strategy of partnering with hospitals, health systems and physician practices, Alliance provides quality clinical services for over 1,000 hospitals and other healthcare partners in 45 states, where approximately 2,400 Alliance Team Members are committed to providing exceptional patient care and exceeding customer expectations. For more information, visit www.alliancehealthcareservices-us.com.
About Tahoe
Tahoe is an investment holding company based in Fuzhou, China, holding a diversified portfolio of assets in various industries including real estate development, securities, hospitality, biomedicine and healthcare. Tahoe was founded in 1996 and its total assets exceeded $13 billion as of December 31, 2015. Tahoe’s diversified portfolio includes controlling ownership in Thai Hot Group, one of the leading real-estate developers in China listed on the Shenzhen Stock Exchange (SZSE:000732). Tahoe is also the third largest shareholder of the Shanghai Stock Exchange listed Dongxing Securities (SHSE:601198). Tahoe expanded its business landscape to include biomedicine and healthcare industry by acquiring a large-scale pharmaceutical company. In early 2015, Tahoe made healthcare and medical services one of its top priorities, including radiology and oncology, and it intends to expand healthcare services in mainland China to an underserved healthcare marketplace. Qisen Huang is the Founder and Chairman of Tahoe.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to, without limitation, the Company’s long-term value proposition, growth and international market and other opportunities. Forward-looking statements can be identified by the use of forward looking language such as “believe,” “anticipate,” “expect,” “estimate,” “intend,” “plan,” “project,” “will be,” “will continue,” “will result,” “could,” “may,” “might,” or any variations of such words with similar meanings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. For a complete list of risks and uncertainties, please refer to the Risk Factors section of the Company’s Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission.
Alliance HealthCare Services, Inc.
Rhonda Longmore-Grund
Executive Vice President
Chief Financial Officer
949.242.5300
$AKAO Positive Results #Phase3 #cUTI and #CRE #ClinicalTrials of #Plazomicin
— EPIC registration trial successfully achieves FDA primary endpoints in patients with complicated urinary tract infections (cUTI) —
— EPIC demonstrates superiority on EMA primary endpoints —
— CARE descriptive trial shows 71 percent relative reduction in Day 28 all-cause mortality compared with colistin in patients with serious CRE infections —
— Plazomicin well tolerated in both trials and shows improved overall safety compared with colistin in CARE trial —
— Company plans to proceed with regulatory submissions in the U.S. and Europe —
— Company to host a conference call and webcast today at 8:30 a.m. EST —
SOUTH SAN FRANCISCO, Calif., Dec. 12, 2016 — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that its lead product candidate, plazomicin, met the objective of non-inferiority compared to meropenem for the U.S. Food and Drug Administration (FDA) and achieved superiority for the European Medicines Agency (EMA) primary efficacy endpoints in the Phase 3 EPIC registration trial in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In addition, in the Phase 3 CARE trial in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE) a lower rate of mortality or serious disease-related complications was observed for plazomicin compared with colistin therapy, one of the few remaining antibiotics for treatment of infections due to CRE.
“We are thrilled with the outcome of both the EPIC and CARE clinical trials and the potential opportunity for plazomicin to address many of the multi-drug resistant bacterial infections occurring every day,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “We are grateful to the patients and investigators who were involved in both of these studies, and we look forward to seeking plazomicin’s approval from FDA and EMA. We believe that, if approved, plazomicin will provide an important new option in treating MDR infections, including those caused by CRE.”
Achaogen plans to submit a New Drug Application (NDA), which will include EPIC and CARE data, to the FDA in the second half of 2017. The Company also plans to submit a Marketing Authorization Application (MAA) to the EMA in 2018. In addition, Achaogen plans to publicly present detailed results from both the EPIC and CARE trials in 2017.
“These data are exceptional and better than I would have expected – plazomicin’s superiority in microbiologic cure for patients with cUTI at the test-of-cure visit compared to meropenem, a gold standard for treating MDR infections, is impressive. Importantly, the safety profile of the drug looks favorable,” said James A. McKinnell, Assistant Professor of Medicine at the David Geffen School of Medicine and LA Biomed at Harbor-UCLA. “The data from the CARE trial provides compelling evidence for plazomicin as a treatment option for serious infections due to CRE. The sample size for the CARE study was small, but the data show a clear trend in favor of plazomicin in terms of efficacy and overall safety compared to colistin. CRE infections cause serious morbidity and mortality and seem to be on the rise. Based on these data, plazomicin would be a valuable addition to my short list of available treatment options for both empiric and directed treatment of patients, and as a single agent or in combination with other antibiotics.”
In the EPIC trial, plazomicin successfully met the objective of non-inferiority compared to meropenem for the FDA-specified primary efficacy endpoints, and achieved superiority for the EMA-specified primary efficacy endpoints.
Results for FDA pre-specified composite endpoint of clinical cure and microbiological eradication in the microbiological modified intent-to-treat (mMITT) population were as follows:
- Day 5: 88.0% plazomicin vs. 91.4% meropenem (difference -3.4%, 95% CI: -10.0, 3.1%), indicating statistical non-inferiority
- Test-of-Cure: 81.7% plazomicin vs. 70.1% meropenem (difference 11.6%, 95% CI: 2.7, 20.3%), indicating statistical superiority
Results for EMA-specified endpoints of microbiological eradication at the test-of-cure visit were as follows:
- mMITT: 87.4% plazomicin vs. 72.1% meropenem (difference 15.4%, 95% CI: 7.5, 23.2%), indicating statistical superiority
- ME: 90.5% plazomicin vs. 76.6% meropenem (difference 13.9%, 95% CI: 6.3, 21.7%), indicating statistical superiority
Phase 3 EPIC Trial in Patients with cUTI: Summary of FDA and EMA Primary Efficacy Endpoints
(* indicates statistical superiority)
Plazomicin n/N (%) |
Meropenem n/N (%) |
Difference (%)a (95% CI) |
|
Composite endpoint at Day 5, mMITT (FDA) | 168/191 (88.0%) | 180/197 (91.4%) | -3.4% (-10.0, 3.1%) |
Composite endpoint at TOC, mMITT (FDA) | 156/191 (81.7%) | 138/197 (70.1%) | 11.6% (2.7, 20.3%)* |
Microbiological eradication at TOC, mMITT (EMA) | 167/191 (87.4%) | 142/197 (72.1%) | 15.4% (7.5, 23.2%)* |
Microbiological eradication at TOC, ME (EMA) | 162/179 (90.5%) | 134/175 (76.6%) | 13.9% (6.3, 21.7%)* |
CI: confidence interval; ME: microbiologically evaluable; mMITT: microbiological modified intent-to-treat; TOC: test-of-cure;a Difference = plazomicin minus meropenem
Plazomicin was well tolerated with no new safety concerns identified in the EPIC trial. Total treatment emergent adverse events (TEAEs) related to renal function were reported in 3.6% and 1.3% of patients in the plazomicin and meropenem groups, respectively. TEAEs related to cochlear or vestibular function were reported in a single patient in each of the plazomicin and meropenem treatment groups. Both events were considered mild and resolved completely.
In the Phase 3 CARE trial in patients with serious infections due to CRE a lower rate of mortality or serious disease-related complications was observed for plazomicin compared with colistin therapy.
Results from the CARE trial were as follows:
- Day 28 all-cause mortality or significant disease related complications (primary endpoint); 23.5% plazomicin vs. 50.0% colistin (difference 26.5%, 90% CI: -0.7, 51.2%)
- Day 28 all-cause mortality; 11.8% plazomicin vs. 40.0% colistin (difference 28.2%, 90% CI: 0.7, 52.5%)
Phase 3 CARE Trial in Patients with BSI or HABP/VABP due to CRE
(Cohort 1 mMITT population)
Plazomicin n/N (%) |
Colistin n/N (%) |
Differencea (90% CI) |
Relative Reduction |
||
Day 28 all-cause mortality or significant disease-related complications | 4/17 (23.5%) | 10/20 (50.0%) | 26.5% (-0.7, 51.2%) |
53.0 | % |
Day 28 all-cause mortality | 2/17 (11.8%) | 8/20 (40.0%) | 28.2% (0.7, 52.5%) |
70.5 | % |
a Difference = colistin minus plazomicin
The safety profile of plazomicin was favorable to that of colistin in critically ill patients in the CARE trial. Study drug-related TEAEs related to renal function were reported in 16.7% and 38.1% of patients in the plazomicin and colistin groups, respectively. No TEAEs related to cochlear or vestibular function were reported in either group.
About the EPIC Trial
EPIC (Evaluating plazomicin in cUTI) was a multinational, randomized, controlled, double-blind clinical trial in adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). The trial enrolled 609 patients who were randomized 1:1 to receive plazomicin 15 mg/kg as a once daily 30-minute intravenous (IV) infusion or meropenem 1.0 gram every 8 hours as a 30 minute IV infusion. After a minimum of 4 days of IV therapy, patients who met protocol-defined criteria for improvement were allowed to step-down to oral levofloxacin to complete a total of 7 to 10 days of therapy (IV plus oral).
About the CARE Trial
CARE (Combating Antibiotic Resistant Enterobacteriaceae) was a multinational, open label, Phase 3 clinical trial evaluating the efficacy and safety of plazomicin in patients with serious bacterial infections due to CRE. The study included two cohorts of patients. Cohort 1 (N=39) was a randomized, comparator-controlled cohort to compare plazomicin with colistin (either in combination with meropenem or tigecycline) for the treatment of bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP) or ventilator associated bacterial pneumonia (VABP) due to CRE. Cohort 1 enrolled 30 patients with BSI and 9 patients with HABP/VABP. Cohort 2 (N=30) was a single-arm expanded access cohort to evaluate plazomicin-based therapy in patients with BSI, HABP/VABP or cUTI due to CRE who were not eligible for enrollment in Cohort 1.
The primary analysis for Cohort 1 was conducted in the mMITT population (patients with confirmed CRE infection) and was defined as all-cause mortality at Day 28 or significant disease related complications. Due to limitations of the small sample size, no formal statistical hypothesis testing was performed, but a two-sided 90% exact confidence interval is provided to describe the degree of variability around the observed differences.
Conference Call
The Company will host a conference call today, December 12, 2016 at 8:30 a.m. EST/5:30 a.m. PST. To participate by telephone, please dial 888-857-6929 (domestic) or 719-325-2328 (international). The conference ID number is 1600601. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.achaogen.com. The archived audio webcast will remain available on the Company’s website for 30 days following the conference call.
About Achaogen
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. Achaogen’s LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. LpxC inhibitors are the second class of molecules from Achaogen’s gram-negative antibiotic discovery engine. For more information, please visit www.achaogen.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein 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, including, but not limited to, Achaogen’s plan to submit an NDA to the FDA in the second half of 2017, Achaogen’s plans to submit an MAA to the EMA in 2018, Achaogen’s expectations regarding whether the full CARE trial results will be submitted as supportive data with the plazomicin NDA submission and Achaogen’s plan to publicly present detailed results from both the EPIC and CARE trials in 2017. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for an in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk that bacteria may evolve resistance to plazomicin; risks and uncertainties as to Achaogen’s ability to raise additional capital to support the development and potential commercialization of plazomicin and its other programs; uncertainties regarding the availability of adequate third-party coverage and reimbursement for newly approved products; Achaogen’s reliance on third parties to conduct certain preclinical studies and all of its clinical trials; Achaogen’s reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; Achaogen’s dependence on its President and Chief Executive Officer; risks and uncertainties related to the acceptance of government funding for certain of Achaogen’s programs, including the risk that BARDA could terminate Achaogen’s contract for the funding of the plazomicin development program; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen’s patents or proprietary rights; and the risk that Achaogen’s proprietary rights may be insufficient to protect its technologies and product candidates. 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 Achaogen’s business in general, see Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
AKAO-G
Investor Contact: Hans Vitzthum 212.915.2568 hans@lifesciadvisors.com Media Contact: Denise Powell 510.703.9491 denise@redhousecomms.com
$NETE Launches #PaymentAcceptance Module, Enabled by #PayOnline for #VTBInsurance
PayOnline subsidiary utilizes Telegram instant messenger application to enable payment services for insurance premiums
MIAMI, FL–(Dec 13, 2016) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services, today announces that its subsidiary PayOnline has launched a payment acceptance module for the popular cloud-based mobile and desktop instant messenger application, “Telegram,” for use within the high-volume insurance industry. This first-of-its-kind payment service for insurance premiums is made possible by PayOnline, and is now available for VTB Insurance, a leading insurance company in Russia.
The Telegram messaging app focuses on security and speed. Telegram reports that as of February 2016, it has 100 million monthly active users equating to 350,000 new users each day, and 15 billion messages daily messages that are generated over a secure and encrypted system.
Harnessing the value and convenience of this secure instant messenger payment acceptance technology, VTB Insurance billing system now allows instant payments for insurance premiums through the Telegram messenger app. With PayOnline’s integration, insurance registration takes just minutes and payments are accepted directly through the Telegram instant messenger app. Simultaneously, VTB Insurance has launched a service that allows tourists to process their insurance policies via Telegram and receive e-Policies instantly.
PayOnline currently provides payment acceptance services to more than 3,000 online, multi-channel merchants and service providers in CIS, Europe and Asia. The company’s goal is to establish additional monetization channels for its merchants by enabling smart payments through all channels of interaction between merchants and consumers that will add convenience and speed to everyday commerce.
About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US it aims to grow transactional revenue by innovating SME productivity services such as its cloud based, restaurant point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Further information is available at www.netelement.com.
Forward-Looking Statements
Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to whether the development of the payment acceptance module on “Telegram” will positively impact the Company. Additional examples of such risks and uncertainties are: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Net Element, Inc.
media@netelement.com
+1 (786) 923-0502
$EXPI Retains #MZGroup as its #InvestorRelations Advisor
BELLINGHAM, WA–(December 15, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI), the holding company for eXp Realty LLC, The Agent-Owned Cloud Brokerage®, has retained MZ Group as its investor relations advisor.
MZ Group will assist and advise eXp World Holdings with communicating its corporate, financial, and investor developments to shareholders, and assisting the Company with building its public brand and investor base.
“We have chosen to partner with MZ Group to bolster our investor relations and outreach efforts during this time of rapid growth within our Company,” said Glenn Sanford, Founder, CEO and Chairman of eXp World Holdings, Inc. “While we have more than doubled in size over the past year due in large part to the dedicated efforts of our existing agent and broker network, we believe there is room for sustained growth as we continue to invest in our core infrastructure and agent and broker network. It is our hope that MZ Group will help to communicate new developments and improvements at eXp World Holdings to the capital markets as we strive to increase shareholder value.”
“eXp Realty’s unique immersive 3D cloud-based platform has attracted some of the top real estate agents across the United States and parts of Canada to join the Company,” said Ted Haberfield, President of MZ Group North America. “The management consists of highly qualified industry professionals that have demonstrated the ability to scale an innovative business model in an established industry. We look forward to assisting the executive team at eXp World Holdings with an effective corporate communications and investor relations program.”
About eXp World Holdings, Inc.
eXp World Holdings, Inc. (OTCQB: EXPI) 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.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers real estate professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information, please visit the Company’s Twitter, LinkedIn, Facebook, YouTube, or visit www.eXpWorldHoldings.com. For eXp Realty please visit: www.eXpRealty.com.
Safe Harbor Statement
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:
Greg Falesnik
MZ Group – MZ North America
greg.falesnik@mzgroup.us
www.mzgroup.us
949-385-6449
Corporate Inquiries:
Glenn Sanford
CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
www.expworldholdings.com
360-685-4206
$MYGN #EndoPredict #BreastCancer #Test @SABCSSanAntonio, Significantly Outperforms Gen1
New Data Are Being Featured in a Podium Presentation at SABCS
SALT LAKE CITY, Dec. 09, 2016 — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced results of a large head-to-head study comparing the efficacy of six tests used to predict the recurrence of breast cancer. A key finding was that EndoPredict® (EPclin), a second-generation test, was superior to Oncotype Dx™ (RS), a first-generation test, in predicting the long-term recurrence of breast cancer. The results are being featured today in a podium presentation at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.
“In this important study, EndoPredict more accurately predicted the risk of breast cancer recurrence than the first-generation Oncotype Dx test, particularly in years five to 10 following surgery when half of breast cancer recurrences will happen,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. “Clinicians can consider using EndoPredict to identify patients who can forgo chemotherapy with confidence, knowing they have a low risk of recurrence over 10 years.”
Podium Presentation
Title: Comprehensive comparison of prognostic signatures for breast cancer in TransATAC.
Presenter: Ivana Sestak, Ph.D.
Date: Friday, Dec.9, 2016: 4:15 p.m. CT.
Location: S6-05; General Session 6 – Hall 3.
This study was led by scientists at the Institute of Cancer Research in London. The analysis included 818 women with ER+/HER2- breast cancer (591 node-negative; 227 node-positive) from the TransATAC study and compared the power of six predictive signatures, including: clinical treatment score, immunohistochemical markers, Oncotype Dx recurrence score (RS), breast cancer index (BCI), Prosigna™ and EndoPredict (EPClin). Distant recurrence of breast cancer was the primary endpoint and the median follow-up period was 10 years.
Overall, each of the three second-generation tests evaluated (breast cancer index, Prosigna and EndoPredict) outperformed Oncotype Dx in this cohort in predicting the recurrence of breast cancer in both node-negative and node-positive patients across both zero to 10 and five to 10 years post-surgery. In a head-to-head comparison between EndoPredict and Oncotype Dx in this study:
- EndoPredict offered more predictive power than Oncotype Dx across zero to 10 years.
- The data show that the likelihood ratio (LRx2, a common measure of predictive power) for EndoPredict was almost double that of Oncotype Dx in node-negative patients (EndoPredict: LRX2= 40.6; Oncotype: LRX2=22.8) and was five times higher in node-positive patients (EndoPredict: LRX2= 35.6; Oncotype: LRX2=6.4).
- EndoPredict had superior predictive power over Oncotype Dx between five to 10 years.
- The likelihood ratio for EndoPredict was seven times higher than for Oncotype Dx in node-negative patients (EndoPredict: LRX2= 24.0; Oncotype: LRX2=3.4) and 13 times higher in node-positive patients (EndoPredict: LRX2= 14.9; Oncotype: LRX2=1.1). Importantly, the likelihood ratio for Oncotype DX failed to achieve statistical significance in predicting cancer recurrence in years five to 10 for either node-positive or node-negative patients, indicating an inability to predict distant recurrence over the five to 10 year timeframe.
- EndoPredict was superior in classifying node-positive patients as low-risk compared to Oncotype Dx.
- Node-positive patients classified as low risk by EndoPredict had a substantially lower 10-year recurrence rate (5.6 percent) than patients classified as low risk by Oncotype Dx (26.2 percent) as well as a lower five to 10 year recurrence rate (3.3 percent for EndoPredict vs 17.9 percent for Oncotype Dx).
“Myriad is committed to research that improves care for patients with breast cancer. Patients at high risk of cancer recurrence are candidates for adjuvant chemotherapy after surgery, while those at low risk can be spared chemotherapy and the side effects,” said Lancaster. “We believe EndoPredict will help clinicians and patients understand the risk of breast cancer recurrence and identify more patients who can safely forgo chemotherapy. Additionally, EndoPredict does not contain an intermediate risk category and each patient receives a clear test result, allowing oncologists to confidently develop their treatment plan.”
The TransATAC study, in part, was previously published in the Journal of the National Cancer Institute (http://jnci.oxfordjournals.org/content/108/11/djw149.abstract). The current presentation at SABCS expands on that article and provides a comprehensive comparison of prognostic signatures for breast cancer. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS16.
About EndoPredict
EndoPredict is a second-generation, multigene test designed to predict disease recurrence in patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. In contrast to the first-generation multigene prognostic test (i.e., Oncotype Dx), EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredictusa.com.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company’s website: https://www.myriad.com/.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris, EndoPredict and GeneSight are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G
Note to Editors
Prosigna is a trademark of NanoString Technologies, Seattle, Wash. Oncotype Dx is a trademark of Genomic Health, Redwood City, Calif.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the EndoPredict test significantly outperforming the first-generation test in predicting the risk of node-negative and node-positive breast cancer recurrence; the EndoPredict test being superior to Oncotype Dx and more accurate in predicting the long-term recurrence of breast cancer; the three second-generation tests evaluated outperforming Oncotype Dx in predicting the recurrence of breast cancer in both node-negative and node-positive patients across both zero to 10 and five to 10 years post-surgery; EndoPredict testing offering more predictive power than Oncotype Dx across zero to 10 years; EndoPredict testing having superior predictive power over Oncotype Dx between five to 10 years; EndoPredict testing being superior in classifying node-positive patients as low-risk compared to Oncotype Dx; our belief that EndoPredict testing will help clinicians and patients understand the risk of breast cancer recurrence and identify more patients who can safely forgo chemotherapy; data being presented at the 2016 San Antonio Breast Cancer Symposium being held Dec. 6 – Dec. 10, 2016 in San Antonio, Texas; and the Company’s strategic directives under the captions “About EndoPredict” and “About Myriad Genetics.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual report on Form 10-K for the fiscal year ended June 30, 2016, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
Media Contact: Ron Rogers (908) 285-0248 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
$OPTT #Q2 #FY16 Results
PENNINGTON, N.J., Dec. 09, 2016 — Ocean Power Technologies, Inc. (Nasdaq:OPTT) today announced financial results for its Fiscal 2017 second quarter ended October 31, 2016.
George H. Kirby, President and Chief Executive Officer of OPT, stated, “We continue to make measurable progress towards executing on our strategic business plan, and we are pleased with the developments throughout the second quarter and to date. Our accomplishments include successfully completing a pre-requisite stage gate review with MES and securing a new contract with the U.S. Department of Defense Office of Naval Research to conduct the design of a new mass-spring oscillating PowerBuoy for mission critical sensors. In October we completed a public offering of common stock with net proceeds of approximately $6.9 million. In early November we secured a joint marketing agreement with Sonalysts Inc., received court approval of the class action settlement, and received nearly $700,000 through New Jersey’s Technology Business Tax Certificate Transfer Program.”
Mr. Kirby continued, “We have continued our aggressive market outreach through direct discussions with potential partners and end-users in our target markets as an essential element of our product launch and commercialization strategy. We also had two PowerBuoys operating simultaneously off the coast of New Jersey through October 2016. We retrieved our pre-commercial buoy in October for updating to commercial status, while our commercial buoy was retrieved in early December, upon completing all intended testing and validation, to then be prepped and subsequently shipped to MES in Japan. We believe these achievements provide us with strong momentum going into our second half of the fiscal year.”
Results for the Second Fiscal Quarter Ended October 31, 2016
For the three months ended October 31, 2016, OPT reported revenue of $0.2 million, as compared to revenue of $0.5 million for the three months ended October 31, 2015. The decrease in revenues over the prior year was primarily related to lower revenue from MES during the three months ended October 31, 2016 as compared to the three months ended October 31, 2015, which included revenue from our WavePort contract and billable work under our prior contracts with the U.S. Department of Energy.
The net loss for the three months ended October 31, 2016 was $1.0 million as compared to a net loss of $3.0 million for the three months ended October 31, 2015. The decrease in net loss is mainly attributable to lower selling, general, and administrative costs and the decline in the fair market value of the common stock warrants liability. These were partially offset by higher product development costs.
Results for the Six Months Ended October 31, 2016
For the six months ended October 31, 2016, OPT reported revenue of $0.4 million, as compared to revenue of $0.6 million for the six months ended October 31, 2015. The net loss for the six months ended October 31, 2016 was $4.8 million, as compared to a net loss of $7.2 million for the six months ended October 31, 2015. The decrease in net loss is due to lower product development costs and selling, general, and administrative costs as well as the decline in the fair market value of the common stock warrants liability.
Balance Sheet and Available Cash
As of October 31, 2016, total cash, cash equivalents, and marketable securities were $12.5 million, up from $6.8 million on April 30, 2016. As of October 31, 2016 and April 30, 2016, restricted cash was $0.3 million for each period. Net cash used in operating activities was $6.3 million during the six months ended October 31, 2016, which includes $0.7 million of costs related to the litigation settlement of $0.5 million and additional legal costs of $0.2 million, compared with $7.0 million for the six months ended October 31, 2015. Excluding these items, net cash used in operating activities was $5.6 million. During the quarter ended October 31, 2016, OPT completed a public offering of common stock wherein $6.9 million net proceeds were raised.
Conclusion
Mr. Kirby concluded, “We believe our combined ocean deployments, aggressive market outreach to key stakeholders in our target markets, and our utmost focus on achieving a reliable product with a clear value proposition have strongly contributed to advancing our commercialization efforts. We remain focused on progressing our commercialization strategy by building strategic partnerships to accelerate market access, expanding our product delivery and support capabilities, and advancing application demonstrations for early adopters.”
Conference Call Details
The Company will host a conference call and webcast to review financial and operating results. The call will be held on Tuesday, December 13, 2016, at 9:00 a.m. eastern time. Please call 1-844-473-0979 (toll free in the U.S.) or 574-990-1390 (for international callers) and enter pass code 27058843. Additionally, the call will be webcast live at the Company’s website at www.oceanpowertechnologies.com. A telephonic replay will be available from 12:00 p.m. eastern time the day of the teleconference until December 20, 2016. To listen to the archived call, dial 1-855-859-2056 and enter pass code 27058843, or access the webcast replay via the Company website at www.oceanpowertechnologies.com, where a transcript will be posted once available.
About Ocean Power Technologies
Headquartered in Pennington, New Jersey, Ocean Power Technologies (Nasdaq:OPTT) is a pioneer in renewable wave-energy technology that converts ocean wave energy into electricity. OPT has developed and is seeking to commercialize its proprietary PowerBuoy® technology, which is based on a modular design and has undergone periodic ocean testing since 1997. OPT specializes in designing cost-effective, and environmentally sound ocean wave based power generation and management technology.
Forward-Looking Statements
This release may contain “forward-looking statements” that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the Company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company’s most recent Forms 10-Q and 10-K and subsequent filings with the SEC for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.
FINANCIAL TABLES FOLLOW
Additional information may be found in the Company’s Quarterly Report on Form 10-Q that has been filed with the U.S. Securities and Exchange Commission (“SEC”). The Form 10-Q may be accessed at www.sec.gov or at the Company’s website in the Investor Relations section.
OCEAN POWER TECHNOLOGIES, INC. AND SUBSIDIARIES | ||||||||||||||
Consolidated Balance Sheets | ||||||||||||||
ASSETS | Oct 31, 2016 | Apr 30, 2016 | ||||||||||||
(unaudited) | ||||||||||||||
Current assets: | ||||||||||||||
Cash and cash equivalents | $ | 12,512,185 | $ | 6,729,814 | ||||||||||
Marketable securities | 25,000 | 75,000 | ||||||||||||
Restricted cash | 305,690 | 299,543 | ||||||||||||
Unbilled receivables | 102,730 | 37,465 | ||||||||||||
Litigation receivable | 2,500,000 | 2,500,000 | ||||||||||||
Other current assets | 385,308 | 116,805 | ||||||||||||
Total current assets | 15,830,913 | 9,758,627 | ||||||||||||
Property and equipment, net | 220,180 | 273,049 | ||||||||||||
Other noncurrent assets | 320,599 | 319,450 | ||||||||||||
Total assets | $ | 16,371,692 | $ | 10,351,126 | ||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||
Current liabilities: | ||||||||||||||
Accounts payable | $ | 142,781 | $ | 372,700 | ||||||||||
Accrued expenses | 2,881,505 | 2,674,841 | ||||||||||||
Litigation payable | 2,500,000 | 3,000,000 | ||||||||||||
Unearned revenue | – | 39,146 | ||||||||||||
Warrant liabilities | 548,382 | – | ||||||||||||
Current portion of long-term debt and capital lease obligations | 33,796 | 81,541 | ||||||||||||
Total current liabilities | 6,106,464 | 6,168,228 | ||||||||||||
Long-term debt and capital lease obligations | 41,167 | 54,567 | ||||||||||||
Deferred credits payable non-current | 600,000 | 600,000 | ||||||||||||
Total liabilities | 6,747,631 | 6,822,795 | ||||||||||||
Commitments and contingencies | ||||||||||||||
Ocean Power Technologies, Inc. Stockholders’ equity: | ||||||||||||||
Common stock, $0.001 par value; authorized 50,000,000 shares, | ||||||||||||||
issued 6,321,040 and 2,352,100 shares, respectively | 6,321 | 2,352 | ||||||||||||
Treasury stock, at cost; 13,254 and 6,894 shares, respectively | (174,894 | ) | (137,766 | ) | ||||||||||
Additional paid-in capital | 192,632,350 | 181,670,121 | ||||||||||||
Accumulated deficit | (182,676,542 | ) | (177,884,011 | ) | ||||||||||
Accumulated other comprehensive loss | (163,174 | ) | (122,365 | ) | ||||||||||
Total equity | 9,624,061 | 3,528,331 | ||||||||||||
Total liabilities and stockholders’ equity | $ | 16,371,692 | $ | 10,351,126 | ||||||||||
Ocean Power Technologies, Inc. and Subsidiaries | |||||||||||||||||||||||
Consolidated Statements of Operations | |||||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||||
Three Months Ended October 31, | Six Months Ended October 31, | ||||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||||
Revenues | $ | 169,964 | $ | 494,412 | $ | 372,353 | $ | 600,078 | |||||||||||||||
Cost of revenues | 125,146 | 494,412 | 252,431 | 600,078 | |||||||||||||||||||
Gross profit | 44,818 | – | 119,922 | – | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Product development costs | 1,307,734 | 1,177,656 | 2,944,106 | 3,660,444 | |||||||||||||||||||
Selling, general and administrative costs | 1,723,737 | 1,821,993 | 3,242,296 | 3,728,938 | |||||||||||||||||||
Total operating expenses | 3,031,471 | 2,999,649 | 6,186,402 | 7,389,382 | |||||||||||||||||||
Operating loss | (2,986,653 | ) | (2,999,649 | ) | (6,066,480 | ) | (7,389,382 | ) | |||||||||||||||
Change in fair value of warrant liabilities | 2,017,557 | – | 1,265,488 | – | |||||||||||||||||||
Interest income, net | 2,232 | 3,712 | 2,046 | 8,835 | |||||||||||||||||||
Other (expense) income, net | – | (8,080 | ) | – | 242,927 | ||||||||||||||||||
Foreign exchange gain (loss) | 1,780 | (24,801 | ) | 6,415 | (5,842 | ) | |||||||||||||||||
Net loss | (965,084 | ) | (3,028,818 | ) | (4,792,531 | ) | (7,143,462 | ) | |||||||||||||||
Less: Net (profit) loss attributable to the non-controlling interest | |||||||||||||||||||||||
in Ocean Power Technologies (Australasia) Pty Ltd. | – | 2,057 | – | (45,340 | ) | ||||||||||||||||||
Net loss attributable to Ocean Power Technologies, Inc. | $ | (965,084 | ) | $ | (3,026,761 | ) | $ | (4,792,531 | ) | $ | (7,188,802 | ) | |||||||||||
Basic and diluted net loss per share | $ | (0.25 | ) | $ | (1.71 | ) | $ | (1.51 | ) | $ | (4.08 | ) | |||||||||||
Weighted average shares used to compute basic and | |||||||||||||||||||||||
diluted net loss per share | 3,891,512 | 1,773,978 | 3,180,501 | 1,762,805 | |||||||||||||||||||
OCEAN POWER TECHNOLOGIES, INC. AND SUBSIDIARIES | ||||||||||||||
Consolidated Statements of Cash Flows | ||||||||||||||
(Unaudited) |
||||||||||||||
Six Months Ended October 31, | ||||||||||||||
2016 | 2015 | |||||||||||||
Cash flows from operating activities: | ||||||||||||||
Net loss | $ | (4,792,531 | ) | $ | (7,143,462 | ) | ||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||
Foreign exchange (loss) gain | (6,415 | ) | 5,842 | |||||||||||
Depreciation and amortization | 68,475 | 55,629 | ||||||||||||
Compensation expense related to stock option grants & restricted stock | 628,304 | 276,912 | ||||||||||||
Change in fair value of warrant liabilities | (1,265,488 | ) | – | |||||||||||
Changes in operating assets and liabilities: | ||||||||||||||
Accounts receivable | – | (1,357 | ) | |||||||||||
Unbilled receivables | (65,265 | ) | 34,862 | |||||||||||
Other current assets | (269,157 | ) | (144,364 | ) | ||||||||||
Other noncurrent assets | (35,690 | ) | 51,718 | |||||||||||
Accounts payable | (231,572 | ) | (92,077 | ) | ||||||||||
Accrued expenses | (275,053 | ) | (28,408 | ) | ||||||||||
Unearned revenues | (39,146 | ) | – | |||||||||||
Net cash used in operating activities | (6,283,538 | ) | (6,984,705 | ) | ||||||||||
Cash flows from investing activities: | ||||||||||||||
Maturities of marketable securities | 50,000 | 50,000 | ||||||||||||
Restricted cash | (6,147 | ) | 50,829 | |||||||||||
Purchases of equipment | (11,500 | ) | (11,130 | ) | ||||||||||
Net cash provided by investing activities | 32,353 | 89,699 | ||||||||||||
Cash flows from financing activities: | ||||||||||||||
Proceeds from issuance of common stock and related warrants, net of costs | 12,151,764 | 4,798 | ||||||||||||
Repayment of debt | (63,401 | ) | (50,000 | ) | ||||||||||
Acquisition of treasury stock | (37,128 | ) | (1,724 | ) | ||||||||||
Net cash provided by (used in) financing activities | 12,051,235 | (46,926 | ) | |||||||||||
Effect of exchange rate changes on cash and cash equivalents | (17,679 | ) | (54,480 | ) | ||||||||||
Net increase (decrease) in cash and cash equivalents | 5,782,371 | (6,996,412 | ) | |||||||||||
Cash and cash equivalents, beginning of period | 6,729,814 | 17,335,734 | ||||||||||||
Cash and cash equivalents, end of period | $ | 12,512,185 | $ | 10,339,322 |
Company Contact: Matthew T. Shafer Chief Financial Officer of OPT Phone: 609-730-0400 Investor Relations Contact: Andrew Barwicki Barwicki Investor Relations Inc. Phone: 516-662-9461
$QTNA Wins Prestigious Global #Semiconductor Alliance Award
FREMONT, Calif., Dec. 09, 2016 — Quantenna Communications, Inc. (Nasdaq:QTNA), a leading provider of high-performance Wi-Fi solutions, announced today that it received the prestigious “Most Respected Private Semiconductor Company” award at the 2016 Global Semiconductor Alliance (GSA) Awards Dinner Celebration on December 8th. The semiconductor industry’s annual event honored outstanding semiconductor companies worldwide that have demonstrated excellence through their vision, strategy, execution and future opportunity.
The GSA identified leading semiconductor companies that have demonstrated market growth through technological innovation and exceptional business management strategies. The awards are voted by GSA’s member companies to honor their achievements. Previously, Quantenna won the “Start-Up to Watch” award in 2013 and last year earned the “Most Respected Private Company” award. Quantenna recently completed its initial public offering and is now listed on Nasdaq; the award vote was cast prior to its IPO.
“GSA has been following Quantenna’s growth for many years and recognized the company with three awards in two different categories in the last four years,” said Jodi Shelton, President of GSA. “GSA also congratulates Quantenna on their recent IPO and looks forward to their continued success.”
“We are humbled that the GSA and our peers have again recognized Quantenna as a company that is relentlessly pushing the semiconductor Wi-Fi market,” said Dr. Sam Heidari, Chairman and CEO at Quantenna. “This award is the perfect ending to our journey as a private company and we look forward to writing a new chapter of our success as a public company.”
About GSA
The Global Semiconductor Alliance (GSA) mission is to support the global semiconductor industry and its partners by offering a comprehensive view of the industry. This enables members to better anticipate market opportunities and industry trends, preparing them for technology and business shifts. It addresses the challenges within the supply chain including IP, EDA/design, wafer manufacturing, test and packaging to enable industry-wide solutions. Providing a platform for meaningful global collaboration through efficient power networking for global semiconductor leaders and their partners, the Alliance identifies and articulates market opportunities, encourages and supports entrepreneurship, and provides members with comprehensive and unique market intelligence. Members include companies throughout the supply chain representing 30 countries across the globe. www.gsaglobal.org
About Quantenna Communications
Quantenna (Nasdaq:QTNA) is a global leader and innovator of leading-edge performance Wi-Fi solutions. Quantenna introduced the world’s first 10G Wi-Fi technology for a new generation of access points in home, enterprise and public spaces and continues to innovate. Quantenna’s Wi-Fi solutions offer superior performance, and establish benchmarks for speed, range, efficiency and reliability. With MAUI, Quantenna’s cloud-based Wi-Fi analytics platform that complement its chipset solutions, service providers can deliver real-time, automated Wi-Fi monitoring, optimization, and self-healing to their customers around the clock to help achieve the best Wi-Fi experience. Quantenna is Wi-Fi perfected. For more information, visit www.quantenna.com.
Media Contact: Sally Chan ychan@quantenna.com +1-510-897-2711
$ORIG #Q3 #FY16 Release Date, Conference Call and Webcast
GRAND CAYMAN, CAYMAN ISLANDS–(Dec 9, 2016) – Ocean Rig UDW Inc. (NASDAQ: ORIG) (“Ocean Rig”), a global provider of offshore deepwater drilling services, announced today that it will release its results for the third quarter 2016 after the market closes in New York on Wednesday, December 14, 2016.
Conference Call details:
Thursday, December 15, 2016, at 8:00 a.m. ET
Participants should dial into the call 10 minutes before the scheduled time using the following numbers: 1(866) 819-7111 (from the US), 0(800) 953-0329 (from the UK) or +(44) (0) 1452 542 301 (from outside the US). Please quote “Ocean Rig”.
A replay of the conference call will be available until Thursday, December 22, 2016. The United States replay number is 1(866) 247-4222; from the UK 0(800) 953-1533; the standard international replay number is (+44) (0) 1452 550 000 and the access code required for the replay is: 55592075#.
Slides and audio webcast:
There will also be a simultaneous live webcast over the Internet, through the Ocean Rig UDW Inc. website (www.ocean-rig.com). Participants to the live webcast should register on the website approximately 10 minutes prior to the start of the webcast.
About Ocean Rig UDW Inc.
Ocean Rig is an international offshore drilling contractor providing oilfield services for offshore oil and gas exploration, development and production drilling, and specializing in the ultradeepwater and harsh-environment segment of the offshore drilling industry.
Ocean Rig’s common stock is listed on the NASDAQ Global Select Market where it trades under the symbol “ORIG”.
Visit the Company’s website at www.ocean-rig.com.
NOTE: Matters discussed in this release may constitute forward-looking statements. Forward-looking statements relate to Ocean Rig’s expectations, beliefs, intentions or strategies regarding the future. These statements may be identified by the use of words like “anticipate’, “believe’, “estimate’, “expect’, “intend’, “may’, “plan’, “project’, “should’, “seek’, and similar expressions. Forward-looking statements reflect Ocean Rig’s current views and assumptions with respect to future events and are subject to risks and uncertainties.
The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in Ocean Rig’s records and other data available from third parties. Although Ocean Rig believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond Ocean Rig’s control, Ocean Rig cannot assure you that it will achieve or accomplish these expectations, beliefs or projections described in the forward-looking statements contained herein. Actual and future results and trends could differ materially from those set forth in such statements.
Important factors that, in Ocean Rig’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include (i) factors related to the offshore drilling market, including supply and demand, utilization, day rates and customer drilling programs; (ii);hazards inherent in the drilling industry and marine operations causing personal injury or loss of life, severe damage to or destruction of property and equipment, pollution or environmental damage, claims by third parties or customers and suspension of operations; (iii) changes in laws and governmental regulations, particularly with respect to environmental matters; (iv) the availability of competing offshore drilling vessels; (v) political and other uncertainties, including risks of terrorist acts, war and civil disturbances; piracy; significant governmental influence over many aspects of local economies, seizure; nationalization or expropriation of property or equipment; repudiation, nullification, modification or renegotiation of contracts; limitations on insurance coverage, such as war risk coverage, in certain areas; political unrest; foreign and U.S. monetary policy and foreign currency fluctuations and devaluations; the inability to repatriate income or capital; complications associated with repairing and replacing equipment in remote locations; import-export quotas, wage and price controls imposition of trade barriers; regulatory or financial requirements to comply with foreign bureaucratic actions; changing taxation policies; and other forms of government regulation and economic conditions that are beyond our control; (vi) the performance of our rigs; (vii) our ability to procure or have access to financing and comply with our loan covenants; (viii) our ability to successfully employ our drilling units; (ix) our capital expenditures, including the timing and cost of completion of capital projects; and (x) our revenues and expenses. Due to such uncertainties and risks, investors are cautioned not to place undue reliance upon such forward-looking statements.
Contact:
Investor Relations / Media:
Nicolas Bornozis
Capital Link, Inc. (New York)
Tel. 212-661-7566
E-mail: oceanrig@capitallink.com
$ACIU #Immune Partner #Genentech $RHHBY Data on #Alzheimer’s Therapy #Crenezumab
- Crenezumab higher dose in CREAD Phase 3 Alzheimer’s trial supported by exposure-response model
- Phase 1b dose-escalation study results support 60mg/kg dose in CREAD Phase 3
Lausanne, Switzerland, December 9, 2016 – AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage biopharmaceutical company focused on neurodegenerative diseases, today announced that its partner Genentech, member of Roche group, has presented important data to support the unique binding and increased dosing of its Alzheimer’s therapy on crenezumab, an anti-Abeta antibody. These data were presented at the 9th Clinical Trials on Alzheimer’s disease Conference (CTAD) in San Diego, USA: they were from a Phase 1b safety study and an exposure-response model to evaluate the best dose of crenezumab for the treatment of people with Alzheimer’s disease. The model predicts, relative to the Phase 2 trials, an improved outcome of the CREAD Phase 3 clinical trial in patients with prodromal-to-mild Alzheimer by using the higher dose of 60mg/kg of crenezumab.
Prof. Andrea Pfeifer, CEO of AC Immune, commented: “We are impressed by the drug-disease model, as well as the safety data of the Phase 1b study which further support the higher dose of crenezumab in the Phase III trial targeting prodromal-to-mild Alzheimer patients.”
About the crenezumab drug-disease progression model
Genentech has developed a comprehensive drug-disease progression model to simulate the Phase 3 clinical trial and estimate the likelihood of achieving relative reduction in disease progression in patients treated with different doses of crenezumab, in different patient populations. The drug-disease model adequately described the historical longitudinal decline in ADAS-Cog 12[1] and CDR-SB[2] in mild to moderate AD patients of crenezumab in Phase 2 studies (ABBY/BLAZE).
The clinical trial simulations using the drug-disease model predict a meaningful response of crenezumab in patients with mild AD at a dose of 60mg/kg IV every 4 weeks, as measured by CDR-SB and ADAS-Cog 12. This dose of 60mg/kg IV was selected by Genentech for the Phase 3 CREAD trial, which started recruitment of patients in Q1 2016.
About the Phase 1b study results
Genentech presented the results of the first two cohorts of the Phase 1b crenezumab dose escalation study (NCT02353598) in 52 patients with mild-to-moderate Alzheimer’s disease. No dose-limiting toxicities were observed at 30, 45 and 60mg/kg doses of crenezumab. No events of Amyloid Related Imaging Abnormality-Edema (ARIA-E) were observed in the Phase 1b study and only a few patients (6 of 52) showed asymptomatic Amyloid Related Imaging Abnormality-Hemsiderin(ARIA-H) which did not result in treatment discontinuation. The pharmacokinetic profile of crenezumab is dose proportional up to the 60mg/kg dose and is consistent with historical data. The serum concentrations at this dose are four fold higher than in the 15mg/kg IV every four weeks dose used in the Phase 2 trials. These safety and pharmacokinetic data of the Phase 1b dose escalation study support the continued treatment of patients with crenezumab at a higher dose of 60mg/kg.
About Crenezumab
Crenezumab was discovered by AC Immune using its SupraAntigen technology platform and out-licensed to Genentech in 2006 as a potential therapy for Alzheimer’s disease. Crenezumab is a fully humanized IgG4 monoclonal antibody that binds all forms of misfolded Abeta proteins, but especially to Abeta oligomers, to prevent and break up Abeta aggregation and promote Abeta disaggregation. The IgG4 subclass has reduced the effector function, allowing microglia to clear Abeta from the brain while minimizing an inflammatory response.
Genentech is currently evaluating the clinical efficacy and safety of crenezumab in a Phase 3 clinical trial, CREAD, in 750 participants with prodromal or mild Alzheimer’s disease, which started in Q1 2016 and is expected to read out in 2020. In addition crenezumab was chosen by an international panel of experts, including the US National Institutes of Health, for use in a first-ever prevention trial in Alzheimer’s disease in a large extended family in Colombia (API ADAD) in 2012.
About Alzheimer’s disease
It is becoming increasingly clear that Alzheimer’s disease develops because of a complex series of events that take place in the brain over a long period of time. Two proteins – Tau and beta-amyloid (Abeta) – are recognized as major hallmarks of neurodegeneration: tangles and other abnormal forms of Tau protein accumulate inside the brain cells and spread between cells, while plaques and oligomers formed by beta-amyloid occur outside the brain cells of people with AD.
AD is one of the biggest burdens of society with a dramatic and growing worldwide incidence rate of one new case every three seconds, or 9.9 million new cases of dementia each year. Since the incidence and prevalence of AD increase with age, the number of patients will grow significantly as society ages. Worldwide in 2015 there are 46.8 million people living with dementia and by 2050 it is expected that global patient numbers will triple to 131.5 million. It is estimated that the annual societal and economic cost of dementia has risen from US$ 604 billion in 2010 to US$ 818 billion in 2015. In the US, AD is now the 6th leading cause of death across all ages and is the fifth leading cause of death for those aged 65 and older.
About AC Immune
AC Immune is a clinical stage Swiss-based biopharmaceutical company focused on neurodegenerative diseases with four product candidates in clinical trials. The Company designs, discovers and develops therapeutic and diagnostic products intended to prevent and modify diseases caused by misfolding proteins. AC Immune’s two proprietary technology platforms create antibodies, small molecules and vaccines designed to address a broad spectrum of neurodegenerative indications, such as Alzheimer’s disease. The Company’s pipeline features seven therapeutic and three diagnostic product candidates. The most advanced of these is crenezumab, an anti-Abeta antibody in Phase 3 clinical studies that is being advanced by the collaboration partner Genentech, Inc., a member of the Roche Group. Other business partners include Biogen, Janssen Pharmaceuticals, Nestlé Institute of Health Sciences and Piramal Imaging.
Forward looking statements
This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of AC Immune’s product candidates, the clinical utility of AC Immune’s product candidates, the timing or likelihood of regulatory filings and approvals, AC Immune’s intellectual property position and AC Immune’s financial position. These risks and uncertainties also include those described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in AC Immune’s Registration Statement on Form F-1 and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
For further information please contact:
Prof. Andrea Pfeifer Chief Executive Officer Phone: +41-21-345 91 21 E-mail:andrea.pfeifer@acimmune.com |
Eva Schier Corporate Communications Manager Phone: +41-21-345 91 34 Mobile: +41 79 926 66 03 E-mail: eva.schier@acimmune.com |
Nick Miles/ Toomas Kull Cabinet Privé de Conseils s.a. Phone : +41 22 321 45 40 E-mail : miles@cpc-pr.com kull@cpc-pr.com |
In the US Ted Agne The Communications Strategy Group Inc. Phone: +1 781 631 3117 E-mail: edagne@comstratgroup.com |
[1] ADAS-Cog 12: Alzheimer’s Disease Assessment Scale-cognitive subscale ADAS-cog is a widely used scale in clinical trials which measures the patient’s performance on tests of memory and other areas of cognition, especially orientation, praxis and language.
[2] CDR-SB: Clinical Dementia Rating Scale Sum of Boxes is an assessment of an overall function of the patient in daily life. The patient’s performance in the six domains of memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care are assessed by interviewing the patient and caregiver.
$DRAM Acquisition Target $GG Doubles Down on #Keystone Project #Nevada
— Increases property claims by 23% due to favorable results from recent geological surveys — Total claims represent approximately 7,500 acres on Cortez Trend in North Central Nevada — Initiates 2016 exploration program
PRINCETON, N.J., Dec. 8, 2016 — Dataram Corporation (NASDAQ: DRAM) today announced that its acquisition target U.S. Gold Corp. (“USGC”) completed the staking of 71 additional claims for the Keystone Project, located on the Cortez Trend in North Central Nevada. The Keystone Project consists of 377 unpatented lode mining claims including the 71 additional and newly staked claims on the north eastern end of the property in Eureka County, Nevada. This represents approximately 7,500 acres or between 11 to 12 square miles.
“Keystone represents a large, district scale opportunity,” said Dave Mathewson, U.S. Gold Corp.’s VP and Head of Nevada Exploration. “I have been on and off the Keystone property for the last 30 years and Keystone represents one of the best exploration opportunities in Nevada. This is the first time in the last 30 years that one single company has consolidated the entire district, providing the benefit of being able to design our exploration program based upon geology instead of claim boundaries. We are excited about the Keystone project and look forward to providing additional updates as our 2016 exploration program advances.”
The 2016 exploration program consists of:
- Property scouting, additional claim staking and initial target reconnaissance
- Digitization of all prior analog data to build a current geological property database
- A detailed mapping program to accurately identify all of the properties geological characteristics
- A thorough gravity survey conducted by J L Wright Geophysics to help define initial drill targets
- Soil sampling and geo-chemistry
- Rock sampling
- Drill target selection and initial permitting
- Drilling
“We are excited about the 2016 Keystone exploration program,” continued Mr. Mathewson. “My approach to exploration has always been a process driven, model-based methodology. This is the same approach we used at Gold Standard Ventures to make the initial discovery at Railroad. Keystone represents a tremendous opportunity as the rock formations, setting, location and geological indications present an ideal setting for a potential discovery. With these additional claims, I am confident our existing land package effectively controls every part of the visible system and prospective extensions based upon gravity data.”
Dataram’s Chairman and CEO Mr. Dave Moylan further commented “the Keystone project represents an excellent opportunity for Dataram’s acquisition target. We believe the additional land position at Keystone provides significant exploration upside with what is now a much larger property position. With the additional 71 claims secured, the intent is to further explore and develop the project which includes selecting target drill sites initiating permitting and drilling. Our hope is this could lead to a potential discovery, a future mineral resource estimate, and eventually, commencing pre-feasibility work.
“We are encouraged by the momentum building at the acquisition target as it reaffirms our commitment to creating accretive value-added opportunities to our shareholders. The Keystone project represents an evolutionary step in assembling a portfolio of discovery and development stage projects in North America. The Copper King Project in southeastern Wyoming was the first step, and the Keystone Project in Nevada is the next significant growth step for the U.S. Gold Corp. business. As such, we are pleased to confirm that the staking of claims has been completed and the 2016 exploration program has begun. ”
Keystone is an early tertiary aged intrusive in lower plate window. The property has extensive hydrothermal alteration systems with regional and range-front structure zones. The potential target is a “Cortez Hills” type deposit at shallow to medium depth. The Keystone Project is positioned on the prolific Cortez gold trend, one of the world’s leading gold producing regions. The project is centered on a granitic intrusion that warped the local Paleozoic stratigraphy into a dome, allowing for exposure of highly favorable Devonian, Carboniferous (Mississippian-Pennsylvania) and Permo-Triassic rocks including key likely host rocks for mineralization, the silty carbonate strata of the Horse Creek Formation and the Wenban Limestone, as well as possible sandy clastic units of the Diamond Peak Formation. The Horse Canyon and Wenban rocks are the primary host rocks at the nearby Cortez Hills Mine and Gold Rush deposit currently operated by Barrick Gold.
In the late 1800’s, the Keystone mine was a small producing mine with more than 140 historical drill holes on the property. No comprehensive, modern-era, model-driven exploration has ever been conducted on the Keystone Project. Previously, significant amounts of low grade (+/- 0.02 opt) and anomalous gold were intersected, but results were considered uneconomic, and prior projects were terminated.
About Dataram Corporation
Dataram is an independent manufacturer of memory products and provider of performance solutions that increase the performance and extend the useful life of servers, workstations, desktops and laptops sold by leading manufacturers such as Dell, Cisco, Fujitsu, HP, IBM, Lenovo and Oracle. Dataram’s memory products and solutions are sold worldwide to OEMs, distributors, value-added resellers and end users. Additionally, Dataram manufactures and markets a line of Intel Approved memory products for sale to manufacturers and assemblers of embedded and original equipment. 70 Fortune 100 companies are powered by Dataram. Founded in 1967, the Company is a US based manufacturer, with presence in the United States, Europe and Asia. For more information about Dataram, visit www.dataram.com.
Safe Harbor
Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words “anticipate,” “believe,” “estimate,” “may,” “intend,” “expect” and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These risks include, but are not limited to, risks and uncertainties associated with the price of the Company’s common stock and its ability to satisfy the continued listing standards of The NASDAQ Stock Market, the impact of economic, competitive and other factors affecting the Company and its operations, markets, products, changes in the price of memory chips, changes in the demand for memory systems, increased competition in the memory systems industry, order cancellations, delays in developing and commercializing new products, risks related to the Company’s previously announced acquisition target, U.S. Gold Corp., faced by junior exploration companies generally engaged in pre-production activities; maintenance of important business relationships; and other factors described in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, including the Risk Factors with respect to U.S. Gold contained in the Current Report on Form 8-K filed on November 29, 2016, filed with the Securities and Exchange Commission, which can be reviewed at www.sec.gov. The Company has based these forward-looking statements on its current expectations and assumptions about future events. While management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory, and other risks, contingencies, and uncertainties, most of which are difficult to predict and many of which are beyond the Company’s control. The Company does not assume any obligations to update any of these forward-looking statements.
For additional information, please contact:
Dataram Contact:
Jeffrey Goldenbaum
Director, Marketing
609-799-0071
info@dataram.com
$XRDC Announces Disposition of Shares in #Centrify Corporation
LINCOLN, Neb., Dec. 8, 2016 — Crossroads Capital, Inc. (Nasdaq: XRDC) (the “Company”) has announced the sale of its entire position in Centrify Corporation (“Centrify”).
On December 7, 2016, the Company sold its entire position of 1,084,873 shares of Centrify Series E Convertible Preferred Stock for $3,200,000.
Ben H. Harris, J.D., Chief Executive Officer and President of the Company, said: “In addition to the recent disposition of a portion of our interest in Metabolon, Inc., the sale of all of our Series E shares in Centrify furthers our investment objective of preserving capital and maximizing stockholder value.”
Mr. Harris added, “Consistent with the Company’s investment objective, we will not be re-investing these proceeds. In due course, we intend to issue future announcements regarding a cash distribution to shareholders.”
About Crossroads Capital, Inc.
Crossroads Capital, Inc. (www.xroadscap.com) is a closed-end fund regulated as a business development company under the Investment Company Act of 1940.
Investor Relations Contact: | Ben H. HarrisChief Executive Officer and President |
(402) 261-5345 | |
ben@xroadscap.com |
Forward-Looking Statements
This press release may contain statements of a forward-looking nature relating to future events. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions. These statements reflect Crossroads Capital’s current beliefs, and a number of important factors could cause actual results to differ materially from those expressed in this press release, including the factors set forth in “Risk Factors” set forth in Crossroads Capital’s Form 10-K and Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and subsequent filings with the SEC. Please refer to Crossroads Capital’s SEC filings for a more detailed discussion of the risks and uncertainties associated with its business, including but not limited to the risks and uncertainties associated with investing in micro- and small-cap companies. Except as required by the federal securities laws, Crossroads Capital undertakes no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. The reference to Crossroads Capital’s website has been provided as a convenience, and the information contained on such website is not incorporated by reference into this press release.
SOURCE Crossroads Capital, Inc.
$FNCX Board Taps Frank E. Barnes III as Independent Director
Function(x) Inc. complies with Nasdaq requirement related to independent director representation on its Board of Directors
Function(x) Inc. (Nasdaq:FNCX) (the “Company”) today announced that as a result of the appointment of Frank E. Barnes III as an independent director of the Company effective November 30 2016, the Company received formal notification from Nasdaq of its compliance with Nasdaq Listing Rules 5605(b)(1) and 5605(c)(2) (the “Rules”) on December 6, 2016. Mr. Barnes is a member of each of the Company’s Audit, Compensation and Nominating and Corporate Governance committees and joins Messrs. Robert F.X. Sillerman, Peter Horan, Michael Meyer and Mitchell Nelson on the Board.
“Mr Barnes’ 30 years of extensive experience and financial expertise in the media, entertainment and other industries adds a valuable perspective to our Board of Directors,” says Mr. Sillerman, Chairman and CEO of Function(x). “We appreciate his willingness to serve as an independent director and look forward to benefitting from his judgment and counsel as we enter a new phase of the Company growth and build up on our current successes.”
As the executive director of Carolina Barnes Corporation, and president of its former NASD/FINRA-registered broker-dealer, Mr. Barnes has broad experience in making principal investments in and serving as financial and strategic senior advisor to growth companies with responsibilities for recapitalizations, private placements, mergers and acquisitions, and going public transactions. Prior to founding Carolina Barnes in 1989, Mr. Barnes was employed with Mabon Nugent & Co., a privately held investment banking firm, as the executive vice president responsible for its investment and merchant banking groups. In addition to his responsibilities within Carolina Barnes, Mr. Barnes has served as chief revenue officer and director of Storage Blue Equities LLC, a self-storage warehouse business, and as president and director of Ocean State Windpower Inc., a manufacturer of wind turbine generators. Throughout the course of his career, Mr. Barnes has served both as a senior executive and on the board of directors of over a dozen companies, including serving as a director and member of the Nominating and Corporate Governance Committee and Special Committee of SFX Entertainment Inc.
Following the appointment of Mr. Barnes, the Company received formal notification from Nasdaq that it has satisfied all the requirements relating to the Rules, which required that the Company have three independent directors on its Audit Committee and maintain a majority of independent directors at all times. Upon the resignation of Ms. Birame Sock as an independent director on August 1, 2016 in connection with her appointment to serve as President and Chief Operating Officer of Function(x), the Company no longer met such criteria and had 6 months to nominate a new independent director. Messrs. Barnes, Horan and Meyer, all independent, are a majority of the Company’s Board of Directors and constitute all the members of the Audit Committee, putting the company in full compliance as it relates to Board structure.
About Function(x) Inc.
Function(x) operates Wetpaint.com, the leading online destination for entertainment news for millennial women, covering the latest in television, music, and pop culture, and Rant, a leading digital publisher with original content in the sports, entertainment, pets, and style verticals. Function(x) Inc. is also a majority shareholder of DraftDay Gaming Group, which is well-positioned to become a significant participant in the expanding fantasy sports market, offering a high-quality daily fantasy sports experience both directly to consumers and to businesses desiring turnkey solutions to new revenue streams. Function(x) Inc. also owns Choose Digital, a digital marketplace platform that allows companies to incorporate digital content into existing rewards and loyalty programs in support of marketing and sales initiatives. For more information, visit www.functionxinc.com.
Forward-Looking Statements
This press release may contain 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, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. All information provided in this press release is as of the date of this release. Except as required by law, Function(x), Inc. undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.
For Function(x):
Investors:
Michelle Lanken, 212-231-0092
Chief Financial Officer
mlanken@functionxinc.com
or
Media Relations:
IRTH Communications
Robert Haag, 866-976-4784
Managing Partner
$COOL & #PolarityTE Enter Into #Merger Agreement
Appoints Denver Lough, MD, PhD as Chief Executive Officer and Chairman of the Board; Appoints Edward Swanson, MD as Chief Operating Officer and Director; Executive Vice President John Stetson named Director; Majesco accepts subscription agreements for $2.25 million
SOUTH PLAINFIELD, NJ–(Dec 8, 2016) – Majesco Entertainment, Inc. (NASDAQ: COOL) (“Majesco”), announced today it had signed a definitive merger agreement with PolarityTE, Inc. (“Polarity”) www.polarityte.com. Polarity is an entirely new and radically unique regenerative medicine company committed to developing the first forms of functionally-polarized autologous tissues for use in medical procedures requiring reconstructive applications by surgeons and wound care specialists.
Upon the closing of the transactions, Polarity will become a wholly-owned subsidiary of Majesco. Majesco will issue preferred stock in the transaction which, when converted, would represent approximately 50% of the issued and outstanding common stock of Majesco on a fully diluted basis. In connection with the merger agreement, Majesco also entered into stock purchase agreements for the purchase of 750,000 shares of common stock at a purchase price of $3.00 per share to accredited investors for gross proceeds of $2,250,000.
At signing of the merger agreement, Dr. Denver Lough, was named Chief Executive Officer and Chairman of the Board of Majesco (to be renamed PolarityTE, Inc.) and Dr. Edward Swanson was named Chief Operating Officer and Director. Both Dr. Lough and Dr. Swanson had worked as residents in plastic and reconstructive surgery at the esteemed Johns Hopkins University School of Medicine. In leaving Johns Hopkins careers as plastic surgeons, they hope to be able to impact as many patients as possible by developing and translating the technology of PolarityTE into a clinical reality. The company will be headquartered in Salt Lake City, Utah where the Company is establishing its biomedical R&D facilities and tissue manufacturing center.
“We did not leave our resident careers at Johns Hopkins Hospital to merely change biotech — we left to change the future of medicine. This opportunity allows us to disrupt the field with our entirely new proprietary technology platform across a wide variety of tissues so that all patients will eventually be offered a pragmatic method of regenerative wound healing and personalized tissue engineering. Our goals are simple: A superior technology, a superior team and a superior network of world leaders in translational medicine to augment the delivery of autologous products for the regeneration of self,” said Dr. Lough who continued “We sincerely wish to thank Barry Honig, the Majesco Board of Directors and Dr. Phillip Frost for their confidence in PolarityTE and we promise to not disappoint.”
Newly appointed COO, Dr. Edward Swanson, echoed Dr. Lough’s statements and added, “PolarityTE will change the landscape of regenerative medicine, beginning with our first target tissue: skin. Prior to the groundbreaking discovery by Dr. Lough, the world had never seen true regeneration of functional skin, including all layers and hair. Skin regeneration of this magnitude is thought of as the holy grail by burn surgeons.”
Barry Honig, former CEO of Majesco, said, “We are pleased to announce that we have reached an agreement to merge with PolarityTE. PolarityTE’s entirely new concept in tissue engineering will revolutionize the future of regenerative medicine and help address critical unmet medical needs. In addition to their wildly novel technology, what further lead to our excitement in this deal with PolarityTE was their unmatched clinical advisory board, signaling to us the tremendous momentum behind this company and its technology. I have no doubt that PolarityTE will be the name in autologous tissue engineering in the future after meeting with their leadership, seeing their technology, and speaking with members of their clinical advisory board.”
The merger, which has been approved by the board of directors of both companies, is subject to certain closing conditions, including NASDAQ approval, approval by stockholders of Majesco, minimum cash balance of Majesco at closing, and other customary closing conditions.
Majesco’s common stock trades on The NASDAQ Capital Market under the symbol “COOL.”
About Majesco Entertainment Company
Majesco Entertainment Company is an innovative developer, marketer, publisher and distributor of interactive entertainment for consumers around the world. Building on more than 25 years of operating history, Majesco develops and publishes a wide range of video games on digital networks through its Midnight City label. Majesco is headquartered in Plainfield, New Jersey, and its common stock is traded on The NASDAQ Capital Market under the symbol: COOL. More info can be found online at majescoent.com or on Twitter at twitter.com/majesco.
About PolarityTE
PolarityTE, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough MD, PhD. This radical and proprietary technology employs a patients’ own cells for the healing of full-thickness functionally-polarized tissues. If clinically successful, the PolarityTE platform will be able to provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient’s own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. It is because PolarityTE uses a natural and biologically sound platform technology, which is readily adaptable to a wide spectrum of organ and tissue systems, that the company and its world-renowned clinical advisory board, are poised to drastically change the field and future of translational regenerative medicine. More info can be found online at polarityte.com
Welcome to the Shift
Forward-Looking Statements
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company’s ongoing compliance with the requirements of The NASDAQ Stock Market and the Company’s ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should'” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
$EACQ Announces Intent to Adjourn Special Meeting of Stockholders
Easterly Acquisition Corp. (“Easterly”) (NASDAQ: EACQ) today announced that it intends to convene and then adjourn, without conducting any business, its special meeting of stockholders (the “Special Meeting”) to be held with respect to its proposed business combination with Sungevity, Inc. (“Sungevity”) pursuant to the Agreement and Plan of Merger, dated as of June 28, 2016, as amended, by and among the Company, its wholly-owned subsidiary, Solaris Merger Sub, Inc. (“Merger Sub”), Sungevity and Shareholder Representative Services LLC, which provides for the merger (the “Merger”) of Merger Sub with and into Sungevity.
Easterly intends to reconvene the Special Meeting at 10:00 a.m., Eastern Time, on December 23, 2016, at the offices of Easterly Acquisition Corp., 375 Park Avenue, 21st Floor, New York, New York 10152. In connection with the adjournment of the Special Meeting to a later date and time, the deadline for delivery of public shares in connection with the redemption rights held by Easterly’s stockholders is 5:00 p.m., Eastern Time two business days prior to the reconvened Special Meeting, which deadline would be 5:00 p.m., Eastern Time, on December 21, 2016.
At the Special Meeting, holders of Easterly’s common stock will be asked to approve and adopt the Merger Agreement, including the proposed Merger, and such other proposals as disclosed in the definitive proxy statement/prospectus relating to the Special Meeting. The full meeting agenda is detailed in the definitive joint proxy and consent solicitation statement/prospectus, which is included as part of the Registration Statement on Form S-4, as amended (File No. 333-212590), of Easterly.
About Sungevity
Sungevity is a technology-driven solutions provider, offering exceptional service and choice to residential and commercial solar energy customers. Sungevity’s asset-light business model focuses on value-added in-house services for software platform development, project management and customer experience; this focus is enabled by a strong, scalable network of third-party providers for asset-intensive and/or lower margin provision of hardware, installation services and financing. Sungevity’s disruptive and competitive model delivers greater value directly to customers and, for stockholders, captures immediate financial value at the time of sale.
About Easterly Acquisition Corp.
Easterly Acquisition Corp. is a Special Purpose Acquisition Company sponsored by Easterly Acquisition Sponsor, LLC, an affiliate of Easterly LLC, for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses or assets. Easterly Acquisition Corp. completed its initial public offering in August 2015, raising $200 million in cash proceeds. Easterly Acquisition Corp.’s officers and certain of its directors are affiliated with Easterly LLC.
About Easterly LLC
Easterly LLC is an asset management firm that develops engaged partnerships with innovative, growth-oriented companies. Easterly’s core expertise is in acting as a principal to grow business platforms. Easterly enhances businesses as a partner through capital formation, corporate development, and strategic implementation activities. Easterly’s principals have a proven track record of delivering outperformance to both public and private investors across a variety of sectors.
Additional Information About the Transaction and Where to Find It
This press release relates to a proposed business combination between Easterly and Sungevity and may be deemed to be solicitation material in respect of the proposed business combination between Easterly and Sungevity. The proposed business combination will be submitted to the respective stockholders of Easterly and Sungevity for their approval. In connection with the proposed business combination, Easterly filed with the SEC the Registration Statement and the definitive joint proxy and consent solicitation statement/prospectus forming a part thereof. This communication is not a substitute for the Registration Statement and definitive joint proxy and consent solicitation statement/prospectus that Easterly filed with the SEC on November 9, 2016, or any other documents that Sungevity or Easterly may file with the SEC or send to their respective stockholders in connection with the proposed transaction. The Registration Statement and definitive joint proxy and consent solicitation statement/prospectus contain important information about Easterly, Sungevity, the proposed business combination and related matters. Investors and security holders are urged to read the Registration Statement and definitive joint proxy and consent solicitation statement/prospectus carefully.
A copy of the definitive joint proxy and consent solicitation statement/prospectus was sent to all stockholders of Easterly and Sungevity as of their respective record dates for seeking the required stockholder approvals. Investors and stockholders can obtain free copies of the Registration Statement and definitive joint proxy and consent solicitation statement/prospectus and other documents filed with the SEC by Easterly through the web site maintained by the SEC at www.sec.gov. In addition, investors and stockholders can obtain free copies of the Registration Statement and definitive joint proxy and consent solicitation statement/prospectus from Easterly by accessing the Easterly’s website at www.easterlyacquisition.com.
Participants in Solicitation
Easterly and Sungevity, and their respective directors and executive officers, may be deemed participants in the solicitation of proxies of Easterly’s stockholders in respect of the proposed business combination. Information about the directors and executive officers of Easterly and Sungevity is set forth in the Registration Statement and definitive joint proxy and consent solicitation statement/prospectus. Investors may obtain additional information about the interests of such participants by reading the Registration Statement and definitive joint proxy and consent solicitation statement/prospectus.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. Forward-looking statements may relate to the proposed business combination between Easterly and Sungevity and any other statements relating to future results, strategy and plans of Easterly and Sungevity (including certain projections and business trends, and statements which may be identified by the use of the words “plans”, “expects” or “does not expect”, “estimated”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”). Forward-looking statements are based on the opinions and estimates of management of Easterly or Sungevity, as the case may be, as of the date such statements are made, and they are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. For Sungevity, these risks and uncertainties include, but are not limited to, its revenues and operating performance, general economic conditions, industry trends, legislation or regulatory requirements affecting the business in which it is engaged, management of growth, its business strategy and plans, fluctuations in customer demand, the result of future financing efforts and its dependence on key personnel. For Easterly, factors include, but are not limited to, the successful combination of Easterly with Sungevity’s business, the ability to retain key personnel and the ability to achieve stockholder and regulatory approvals and to successfully close the transaction. Additional information on these and other factors that may cause actual results and Easterly’s performance to differ materially is included in Easterly’s periodic reports filed with the SEC, including but not limited to Easterly’s Form 10-K for the year ended December 31, 2015 and subsequent Forms 10-Q and in the Registration Statement and the definitive joint proxy and consent solicitation statement/prospectus. Copies may be obtained by contacting Easterly or the SEC. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. These forward-looking statements are made only as of the date hereof, and Easterly undertakes no obligations to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
No Offer or Solicitation
The information in this press release is for informational purposes only and is neither an offer to sell or purchase, nor the solicitation of an offer to buy or sell any securities, nor is it a solicitation of any vote, consent, or approval in any jurisdiction pursuant to or in connection with the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933 and otherwise in accordance with applicable law.
Easterly Acquisition Corp.
646-712-8300
info@easterlyacquisition.com
$NWMH #NetworkNewsWire @NNWMedia Releases Exclusive #CEO Audio #Interview
NEW YORK, NY / December 8, 2016 / NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions for business, today announces the online availability of its interview with National Waste Management Holdings, Inc. (OTC PINK: NWMH), an emerging vertically integrated solid waste management company rapidly growing its presence on the East Coast.
The interview can be heard at http://nnw.fm/nwmh-interview-dec-2016.
NNW’s communications solutions include social communications, news aggregation and syndication as well as enhanced new release services designed to introduce private and public companies to a wide range of audiences. Leveraging a network of more than 5,000 key distribution outlets, NNW gives its clients a voice – be it through audio interview, video production or other tailored means – to better communicate with the investment community.
National Waste CEO Louis “Tiny” Paveglio and CFO Dali Kranzthor recently joined NNW’s Stuart Smith to discuss how the company applies its acquisition-based business model to expand its market presence and diversify revenue streams.
Paveglio begins the interview with a brief overview of National Waste’s position as a vertically integrated waste management company that specializes in landfills, transfer stations, residential and commercial dumpster service, as well as residential garbage collection in Central and Western Florida and upstate New York.
National Waste’s growth strategy centers on the timely acquisition of businesses to fulfill the company’s long-term goal of extending its reach and servicing the entire East Coast. This endeavor is undertaken by a management team with considerable hands-on and industry-relative experience – as is detailed in the interview – with a track record of executing this strategy.
“Our goal is to do one acquisition a quarter, and we are going to meet that goal. We plan on finishing one up here in the fourth quarter and in 2017 we already have a couple acquisitions that we are doing due diligence on and we intend to roll those in on the first two quarters of 2017,” Paveglio says.
Kranzthor adds to the discussion, noting the advantages of two key acquisitions completed in 2015, but reflective of the current corporate goal to become vertically integrated.
“We had two key acquisitions that occurred at the end of 2015; two that we did in rapid succession … each one of those almost doubled the company and it also gave us a giant geographic footprint in upstate New York,” he says. “The other goal here is to become completely vertically integrated. The highest profitability and the highest margins are when you can take the garbage collection all the way cradle to grave. Very few players in this market have the ability to vertically integrate and have the funds and infrastructure … Only the biggest and the best have the ability to pull that off and so we’re emulating that with our current acquisitions …”
The interview then moves to discussion about National Waste’s expectations for 2017, which include at least one acquisition per quarter, increasing relationships with financiers to fund acquisitions, and continuing the corporate message to investors.
“The exciting thing is that this industry of waste management has a lot of eyes on it and we’ve seen … some amazing acquisitions at the very top level. … As a leading company in this space we see that we’re going to basically stumble upon many more opportunities … It’s a very exciting industry and I think over the next couple of years we’re going to see a lot of highlights in this area and a lot more people are going to see us high on the radar,” concludes Kranzthor.
About National Waste Management Holdings, Inc.
National Waste Management Holdings, Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services.
For more information, visit www.NationalWasteMgmt.com.
About NetworkNewsWire
NetworkNewsWire (NNW) is a multifaceted financial news and publishing company that delivers a new generation of social communication solutions, news aggregation and syndication, and enhanced news release services. Leveraging a professional team of journalists and writers, NNW introduces private and public companies to a wide audience of investors, consumers, journalists and the general public via social media and a rapidly expanding network of over 5,000 key distribution outlets. Cutting through information overload, NNW’s innovative and proprietary systems clearly and succinctly deliver its clients much needed visibility, recognition and brand awareness. NNW is where news, content and information converge.
For more information, visit www.NetworkNewsWire.com.
Forward-Looking Statements
This 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. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Communications Contact:
NetworkNewsWire (NNW)
New York, New York
editor@NetworkNewsWire.com
212-418-1217
www.NetworkNewsWire.com
$COVS Launches Supplier Engagement Platform for #SAIC $GM and #NextEV in #China
DETROIT and SHANGHAI, China, Dec. 07, 2016 — Covisint Corporation (Nasdaq:COVS) today announced that it has signed agreements with Chinese automotive OEMs, SAIC General Motors (SGM) and NextEV to launch supplier engagement platforms for each of their global enterprises.
The Covisint platform provides the foundation for SAIC General Motors (SGM) and NextEV to provide easy access to critical applications and content to their ecosystem of suppliers, regardless of size or location, and enable both SAIC General Motors and NextEV to realize the following benefits:
- Extend their enterprise to manage external supplier users with single sign-on to critical resources based on user types.
- Delegated administration both for security and access, as well as for content management and collaboration resources.
- Manage, automate and govern the complex network of people, systems, and things that need access to resources.
- Authenticated and unauthenticated content that can be personalized and presented to users based upon attributes such as location, division and role.
- Anytime, anywhere support with industry-leading service level agreements and availability.
“Innovative, high-growth companies like SGM and NextEV recognize the need for a single, global platform to meet their next generation supply chain needs,” said Steve Asam, CTO, Covisint. “We are proud to expand our global platform to enable the first and only Automotive Exchange to be hosted in China.”
Established in June 1997, SAIC General Motors (SGM) is a joint venture between SAICMOTOR and General Motors, and is the largest automotive OEM in China. Today, SGM is a multi-brand company with more than twenty product lines, including the world-renowned Buick, Chevrolet, and Cadillac brands, covering the luxury, compact, sedan, MPV, and SUV segments, as well as hybrid and electric vehicles. They expect over 5,000 suppliers to be connected to the platform in the near future.
Covisint was recognized as supplier of the year by SAIC GM in 2016 and was the sole IT supplier to receive this award.
NextEV is the newest Chinese electric vehicle OEM headquartered in San Jose and has over 2,000 employees across 12 countries. NextEV released the NIO brand, as well as model EP9 as the first ultra-pure electric vehicle in China on November 21, 2016.
“Covisint is the leader in providing automotive supply chain solutions in China, as our global network continues to grow,” said Yan Zhang, General Manager of Asia Pacific Operations for Covisint. “This continued growth in China validates the value our platform delivers.”
SAIC General Motors and NextEV join the world’s largest automotive supplier network, which has over 97,000 suppliers globally connected to 7 global OEMs. Over 600,000 supplier users access more than 700 applications and services across these OEMs. The community is multi-lingual available in over 10 languages and with 24x7x365 help desk support in 6 global locations.
About Covisint Corporation
Covisint is the leading Cloud Platform for building Identity and Internet of Things (IoT) applications. Our Cloud Platform technology facilitates the rapid development of identification, authorization and connection of complex networks of people, processes, systems and things.
The Covisint Cloud Platform supports customers in their endeavors to securely identify, authenticate and connect users, devices, applications and information. It supports 2,000 organizations who connect more than 212,000 business partners and customers that support $4 billion in ecommerce transactions annually. Learn more at www.covisint.com.
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Investor Relations Contact
866-319-7659
investors@covisint.com
Media Contact
Brad Schechter
Vice President, Corporate Marketing
248-483-2097
bschecht@covisint.com
For Sales and Marketing Information
Covisint Corporation, 26533 Evergreen Road, Suite 500, Southfield, MI 48076, 800-229-4125
http://www.covisint.com
Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934 – that is, statements related to future events. In this context, forward-looking statements may address our expected future business and financial performance, and often contain words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “will”, “should”, “could”, “would” or “may” and other words of similar meaning. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. For Covisint, particular risks and uncertainties that could cause our actual future results to differ materially from those expressed in our forward-looking statements include, risks and uncertainties related to the customer’s launch of the solution within their eco-system; our ability to continue to host the platform in China; our ability to attract new customers; unpredictable macro-economic conditions; and other risks and uncertainties discussed in this and our other filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended March 31, 2016 and subsequent Quarterly Reports on Form 10-Q. We do not undertake to update our forward-looking statements except as required by law.
$NSU Reports Upper Zone #Drill #Results at #Timok
Nevsun Reports Upper Zone Drill Results at Timok
Canada NewsWire
VANCOUVER, Dec. 7, 2016
VANCOUVER, Dec. 7, 2016 – Nevsun Resources Ltd. (TSX:NSU) (NYSE MKT:NSU) (“Nevsun” or the “Company”) is pleased to announce new assay results from on-going drilling of the Upper Zone at the Company’s Timok copper-gold project (“Timok Project”).
HIGHLIGHTS
- Drilling continues to confirm continuity and the high-grade nature of the Upper Zone
- New massive and semi-massive sulphide intersections include:
- TC160121: 182.3m @ 4.17% Cu, 4.80g/t Au, including 40.5m @ 11.61% Cu, 12.9g/t Au
- TC160119: 86.2m @ 9.47% Cu, 8.83g/t Au, including 46.5m @ 15.61% Cu, 11.29g/t Au
- TC160117: 98.8m @ 9.82% Cu, 8.86g/t Au, including 33.0m @ 20.04% Cu, 14.35g/t Au
- TC160114: 171.0m @ 4.94% Cu, 5.21g/t Au, including 10.5m @ 11.09% Cu, 7.82g/t Au and 24.0m @ 10.27% Cu, 6.71g/t Au, and 7.5m @ 7.88% Cu, 3.78g/t Au
- Additional 18,500m of drilling in progress to further improve confidence in the resource
Nevsun CEO, Cliff Davis, commented, “The assays reported today represent about 25% of the planned in-fill drilling designed to confirm and upgrade the resource of the Timok Upper Zone mineralization. The work on our Pre-Feasibility Study is progressing well. Recent meetings with both the Prime Minister of Serbia and the Minister of Mines and Energy have demonstrated the State’s very strong support for international investment and in particular, the development of the Timok Project.”
Detailed drill results, sections and a plan map of drill hole locations are attached to this news release. Holes are designed to intersect the high sulphidation mineralization at 90 to 100% of true width.
Timok Copper-Gold Project
The Timok Project is located in eastern Serbia near the Bor mining and smelting complex. The Timok Project is focussed on the Cukaru Peki (“Timok”) deposit which includes the high grade Upper Zone (characterized by massive and semi-massive sulphide mineralization) and the Lower Zone (characterized by porphyry-style mineralization). The Upper Zone has an extremely high copper and gold content consisting of 1.7 million tonnes of indicated resource grading 13.5% copper and 10.4 g/t gold and 35.0 million tonnes of inferred resource grading 2.9% copper and 1.7 g/t gold.
Timok Upper Zone
The high sulphidation epithermal (“HSE”) mineralization in the Upper Zone comprises massive sulphide, semi-massive and also vein, stockwork, dissemination and hydrothermal breccia matrix sulphide hosted by strongly altered andesite. The HSE mineralization forms a single coherent zone at depths ranging from 400 to over 800m below surface. Pyrite is the dominant sulphide mineral and covellite the principal copper mineral with lesser enargite, bornite and chalcocite occurring in veins, hydrothermal breccias, disseminations and replacement. Gold is associated primarily with the copper sulphides.
Quality Assurance
Drill core samples were collected in accordance with protocols that are compatible with accepted industry procedures and best practice. The Company conducts its own analysis of QAQC generated by the systematic inclusion of certified reference materials, blank samples and duplicate samples. The analytical results from the quality control samples have been evaluated and have been demonstrated to conform to best practice standards.
Mr. Peter Manojlovic, P.Geo., Nevsun’s VP Exploration, is a Qualified Person as defined by NI 43-101. Mr. Manojlovic has reviewed the technical content of this press release and approved its dissemination.
About Nevsun Resources Ltd.
Nevsun Resources Ltd. is the 60% owner of the high grade Bisha Mine in Eritrea. Bisha has nine years of reserve life, generating revenue from both copper and zinc concentrates containing gold and silver by-products. Nevsun has a strong balance sheet, no debt and pays a peer leading quarterly dividend. Nevsun is well positioned to grow shareholder value through exploration at Bisha and the newly acquired Serbian assets that include the high-grade copper-gold Timok Project.
Forward Looking Statements
The above contains forward-looking statements or forward-looking information within the meaning of the United States Private Securities Litigation Reform Act of 1995, and applicable Canadian securities laws. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “hopes”, “intends”, “estimated”, “potential”, “possible” and similar expressions, or statements that events, conditions or results “will”, “may”, “could” or “should” occur or be achieved. Forward-looking statements are statements concerning the Company’s current beliefs, plans and expectations about the future including but not limited to statements and information made concerning: statements relating to the business, prospects and future activities of, and developments related to the Company, anticipated dividends, goals, strategies, future growth, planned future acquisitions and explorations activities, the adequacy of financial resources and other events or conditions that may occur in the future, and are inherently uncertain. The actual achievements of the Company or other future events or conditions may differ materially from those reflected in the forward-looking statements due to a variety of risks, uncertainties and other factors, including, without limitation, the risks that are more fully described in the Company’s Management Information Circular dated May 18, 2016, and the Company’s Annual Information Form for the fiscal year ended December 31, 2015, which are incorporated herein by reference. The Company’s forward-looking statements are based on the beliefs, expectations and opinions of management on the date the statements are made and the Company assumes no obligation to update such forward-looking statements in the future, except as required by law. For the reasons set forth above, investors should not place undue reliance on the Company’s forward-looking statements.
Further information concerning risks and uncertainties associated with these forward-looking statements and our business can be found in our Annual Information Form for the year ended December 31, 2015, which is available on the Company’s website (www.nevsun.com), filed under our profile on SEDAR (www.sedar.com) and on EDGAR (www.sec.gov) under cover of Form 40-F.
NEVSUN RESOURCES LTD.“Cliff T. Davis”
Cliff T. Davis
|
$HQY New Balance Booster Helps Defuse Common High Deductible Fears
HealthEquity, Inc. (NASDAQ: HQY), a leading health savings account (HSA) provider, is pleased to launch Balance Booster™. This new feature, available to employers offering HealthEquity HSAs, provides members advance access to funds. Account holders with access to this feature no longer have to worry about incurring medical costs early in the year before their HSA balance has grown.
“For years, flexible spending accounts were attractive because the total annual funding was made available up front,” stated Brad Bennion, HealthEquity senior vice president of product. “With HealthEquity’s Balance Booster, an HSA can now provide a similar benefit but with the added advantage of being a long-term savings account. There is no use-it-or-lose-it limitation.”
Paired with a high deductible health plan, an HSA provides an unparalleled opportunity for triple tax benefits and lower insurance premiums. However, consumers have traditionally feared the high deductible paired with the requirement to grow their HSA balance before they can pay for expenses. HealthEquity’s Balance Booster allows employers to make funds available on ‘day one’ for immediate access to account holders when they need them.
For more information, visit www.HealthEquity.com/BalanceBooster.
About HealthEquity
Founded in 2002, HealthEquity is one of the nation’s largest dedicated health savings custodians. The company’s innovative technology platform and tax-advantaged accounts help members build health savings, while controlling health care costs. HealthEquity services more than 2.3 million health savings accounts for 80 health plan partners and employees at more than 33,000 companies across the United States.
HealthEquity
Cody Dingus, 801-633-5466
cdingus@healthequity.com
$FRD Elects #MikeTaylor to Board, #JonathanHolcomb and #MichaelThompson to #VP
On December 2, 2016, the board of directors (the “Board”) of Friedman Industries, Incorporated (NYSE – MKT Trading symbol: FRD)(the “Company”) voted to increase the size of the Board from seven directors to eight directors and elected Michael J. Taylor to the Board to fill the resulting vacancy. Mr. Taylor, age 57, retired in 2014 from a 33-year career in the steel industry. Most recently, Mr. Taylor served as President of Cargill Metals Supply Chain from 2003 to 2014. Mr. Taylor brings an extensive knowledge of the steel industry to the Board.
On December 2, 2016, the Board approved the officer appointments of Jonathan Holcomb as Vice President – Coil Sales and Michael Thompson as Vice President – Tubular Sales. Mr. Holcomb, age 43, has been an employee of the Company for 19 years serving as a coil segment salesman. Mr. Thompson, age 42, has been an employee of the Company for 17 years serving as Sales Manager of Texas Tubular Products since 2010. Mr. Holcomb and Mr. Thompson will report to Thomas Thompson, Senior Vice President – Sales and Marketing. Both of these officer appointments will become effective January 1, 2017.
For further information regarding this press release, please contact Alex LaRue, Vice President – Secretary and Treasurer, at (903) 758-3431.
Friedman Industries, Incorporated
Alex LaRue, (903) 758-3431
Vice President – Secretary and Treasurer
$CMLS Announces Entry into Refinancing Support Agreement
ATLANTA, Dec. 07, 2016 — Cumulus Media Inc. (NASDAQ:CMLS) (the “Company”) today announced that it has entered into a refinancing support agreement (the “Refinancing Support Agreement”) with the holders of approximately $349.7 million, or 57.3%, of the aggregate principal amount of the outstanding 7.75% Senior Notes due 2019 (the “Outstanding Notes”) issued by Cumulus Media Holdings Inc. (“Holdings”), a direct wholly-owned subsidiary of the Company, and guaranteed by the Company. The Refinancing Support Agreement sets forth the terms of a refinancing of the Outstanding Notes and pursuant to its terms the Supporting Noteholders have agreed to tender their Outstanding Notes in a private exchange offer to be made by the Company (the “Exchange Offer”), subject to certain conditions set forth in the Refinancing Support Agreement.
The purpose of the Exchange Offer is to refinance the Outstanding Notes and thereby reduce, and extend the maturity of, the Company’s indebtedness, which the Company believes will promote its long-term financial viability. The Company will not retain any cash proceeds from borrowings incurred in connection with the Exchange Offer. The Outstanding Notes tendered and refinanced in connection with the Exchange Offer will be retired and cancelled and will not be reissued.
If 100% of the aggregate principal amount of the Outstanding Notes is tendered and accepted in the Exchange Offer, upon completion of the Exchange Offer, former noteholders will hold 33.3% of the common equity of the Company and the Company will have retired $610.0 million in outstanding unsecured indebtedness represented by the Outstanding Notes and incurred $305.0 million in secured indebtedness represented by the revolving loans (as defined below) under the Company’s existing credit agreement (as defined below).
The consideration to be provided to holders in the Exchange Offer will consist of (i) at the holder’s option, (a) revolving loans due 2020 (the “revolving loans”) or (b) participation interests in the revolving loans (the “participation interests”) and (ii) shares of the Company’s Class A common stock (“Class A common stock”) (and/or warrants to purchase an equal number of shares of Class A common stock if deemed necessary to comply with the requirements of the Communications Act of 1934, as amended, or the rules, regulations and policies promulgated by the Federal Communications Commission in effect from time to time (the “warrants”)) for any and all Outstanding Notes tendered by such holders in the Exchange Offer. At the settlement date of the Exchange Offer (the “Settlement Date”), the participation interests will automatically be deposited into an entity that the Company will establish to effect the refinancing, Cumulus Pass Through Trust, a Delaware statutory trust (the “Trust”), in exchange for an equal aggregate principal amount of new trust certificates due 2020 (the “trust certificates”), representing fractional undivided interests in the property of the Trust (the “Trust Property”). The Trust Property will consist of:
a) participation interests in the revolving loans, with an aggregate principal amount equal to the aggregate principal amount of outstanding trust certificates;
b) funds resulting from payments made in respect of interest and fees on the revolving loans and repayments of revolving loans with a corresponding reduction in commitments, in each case which are deposited into the Trust from time to time for distribution to holders of trust certificates (“Certificateholders”);
c) funds resulting from repayments of principal on the revolving loans without a corresponding reduction in commitments that are deposited on behalf of the Trust with an institution, as a lender under the existing credit agreement (the “new revolving lender”), from time to time and held by the new revolving lender to fund any future revolving borrowings or for distribution to the Trust for distribution to Certificateholders once the commitments relating to such repayment amounts have been terminated; and
d) certain other assets and contractual rights and remedies as described in more detail in the Offering Memorandum that will be provided to noteholders in connection with the Exchange Offer (the “Offering Memorandum”).
The revolving loans will be issued under the Amended and Restated Credit Agreement, dated as of December 23, 2013, among Holdings, as borrower, the Company, as parent, JPMorgan Chase Bank, N.A., as administrative agent (the “Administrative Agent”), and the other parties from time to time party thereto (the “existing credit agreement”). In connection with the Exchange Offer, Holdings will enter into two amendments to the existing credit agreement to (i) provide for the incurrence of the revolving loans pursuant to an Incremental Revolving Facility (as defined in our existing credit agreement) in an aggregate amount sufficient to consummate the Exchange Offer and (ii) include certain modifications to the terms of our existing revolving credit facility under the existing credit agreement (our “existing revolver”), including to (a) extend the Revolving Credit Termination Date (as defined in our existing credit agreement) to November 23, 2020, (b) modify the financial covenant in section 8.1 of our existing credit agreement to permit the borrowing of the revolving loans in connection with the Exchange Offer and require compliance with the Consolidated First Lien Net Leverage Ratio (as defined in our existing credit agreement) at the levels currently set forth in our existing credit agreement for any future borrowings under our existing revolver, (c) upon completion of the Exchange Offer, elimination of the financial maintenance covenant under our existing revolver, (d) increase the Applicable Margin (as defined in our existing credit agreement) with respect to the revolving loans to 13.25%, subject to a 1.0% floor, for Eurodollar Rate loans (as defined in our existing credit agreement), and 12.25%, subject to a 2.0% floor, for ABR loans (as defined in our existing credit agreement) and (e) increase the undrawn commitment fee to 5.0%.
In order to effect the Exchange Offer, Holdings will borrow up to $305.0 million aggregate principal amount of revolving loans under the existing credit agreement. The revolving loans will be general obligations of Holdings, secured by first priority liens, ratably with the first priority liens securing other obligations under the existing credit agreement, on substantially all of the assets of Holdings (other than certain excluded assets) and will be guaranteed on a senior secured basis by the Company and the subsidiaries of Holdings that guarantee the other obligations under the existing credit agreement.
In connection with the Exchange Offer, the Company will amend and restate its Third Amended and Restated Certificate of Incorporation to provide for the issuance of (i) shares of Class D common stock of the Company (the “Class D common stock”), and (ii) shares of Class E common stock of the Company (the “Class E common stock”) to certain Supporting Noteholders, in addition to the consideration otherwise provided to those Supporting Noteholders in the Exchange Offer, in consideration of the Company’s obligations under the Refinancing Support Agreement to provide such Supporting Noteholders with certain governance rights, including the ability for the holders of the Class D common stock to nominate one director to the Company’s board of directors and for the holders of the Class E common stock to nominate one director to the Company’s board of directors (collectively, the “Noteholder Directors”). For a specified period thereafter, Supporting Noteholders that receive Class D common stock and Class E common stock may elect or designate the Noteholder Directors at each annual meeting of the Company’s stockholders. The shares of Class D common stock and Class E common stock issued to such Supporting Noteholders will not have any voting rights, other than with respect to the election of the Noteholder Directors or as provided by law. The holders of Class D common stock and Class E common stock will share equally on a per share basis with the holders of Class A common stock (and warrants for Class A common stock) with respect to dividends or other distributions that may be declared by the Company’s board of directors from time to time or in the liquidation or winding up of the Company. The shares of Class D common stock and Class E common stock will be automatically convertible into an equal number of shares of Class A common stock upon the occurrence of certain events or at the option of the holder thereof.
In connection with the Exchange Offer, the new revolving lender and those Eligible Holders receiving revolving loans in the Exchange Offer will seek an assignment of the revolving commitments (currently held by the lenders under our existing revolver, which will become effective upon the consent of the Administrative Agent, which may not be unreasonably withheld or delayed.
Further detail regarding the Exchange Offer, including certain conditions to the consummation of the Exchange Offer, has been provided in a Current Report on Form 8-K filed by the Company on the date hereof and available on www.sec.gov.
About Cumulus Media
A leader in the radio broadcasting industry, Cumulus Media (NASDAQ:CMLS) combines high-quality local programming with iconic, nationally syndicated media, sports and entertainment brands to deliver premium content choices to the 245 million people reached each week through its 447 owned-and-operated stations broadcasting in 90 U.S. media markets (including eight of the top 10), more than 8,200 broadcast radio stations affiliated with its Westwood One network and numerous digital channels. Together, the Cumulus/Westwood One platforms make Cumulus Media one of the few media companies that can provide advertisers with national reach and local impact. Cumulus/Westwood One is the exclusive radio broadcast partner to some of the largest brands in sports, entertainment, news, and talk, including the NFL, the NCAA, the Masters, the Olympics, the GRAMMYs, the Academy of Country Music Awards, the American Music Awards, the Billboard Music Awards, Westwood One News, and more. Additionally, it is the nation’s leading provider of country music and lifestyle content through its NASH brand, which serves country fans nationwide through radio programming, exclusive digital content, and live events. For more information, visit www.cumulus.com.
Forward-Looking Statements
Certain statements in this release may constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Such statements are statements other than historical fact and relate to our intent, belief or current expectations primarily with respect to certain historical and our future operating, financial, and strategic performance. Any such forward-looking statements are not guarantees of future performance and may involve risks and uncertainties. Actual results may differ from those contained in or implied by the forward-looking statements as a result of various factors including, but not limited to, risks and uncertainties relating to the need for additional funds to service our debt and to execute our business strategy, our ability to access borrowings under our revolving credit facility, our ability from time to time to renew one or more of our broadcast licenses, changes in interest rates, changes in the fair value of our investments, the timing of, and our ability to complete any acquisitions or dispositions pending from time to time, costs and synergies resulting from the integration of any completed acquisitions, our ability to effectively manage costs, our ability to generate and manage growth, the popularity of radio as a broadcasting and advertising medium, changing consumer tastes, the impact of general economic conditions in the United States or in specific markets in which we currently do business, industry conditions, including existing competition and future competitive technologies and cancellation, disruptions or postponements of advertising schedules in response to national or world events, our ability to generate revenues from new sources, including local commerce and technology-based initiatives, the impact of regulatory rules or proceedings that may affect our business from time to time, our ability to continue to meet the listing standards for our Class A common stock to continue to be listed for trading on the NASDAQ stock market, the write off of a material portion of the fair value of our FCC broadcast licenses and goodwill, and other risk factors described from time to time in our filings with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2015 and any subsequently filed Forms 10-Q. Many of these risks and uncertainties are beyond our control, and the unexpected occurrence or failure to occur of any such events or matters could significantly alter our actual results of operations or financial condition. Cumulus Media Inc. assumes no responsibility to update any forward-looking statement as a result of new information, future events or otherwise.
For further information, please contact: Cumulus Media Inc. Collin Jones Investor Relations 404-260-6600 collin.jones@cumulus.com
$SPWR Announces #Restructuring Program
Positions Company for Sustained Profitability Provides Key Metrics for 2017
SAN JOSE, Calif., Dec. 7, 2016 — SunPower Corp. (NASDAQ:SPWR) today announced a broad restructuring program to position the company for long term, sustainable growth.
“As we announced in our third quarter 2016 earnings release, given the current market dislocation, we have made the strategic decision to implement a broad restructuring program to position the company for sustained, long term profitability,” said Tom Werner, SunPower president and CEO. “We believe that our restructuring initiatives will enable us to successfully navigate through the current market transition and maximize cash flow while successfully positioning the company for the next phase of industry growth.”
The company will implement the following initiatives:
- Rationalize capacity to balance production with near-term profitable demand through the closure of its ~700-megawatt (MW) nameplate capacity Fab 2 facility
- Implement a global workforce reduction of approximately 25 percent or 2,500 employees
- Reduce 2017 annual operating expenses to less than $350 million
- Substantially decrease 2016 inventory to improve working capital and de-lever its balance sheet
- Reduce annual 2017 capital expenditure by more than 50 percent to approximately $100 million
- Continue to invest in next generation cell and module technology as well as complete solutions
As a result of these initiatives, the company expects to incur total restructuring charges of $225 million to $275 million through the end of 2017 of which approximately 30 percent will be in cash.
“We believe these actions, which are fully supported by our board of directors, are important to position the company for sustained profitability through the current industry transition. We are committed to our diversified go to market strategy, continuing to invest in our industry leading technology and product solutions, reducing our operational and manufacturing cost structure and continuing to allocate resources to those areas that will improve our global competitive position. With solar at grid parity in many markets, we believe the long-term industry opportunity has never been greater,” concluded Werner.
“This comprehensive restructuring program will enable us to successfully navigate the current challenging industry conditions while positioning us for success over the long term,” said Chuck Boynton, SunPower chief financial officer. “In the short term, we remain focused on improving working capital and maximizing cash flow which will strengthen our balance sheet while providing the resources necessary to fund our strategic growth plans.”
Financial Outlook
As a result of its announced and previous initiatives, the company will record restructuring charges of at least $150 million on a GAAP basis in the fourth quarter of 2016. Also, consistent with its focus on increasing cash flow, the company will record a fourth quarter GAAP and non-GAAP charge in the range of $50 million to $55 million as a result of the anticipated sale of above market polysilicon. The company’s previously disclosed 2016 fiscal year guidance did not reflect the impact of these two fourth quarter charges.
Additionally, the company is providing the following key financial metrics for 2017.
Revenue of $1.8 billion to $2.3 billion on a GAAP basis and $2.1 billion to $2.6 billion on a non-GAAP basis, non-GAAP operational expenses of less than $350 million, capital expenditures of approximately $100 million, gigawatts (GW) deployed in the range of 1.3 GW to 1.6 GW. Also, the company expects to record GAAP restructuring charges totaling $75 million to $125 million in fiscal year 2017.
Additionally, the company expects to generate positive cash flow from operations through the end of fiscal year 2017 and exit the year with approximately $300 million in cash. The company believes that cash flow and liquidity are the key evaluation metrics for its investors.
The company will host a conference call for investors this morning to discuss its restructuring program and 2017 financial outlook at 5:30 a.m. Pacific Time. The call will be webcast and can be accessed from SunPower’s website at http://investors.sunpower.com/events.cfm.
This press release contains both GAAP and non-GAAP financial information. Non-GAAP figures are reconciled to the closest GAAP equivalent categories in the financial attachment of this press release. Please note that the company has posted supplemental slides related to today’s announcement on the Events and Presentations section of SunPower’s Investor Relations page at http://investors.sunpower.com/events.cfm.
About SunPower
As one of the world’s most innovative and sustainable energy companies, SunPower Corp. (NASDAQ:SPWR) provides a diverse group of customers with complete solar solutions and services. Residential customers, businesses, governments, schools and utilities around the globe rely on SunPower’s more than 30 years of proven experience. From the first flip of the switch, SunPower delivers maximum value and performance throughout the long life of every solar system. Headquartered in Silicon Valley, SunPower has dedicated, customer-focused employees in Africa, Asia, Australia, Europe, and North and South America. For more information about how SunPower is changing the way our world is powered, visit www.sunpower.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: (a) our positioning for future success, long-term profitability, competitive position, and our ability to successfully navigate current market conditions and succeed in the next phase of industry growth; (b) our expectations for the solar industry and the markets we serve, including near-term market conditions, the long-term fundamentals for solar power, and prospects for long-term industry growth; (c) our restructuring and cost reduction plans; (d) our expectations for the timing, success and financial impact of our restructuring and other initiatives, including impact on our balance sheet, long-term cash flow and annual operating and other expenses; (e) our ability to improve working capital, maximize cash flow, reduce costs, balance production with near-term profitable demand, lower inventory, reduce capital expenditures, improve liquidity, allocate investments, appropriately size our manufacturing and fund our strategic plans, and to meet any of our goals in respect of any of the foregoing measures; (f) anticipated restructuring and other accounting charges; and (g) key financial metrics for fiscal year 2017, including GAAP and non-GAAP revenue, operational expenses, capital expenditures and gigawatts deployed. These forward-looking statements are based on our current assumptions, expectations and beliefs and involve substantial risks and uncertainties that may cause results, performance or achievement to materially differ from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: (1) competition in the solar and general energy industry and downward pressure on selling prices and wholesale energy pricing; (2) our liquidity, substantial indebtedness, and ability to obtain additional financing for our projects and customers; (3) regulatory changes and the availability of economic incentives promoting use of solar energy; (4) challenges inherent in constructing certain of our large projects; (5) the success of our ongoing research and development efforts and our ability to commercialize new products and services, including products and services developed through strategic partnerships; (6) fluctuations in our operating results; (7) appropriately sizing our manufacturing capacity and containing manufacturing difficulties that could arise; (8) challenges managing our joint ventures and partnerships; (9) challenges executing on our HoldCo and YieldCo strategies, including the risk that 8point3 Energy Partners may be unsuccessful; (10) fluctuations or declines in the performance of our solar panels and other products and solutions; (11) our ability to identify and successfully implement concrete actions to meet our cost reduction targets, reduce capital expenditures, and implement our planned restructuring initiatives, including the planned realignment of our manufacturing operations and power plant segment; and (12) the outcomes of previously disclosed litigation. A detailed discussion of these factors and other risks that affect our business is included in filings we make with the Securities and Exchange Commission (SEC) from time to time, including our most recent reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.” Copies of these filings are available online from the SEC or on the SEC Filings section of our Investor Relations website at investors.sunpower.com. All forward-looking statements in this press release are based on information currently available to us, and we assume no obligation to update these forward-looking statements in light of new information or future events.
©2016 SunPower Corporation. All rights reserved. SUNPOWER, the SUNPOWER logo, HELIX and OASIS are trademarks or registered trademarks of SunPower Corporation in the U.S. and other countries as well. Other marks are the property of their respective owners.
Use of Non-GAAP Financial Measures
To supplement its consolidated financial results presented in accordance with GAAP, the company uses non-GAAP measures that are adjusted for certain items from the most directly comparable GAAP measures, as described below. Management believes that each of these non-GAAP measures is useful to investors, enabling them to better assess changes in each of these key elements of the company’s results of operations across different reporting periods on a consistent basis, independent of certain items as described below. Thus, each of these non-GAAP financial measures provides investors with another method to assess the company’s operating results in a manner that is focused on its ongoing, core operating performance, absent the effects of these items. Management uses these non-GAAP measures internally to assess the business, its financial performance, current and historical results, as well as for strategic decision-making and forecasting future results. Many of the analysts covering the company also use these non-GAAP measures in their analyses. Given management’s use of these non-GAAP measures, the company believes these measures are important to investors in understanding the company’s operating results as seen through the eyes of management. These non-GAAP measures are not prepared in accordance with GAAP or intended to be a replacement for GAAP financial data; the non-GAAP measures should be reviewed together with the GAAP measures and are not intended to serve as a substitute for results under GAAP, and may be different from non-GAAP measures used by other companies.
Non-GAAP Adjustments Based on International Financial Reporting Standards (“IFRS”)
The company’s non-GAAP results include adjustments to recognize revenue and profit under IFRS that are consistent with the adjustments made in connection with the company’s reporting process as part of its status as a consolidated subsidiary of Total S.A., a foreign public registrant which reports under IFRS. Differences between GAAP and IFRS reflected in the company’s non-GAAP results are further described below. In these situations, management believes that IFRS enables investors to better evaluate the company’s revenue and profit generation performance, and assists in aligning the perspectives of our management and noncontrolling shareholders with those of Total S.A., our controlling shareholder.
- Sale-leaseback transactions. The company includes adjustments related to the revenue recognition on certain sale-leaseback transactions based on the net proceeds received from the buyer-lessor. Under GAAP, these transactions are accounted for under the financing method in accordance with real estate accounting guidance. Under such guidance, no revenue or profit is recognized at the inception of the transaction, and the net proceeds from the buyer-lessor are recorded as a financing liability. Imputed interest is recorded on the liability equal to the company’s incremental borrowing rate adjusted solely to prevent negative amortization.
For more information about this non-GAAP financial measure as well as other non-GAAP financial measures used by the company, please see the company’s Current Report on Form 8-K filed on November 9, 2016, and the table captioned “FY 2017 Guidance” set forth at the end of this release.
FY 2017 GUIDANCE | Fiscal 2017 |
Revenue (GAAP) | $1,800,000-$2,300,000 |
Revenue (non-GAAP) (1) | $2,100,000-$2,600,000 |
Estimated non-GAAP amounts above for fiscal 2017 include net adjustments that increase revenue by approximately $300 million related to sale-leaseback transactions.
$PI Closing of Follow-On #PublicOffering Full Exercise of the Underwriters’ Option
SEATTLE, Dec. 07, 2016 — Impinj, Inc. (NASDAQ:PI), a leading provider and pioneer of solutions for identifying, locating and authenticating everyday items using RAIN RFID, today announced the closing of its follow-on public offering of 4,043,249 shares of common stock at a price to the public of $27.00 per share, which included the full exercise of the underwriters’ option to purchase 527,380 additional shares from Impinj. The number of shares sold in the offering included 1,527,380 shares sold by Impinj and 2,515,869 shares sold by certain selling stockholders. The company estimates net proceeds from the offering to be approximately $38.7 million, after deducting underwriting discounts and commissions and estimated offering expenses. Impinj did not receive any proceeds from the sale of the shares by the selling stockholders.
Morgan Stanley, RBC Capital Markets, Pacific Crest Securities, a division of KeyBanc Capital Markets, and Piper Jaffray acted as joint book-running managers for the offering. Needham & Company acted as lead manager and Canaccord Genuity acted as co-manager.
The offering was made only by means of a written prospectus forming part of the effective registration statement. Copies of the final prospectus relating to the offering, when available, may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281-8098, or by email to equityprospectus@rbccm.com, or by telephone at (877) 822-4089; Pacific Crest Securities, a division of KeyBanc Capital Markets Inc., Attention: Equity Syndicate, 127 Public Square, 4th Floor, Cleveland, Ohio 44114, or by telephone at (800) 859-1783; and Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, Minneapolis, MN 55402, or by email to prospectus@pjc.com, or by telephone at (800) 747-3924.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on December 1, 2016. Copies of the registration statement, as amended, can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Investor Relations Contact: Maria Riley & Chelsea Lish The Blueshirt Group ir@impinj.com (206) 315-4470 Media Contact: Erika Goodmanson Sr. Director, Marketing and Communications egoodmanson@impinj.com (206) 812-9744
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