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$DGLY Exploring Strategic Alternatives
Roth Capital Partners Engaged to Assist in the Process
Lenexa, KS, Nov. 08, 2017 — Digital Ally, Inc. (NASDAQ: DGLY) today announced that its Board of Directors has initiated a process to explore a full range of strategic alternatives to best position the Company for the future including, but not limited to, monetizing its patent portfolio and related patent infringement litigation against Axon Enterprise, Inc. (“Axon,” formerly known as TASER International, Inc.) and Enforcement Video, LLC d/b/a WatchGuard Video (“WatchGuard”), the sale of the Company as a whole, or the sale of select properties or groups of properties or individual businesses. The result of the strategic review may also include the continued implementation of the Company’s business plan. The Company has retained Roth Capital Partners LLC (“Roth”) to assist in this process. There can be no assurance a transaction will result from this process and the Company does not intend to disclose additional details unless and until it has entered into a specific transaction.
The Company has recently received several unsolicited inquiries from parties involving a variety of alternatives including, but not limited to, 1) seeking distribution and/or licensing rights to the Company’s patented VuLink® auto-activation technology, 2) seeking distribution and/or licensing rights to the Company’s suite of patents other than the VuLink; 3) full sale of the Company; and 4) partial sale of its law enforcement or commercial divisions. In addition, the Company has recently entered into an exclusive distribution agreement with VieVU, LLC regarding the Company’s patented VuLink product line. The Company believes the unsolicited inquiries are being driven by the recent and important wins it received in the U.S. Patent Office (the “Patent Office”) that confirm the validity of our VuLink and related auto-activation technologies. Digital’s Board of Directors and management engaged Roth to ensure that the Company and its shareholders consider all reasonable alternatives to maximize shareholder value, given the multiple inquiries.
On July 6, 2017, the Patent Office denied Axon’s petition for inter partes review (“IPR”) of Digital’s Patent No. 9,253,452 (the “’452 Patent”). And on August 3, 2017, the Patent Office denied Axon’s final petition for IPR of the ‘452 Patent. This was Axon’s final attempt to invalidate the ‘452 Patent before the Patent Office.
With the Patent Office determining that Axon failed to demonstrate even a reasonable likelihood of invalidating the ‘452 Patent in its IPR petition, an IPR status update was submitted to the District Court of Kansas. The Court can now decide whether to maintain the stay of the litigation that was implemented pending the results of the IPR petitions. The Company believes that there will be no reason to maintain the stay and, if lifted, it will request an expedited schedule for trial.
On May 27, 2016, Digital filed a complaint against WatchGuard in the U.S. District Court for the District of Kansas alleging patent infringement based on WatchGuard’s VISTA Wifi and 4RE In-Car product lines. In May 2016, WatchGuard filed an IPR petition with the Patent Office challenging the validity of the ‘950 Patent and filed a motion to stay litigation, pending at least a preliminary decision from the PTAB regarding the IPR petition filed challenging the ‘950 Patent and four additional IPR petitions filed by Axon challenging the ‘292 Patent and the ‘452 Patent. In doing so, WatchGuard agreed to be bound by the Patent Office’s decision in connection with the four IPR petitions filed by Axon against the ‘292 Patent and the ‘452 Patent. A compromise was subsequently reached under which the court stayed the case, and ordered the parties to submit a report by January 5, 2018 notifying the court about the status of the pending IPR petitions. The Patent Office subsequently denied institution of all of Axon’s IPR petitions against the ‘452 Patent, which means these requests will not proceed. The Company expects Patent Office to render its decision in the near future regarding whether it will grant institution of WatchGuard’s IPR regarding the ‘950 Patent.
“We are excited to pursue the cases and now focus on the significant damages associated with Axon’s infringement of the ‘452 Patent,” said Digital’s CEO, Stanton E. Ross. “With the defeat of Axon’s IPRs for the ‘452 Patent, we will request an expedited path to trial where a jury can assess Axon’s willful infringement of the ‘452 Patent and award Digital Ally appropriate damages. We also seeking the Court to enjoin all further sales of Axon’s non-SPPM Signal technology.”
About Digital Ally
Digital Ally®, headquartered in Lenexa, KS, specializes in the design and manufacturing of the highest quality video recording equipment and video analytic software. Digital Ally pushes the boundaries of technology in industries such as law enforcement, emergency management, commercial fleets, and consumer use. Digital Ally’s complete product solutions include in-car and body cameras, cloud and local management software, and automatic recording technology. These products work seamlessly together and are simple to install and operate. Digital Ally products are sold by domestic direct sales representatives and international distributors worldwide.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the control of management. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. A wide variety of factors that may cause actual results to differ from the forward-looking statements include, but are not limited to, the following: whether a transaction will result from the initiative with Roth Capital Partners; whether the Company will achieve positive outcomes in its patent litigation with various parties, including Axon Enterprise, Inc. and WatchGuard; whether the Patent Office rulings will curtail, eliminate or otherwise have an effect on the actions of Axon, WatchGuard and other parties respecting the Company, its products and customers; competition from larger, more established companies with far greater economic and human resources; its ability to attract and retain customers and quality employees; the effect of changing economic conditions; and changes in government regulations, tax rates and similar matters. These cautionary statements should not be construed as exhaustive or as any admission as to the adequacy of the Company’s disclosures. The Company cannot predict or determine after the fact what factors would cause actual results to differ materially from those indicated by the forward-looking statements or other statements. The reader should consider statements that include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “plans”, “projects”, “should”, or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. The Company does not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise. Additional information respecting factors that could materially affect the Company and its operations are contained in its annual report on Form 10-K for the year ended December 31, 2016 and quarterly report on Form 10-Q for the three and six months ended June 30, 2017, as filed with the Securities and Exchange Commission.
Contact Information Stanton Ross, CEO Tom Heckman, CFO Digital Ally, Inc 913-814-7774 info@digitalallyinc.com
$CVO Awarded 2020 U.S. Census Printing and Mailing Contract
STAMFORD, Conn., Nov. 8, 2017 — Cenveo, Inc. (NASDAQ: CVO), a global leader in digital manufacturing and fulfillment of envelopes, labels, print and related communication resources, has been awarded the 2020 Census Printing and Mailing Contract from the U.S. Census Bureau. The two-year $61 million contract is one of the largest contracts for printing and mailing ever awarded by the U.S. Government Publishing Office.
“Cenveo’s award of the 2020 U.S. Census is a reflection of our core capabilities and expertise, manufacturing and fulfillment,” said Robert G. Burton, Sr., Cenveo’s Chairman and Chief Executive Officer. “We are well-positioned to execute and manage all aspects of this program successfully and with the level of quality and security expected. We are honored to be a part of this program that will achieve a lasting impact to the future of our country.”
The contract will involve the manufacturing and fulfillment of 1.6 billion pieces, including letters, envelopes, inserts, questionnaires and postcards. The majority of the work will be performed at Cenveo’s printing and binding facilities located in Southern California (Los Angeles) locations and other work performed across the United States.
“The U.S. Census is a massive manufacturing and fulfillment program that requires the utmost degree of precision and operational planning,” said Michael Burton, Chief Operating Officer of Cenveo. “We are excited and committed to partner with the U.S. Census team and confident in our ability to deliver this program.”
Visit www.census.gov to learn more about the 2020 U.S. Census Printing and Mailing Contract.
Cenveo (NASDAQ: CVO), world headquartered in Stamford, Connecticut, is a leading global provider of print and related resources, offering world-class solutions in the areas of custom labels, envelopes, commercial print, content management and publisher solutions. The company provides a one-stop offering through services ranging from design and content management to fulfillment and distribution. With a worldwide distribution platform, we pride ourselves on delivering quality solutions and service every day to our customers. For more information please visit us at www.cenveo.com.
Statements made in this release, other than those concerning historical financial information, may be considered “forward-looking statements,” examples of which include statements relating to our 2017 outlook and future financial condition and operating results, as well as any other statement that does not directly relate to any historical or current fact. These forward-looking statements are based upon current expectations and involve a number of assumptions, risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. In view of such uncertainties, investors should not place undue reliance on our forward-looking statements. Such statements speak only as of the date of this release and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Factors which could cause actual results to differ materially from management’s expectations include, without limitation: (i) our substantial level of indebtedness could materially adversely affect our financial condition, liquidity and ability to service or refinance our debt, and prevent us from fulfilling our business obligations; (ii) our ability to pay the principal of, or to reduce or refinance, our outstanding indebtedness; (iii) the terms of our indebtedness imposing significant restrictions on our operating and financial flexibility; (iv) additional borrowings available to us could further exacerbate our risk exposure from debt; (v) United States and global economic conditions have adversely affected us and could continue to adversely affect us; (vi) our ability to successfully integrate acquired businesses with our business; (vii) a decline in our consolidated profitability or profitability within one of our individual reporting units could result in the impairment of our assets, including goodwill and other long-lived assets; (viii) the industries in which we operate our business are highly competitive and extremely fragmented; (ix) a general absence of long-term customer agreements in our industry, subjecting our business to quarterly and cyclical fluctuations; (x) factors affecting the United States Postal Service’s impacting demand for our products; (xi) the availability of the Internet and other electronic media adversely affecting our business; (xii) increases in paper costs and decreases in the availability of raw materials; (xiii) increases in energy and transportation costs; (xiv) our labor relations; (xv) our compliance with environmental laws; (xvi) our dependence on key management personnel; (xvii) any failure, interruption or security lapse of our information technology systems and (xviii) there can be no assurances that our profitability plan will satisfy the NASDAQ or result in achieving compliance with its listing standards. This list of factors is not exhaustive, and new factors may emerge or changes to the foregoing factors may occur that would impact our business. Additional information regarding these and other factors can be found in Cenveo, Inc.’s periodic filings with the SEC, which are available at www.cenveo.com.
Inquiries from analysts and investors should be directed to Ayman Zameli at (203) 595-3063.
$ONCS Positive Updated Long-Term Follow-Up Data, Phase 2 ImmunoPulse® IL-12, Melanoma
Updated Phase 2 Efficacy and Durability Findings to Be Presented at the 2017 Society for Immunotherapy of Cancer Annual Meeting OncoSec to Host Analyst and Investor Event During the 2017 Society for Immunotherapy of Cancer Annual Meeting in National Harbor, MD
SAN DIEGO, Nov. 8, 2017 — OncoSec Medical Incorporated (“OncoSec” or “Company”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced positive updated long-term follow-up data from its Phase 2 OMS I-102 combination study of ImmunoPulse® IL-12 and pembrolizumab in patients unlikely to respond to anti-PD-1 therapy. The updated data will be presented in an oral poster presentation (P524) by Dr. Alain Alagzi at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.
The updated clinical and correlative immune-focused biomarker data demonstrated a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response and median PFS not yet reached. Building upon previously reported data of a best overall response rate (BORR) of 50% (41% complete response [CR] rate), the updated data further demonstrate that the combination of these therapies can prime a coordinated innate and adaptive immune response, and strongly suggests a synergistic relationship with anti-PD-1. The latest findings further demonstrate that this combination approach can reshape the tumor microenvironment, yielding a robust intratumoral and systemic anti-tumor response converting “cold” tumors to “hot,” potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy.
“Overall, the Phase 2 trial results, including progression free survival beyond two years in multiple patients, duration of response, best overall response rate, and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of ImmunoPulse IL-12 plus pembrolizumab as a viable treatment option for patients diagnosed with metastatic melanoma,” said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.
Dan O’Connor, CEO of OncoSec noted: “The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy.”
The full abstract is available and can be viewed on the STIC website at www.sitcancer.org. The poster is available in the Publications section of OncoSec’s website.
Analyst Event in National Harbor, MD
OncoSec will host an analyst and investor event with clinical investigators on Friday, November 10, 2017 at 7:00 a.m. EST in National Harbor, MD during the 2017 Society of Immunotherapy for Cancer Annual Meeting. The event will include a presentation and discussion of updated clinical data for the company’s ImmunoPulse IL-12 program, highlighting the global, registration-directed PISCES/KEYNOTE-695 trial. The event will be held in-person and via live webcast.
Investors and analysts are invited to listen to a live audio webcast of the presentation. To access the audio broadcast, please dial (877) 731-1960 and enter the conference ID number 4938639. To join via webcast, please use the following link: https://edge.media-server.com/m6/p/aj3vpts5. An archived version of the presentation will be available for 90 days on the “Investors” section of OncoSec’s website: http://ir.oncosec.com/events-presentations.
For those interested in attending this event in person, please contact media@oncosec.com. Please RSVP in advance as seating is limited.
Peer-Reviewed Publication
The findings published in Immunotherapy provide an overview of OncoSec’s preclinical and Phase 1 clinical data demonstrating that ImmunoPulse IL-12 plus electroporation is safe and well-tolerated by patients. Many patients do not respond to anti-PD-1 therapies alone, representing a significant unmet medical need. ImmunoPulse IL-12 has shown to increase intratumoral lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune responses, potentially boosting the activity of PD-1 antibodies without significant systemic toxicity.
For the full-article please visit, https://www.ncbi.nlm.nih.gov/pubmed/29064334.
About the SITC Annual Meeting
The Society for Immunotherapy of Cancer (SITC) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to http://www.sitcancer.org/2017.
About PISCES/KEYNOTE-695
PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or “tavo”) delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12 (tavokinogene telseplasmid [pIL-12] or “tavo”). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
University of California Disclaimer
The information stated above was prepared by OncoSec Inc. and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by The Regents of the University of California, its officers, agents and employees.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements about OncoSec’s business strategies, including advancement of its lead melanoma program and its broader clinical portfolio and plans to pursue collaborations with industry partners, as well as the potential contributions and impact of new directors on these strategies. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the negative of these terms or other comparable terminology.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause OncoSec’s results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: the status, progress and results of clinical programs; ability to obtain regulatory approvals for, and the level of market opportunity for, OncoSec’s product candidates; OncoSec’s business plans, strategies and objectives, including plans to pursue collaboration, licensing or other similar arrangements or transactions; expectations regarding OncoSec’s liquidity and performance, including expense levels, sources of capital and ability to maintain operations as a going concern; the competitive landscape of OncoSec’s industry; and general market, economic and political conditions; and the other factors discussed in OncoSec’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended July 31, 2017.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
CONTACT:
Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com
Media Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
media@oncosec.com
$OTIC Positive Results from AVERTS-2 Phase 3 Trial of OTIVIDEX
- Achieved primary endpoint (p value = 0.029)
- Company plans to meet with FDA to discuss results and clinical requirements for registration
- Management will review results during third quarter conference call at 4:30 p.m. EST today
SAN DIEGO, Nov. 08, 2017 – Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the AVERTS-2 Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease achieved its primary efficacy endpoint (p value = 0.029). Otonomy plans to review these results with the U.S. Food and Drug Administration (FDA) and discuss clinical requirements for registration of OTIVIDEX for patients with Ménière’s disease. The company expects to provide an update from discussions with the FDA during the first quarter of 2018.
Top-line results for the AVERTS-2 trial are as follows:
- The clinical trial achieved its primary endpoint of count of definitive vertigo days (DVD) by Poisson Regression analysis in Month 3 for OTIVIDEX vs. placebo (p value = 0.029) based on analysis of all 174 patients enrolled in the trial.
- The OTIVIDEX group demonstrated a 6.2 day reduction in the mean reported number of DVD from baseline to Month 3 with a 2.5 day mean difference between OTIVIDEX and placebo in Month 3.
- For subjects who completed daily diaries through Month 3 (n=105), there was a 68% reduction in vertigo frequency from baseline to Month 3 in the OTIVIDEX group vs. 40% for placebo.
“The success of the AVERTS-2 trial clearly demonstrates the treatment benefit of OTIVIDEX in patients with Ménière’s disease, and these results are consistent with our expectations based on the Phase 2b trial,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We will complete analysis of this trial and prepare for discussions with the FDA which we expect to occur during the first quarter of 2018. We will also further assess the AVERTS-1 trial to identify factors that might explain the different outcome in that trial and inform the design of our clinical program to support an NDA filing.”
The AVERTS-2 Phase 3 trial was a four month, prospective, randomized, double-blind, placebo-controlled trial of patients with unilateral Ménière’s disease conducted in Europe. Following an initial one month lead-in period, eligible subjects were randomized 1:1 to a single intratympanic injection of OTIVIDEX or placebo. Subjects continued in the trial for up to an additional three months of observation. A total of 174 patients were randomized into the study with 105 patients completing daily diaries through three months of post-treatment observation before the trial was terminated on August 31, 2017. OTIVIDEX was generally well-tolerated with no drug-related serious adverse events observed.
Webcast and Conference Call
Otonomy management will review the results during the third quarter webcast and conference call today at 4:30 p.m. EST. A slide presentation for the call will be available shortly before the event on Otonomy’s website on the “Events and Presentations” page at http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-calendar. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 4495749. A live webcast of the call will be available online in the investor relations section of Otonomy’s website at www.otonomy.com and will be archived there for 30 days.
About Otonomy
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO® (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, an sNDA has been accepted for filing by the FDA for acute otitis externa (AOE) and a successful End-of-Phase 2 review has been completed with the FDA for acute otitis media with tympanostomy tubes (AOMT). OTIVIDEXTM is a steroid in development for the treatment of Ménière’s disease. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that has completed a Phase 1 clinical safety trial. Multiple programs targeting sensorineural hearing loss including age-related hearing loss are in preclinical development. These programs involve the anatomical and functional restoration of ribbon synapses, protection of hair cells from chemotoxicity, and regeneration of hair cells. For additional information please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, plans to meet with the FDA regarding the clinical development requirements for OTIVIDEX and the timing of any such meeting, timing of future pipeline updates from Otonomy, and statements by Otonomy’s president and CEO. Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTIVIDEX and OTO-311, and label expansion indications for OTIPRIO; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy’s product candidates; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct nonclinical studies and clinical trials; the timing and outcome of hospital pharmacy and therapeutics reviews and other facility reviews; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy’s dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to OTIPRIO and its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 8, 2017, and Otonomy’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.
Contacts:
Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
$KBSF Announces Senior Management and Board of Directors Changes
SHISHI, China, Nov. 7, 2017 — KBS Fashion Group Limited (NASDAQ: KBSF) (“KBS” or the “Company”), a vertically-integrated casual menswear company in China, today announced changes to its senior management and Board of Directors (the “Board”).
On November 1, 2017, Mr. Keyan Yan resigned from his positions as Chief Executive Officer (“CEO”) and President of the Company. Mr. Yan will continue to serve as Chairman of the Board. The Board has appointed Mr. Xiaowen Zheng (“Mr. Zheng”) as its new CEO and President, effective immediately. The Board also voted to appoint Xiaowen Zheng as director of the company and the size of board increased to eight. Additionally, Ms. Lixia Tu, who currently serves as Chief Financial Officer of the Company, was appointed as Secretary of the Company, effective immediately.
Mr. Zheng has extensive experience in China’s advertising and media industries. Prior to this appointment, as the founder, Mr. Zheng has served as Chairman and CEO of Shancangzi (Xiamen) Culture Communications Co. Ltd. (“SCZ”), a China-based advertising and branding agency, since its inception in 2007. Mr. Zheng currently also serves as a board director of Advertising Association of Fujian Province and Advertising Association of Xiamen City, a member of China Public Relations Association. Mr. Zheng attended Executive Development Program in Economics at Xiamen University and holds a Bachelor Degree in Information Management and Systems from Yang-En University.
Mr. Yan, Chairman of KBS, welcomed Mr. Zheng to his new positions, “Xiaowen is an expert in advertising and branding and has successfully led his SCZ team in promoting leading brands, such as Coca-Cola, Mercedes-Benz, Uni-President, Wanda Plaza, in the Fujian market where we have the strongest presence. The Board is thrilled that Xiaowen has agreed to take up the torch and lead KBS’ next chapter.”
Mr. Zheng, the new CEO of KBS, added, “KBS is a truly differentiated brand in the garment industry and has a solid foundation to excel in the long run. I feel privileged to join KBS and look forward to working closely with the Board and other senior management members to take the Company to the next level.”
About KBS Fashion Group Limited
Headquartered in Shishi, China, KBS Fashion Group Limited, through its subsidiaries, is engaged in the business of designing, manufacturing, selling and distributing its own casual menswear brand, KBS, through a network of 50 KBS branded stores (as of June 30, 2017) and over a number of multi-brand stores. To learn more about the Company, please visit its corporate website at www.kbsfashion.com.
Safe Harbor Statement
This press release may contain certain “forward-looking statements” relating to the business of KBS Fashion Group Limited, and its subsidiary companies. All statements, other than statements of historical fact included herein, are “forward-looking statements” in nature within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
For further information, please contact:
Lisa Tu
Chief Financial Officer
T: +86 158-5972-2469
E: lingsantu@hotmail.com
Tony Tian, CFA
Weitian Group LLC
T: +1 732-910-9692
E: tony.tian@weitian-ir.com
$GSV Intersects 136m of 2.67 g Au/t at the Dark Star Oxide Gold Deposit
Infill core hole DS17-20 extends the high-grade oxide zone with an intercept of 22.1m of 6.89 g Au/t
VANCOUVER, British Columbia, Nov. 07, 2017 — Gold Standard Ventures Corp. (TSX:GSV) (NYSE AMERICAN:GSV) (“Gold Standard” or the “Company) today announced results from 11 exploration and infill holes at the Dark Star oxide gold deposit on its 100%-owned/controlled Railroad Project in Nevada’s Carlin Trend. These drill holes are a portion of Gold Standard’s 2017 US$15.5 million program which includes up to 48,800 m of reverse-circulation (RC) and core drilling in 117 holes (see February 2, 2017 news release). The infill drilling is designed to reduce drill spacing in critical portions of Dark Star to 30m. Recent results either confirm or outperform the current resource block model.
Infill core hole DS17-20 intersected 136.0m of 2.67 g Au/t approximately 30m north of DS16-03B (101.2m of 1.54 g Au/t) and approximately 90m south of DS16-08 (126.2m of 4.07 g Au/t). These new results are expected to significantly improve the grade of the current block model in the northern portion of Dark Star (please go to the following link – https://goldstandardv.com/lp/dark-star-nov2017-map).
Jonathan Awde, CEO and Director of Gold Standard commented: “The Dark Star oxide deposit continues to surprise us to the upside. First, the high-grade zone to the north is expanding laterally beyond our modeling, which is likely to increase grade and ounces in our next resource estimate. Second, this drilling has confirmed that Dark Star remains wide open both to the east and the west. We suspect that it may also continue further to the north and this year’s drilling is testing this direction as well. Third, and perhaps most intriguing, we are seeing evidence that higher grade oxide material may reoccur at deeper levels of the deposit than originally thought. Overall, we think the Dark Star deposit is going to look very different at the end of this program than it did a year ago.”
Mr. Awde also noted that the positive Dark Star drill results, coupled with the high gold recovery rates averaging 86.5% on material in column testing (see October 25, 2017 news release), further establish Dark Star as a high-quality oxide gold deposit.
Key Highlights
- In the northern portion of Dark Star, infill core hole DS17-20 intersected 136.0m of 2.67 g Au/t, including 3 higher-grade zones of 15.7m of 3.02 g Au/t, 22.1m of 6.89 g Au/t and 14.3m of 3.80 g Au/t respectively. The DS17-20 intercept is approximately 30m north of DS16-03B (101.2m of 1.54 g Au/t as announced on April 18, 2017) and approximately 90m south of DS16-08 (126.2m of 4.07 g Au/t as announced on April 18, 2017). Gold mineralization in DS17-20 appears to outperform the resource block model in this portion of the oxide deposit, and confirm the lateral continuity of a +2.0g Au/t gold zone located in the immediate hanging wall of the Ridgeline fault (please go to the following link – https://goldstandardv.com/lp/dark-star-nov2017-map).
- In the southern portion of Dark Star, infill core hole DS17-22 intersected 55.8m of 0.94 g Au/t including 16.8 of 1.28 g Au/t. This hole confirms the tenor and grade of the block model in this location and enhances and upgrades the geological understanding of wide-spaced RC drill holes.
- Two RC exploration holes have extended the Dark Star deposit to the east. DS17-26 intersected 47.3m of 0.52 g Au/t, and DS17-27 intersected two mineralized zones including 51.8m of 0.76 g Au/t and 53.4m of 0.74 g Au/t. DS17-27 ended in 2.19 g/t gold at a depth of 183m, extending the oxide gold mineralization 45m deeper than the current Dark Star resource model. This intercept may reflect the occurrence of previously unknown deeper horizons of better grade oxide material which could have important implications for the deposit as a whole.
- Two other RC exploration holes have extended the Dark Star deposit to the west. DS17-21 intersected 13.7m of 1.24 g Au/t and DS17-23 intersected 12.2m of 1.41 g Au/t west of the existing Dark Star block model and towards the Pinion deposit. Additional exploration drilling is planned to test targets to the west of Dark Star.
Dark Star drill results are as follows:
| Drill Hole | Method | Azimuth | Incl. | TD (m) | Intercept (m) | Thickness (m) | Grade (g Au/t) |
| DS17-17 | RC | 090 | -45 | 471.0 | 15.2 – 18.3 | 3.1 | 0.21 |
| 21.3 – 24.4 | 3.1 | 0.29 | |||||
| 32.0 – 33.5 | 1.5 | 0.43 | |||||
| DS17-18 | RC | 090 | -45 | 318.6 | 6.1 – 29.0 | 22.9 | 0.57 |
| DS17-19 | RC | -90 | 446.6 | 236.3 – 242.4 | 6.1 | 0.51 | |
| 350.6 – 358.2 | 7.6 | 0.50 | |||||
| 393.2 – 396.3 | 3.1 | 0.56 | |||||
| DS17-20 | Core | -90 | 197.9 | 37.8 – 173.8 | 136.0 | 2.67 | |
| Including Including Including |
42.8 – 58.5 | 15.7 | 3.02 | ||||
| 103.8 – 125.9 | 22.1 | 6.89 | |||||
| 157.9 – 172.2 | 14.3 | 3.80 | |||||
| DS17-21 | RC | -90 | 591.5 | 271.3 – 274.4 | 3.1 | 2.69 | |
| 300.3 – 303.4 | 3.1 | 0.21 | |||||
| 387.2 – 388.7 | 1.5 | 0.23 | |||||
| 393.3 – 397.9 | 4.6 | 0.22 | |||||
| 431.4 – 440.5 | 9.1 | 0.20 | |||||
| 455.8 – 457.3 | 1.5 | 0.24 | |||||
| 468.0 – 481.7 | 13.7 | 1.24 | |||||
| DS17-22 | Core | -90 | 91.5 | 0 – 55.8 | 55.8 | 0.94 | |
| Including Including |
20.0 – 26.2 | 6.2 | 2.63 | ||||
| 33.5 – 50.3 | 16.8 | 1.28 | |||||
| 56.4 – 57.9 | 1.5 | 0.27 | |||||
| 89.9 – 91.4 | 1.5 | 0.25 | |||||
| DS17-23 | RC | 180 | -65 | 118.9 | 106.7 – 118.9 | 12.2 | 1.41 |
| DS17-24 | RC | 360 | -63 | 167.7 | 54.9 – 64.0 | 9.1 | 0.30 |
| DS17-25 | RC | 090 | -65 | 167.7 | 120.4 – 128.0 | 7.6 | 0.41 |
| DS17-26 | RC | 090 | -80 | 122.0 | 3.1 – 9.2 | 6.1 | 0.35 |
| Including | 16.7 – 64.0 | 47.3 | 0.52 | ||||
| 42.7 – 48.8 | 6.1 | 1.00 | |||||
| DS17-27 | RC | 090 | -80 | 182.9 | 65.5 – 117.3 | 51.8 | 0.76 |
| IncludingIncluding | 85.3 – 89.9 | 4.6 | 2.38 | ||||
| 122.0 – 123.5 | 1.5 | 0.32 | |||||
| 129.5 – 182.9 | 53.4 | 0.74 | |||||
| 160.1 – 166.2 | 6.1 | 1.75 | |||||
** Gold intervals reported in this table were calculated using a 0.20 g Au/t cutoff. Weighted averaging has been used to calculate all reported intervals. True widths are estimated at 70-90% of drilled thicknesses.
Mac Jackson, Gold Standard’s Vice President of Exploration stated: “Infill development and step out exploration drilling continue to grow the Dark Star deposit, making significant additions to the high-grade oxide core of the deposit. With the confirmation of the geologic model and controls on the high-grade oxide mineralization, we are able to target and add high quality, readily leachable oxide ounces. We continue to drill at Dark Star and also test new targets in the same Pennsylvanian-Permian host rocks along the Dark Star corridor and at Jasperoid Wash with additional results pending.”
Gold Standard would also like to welcome Mr. Mark Laffoon to the Company as a Senior Engineer. Mr. Laffoon brings over 38 years of management and successful mine engineering experience to Gold Standard from his work in the western United States. Mr. Laffoon will lead the engineering work to develop the Dark Star and Pinion oxide gold deposits.
Sampling Methodology, Chain of Custody, Quality Control and Quality Assurance
All sampling was conducted under the supervision of the Company’s project geologists and the chain of custody from the project to the sample preparation facility was continuously monitored. Core was cut at the company’s facility in Elko and one quarter was sent to the lab for analysis and the remaining material retained in the original core box. A blank or certified reference material was inserted approximately every tenth sample. The core and RC samples were delivered to either ALS Minerals or Bureau Veritas Mineral Laboratories preparation facility in Elko, NV where they were crushed and pulverized. Resulting sample pulps were shipped to either ALS Minerals or Bureau Veritas certified laboratory in Sparks, NV or Vancouver, BC. Pulps were digested and analyzed for gold using fire assay fusion and an atomic absorption spectroscopy (AAS) finish on a 30 gram split. Over limit gold assays were determined using a fire assay fusion with a gravimetric finish on a 30 gram split. All other elements were determined by ICP analysis. Data verification of the analytical results included a statistical analysis of the standards and blanks that must pass certain parameters for acceptance to insure accurate and verifiable results.
Drill hole deviation was measured by gyroscopic down hole surveys that were completed on all holes by International Directional Services of Elko, NV. Final collar locations are surveyed by differential GPS by Apex Surveying, LLC of Spring Creek, Nevada.
The scientific and technical content contained in this news release have been reviewed, verified and approved by Steven R. Koehler, Gold Standard’s Manager of Projects, BSc. Geology and CPG-10216, a Qualified Person as defined by NI 43-101, Standards of Disclosure for Mineral Projects.
ABOUT GOLD STANDARD VENTURES – Gold Standard is an advanced stage gold exploration company focused on district scale discoveries on its Railroad-Pinion Gold Project, located within the prolific Carlin Trend. The 2014 Pinion and Dark Star gold deposit acquisitions offer Gold Standard a potential near-term development option and further consolidates the Company’s premier land package on the Carlin Trend. The Pinion deposit now has an NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 31.61 million tonnes grading 0.62 g/t Au, totaling 630,300 ounces of gold and an Inferred Resource of 61.08 million tonnes grading 0.55 g/t Au, totaling 1,081,300 ounces of gold, using a cut-off grade of 0.14 g/t Au. The Dark Star deposit, 2.1 km to the east of Pinion, has a NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 15.38 million tonnes grading 0.54 g/t Au, totaling 265,100 ounces of gold and an Inferred Resource of 17.05 million tonnes grading 1.31 g/t Au, totaling 715,800 ounces of gold, using a cut-off grade of 0.2 g Au/t. The North Bullion deposit, 7 km to the north of Pinion, has a NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 2.92 million tonnes grading 0.96 g/t Au, totaling 90,100 ounces of gold and an Inferred Resource of 10.97 million tonnes grading 2.28 g/t Au, totaling 805,800 ounces of gold, using a cut-off grade of 0.14 g Au/t for near surface oxide and 1.25 to 2.25 g Au/t for near surface sulfide and underground sulfide respectively.
Neither the TSX nor its regulation services provider nor the NYSE AMERICAN accepts responsibility for the adequacy or accuracy of this news release.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. All statements, other than statements of historical fact, included herein including, without limitation, statements about our potential near term development option are forward looking statements. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Risk factors affecting the Company include, among others: the results from our exploration programs, global financial conditions and volatility of capital markets, uncertainty regarding the availability of additional capital, fluctuations in commodity prices; title matters; and the additional risks identified in our filings with Canadian securities regulators on SEDAR in Canada (available at www.sedar.com) and with the SEC on EDGAR (available at www.sec.gov/edgar.shtml). These forward-looking statements are made as of the date hereof and, except as required under applicable securities legislation, the Company does not assume any obligation to update or revise them to reflect new events or circumstances.
CAUTIONARY NOTE FOR U.S. INVESTORS REGARDING RESERVE AND RESOURCE ESTIMATES
All resource estimates reported by the Company were calculated in accordance with the Canadian National Instrument 43-101 and the Canadian Institute of Mining and Metallurgy Classification system. These standards differ significantly from the requirements of the U.S. Securities and Exchange Commission for descriptions of mineral properties in SEC Industry Guide 7 under Regulation S-K of the U. S. Securities Act of 1933. In particular, under U. S. standards, mineral resources may not be classified as a “reserve” unless the determination has been made that mineralization could be economically and legally produced or extracted at the time the reserve determination is made. Accordingly, information in this press release containing descriptions of the Company’s mineral properties may not be comparable to similar information made public by US public reporting companies.
On behalf of the Board of Directors of Gold Standard,
“Jonathan Awde”
Jonathan Awde, President and Director
FOR FURTHER INFORMATION PLEASE CONTACT:
Jonathan Awde
President
Tel: 604-669-5702
Email: info@goldstandardv.com
Website: www.goldstandardv.com
$NKTR Presents Preclinical Data on Regulatory T Cell Stimulator NKTR-358
SAN FRANCISCO, Nov. 7, 2017 — Nektar Therapeutics (Nasdaq: NKTR) today announced it is presenting preclinical data on NKTR-358, a potential first-in-class resolution therapeutic that may address the underlying immune system imbalance in patients with many immune conditions, at the 2017 American College of Rheumatology (ACR/ARHP) Annual Meeting in San Diego from November 3-8, 2017.
NKTR-358 is a novel immunological therapy designed to target the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 can act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.
“Data from these studies show that NKTR-358 drives the proliferation and sustained preferential activation of regulatory T cells, both of which are critically important to restore balance to the immune system,” said Jonathan Zalevsky, Ph.D., Senior Vice President of Biology and Preclinical Development at Nektar Therapeutics. “NKTR-358 also produces antigen-specific Treg memory to suppress inflammatory responses in experimental mouse models of hypersensitivity, and showed strong efficacy in a mouse model of systemic lupus erythematosus. We are very excited about the potential for NKTR-358 to restore the body’s natural self-tolerance mechanisms and resolve the immune system dysfunction associated with autoimmune disorders.”
More than 23 million Americans have an autoimmune disease – nearly eight percent of the U.S. population – and the prevalence is continuing to rise.i,ii There are more than 80 known types of autoimmune diseases, including lupus, Crohn’s disease, psoriasis and rheumatoid arthritis.iii
In July 2017, Nektar entered into a strategic collaboration with Eli Lilly and Company to develop and commercialize NKTR-358 in multiple autoimmune conditions.
Details of the preclinical data presentation at ACR are as follows:
Abstract 2715: “NKTR-358: A Selective, First-in-Class IL-2 Pathway Agonist Which Increases Number and Suppressive Function of Regulatory T Cells for the Treatment of Immune Inflammatory Disorders.”
Presenter: John Langowski, Ph.D.
Poster Session and Title: ACR Poster Session C, T Cell Biology and Targets in Autoimmune Disease Poster II
Date and Time: Tuesday, November 7, 2017 from 9:00-11:00 a.m. PT
- NKTR-358 delivers sustained, preferential activation of regulatory T cells.
- In non-human primates, a single administration of NKTR-358 led to increases in Treg mobilization for over 14 days.
- In a mouse model of cutaneous hypersensitivity, NKTR-358 significantly suppressed antigen-induced inflammatory responses, an effect which was antigen-specific and associated with establishment of Treg memory.
- NKTR-358 was efficacious in a spontaneous mouse model of systemic lupus erythematosus (SLE).
The poster will be available for download on the Nektar website: http://www.nektar.com/pipeline/rd-pipeline/nktr-358.
The ACR/ARHP Annual Meeting is the premier educational event for physicians, health professionals, and scientists who treat or research those with or at risk for arthritis and rheumatic and musculoskeletal diseases.
About NKTR-358
NKTR-358 is being developed as a once or twice-monthly self-administered injection for a number of autoimmune diseases. In March of 2017, Nektar began the first Phase 1 dose-finding trial of NKTR-358 to evaluate single-ascending doses of NKTR-358 in approximately 50 healthy subjects. The study will measure Treg mobilization, functional activity, pharmacokinetics and safety, with the goal of establishing a range of dose levels to be advanced into a multiple-ascending dose trial in patients with an autoimmune condition (such as psoriasis or systemic lupus erythematosus (SLE) or others). In July 2017, Nektar entered into a strategic collaboration with Eli Lilly and Company to develop and commercialize NKTR-358 in multiple autoimmune conditions.
About Nektar
Nektar Therapeutics is a research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar’s proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: “potential,” “can,” “plan,” “expect,” “could,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-358, the timing and availability of clinical data for NKTR-358, the future clinical development plans for NKTR-358, the commercial and therapeutic potential of NKTR-358, and the potential of our technology and drug candidates in our research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of NKTR-358 are based on findings and observations from preclinical findings; (ii) NKTR-358 is in early-stage clinical development and the risk of failure remains high and failure can unexpectedly occur due to efficacy, safety or other unpredictable factors even after positive findings in previous preclinical studies; (iii) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-358) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (v) patents may not issue from our patent applications for NKTR-358, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q with the Securities and Exchange Commission on August 9, 2017. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
For Investors:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585
Jodi Sievers of Nektar Therapeutics
415-482-5593
For Media:
Jennifer Paganelli
347-658-8290
jpaganelli@purecommunications.com
i The American Autoimmune Related Diseases Association. Autoimmune Statistics. https://www.aarda.org/news-information/statistics/
ii Johns Hopkins University. Autoimmune Disease Research Center. http://autoimmune.pathology.jhmi.edu/faqs.cfm
iii The American Autoimmune Related Diseases Association. Autoimmune Statistics. https://www.aarda.org/news-information/statistics/
$IZEA All-Time Record Revenue of $8.2 Million in Q3
ORLANDO, Fla.
First Adjusted EBITDA Positive Quarter Since Becoming a Public Company
IZEA, Inc. (NASDAQ: IZEA), operator of IZEAx, the premier online marketplace connecting brands and publishers with influential content creators, reported financial results for the third quarter ended September 30, 2017.
Q3 2017 Financial Highlights Compared to Same Year-ago Quarter
- Adjusted EBITDA was $221,000, compared to $(886,000), an improvement of $1.1 million.
- Total revenue up 9% to $8.2 million, compared to $7.5 million.
- Managed Services revenue increased 20% to $7.0 million, compared to $5.8 million.
- Content Workflow revenue decreased 28% to $1.1 million, compared to $1.6 million.
- Revenue backlog, which includes unbilled bookings and unearned revenue, was $11.0 million at the end of the quarter.
- Net bookings increased 2% to $7.9 million compared to $7.7 million.
- Gross profit increased 23% to $4.4 million, with gross margin of 54%.
Trailing Twelve Months Ended September 30, 2017 Compared to Same Year-ago TTM
- Revenue up 10% to $28.8 million, compared to. $26.1 million.
- Managed Services Revenue up 21% to $22.9 million, compared to $19.0 million.
- Gross Profit up 21% to $14.6 million, compared to $12.1 million.
- Adjusted EBITDA improved 46% to $(3.7) million, compared to $(5.8) million.
Management Commentary
“This was a milestone quarter for the company. We crossed $8M in quarterly revenue for the first time, and posted our first EBITDA positive quarter since becoming a public company,” said Ted Murphy, IZEA’s Chairman and CEO. “We have made meaningful progress towards our goal of reaching sustainable, profitable growth, and I am excited by what our team has accomplished to date. Our goal was to have our first EBITDA positive quarter in the second half of 2018 and we are full year ahead of schedule.”
“Our managed sales team continues to deliver impressive results. In addition to all-time record revenue, we delivered all-time record bookings for managed services, the core of our business. Our focus on managed services and the improved margins on those services helped propel us to an EBITDA positive quarter. Custom Content sales were particularly strong, and we are heading into what we expect to be an even stronger Q4 for Managed Services with annual renewals for 2018.”
“We continue to invest in technology to benefit our clients and improve our own operational efficiency. Artificial intelligence and machine learning are being integrated in areas throughout the organization. This technology surfaces new insights, automates processes, and ultimately allows us to accomplish more with less ongoing expense. Our revenue per employee in Q3 increased from $197,000 to $267,000 year over year and remains an efficiency metric we are focused on. Looking forward, we will be announcing additional innovations that leverage big data and artificial intelligence to make us even more effective.”
Q3 2017 Financial Results
Revenue in the third quarter of 2017 increased 9% to $8.2 million compared to $7.5 million in the same year-ago quarter. The increase in our Q3 2017 revenue is primarily due to organic growth in our Managed Services revenue.
Gross profit in the third quarter of 2017 increased 23% by approximately $826,000, as compared to the third quarter of 2016. The increase in gross profit was primarily attributable to a favorable shift to higher margin Managed Services revenue versus lower margin self-service Content Workflow revenue.
Operating expenses in the third quarter of 2017 and 2016 were $5.0 million. Cash-based Opex in the third quarter of 2017 was approximately $4.2 million, compared to $4.5 million in the third quarter of 2016, a decrease of 5% year over year.
Net loss in the third quarter of 2017 was approximately $(559,000), or $(0.10) per share, as compared to a net loss of $(1.5) million, or $(0.28) per share, in the same year-ago quarter. Adjusted EBITDA was approximately $221,000 compared to $(886,000) during the same period of 2016, an improvement of $1.1 million year over year.
Cash and cash equivalents at September 30, 2017 totaled $3.5 million. Receivables at the end of the quarter were $5.3 million, up from $4.1 million at the end of Q2 2017. As of September 30, 2017, the company has accessed $810,000 of a $5.0 million credit line for cash management purposes.
Updated 2017 Outlook
The company expects annual revenue in 2017 will be approximately $29-$30 million, compared to $27.3 million in 2016. The company has increased its gross margin guidance by 200 basis points. Gross margins are now expected to range between 50% to 51% compared to 48% in 2016. Guidance for adjusted EBITDA has improved by $1.0 million and adjusted EBITDA is expected to be approximately $(3.0-3.25) million compared to $(5.2) million in 2016.
Conference Call
IZEA will hold a conference call to discuss its third-quarter 2017 results today at 5:00 p.m. Eastern time. Management will host the call, followed by a question and answer period.
Date: Tuesday, November 7, 2017
Time: 5:00 p.m. Eastern time
Toll-free dial-in number: 1-877-407-4018
International dial-in number: 1-201-689-8471
The conference call will be webcast live and will be available for replay via the investors section of the company’s website at https://izea.com/investors.
Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. A replay of the call will be available after 8:00 p.m. Eastern time on the same day through November 14, 2017.
Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 13672388
About IZEA
IZEA operates IZEAx, the premier online marketplace that connects marketers with influential content creators. IZEAx automates influencer marketing and custom content development, allowing brands and agencies to scale their marketing programs. IZEA creators range from leading social media influencers to accredited journalists. Creators are compensated for producing and distributing unique content on behalf of marketers including long form text, videos, photos and status updates. Marketers receive influential consumer content and engaging, shareable stories that drive awareness. For more information about IZEA, visit https://izea.com.
Use of Non-GAAP Financial Measures “EBITDA” is a non-GAAP financial measure under the rules of the Securities and Exchange Commission. IZEA defines EBITDA as earnings or loss before interest, taxes, depreciation and amortization. IZEA defines “Adjusted EBITDA,” also a non-GAAP financial measure, as earnings or loss before interest, taxes, depreciation and amortization, non-cash stock related compensation, gain or loss on asset disposals or impairment, changes in acquisition cost estimates, and all other non-cash income and expense items such as gains or losses on settlement of liabilities and exchanges, and changes in fair value of derivatives, if applicable. We believe that EBITDA and Adjusted EBITDA provide useful information to investors as they exclude transactions not related to the core cash operating business activities including non-cash transactions. We believe that excluding these transactions allows investors to meaningfully trend and analyze the performance of our core cash operations.
All companies do not calculate EBITDA and Adjusted EBITDA in the same manner, and EBITDA and Adjusted EBITDA as presented by IZEA may not be comparable to those presented by other companies. Moreover, EBITDA and Adjusted EBITDA have limitations as analytical tools, and you should not consider them in isolation or as a substitute for an analysis of our results of operations as reported under GAAP. A reconciliation of GAAP to non-GAAP results is included in the financial tables included in this press release.
Safe Harbor Statement
All statements in this release that are not based on historical fact are “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, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. Examples of forward-looking statements include, among others, statements we make regarding, expectations concerning IZEA’s ability to increase bookings for Managed Services and maintain the margins thereon; anticipated declines in Content Workflow revenue; expectations with respect to operational efficiency; and expectations concerning IZEA’s business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: competitive conditions in the content and social sponsorship segment in which IZEA operates; failure to popularize one or more of the marketplace platforms of IZEA; inability to finance growth initiatives in a timely manner; changing economic conditions that are less favorable than expected; and other risks and uncertainties described in IZEA’s periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and IZEA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
IZEA, Inc.
Justin Braun, 407-215-6218
Manager, Corporate Communications
Justin.braun@izea.com
$MYO Issues November 2017 Shareholder Letter
CAMBRIDGE, Mass.
Provides an Update on Third Quarter 2017 and Ongoing Commercial Activities
Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a commercial stage medical robotics company, today issued a letter to shareholders to give an update on third quarter 2017 and ongoing MyoPro® commercial activities.
An accompanying digital shareholder letter can be viewed at: shareholderletters.myomo.com/q3-17.
Dear Fellow Shareholders:
Welcome to the first edition of our Investor Relations digital shareholder letter, whose purpose is to keep you informed about Myomo’s progress. Since completing our IPO in June, we have been implementing various sales and marketing programs to grow the company. We established additional MyoPro Centers of Excellence to distribute our products to patients around the country; increased our Marketing presence online and begun our international expansion. We are leveraging our FDA registered, CE Marked, and only commercial, proprietary technology to restore function to the millions of patients with upper limb paralysis.
We believe we have the strategic focus, business model, and an expanding operational footprint to ably serve this market, facilitating our growth.
Thank you for your investment in MYO shares, which provides us the resources to grow the business and create shareholder value over time.
Sincerely;
Paul R. Gudonis
Chairman & Chief Executive Officer
About Myomo
Myomo, Inc. is a commercial stage medical robotics company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S. For more information, please visit www.myomo.com.
Forward Looking Statements
This press release contains forward-looking statements regarding the Company’s future business expectations, including the launch of MyoPro for Veterans, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. Our actual results could differ materially from those anticipated in these forward looking statements for many reasons, including, without limitation, risks related to regulatory approval and market acceptance of our products, and the other risk factors contained in our filings made with the Securities and Exchange Commission. More information about factors that potentially could affect Myomo’s financial results is included in Myomo’s filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
For Myomo:
ir@myomo.com
or
Investor Relations:
PCG Advisory
Vivian Cervantes, 212-554-5482
vivian@pcgadvisory.com
or
Public Relations:
Greenough
Rachel Robbins, 617-275-6521
rrobbins@greenough.biz
$CIIX Diversity Drives Success, Company Aims Even Higher for FY2018
November 7, 2017
- Launching its Chinese Daily Video News Broadcast from NYSE on cryptocurrency news in 1Q2018
- CIIX sets FY2018 goals of greater than 100% sales increase, reduced costs, and profitability
- Consilium Global Research projects CIIX to reach revenues of $14.8 million by FY2020 at a compounded annual growth rate (CAGR) of nearly 100%
- CIIX reports FY2017 YOY operating sales gain of 76%
ChineseInvestors.com, Inc. (OTCQB: CIIX) is a diverse company with goals set by Warren Wang, company founder and CEO, of a 100% gain in sales in FY2018 after achieving a 76% YOY increase in operating revenues in FY2017. The goal in FY2018 is not only the large sales gain, but a reduction in costs and profitability.
CIIX is targeting its goal of becoming the primary medical cannabis Chinese community oriented publicly-traded company. It has diverse offerings to the global Chinese-speaking population. These include financial education and market analysis, in addition to R&D and distribution of legalized, hemp-based cannabidiol (CBD). It now also offers Chinese Daily Video News Broadcast on cryptocurrencies and blockchain news from the NYSE, along with its line of CBD-infused skin care products.
At the same time, CIIX is generating subscription revenue and advertising sales. It also offers public relations and investor relations consulting services to Chinese companies.
Recently, it expanded its board by three individuals who have extensive financial and industry experience: Patrick Leung, Keevin Gillespie and Delray Wannemacher. The goal, according to CEO Wang, is to add to the company’s board individuals who can help grow the company’s Consumer Retail and Financial Services/Media divisions.
For more information, visit the company’s website at www.ChineseInvestors.com
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$SSC Launches New Corporate Website, Including New Investor Presentation
NEW YORK, Nov. 6, 2017 — Seven Stars Cloud Group, Inc. (NASDAQ: SSC) (“SSC” or the “Company”), is pleased to announce the launch of its newly redesigned corporate website – http://www.sevenstarscloud.com.
The new site has been optimized to ensure visitors are provided a “user-friendly” experience across all digital devices, including desktop and mobile. This newly redesigned website offers quick and easy access to essential information that offers a more complete understanding of the Company’s products, services and structure. The website also has a comprehensive investor section with updated Company news and events, financial and stock information, SEC filings and corporate governance information.
The Company’s new website will be updated on a regular basis with business activity, corporate milestones, events and investor and financial information.
In addition to the launch of the new website, SSC has provided an updated investor presentation that can be located at SSC Investor Presentation.
CONTACT:
Jason Finkelstein
VP, Investor Relations
Seven Stars Cloud Group, Inc.
212-206-1216
Twitter: @sevenstarscloud
$TXMD Announces Plan to Resubmit the New Drug Application for TX-004HR
BOCA RATON, Fla.
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced a regulatory update regarding the New Drug Application (NDA) for TX-004HR, the Company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
On November 3, 2017, the Company participated in an in-person meeting with the Division of Bone, Reproductive, and Urologic Products of the Food and Drug Administration (FDA). At the meeting, the Division agreed to the resubmission of the NDA for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study.
The Company believes it will be in a position to resubmit the NDA for TX-004HR within the coming weeks, with a potential approval of the NDA within two to six months after resubmission, depending on the classification of the review of the NDA.
“We appreciate the hard work and collaborative effort by the FDA in moving TX-004HR one step closer to approval,” said TherapeuticsMD CEO Robert G. Finizio. “We are extremely pleased with the FDA’s position that an additional pre-approval safety study is no longer necessary for the resubmission of the NDA for TX-004HR.”
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s late stage clinical pipeline includes two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.
Forward-Looking Statements
This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the company’s ability to resolve the deficiencies identified by the FDA in the company’s new drug application for its TX-004HR product candidate and the time frame associated with such resolution; whether the company will be able to prepare an amended NDA for its TX-004HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to prepare an NDA for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; the length, cost and uncertain results of the company’s clinical trials, including any additional clinical trials that the FDA may require in connection with TX-004HR; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
TherapeuticsMD, Inc.
David DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
$FTFT Enters into Agreements to Acquire Financial Assets
XI’AN, China, Nov. 6, 2017 — Future FinTech Group Inc. (NASDAQ: FTFT) (“Future FinTech” or “the Company”), a financial technology company and integrated producer of fruit-related products, today announced that on November 2, 2017, one of its wholly owned subsidiaries, Hedetang Foods (China) Co., Ltd. (“Hedetang”), entered into a series of agreements to acquire financial assets.
“With these agreements, we are continuing to pursue our strategic initiative to reallocate our resources towards the fintech sector which we view as possessing high margin profit potential,” said Mr. Hongke Xue, Chief Executive Officer of Future FinTech. “We believe that the financial assets that we have identified are undervalued and have liquidity elements which are key to our positioning as a lighter asset business. We will continue to strategically pursue fintech opportunities that will make us a leaner enterprise and believe that this will enable us to achieve returns on capital consistent with the goal of maximizing shareholder value.”
The financial assets have been assessed by an appraisal firm, and three of the financial assets are either guaranteed by a third-party company or secured by land use rights. Based upon the appraisal reports, the amounts for these debts that likely could be collected range from 67% to 99.32% of the book amount. Hedetang has agreed to purchase these debts at a price which is 60% of the collectable amount according to appraisal reports. After the consummation of the purchases, the Company has the option to hold, collect or resell these assets at any time. The aggregate capital cost of the four separate transfer agreements total RMB 181,006,980 (or approximately $27,344,096), of which RMB 108,604,188 (or approximately $16,437,248) will be paid in cash and RMB 72,402,792 (or approximately $10,937,638) will be paid in the common shares of the Company, which is subject to shareholder approval to both increase its authorized common stock to 60,000,000 shares and to issue new shares at a special shareholders meeting, which is planned to be held at the end of January 2018.
A summary of the acquisition agreements is as follows:
1) Shaanxi Chunlv Ecological Agriculture Co. Ltd. agreed to transfer all its credit rights of principal and interest in Xi’an Tongji Department Store Co., Ltd. to Hedetang. The book balance of the principal is RMB 23,625,000, the interest is RMB 38,281,900, and the total credit balance including principal and interest is RMB 61,906,900, of which RMB 19,757,800 is guaranteed by a third-party company. According to the appraisal report from Shaanxi Delixin Asset Appraisal Co., Ltd., dated October 23, 2017, the amount for this debt that likely could be collected is RMB 50,210,400, which is 81.11% of the total debt. Hedetang agreed to purchase the creditor’s rights of this debt for RMB 30,126,240, which is 60% of the collectable amount pursuant to the appraisal report.
2) Shaanxi Chunlv Ecological Agriculture Co. Ltd. agreed to transfer all its credit rights of principal and interest in Shaanxi Youyi Co., Ltd. to Hedetang. The book balance of the principal is RMB 45,345,000, the interest is RMB 71,224,300, and the total credit balance including principal and interest is RMB 116,569,300, all of which is guaranteed by a third-party company. According to the appraisal report from Shaanxi Delixin Asset Appraisal Co., Ltd., dated October 23, 2017, the amount for this debt that likely could be collected is RMB 94,421,200, which is 81% of the total debt. Hedetang agreed to purchase the creditor’s rights of this debt for RMB 56,652,720, which is 60% of the collectable amount pursuant to the appraisal report.
3) Shaanxi Fu Chen Venture Capital Management Co., Ltd. agreed to transfer all its credit rights of principal and interest in State Owned Shaanxi No. 8 Cotton and Textile Mill to Hedetang. The book balance of the principal is RMB 72,370,000, the interest is RMB 138,037,700, and the total credit balance including principal and interest is RMB 210,407,700, and there is no effective guarantee or pledged assets to secure this debt. According to the appraisal report from Shaanxi Delixin Asset Appraisal Co., Ltd., dated October 23, 2017, the amount for this debt that likely could be collected is RMB 140,973,200, which is 67% of the total debt. Hedetang agreed to purchase the creditor’s rights of this debt for RMB 84,583,920, which is 60% of the collectable amount pursuant to the appraisal report.
4) Shaanxi Boai Medical Technology Development Co., Ltd. agreed to transfer all its credit rights of principal and interest in Xi’an Yanliang Economic Development Co., Ltd. to Hedetang. The book balance of the principal is RMB 6,350,000, the interest is RMB 9,834,300, and the total credit balance including principal and interest is RMB 16,184,300 which is secured by certain land use rights. According to the appraisal report from Shaanxi Delixin Asset Appraisal Co., Ltd., dated October 23, 2017, the amount for this debt is RMB 16,073,500, which is 99.32% of the total debt. Hedetang agreed to purchase the creditor’s rights of this debt for RMB 9,644,100, which is 60% of the collectable amount pursuant to the appraisal report.
In connection with the financial assets purchase, and to provide funding for its consummation, on November 3, 2017, Future FinTech entered into a Share Purchase Agreement (the “Share Purchase Agreement”) with Mr. Zeyao Xue (“Xue”) pursuant to which Future FinTech agreed to sell 11,362,159 shares of its common stock (the “Shares”) to Xue for an aggregate purchase price of $16,437,248.50 with the per share price for the Shares as the average closing price quoted on the NASDAQ Global Market for the common stock of the Company over the three (3) trading days prior to the date of the Share Purchase Agreement (the “Purchase Price”). Under the terms of the Share Purchase Agreement, the Purchase Price may be adjusted upward if, on the third business day following the later of (i) the public disclosure of the execution of the Acquisition Agreements and (ii) the Company’s filing of its Form 10-Q for the quarter ended September 30, 2017 (in each case, counting the date of disclosure as the first such day, provided that the applicable public disclosure is made prior to the close of trading on such date), the per share closing price of the Company’s common stock quoted on the NASDAQ Global Market (the “Disclosure Price”) is higher than the Purchase Price, the Purchase Price shall be adjusted to the Disclosure Price (the “Adjusted Price”), and in such case Xue shall pay to the Future FinTech an amount equal to (x) the difference between the Purchase Price and the Adjusted Price (y) multiplied by the number of Shares (the “Additional Amount”). If the Disclosure Price is lower than Purchase Price, no adjustment of the Purchase Price shall be made.
Xue currently beneficially owns 2,337,155 shares, or 45.2% of Future FinTech’s issued and outstanding common stock, and Mr. Yongke Xue, a director of Future FinTech, is Xue’s father. The consummation of the Share Purchase Agreement is contingent on Future FinTech receiving shareholder approval to increase its authorized common stock to 60,000,000 shares and approval for the issuance of Shares at a special shareholders meeting to that is planned be held at the end of January 2018.
Safe Harbor Statement
Certain of the statements made in this press release are “forward-looking statements” within the meaning and protections of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause the actual results, performance, capital, ownership or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “estimate,” “continue,” “plan,” “point to,” “project,” “could,” “intend,” “target” and other similar words and expressions of the future.
All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in our annual report on Form 10-K for the year ended December 31, 2016 and otherwise in our SEC reports and filings, including the proxy statement for 2017 annual meeting. Such reports are available upon request from the Company, or from the Securities and Exchange Commission, including through the SEC’s Internet website at http://www.sec.gov. We have no obligation and do not undertake to update, revise or correct any of the forward-looking statements after the date hereof, or after the respective dates on which any such statements otherwise are made.
About Future FinTech Group Inc.
Future FinTech Group Inc. (“Future FinTech” or the “Company”), is an agricultural products company that utilizes financial technology solutions to operate and grow its businesses. The Company is engaged in the production and sales of fruit juice concentrates, fruit beverages, and other fruit related products in China and certain overseas markets. The Company’s fruit juice concentrates are sold to domestic customers and exported directly or via distributors. Its fruit juice products, “Hedetang” and “SkyPeople,” are healthy and nutritious beverages and sold primarily in China. The Company leverages e-commerce and new technology platforms and is building a regional agricultural products commodities market with the goal to become a leader in agricultural finance technology. For more information, please visit http://www.ftft.top/.
For more information, please contact:
COMPANY
| Cindy Liu, Investor Relations Manager |
| Future FinTech Group Inc. |
| Tel: China +86-29-8187-8277 |
| Email: skypeople_annie@163.com |
| Web: http://www.ftft.top |
$HMNY & Helios $100 Million Convertible Notes Agreement to Increase MoviePass Stake
Canaccord Genuity Inc. Acts as Sole Placement Agent
Helios and Matheson Analytics Inc. (Nasdaq: HMNY) (“HMNY”), a provider of information technology services and solutions, and MoviePass Inc., a company that HMNY has agreed to purchase a majority stake in, announced today that HMNY has entered into a securities purchase agreement with institutional investors for HMNY to issue convertible notes in the aggregate principal amount of $100,000,000 (the “Notes”), for the purpose of further funding MoviePass, and for general corporate purposes. HMNY is not obligated to register the resale of any shares underlying the Notes with the Securities and Exchange Commission. Absent registration, the investors may resell the shares underlying the Notes only pursuant to Rule 144 or another available exemption from registration.
The Notes will be convertible, at the option of the holders, at a fixed conversion price of $12.06, subject to adjustment.
The investors paid for the Notes with $5 million in cash up front and $95 million in investor notes payable to HMNY (the “Investor Notes”). The Investors are required to prepay approximately $15.65 million of the Investor Notes to HMNY in equal weekly payments over the next seven weeks. The investors may prepay the remaining balance of the Investor Notes, with the resulting cash being paid to HMNY, in their discretion.
The purpose of the financing transaction is to enable HMNY to pay the remaining $5 million balance that HMNY will owe to MoviePass, subject to certain conditions, under a promissory note that HMNY is obligated to give to MoviePass upon the closing of the previously announced Securities Purchase Agreement, dated August 15, 2017, between HMNY and MoviePass (the “MoviePass Purchase Agreement”), and to increase HMNY’s ownership stake in MoviePass by paying MoviePass up to $20 million upon HMNY’s exercise of its additional investment option under the previously announced Investment Option Agreement, dated October 11, 2017, between HMNY and MoviePass, and for any other transaction where HMNY increases its ownership interests or other rights and interests in MoviePass.
In connection with the financing, MoviePass entered into a waiver agreement with HMNY waiving any rights of MoviePass to terminate the MoviePass Purchase Agreement and all conditions to MoviePass’ obligations under the MoviePass Purchase Agreement. The closing of the MoviePass Purchase Agreement remains subject to approval by HMNY’s stockholders. MoviePass also entered into a guaranty with the investors in the financing guarantying HMNY’s obligations under the Notes.
Canaccord Genuity Inc. acted as sole placement agent for the financing. Palladium Capital Advisors LLC acted as a financial advisor to HMNY in connection with the financing.
“We couldn’t be happier to fuel MoviePass’ growth to enable its subscribers to consume entertainment where it’s best consumed – at the movie theater,” said Ted Farnsworth, Chairman and CEO of HMNY. “Better performance of films during their theatrical window signals greater success throughout the film ecosystem and that’s our ultimate goal. We take the participation of Canaccord Genuity and its institutional investors as a great vote of confidence in HMNY and MoviePass’ future. With the viral and word-of-mouth-driven subscriber growth MoviePass is experiencing, we believe MoviePass is the future of out-of-home entertainment,” Mr. Farnsworth concluded.
“This latest round of investment will allow MoviePass to continue to deliver on its mission of staying the number one movie theater subscription service in the country,” said Mitch Lowe, CEO of MoviePass. “As demand for our service continues to accelerate among consumers, the early data we are seeing on movie-going behavior can be tremendously valuable to both the studios and theaters. This investment should allow us to further augment our data science capabilities and platform to respond to the needs of studios and exhibitors and their challenges in better understanding their customers,” Mr. Lowe concluded.
Key Transaction Details
The Notes consist of (i) Series A Senior Bridge Convertible Notes in the aggregate principal amount of $5,000,000 and (ii) Series B Senior Secured Bridge Convertible Notes in the aggregate principal amount of $95,000,000 for consideration consisting of (i) an upfront cash payment in the amount of $5,000,000, and (ii) secured promissory notes payable by the investors to HMNY in the aggregate principal amount of $95,000,000 (referred to above as the Investor Notes). Under the Investor Notes, the Investors are obligated to fund an additional approximate $2.2 million per week to HMNY for the next seven weeks, for a total gross funding commitment of approximately $20.65 million, including the $5 million payment received for the Series A Notes. The investors may also elect to prepay the remaining balance of the Investor Notes to HMNY at any time in their discretion.
The investors may require HMNY to redeem the Notes at any time after seven months from the issue date of the Notes, including the outstanding principal amount of the Series A Notes and the portion of outstanding principal amount of the Investor Notes for which the investors have prepaid to HMNY a corresponding amount of cash under the Investor Notes, plus accrued unpaid interest on those amounts and a make-whole amount of interest on those amounts calculated through the two year maturity date of the Notes.
The Series A Notes are not secured by any assets of HMNY or MoviePass and the Investor Notes are not secured by any assets of HMNY other than the Investor Notes. The conversion price of the Notes is subject to adjustment in the event the Company sells shares of common stock or common stock equivalents for less than $12.06 per share in the future, subject to customary excluded issuances.
For additional information concerning the details of the financing, please refer to the Current Report on Form 8-K filed by HMNY with the U.S. Securities and Exchange Commission (the “SEC”).
The Notes and shares of common stock issuable upon conversion thereof have not been registered under the Securities Act of 1933, as amended, or any applicable state securities laws and may not be offered or sold absent such registration or pursuant to an available exemption from such registration requirements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
About Helios and Matheson
Helios and Matheson Analytics Inc. (NASDAQ: HMNY) is a provider of information technology services and solutions, offering a range of technology platforms focusing on big data, artificial intelligence, business intelligence, social listening, and consumer-centric technology. Its holdings include RedZone Map™, a safety and navigation app for iOS and Android users, and a community-based ecosystem that features a socially empowered safety map app that enhances mobile GPS navigation using advanced proprietary technology. Through TrendIt, HMNY has acquired technology addressing crowd and migration patterns and consumer behavior in real-time. The patented technology predicts population behavior, along with a crowd’s population size, origin and destination. HMNY is headquartered in New York, NY and listed on the Nasdaq Capital Market under the symbol HMNY. For more information, visit www.hmny.com.
About MoviePass
MoviePass is a technology company dedicated to enhancing the exploration of cinema. As the nation’s premier movie-theater subscription service, MoviePass provides film enthusiasts with a variety of subscription options to enhance their movie-going experience. The service, now accepted at more than 91% of theaters across the United States, is the nation’s largest theater network. Visit: www.moviepass.com.
Additional Information for Stockholders of HMNY about the Proposed Transaction between HMNY and MoviePass and Where to Find It
HMNY plans to file with the SEC and furnish its stockholders with a proxy statement in connection with the proposed transaction with MoviePass and security holders of HMNY are urged to read the proxy statement and the other relevant materials when they become available because such materials will contain important information about HMNY, MoviePass and their respective affiliates and the proposed transaction. The proxy statement and other relevant materials (when they become available), and any and all other documents filed by HMNY with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov.
In addition, investors may obtain a free copy of HMNY’s filings from HMNY’s website at www.hmny.com or by directing a request to: Helios and Matheson Analytics Inc., Attn: Secretary, Empire State Building, 350 Fifth Avenue, Suite 7520, New York, New York 10118, (212) 979-8228.
INVESTORS AND SECURITY HOLDERS OF HMNY ARE URGED TO READ THE PROXY STATEMENT AND THE OTHER RELEVANT MATERIALS WHEN THEY BECOME AVAILABLE BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTION BETWEEN HMNY AND MOVIEPASS.
Participants in the Solicitation
HMNY and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the security holders of HMNY in connection with the proposed transaction between HMNY and MoviePass. Information about those directors and executive officers of HMNY, including their ownership of HMNY securities, is set forth in the annual report on Form 10-K for the year ended December 31, 2016, which was filed with the SEC on April 14, 2017, and its definitive proxy statement on Schedule 14A filed with the SEC on October 3, 2017. Investors and security holders may obtain additional information regarding the direct and indirect interests of HMNY and its directors and executive officers in the proposed transaction by reading the proxy statement and other public filings referred to above.
Cautionary Statement on Forward-looking Statements and Other Information in this Press Release
Certain information in this communication contains “forward-looking statements” about HMNY and MoviePass within the meaning of the Private Securities Litigation Reform Act of 1995 or under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”), that may not be based on historical fact, but instead relate to future events. Forward-looking statements are generally identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. Such forward-looking statements include, without limitation, statements regarding (i) obtaining approval of HMNY’s stockholders of the transactions contemplated by the MoviePass Purchase Agreement (collectively, the “MoviePass Transaction”) and the expected completion of the MoviePass Transaction, (ii) the expected amount of funding from the investors under the Investor Notes, (iii) the expected benefits to HMNY and MoviePass from completing the acquisition and the financing, and (iv) MoviePass’ business and subscriber growth. Statements regarding future events are based on the parties’ current expectations and are necessarily subject to associated risks related to, among other things, the conditions to the closing of the acquisition may not be satisfied, the occurrence of any event, change or other circumstances that could give rise to the termination of the acquisition agreement between MoviePass and HMNY, the occurrence of an event of default under the Notes which would eliminate the investors’ weekly funding obligations under the Investor Notes, MoviePass’ and HMNY’s continuing need for additional financing, and general economic conditions. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements.
Such forward-looking statements are based on a number of assumptions. Although management of HMNY and MoviePass believe that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially and adversely from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects.
Risk factors and other material information concerning HMNY and MoviePass are described in the Current Report on Form 8-K filed with the SEC on October 11, 2017, in HMNY’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and other HMNY filings, including subsequent current and periodic reports, information statements and registration statements filed with the SEC. You are cautioned to review such reports and other filings at www.sec.gov.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on HMNY’s and MoviePass’ current expectations and HMNY does not undertake an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
In particular, MoviePass’ $9.95 per month subscription pricing model is new. There can be no assurance that the resulting rate of increase in its subscribers will continue or be sustained. Moreover, the increase in the number of MoviePass subscribers provides no assurance that the MoviePass business model will lead to profitability.
HMNY Contact:
The Pollack PR Marketing Group
Stephanie Goldman/Mark Havenner, 310-556-4443
sgoldman@ppmgcorp.com / mhavenner@ppmgcorp.com
or
MoviePass Contact:
LaunchSquad for MoviePass
Gavin Skillman, 212-564-3665
gavin@launchsquad.com
$MLNT Announces Successful Completion of Merger
– New Nasdaq-Listed Melinta Therapeutics Will Begin Trading on November 6, 2017 under Ticker MLNT –
NEW HAVEN, Conn., Nov. 06, 2017 — Melinta Therapeutics Inc. (NASDAQ:MLNT), a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, announced that the company’s merger with Cempra, Inc. has closed. Melinta Therapeutics will commence trading on November 6, 2017 on the NASDAQ Global Market under the symbol “MLNT.”
Melinta previously announced that Dan Wechsler has been appointed as Melinta’s new president and chief executive officer. In addition to Mr. Wechsler, the company’s executive leadership team is comprised of seven executives from Melinta and two executives from Cempra. Biographies for the management team may be found on the Melinta website.
“The successful closing of our merger with Cempra is very exciting, as it positions us with significant capital to advance our clinical and commercial efforts for our flagship product, Baxdela®, as well as drive forward our extensive pipeline of anti-infective products,” stated Mr. Wechsler. “It is a privilege to be part of Melinta and I look forward to building on the mission to discover, develop, and market life-saving antibiotics to physicians and the patients they serve.”
Concurrent with the closing of the merger, Melinta also announced that the company’s board of directors will be chaired by Kevin Ferro, co-founder of Vatera Healthcare Partners. The board will also be comprised of former board members from Melinta and Cempra as well as the addition of Jay Galeota, a pharmaceutical veteran who has held diverse key leadership positions including chief strategy and business development officer and president, emerging businesses at Merck & Co. Inc., and who is currently the president and chief operating officer of G&W Laboratories, Inc. Mr. Wechsler will also be appointed to the board. His appointment will be effective ten days following the filing of a supplemental Information Statement on Schedule 14f-1 relating to Mr. Wechsler. Biographies for the board members are listed on the Melinta website.
After giving effect to the merger, pre-closing Melinta stockholders owned, on a fully-diluted basis as calculated under the treasury stock method, approximately 51.6% of the company’s common stock and pre-closing Cempra stockholders owned approximately 48.4% of the company’s common stock.
In connection with Mr. Wechsler’s appointment, Melinta’s independent directors approved an inducement award pursuant to Rule 5635 of the NASDAQ Listing Rules to Mr. Wechsler. The inducement award consists of the grant of a stock option to purchase up to 550,981 shares of Melinta’s common stock at an exercise price equal to Friday’s closing price of the Melinta’s common stock, and the grant of restricted stock units for 183,661 shares of Melinta’s common stock. The stock option and restricted stock unit grants will become twenty-five percent vested on November 3, 2018, with the remaining shares vesting in equal monthly installments thereafter over the next three years, subject to his continuing service with Melinta through the applicable vesting dates. Vesting of the awards will be accelerated upon the occurrence of certain events as set forth in the award agreements evidencing the grants. The stock option and restricted stock units are subject to the terms of the Melinta’s 2011 Equity Incentive Plan, as amended, but were granted outside of the plan, and were granted as an inducement material to Mr. Wechsler’s accepting employment with Melinta in accordance with NASDAQ Listing Rule 5635(c)(4).
Advisors
J.P. Morgan Securities LLC served as financial advisor, and Willkie Farr & Gallagher LLP served as legal counsel to Melinta with respect to the merger. Morgan Stanley served as lead financial advisor and Skadden, Arps, Slate, Meagher & Flom LLP and Wyrick Robbins Yates & Ponton LLP served as legal counsel to Cempra with respect to the transaction. Stifel also served as financial advisor to Cempra with respect to the transaction.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to saving lives threatened by the global public health crisis of bacterial infections, through the development and commercialization of novel antibiotics that provide new and better therapeutic solutions. Melinta’s lead product is Baxdela, an antibiotic approved by the US FDA for use in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Melinta also has an extensive pipeline of preclinical and clinical stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this pipeline provides Melinta with the unique ability to provide doctors and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this communication constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for the company include, but are not limited to: liquidity and trading market for shares following the consummation of the merger; risks related to the costs, timing and regulatory review of the company’s studies and clinical trials, including its ability to address the issues identified by the FDA in the complete response letter relating to the company’s new drug applications for solithromycin for community acquired bacterial pneumonia; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; inability or the delay in obtaining required regulatory approvals for product candidates, which may result in unexpected cost expenditures; failure to realize any value of certain product candidates developed and being developed, in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; inability to commercialize and launch any product candidate that receives regulatory approval, including Baxdela; the company’s anticipated capital expenditures, its estimates regarding its capital requirements and its need for future capital; uncertainties of cash flows and inability to meet working capital needs; cost reductions that may not result in anticipated level of cost savings or cost reductions; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for the company’s products may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; loss of or diminished demand from one or more key customers or distributors; unexpected cost increases and pricing pressures; the possibility of economic recession and its negative impact on customers, vendors or suppliers; and risks associated with the possible failure to realize certain benefits of the merger, including future financial, tax, accounting treatment, and operating results. Many of these factors that will determine actual results are beyond the company’s ability to control or predict.
Other risks and uncertainties are more fully described in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, as amended by Form 10-K/A filed with the SEC on April 13, 2017, and in other filings that the company has made and that the company will make with the SEC, including the proxy statement described below under “Important Information and Where to Find It.” Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release or presentation speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date stated herein.
Important Information and Where to Find It
Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by the company with the SEC at the SEC’s website (http://www.sec.gov), at the company’s website (http://ir.melinta.com/), or by writing to the Secretary, Melinta Therapeutics, Inc., at ir@melinta.com.
For More Information:
Lyn Baranowski
Melinta Therapeutics, Inc.
(203) 848-3346
news@melinta.com
$TRUP Medical Insurance for Pets Helps Canadian Pet Owners Face the Unexpected
Seattle, Nov. 03, 2017 —
No pet owner expects their dog to be unlucky, but when the unexpected occurs, medical insurance for pets can help ease the financial burden of treatment. Trupanion, a medical insurance provider for cats and dogs, saw over 15,000 accident claims for Canadian pets since January 2017 for things like bites, burns, breaks, and foreign body ingestion. The company paid over $4 million CAD toward their care.
Insurance coverage can make a difference in the lives of dogs and cats—taking the focus off of money and placing it back on to their care. Pet owners are able to choose what is best for their pet and veterinarians are able to practice best medicine. This can be critical in the face of a sudden injury.
Removing financial barriers to veterinary care
By offering financial support during an emergency, medical insurance for pets can help pet owners pay for costly veterinary treatments.
Lindsey M. a veterinary technician, was aware of the costs of veterinary medicine when enrolling her Coonhound, Sierra, in insurance. When Sierra ingested part of an entryway rug, Lindsey was faced with a $6,000 bill.
“I am so glad Sierra was covered by Trupanion, or cost could have prevented her from having surgery,” Lindsey said. “It was the greatest feeling bringing her home. Months later, I am so happy I was able to just say yes to the quote and her care.”
Putting a focus on recovery
Even if pet owners are able to cover veterinary costs, the sudden expense can be a stressful distraction. Health insurance can take away some of that financial burden and help the pet owner focus on their pet’s recovery.
Charlie the French Bulldog and his owners were visiting with friends on a fenced rooftop patio in Calgary, Alberta, when Charlie managed to jump onto a bench, over the fence, and off the roof—falling 10 meters.
“Our hearts sank. Just like that he disappeared. It didn’t seem real” said Sandon H., Charlie’s owner. They rushed him to the closest animal hospital. His shoulders and jaw were fractured, but he had a strong fighting spirit. The Trupanion policy covered over $4,800 toward his veterinary expenses. “They took away all of the stress about finances, which allowed us to just focus on Charlie.” After months of hand-feeding, and limited movement, his specialist was amazed how fast he was healing.
“Today, he’s back to normal—running, jumping, playing, cuddling and making us laugh. You wouldn’t even know he fell but for a small scar on his chin. We’re so thankful for Trupanion’s help, and so glad Charlie is back to being himself.”
Helping veterinarians practice best medicine
Pet owners with insurance are also more likely to move forward with “plan A” treatment because they have financial support, which gives veterinarians the ability to do what’s best for the pet.
At 5 months old, Ella the mixed breed dog fell off a chair and broke her leg. She was treated by Princess Animal Hospital in Ontario and the break was expected to heal well—but that’s when Ella’s issues really started. “Unfortunately, Ella’s fracture was not healing properly and she was developing elbow dysplasia which was very painful for her” said a staff member from Princess Animal Hospital. “The end result meant surgery to amputate her leg.” Ella’s owners had coverage for their pup, and were able to move forward with the initial treatment and surgery, which totaled over $6,000.
“Trupanion has been an important part in Ella’s journey to her wellbeing. Now, Ella lives as a fast-running, three-legged pooch who enjoys life and doesn’t live in discomfort anymore.”
About Trupanion
Trupanion is a leader in medical insurance for cats and dogs throughout the United States and Canada. For almost two decades, Trupanion has given pet owners peace of mind so they can focus on their pet’s recovery, not financial stress. Trupanion is committed to providing pet owners with the highest value in pet medical insurance. Trupanion is listed on NASDAQ under the symbol “TRUP”. The company was founded in 2000 and is headquartered in Seattle, WA. Trupanion policies are issued, in the United States, by its wholly-owned insurance entity American Pet Insurance Company and, in Canada, by Omega General Insurance Company. For more information please visit trupanion.com.
MediaRelations@Trupanion.com 206-607-1930
$VRAY MRIdian Linac Selected as MR-Guided Radiotherapy System in Danish Tender
Top Cancer Centers to Bring Benefits of MR-Guided Soft-tissue Visualization and Adaptive Treatment Delivery to Copenhagen
CLEVELAND, Nov. 3, 2017 — ViewRay, Inc. (Nasdaq: VRAY) announced today that the company’s MRIdian® Linac has been selected for installation at Rigshospitalet and Herlev Hospitals in Denmark, as part of a competitive bid and comprehensive technology review. As part of the tender award the regional health system will initially purchase two MRIdian Linac systems.
MRIdian enables a fundamental change from conventional radiotherapy by using diagnostic-quality MR imaging and enabling daily on-table treatment plan adaptation. MRIdian also uniquely allows for continuous MR imaging to automatically control beam delivery to account for subtle anatomical changes that may occur during treatment. Combined, these advancements allow clinicians to tailor the dose more closely to the targeted tumor, potentially mitigating incidental radiation exposure to surrounding healthy tissue and organs.
“Radiation oncology departments are recognizing the value of MR-guidance and its ability to improve the way treatment is visualized, planned and delivered,” said Chris Raanes, president and CEO of ViewRay. “This purchase illustrates the shift that’s taking place in image-guided radiation therapy and its impact on clinical practice.”
The purchase of two MRIdian Linac systems for Rigshospitalet and Herlev Hospitals was part of a collaborative bid with Varian Medical Systems, under which additional Varian treatment machines were also purchased.
About ViewRay
ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian’s high-definition MR was purposely built to deliver high-precision radiation without unnecessary beam distortion, and consequently, help to mitigate skin toxicity and other safety concerns that may otherwise arise when high magnetic fields interact with radiation beams. ViewRay and MRIdian are registered trademarks of ViewRay, Inc.
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause future results to differ materially from those referenced. Forward looking statements, include those with respect to the mitigation of radiation exposure to healthy tissue and organs, improvements to treatments, and shifts in image guided radiation therapy. Given these uncertainties, the reader is advised not to place any undue reliance on any forward-looking statements. Additional risk factors include, among others, the ability to raise the additional funding needed to continue to pursue ViewRay’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC available at www.sec.gov.
$VRNS to Present at November Investor Conferences
NEW YORK, Nov. 03, 2017 — Varonis Systems, Inc. (NASDAQ:VRNS), a leading provider of software solutions that protect data from insider threats and cyberattacks, today announced its participation at the following upcoming conferences:
The RBC Capital Markets Technology, Internet, Media and Telecommunications Conference in New York City on November 8, 2017. The presentation is scheduled for 9:20 a.m. ET.
The Needham Networking & Security Conference in New York City on November 14, 2017. The presentation is scheduled for 9:10 a.m. ET.
The audio presentations will be webcast live and will be available by visiting the “Investor Relations” section of the company’s website at www.varonis.com. The webcasts will be archived on the company’s website for a limited time following the conferences.
Additional Resources
- For more information on Varonis’ solution portfolio, please visit www.varonis.com
- Visit our blog, and join the conversation on Facebook, Twitter, LinkedIn, Podcast and YouTube.
About Varonis
Varonis is a leading provider of software solutions that protect data from insider threats and cyberattacks. Through its innovative Data Security Platform, Varonis allows organizations to analyze, secure, manage, and migrate their volumes of unstructured data. Varonis specializes in file and email systems that store valuable spreadsheets, word processing documents, presentations, audio and video files, emails, and text. This rapidly growing data often contains an enterprise’s financial information, product plans, strategic initiatives, intellectual property, and confidential employee, customer or patient records. IT and business personnel deploy Varonis software for a variety of use cases, including data security, governance and compliance, user behavior analytics, archiving, search, and file synchronization and sharing. With offices and partners worldwide, Varonis had approximately 5,950 customers as of September 30, 2017, spanning leading firms in financial services, healthcare, public, industrial, insurance, energy and utilities, media and entertainment, consumer and retail, technology and education sectors.
Investor Relations Contact:
Yun Kim
Varonis Systems, Inc.
646-640-2149
Email: kimy@varonis.com
News Media Contacts:
Rachel Hunt
Varonis Systems, Inc.
877-292-8767 (ext. 4247)
Email: rhunt@varonis.com
Mia Damiano
Merritt Group
703-390-1502
Email: damiano@merrittgrp.com
$PODD to Ring The Nasdaq Stock Market Closing Bell
ADVISORY, Nov. 03, 2017
What:
Insulet Corporation (Nasdaq:PODD), an innovative medical device company dedicated to making the lives of people with diabetes easier, will visit the Nasdaq MarketSite in Times Square.
In honor of the occasion, Patrick Sullivan, Chairman of the Board & CEO, will ring the Closing Bell.
Where:
Nasdaq MarketSite – 4 Times Square – 43rd & Broadway – Broadcast Studio
When:
Monday, November 6, 2017 – 3:45 p.m. to 4:00 p.m. ET
Insulet Corporation Contact:
Deborah Gordon, Vice President of Investor Relations and Corporate Communications
978.600.7717
dgordon@insulet.com
Nasdaq MarketSite Media Contact:
Emily Pan
(646) 441-5120
emily.pan@nasdaq.com
Feed Information:
Fiber Line (Encompass Waterfront): 4463
Gal 3C/06C 95.05 degrees West
18 mhz Lower
DL 3811 Vertical
FEC 3/4
SR 13.235
DR 18.295411
MOD 4:2:0
DVBS QPSK
Social Media:
For multimedia features such as exclusive content, photo postings, status updates and video of bell ceremonies, please visit our Facebook page:
http://www.facebook.com/NASDAQ.
For photos from ceremonies and events, please visit our Instagram page:
http://instagram.com/nasdaq
For livestream of ceremonies and events, please visit our YouTube page:
http://www.youtube.com/nasdaq/live
For news tweets, please visit our Twitter page:
http://twitter.com/nasdaq
For exciting viral content and ceremony photos, please visit our Tumblr page:
http://nasdaq.tumblr.com/
Webcast:
A live stream of the Nasdaq Closing Bell will be available at:
https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx
Photos:
To obtain a hi-resolution photograph of the Market Close, please go to http://business.nasdaq.com/discover/market-bell-ceremonies and click on the market close of your choice.
About Insulet Corporation
Insulet Corporation (NASDAQ:PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Insulet seeks to expand the use of insulin pump therapy with its Omnipod Insulin Management System among people with insulin-dependent diabetes. The Omnipod System is a revolutionary and easy-to-use tubeless insulin pump that provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s Delivery Systems business partners with global pharmaceutical and biotechnology companies to adapt the Omnipod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. Founded in 2000, Insulet Corporation is based in Billerica, Massachusetts. For more information, please visit: http://www.myomnipod.com.
About Nasdaq:
Nasdaq (Nasdaq:NDAQ) is a leading global provider of trading, clearing, exchange technology, listing, information and public company services. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 90 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to approximately 3,900 total listings with a market value of approximately $12 trillion. To learn more, visit: http://business.nasdaq.com
$MYO Enters Canadian Market
CAMBRIDGE, Mass.
Ottobock to Distribute MyoPro® to Orthotics and Prosthetics Practices Throughout Country
Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a commercial stage medical robotics company, today announced that its Application for a Canadian Medical Device License has been approved by Health Canada. With the license, Myomo and its distribution partner, Ottobock, are now entering the Canadian market for commercial sale of the MyoPro myolelectric arm orthosis (powered brace).
MyoPro is the only lightweight wearable device on the market that can help restore substantial functionality in the paralyzed or weakened arms and hands of individuals who have suffered the effects of a stroke, brachial plexus injury (BPI) or other neuromuscular disease or injury. The orthosis senses a patient’s own EMG signals through non-invasive sensors, allowing a patient to perform activities of daily living including feeding themselves, carrying objects and doing household tasks, and many are able to return to work.
“MyoPro is an exciting device and we are enthusiastic about providing this technology to service the unmet needs of patients in Canada,” said Chris Nolan, Vice President, Orthotics, Ottobock North America. Ottobock is the global market leader in technical orthopedics and prosthetics (O&P).
Stroke and BPI are the conditions most frequently helped by MyoPro. According to OntarioStrokeNetwork.ca, stroke is the leading cause of adult disability in Canada, with 426,000 Canadians living with the effects of stroke. Each year 50,000 new patients survive stroke and are left living with some degree of impairment. Often, these impairments include a weakened or paralyzed arm that might be helped with MyoPro.
Myomo launched its next-generation MyoPro orthosis in June 2017, extending the capabilities of the previous device with significant enhancements, including interchangeable, extended-life rechargeable batteries for continuous daily use. In July, the Company obtained the CE mark, enabling it to enter the European market.
“Gaining approval to market MyoPro in Canada increases the base of patients who may now be able to perform activities of daily living despite losing function in an arm,” said Paul R. Gudonis, Chairman and CEO of Myomo. “Additionally, we are pleased to extend our relationship with Ottobock to help us broaden distribution of the MyoPro product line.”
About Myomo
Myomo, Inc. is a commercial stage medical robotics company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S. For more information, please visit www.myomo.com.
About Ottobock
Ottobock uses innovative technology, superior service, and world-class education to help people with physical mobility challenges. Established in 1919 in Germany, Ottobock opened its doors in the U.S. in 1958 and in Canada in 1978. Currently in its third generation as a privately held company, Ottobock offers products and services to help people maintain or regain their freedom of movement. www.ottobockus.com and www.ottobock.ca
Forward Looking Statements
This press release contains forward-looking statements regarding the Company’s future business expectations, including the launch of MyoPro for Veterans, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. Our actual results could differ materially from those anticipated in these forward looking statements for many reasons, including, without limitation, risks related to regulatory approval and market acceptance of our products, and the other risk factors contained in our filings made with the Securities and Exchange Commission. More information about factors that potentially could affect Myomo’s financial results is included in Myomo’s filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
For Myomo:
ir@myomo.com
or
Investor Relations:
PCG Advisory
Vivian Cervantes, 212-554-5482
vivian@pcgadvisory.com
or
Public Relations:
Greenough
Rachel Robbins, 617-275-6521
rrobbins@greenough.biz
$XBIO Enters Into Sublicense Agreement Related to PolyXen
LEXINGTON, Mass.
– Xenetic to receive one-time payment of $7.5M and single digit royalty payments based upon net sales –
Xenetic Biosciences, Inc. (NASDAQ: XBIO) (“Xenetic” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, announced today that it has entered into a Right to Sublicense Agreement with Baxalta Incorporated, Baxalta US Inc., and Baxalta GmbH (collectively, with their affiliates, “Baxalta”), wholly-owned subsidiaries of Shire plc (LSE: SHP, NASDAQ: SHPG). Pursuant to the Sublicense Agreement, Xenetic granted to Baxalta the right to grant a nonexclusive sublicense to certain patents related to the Company’s PolyXen™ technology that were previously exclusively licensed to Baxalta pursuant to an agreement between the Company and Baxalta in connection with products relating to the treatment of blood and bleeding disorders.
As part of the Sublicense Agreement, Baxalta agreed to pay Xenetic a one-time payment of $7.5 million and single digit royalty payments based upon net sales of the products covered under the sublicense throughout the term of the agreement.
“We are pleased to have entered this agreement with Baxalta and believe this transaction represents validation of the value of the comprehensive IP portfolio established surrounding our proprietary PolyXen platform technology,” said Jeffrey Eisenberg, Chief Executive Officer of Xenetic Biosciences. “This is an exciting advancement for the Company given the immediate non-dilutive funding it provides, but more importantly, the longer-term potential of this agreement which we expect to drive significant value for Xenetic over time.”
This press release is not intended to describe this transaction in its entirety and readers are encouraged to review the Form 8-K the Company filed with the Securities and Exchange Commission today.
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics. Xenetic’s lead investigational product candidate is oncology therapeutic XBIO-101 (sodium cridanimod) for the treatment of progesterone resistant endometrial cancer. Xenetic’s proprietary drug development platforms include PolyXen, which enables next-generation biologic drugs by improving their half-life and other pharmacological properties.
Xenetic is party to an agreement with Baxalta US Inc. and Baxalta AB (wholly owned subsidiaries of Shire plc) covering the development of a novel series of polysialylated blood coagulation factors. This collaboration relies on Xenetic’s PolyXen technology to conjugate polysialic acid (“PSA”) to therapeutic blood-clotting factors, with the goal of improving the pharmacokinetic profile and extending the active life of these biologic molecules. Shire is a significant stockholder of the Company, having invested $10 million in the Company during 2014. The agreement is an exclusive research, development and license agreement which grants Shire a worldwide, exclusive, royalty-bearing license to Xenetic’s PSA patented and proprietary technology in combination with Shire’s proprietary molecules designed for the treatment of blood and bleeding disorders. The first program under this agreement was a next generation Factor VIII, and this program was terminated by Shire following a Phase 1/2 clinical trial. Xenetic and Shire are currently exploring whether to engage in further development of other blood coagulation factors. Additionally, Xenetic has previously received strategic investments from OPKO Health (Nasdaq: OPK), Serum Institute of India Limited and PJSC Pharmsynthez.
For more information, please visit the Company’s website at www.xeneticbio.com and connect on Twitter, LinkedIn, Facebook and Google+.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding changes to the proposals included in the Company’s proxy statement and the Company’s plans to amend or supplement its proxy statement. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These risks and uncertainties include those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and filed with the Securities and Exchange Commission on March 31, 2017, and subsequent reports that it may file with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.
Jenene Thomas Communications, LLC.
Jenene Thomas, 908-938-1475
jenene@jenenethomascommunications.com
$DRNA & Boehringer Ingelheim Chronic Liver Disease Collaboration
INGELHEIM, Germany & CAMBRIDGE, Mass.
- Dicerna to receive up to $201 million in upfront and success-based development and commercialization milestones, excluding royalties, for an undisclosed target
- The collaboration will investigate a new therapeutic approach that enables addressing previously inaccessible drug targets to protect and restore liver functionality in NASH
Boehringer Ingelheim and Dicerna Pharmaceuticals (NASDAQ:DRNA), a leading developer of investigational RNA interference (RNAi) therapeutics, today announced a research collaboration and license agreement to discover and develop novel GalXC™ RNAi therapeutics for the treatment of chronic liver diseases. The partnership will initially focus on nonalcoholic steatohepatitis (NASH), a devastating, chronic liver disease for which there is no approved treatment option.
NASH is caused by the buildup of fat in the liver, potentially leading to liver fibrosis and cirrhosis. It has an especially high prevalence among obese and diabetic patients, and is an area of high unmet medical need. NASH is expected to soon become the most common cause of advanced liver disorders, and it often necessitates liver transplantation.
Dicerna’s GalXC technology platform uses RNAi to inhibit the expression of disease-causing genes by destroying the messenger RNAs (mRNAs) of those genes. This new approach has the potential to treat diseases by silencing previously inaccessible drug targets. It adds a further breakthrough therapy opportunity to Boehringer Ingelheim’s cardiometabolic pipeline and provides additional combination options.
“We believe that Dicerna’s GalXC technology platform is ideally suited for the development of novel RNAi therapies for nonalcoholic steatohepatitis and other chronic liver diseases,” said Douglas M. Fambrough, President and Chief Executive Officer of Dicerna. “With strong capabilities in drug discovery, deep expertise in the cardiometabolic space, and proven commercial experience, Boehringer Ingelheim is a natural partner to speed the development of the first GalXC RNAi program targeting chronic liver disease. The collaboration combines the strong capabilities of both companies to pursue the full potential of Dicerna’s GalXC technology to bring valuable and differentiated RNAi therapies to patients with liver diseases and their healthcare teams, and reflects both the promise of the GalXC technology and the strength of its underlying intellectual property.”
“At Boehringer Ingelheim, our research team is diligently working to discover effective new therapies for NASH and other chronic liver diseases, which is a priority area for us,” said Clive R. Wood, Ph.D., Corporate Senior Vice President Discovery Research at Boehringer Ingelheim. “This partnership complements our existing research efforts and expertise and offers distinct advantages in developing exciting new therapy options,” added Wood.
Boehringer Ingelheim has a long history of excellence in the discovery and development of medicines for cardiometabolic disease patients. It has established a broad portfolio of marketed products for thromboembolic diseases, type 2 diabetes, acute myocardial infarction, hypertension, and cardio-renal risk reduction. The cardiometabolic diseases pipeline extends beyond type 2 diabetes and anticoagulation with a focus on innovative drugs for the treatment of the devastating consequences of diabetes as well as contributing factors like obesity.
Dicerna is building a portfolio of research and development programs to advance the treatment of diseases involving the liver, including chronic liver diseases, viral infectious diseases, cardiovascular diseases and rare diseases. The company aims to leverage its proprietary GalXC technology to develop innovative RNAi therapeutics to positively transform the lives of individuals living with these diseases.
Under the terms of the agreement, Dicerna may receive more than $200 million from Boehringer Ingelheim, including an upfront payment, development and commercial milestone payments, and research and development reimbursement for a GalXC candidate product addressing an undisclosed NASH target. Dicerna is also eligible to receive royalties staggered up to double-digits on worldwide net sales.
About Dicerna Pharmaceuticals, Inc.
Dicerna Pharmaceuticals, Inc., is a biopharmaceutical company focused on the discovery and development of innovative RNAi-based therapeutics for diseases involving the liver, including rare diseases, chronic liver diseases, cardiovascular diseases, and viral infectious diseases. The Company is leveraging its proprietary GalXC™ RNAi technology platform to build a broad pipeline in these core therapeutic areas, focusing on target genes where connections between target gene and diseases are well understood and documented. The Company intends to discover, develop and commercialize novel therapeutics either on its own or in collaboration with pharmaceutical partners. For more information, please visit www.dicerna.com.
About the GalXCTM RNAi Technology Platform
GalXCTM is a proprietary technology platform invented by Dicerna to discover and develop next-generation RNAi-based therapies designed to silence disease-driving genes in the liver. Compounds produced via GalXC are intended to be broadly applicable across multiple therapeutic areas, including rare diseases, chronic liver diseases, cardiovascular disease and viral infectious diseases. Using GalXC, Dicerna’s scientists attach N-acetylgalactosamine sugars directly to the extended region of our proprietary Dicer substrate short-interfering RNA (DsiRNA) molecules, yielding multiple proprietary conjugate delivery configurations. Many of the conjugates produced via GalXC incorporate a folded motif known as a tetraloop in the extended region. Our tetraloop configuration, which is unique to Dicerna’s GalXC compounds, allows flexible and efficient conjugation to the targeting ligands, and stabilizes the RNAi duplex which the Company believes will enable subcutaneous delivery of its RNAi therapies to hepatocytes in the liver, where they are designed to specifically bind to receptors on target cells, potentially leading to internalization and access to the RNAi machinery within the cells. The technology may offer several distinct benefits, as suggested by strong preclinical data. These benefits include: potency that is on par with or better than comparable platforms; highly specific binding to gene targets; long duration of action; and an infrequent subcutaneous dosing regimen.
Dicerna owns and has licensed a portfolio of patents, patent applications and other intellectual property covering: (1) certain aspects of the structure and uses of DsiRNA and GalXC molecules, including their manufacture and use as therapeutics, and RNAi-related mechanisms, (2) chemical modifications to DsiRNA and GalXC molecules that improve their properties and suitability for therapeutic uses, (3) DsiRNA and GalXC molecules directed to specific gene sequences and drug targets as treatments for particular diseases and (4) delivery technologies, such as in the field of lipid nanoparticles and lipid nanoparticle formulation, and chemical modifications such as conjugation to targeting moieties.
About Boehringer Ingelheim
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas, human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.
Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. More information about Boehringer Ingelheim can be found on www.boehringeringelheim.com. or in our annual report: http://annualreport.boehringeringelheim.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding: (i) the therapeutic and commercial potential of GalXC™; (ii) research and development plans related to GalXC; and (iii) the potential of our technology and drug candidates in our research and development pipeline. The process by which an early stage platform such as GalXC could potentially lead to an approved product is long and subject to highly significant risks, particularly with respect to a pre-clinical research collaboration. Applicable risks and uncertainties include those relating to our preclinical research and other risks identified under the heading “Risk Factors” included in our most recent Form 10-Q filing and in other future filings with the SEC. The forward-looking statements contained in this press release reflect Dicerna’s current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements.
For Boehringer Ingelheim:
Boehringer Ingelheim Corporate Center GmbH Media + PR
Dr. Reinhard Malin, +49 6132 77-90815 :: M: + 49 151 150 20 690
Head of Communications Innovation Unit
reinhard.malin@boehringeringelheim.com
www.boehringeringelheim.com
or
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut
Linda Ruckel, 203-791-6672 :: C: 203-957-5114
Associate Director, Media and Corporate Reputation
linda.ruckel@boehringeringelheim.com
www.boehringeringelheim.com
or
For Dicerna Pharmaceuticals:
Rx Communications Group
Paula Schwartz, 917-322-2216
Managing Director
pschwartz@rxir.com
www.rxir.com
or
SmithSolve Communications
Alex Van Rees, 973-442-1555 ext. 111
Account Director
alex.vanrees@smithsolve.com
www.smithsolve.com
$OCRX to be Acquired by $MNK, Along with Hepatic Encephalopathy Therapy
— Mallinckrodt to commence cash tender offer to purchase Ocera Therapeutics for $1.52 per share, plus Contingent Value Right — — Hepatic encephalopathy (HE) is a neuropsychiatric syndrome associated with hyperammonemia (excess ammonia in the blood) that occurs as complications of liver disease, such as cirrhosis — — Roughly 200,000 U.S. hospitalizations result from acute HE each year; approximately 1.5 to 2 million patients are at risk of recurrent HE — — Average of $30,000-$60,000 per hospital stay; total acute and recurrent HE market potential opportunity of $5.0-$7.0 billion — — If approved, OCR-002 is expected to become the first intravenous pharmacologic option indicated for treatment of acute HE in the U.S.; FDA Orphan Drug designation and Fast Track status granted; EMA Orphan Drug designation — — Acquisition further expands Mallinckrodt’s focus on treatments for severe and critical diseases in hepatic and renal conditions; diversifies portfolio pipeline with different
STAINES-UPON-THAMES, United Kingdom, and REDWOOD CITY, Calif., Nov. 2, 2017 — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, and Ocera Therapeutics, Inc. (NASDAQ: OCRX), today announced that they have entered into an agreement under which Mallinckrodt will acquire Ocera, a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for orphan and other serious liver diseases with high unmet medical need. Ocera’s developmental product OCR-002, an ammonia scavenger, is being studied for treatment of hepatic encephalopathy, a neuropsychiatric syndrome associated with hyperammonemia, a complication of acute or chronic liver disease.
OCR-002 is a Phase 2 asset with both intravenous (IV) and oral formulations. Despite inability to meet statistical significance in its primary endpoint, Ocera’s Phase 2 STOP-HE trial1 achieved secondary endpoints that revealed differentiated clinical impact, including demonstrated effect on lowering serum ammonia levels. Mallinckrodt believes that trial design elements, in part, drove the primary outcome and, on acquisition, will invest to establish the optimal dosing regimen prior to initiating a Phase 3 program. Mallinckrodt will have continued engagement with the U.S. Food and Drug Administration (FDA) to confirm the regulatory pathway to gain FDA approval and subsequently launch the IV formulation, expected by 2022, and the oral formulation, expected by 2024.
The FDA granted OCR-002 its Orphan Drug Designation, and the resulting seven years’ exclusivity would be applied upon first approval of the drug. The FDA also granted its Fast Track designation, a process designed to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need2. The European Medicines Agency (EMA) also granted Orphan Drug status to OCR-002. If approved, the drug will have substantial durability through its Orphan Drug status and additionally through intellectual property that extends to at least 20303.
“Hepatic encephalopathy can be a debilitating condition, affecting brain function and, in some cases, resulting in coma or death,” said Steven Romano, M.D., Chief Scientific Officer and Executive Vice President of Mallinckrodt. “We look forward to bringing this much-needed treatment option to patients who suffer from this condition.”
“We believe OCR-002 has the potential to help thousands of patients whose hepatic encephalopathy is insufficiently treated by current therapies,” said Linda S. Grais, M.D., President and Chief Executive Officer, Ocera. “We’re excited by the additional development capability and commercial reach that can be gained by becoming part of Mallinckrodt. With this focus, I’m confident this important treatment can be successfully brought to market.”
Understanding Hepatic Encephalopathy
Roughly 30 to 35 million U.S. patients have chronic liver disease4, which can develop into liver cirrhosis in some cases, a condition where the liver becomes damaged and irreversibly scarred. Cirrhosis can be brought on by a wide range of underlying causes such as nonalcoholic steatohepatitis, or fatty liver disease; alcohol use; hepatitis; autoimmune diseases; diabetes; and obesity. Approximately 5.5 million patients in the U.S. have liver cirrhosis5.
Cirrhosis impedes the liver’s ability to remove toxins from the body, including ammonia. Hepatic encephalopathy (HE) is a critical neuropsychiatric condition resulting from hyperammonemia (excess ammonia in the blood).While many patients who develop HE will have cirrhosis, incidents of HE are also reported in patients with other types of liver disease such as acute liver failure or bypass shunts. Progression of HE is measured through neurocognitive symptoms6, including personality changes, disorientation, stupor and, in severe cases, coma or death.
Acute HE is usually initially diagnosed in the emergency department, and treated by a hepatologist or gastroenterologist; outside the hospital, HE is largely treated by gastroenterologists. Hospitalized HE patients with other underlying triggers or conditions, e.g., gastrointestinal bleeding or infection, will be sent to the intensive care unit (ICU). Severe acute HE patients will also likely be sent to the ICU. The typical length of overall hospital stay for an acute HE episode is five to seven days, though it may be longer for patients with concomitant conditions. Many acute HE patients have a recurrence and will be readmitted to the hospital with subsequent acute HE episodes.
OCR-002 Eliminates Ammonia from Bloodstream through Novel Method of Action
Although the STOP-HE study7 did not meet its primary endpoint, it achieved secondary endpoints that validated OCR-002 as a potent ammonia scavenger, leading to significant reduction in circulating ammonia (p=0.017). In a subsequent, post-hoc analysis of the data, it was observed that the degree of ammonia reduction in patients correlated strongly with clinical improvement. As the response rate also appeared to increase proportionally to dose level, this suggests that some patients in the Phase 2 trial may have been under-dosed.
Treatment with OCR-002 rapidly eliminates ammonia in the bloodstream, excreting it through the kidneys, a more effective and less burdensome method of addressing HE than existing treatment options. Those alternatives include lactulose, a laxative that frequently causes severe diarrhea, and Rifaximin, an antibiotic indicated only for reduction of recurrent HE, which can cause broad gastrointestinal issues and is restricted for patients with severe liver issues.
OCR-002’s active ingredients are ornithine and phenylacetic acid (PAA). The unique method of action includes:
- Ornithine contributes to glutamate, which combines with ammonia to create glutamine, a carrier of ammonia that “pushes” ammonia through the body.
- PAA combines with glutamine to form phenylacetylglutamine, “pulling” ammonia into the urine and excreting it through the kidneys.
The IV formulation of OCR-002, if approved, is expected to provide rapid reduction in symptoms of acute HE, and potentially reduce hospitalization stay. A subset of patients continues to have HE symptoms after discharge. OCR-002’s oral formulation, if approved, is expected to provide post-discharge continuity of care for the HE patient, reducing the risk of recurrent HE episodes and rehospitalization. It is also anticipated that patients may transition from the IV to the oral formulation prior to discharge from the hospital setting.
“We believe OCR-002 has the potential to significantly alter the treatment paradigm for patients suffering from this serious condition,” said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt. “The addition of this highly durable, unique developmental asset to our portfolio is an excellent example of Mallinckrodt’s strategic vision as a patient-centric, innovation driven specialty pharmaceutical growth company focusing on severe and critical conditions.”
Hepatic Encephalopathy Market
Approximately 200,000 U.S. patients are hospitalized with acute HE annually. Acute HE patients’ average hospital stay is five to seven days, at an average cost of $30,000 to $60,000 per stay8. There is a 40 to 50 percent recurrence rate and potential rehospitalization within the first year of an acute event, with the likelihood of recurrence increasing with severity9. Only 50 to 60% of high-risk patients are receiving current standard of care and fewer stay on therapy due to poor compliance10.
The U.S. potential market opportunity is estimated at $5 to $7 billion11,12, with $2 to $3 billion in acute treatment and $3 to $4 billion for recurrent incidents. Approximately 1.5 to 2 million patients are at risk of HE13. As noted, no intravenous FDA-approved therapy exists for the treatment of acute HE.
Ocera holds worldwide rights to OCR-002, and Mallinckrodt estimates the market for HE patients in Europe and Japan to be in the range of 150,000 to 200,000 annually. Mallinckrodt will assess regulatory pathways for approvals in markets outside the U.S. post-acquisition.
Commercialization
If approved, Mallinckrodt expects OCR-002 to be commercialized by the company’s existing sales organizations. At launch, patient access to this unique treatment option would also be supported and enhanced by the company’s strong relationships with hospital networks, insurance companies and group purchasing organizations. Mallinckrodt’s existing infrastructure of clinical and medical affairs experts will also support approval and launch of both formulations of the product. Mallinckrodt will work with the Ocera development team to ensure smooth integration of the development and regulatory plan.
Financial Considerations and Closing
A subsidiary of Mallinckrodt will commence a cash tender offer to purchase all of the outstanding shares of Ocera Therapeutics common stock for $1.52 per share (approximately $42 million), plus one Contingent Value Right to receive one or more payments in cash of up to $2.58 per share (up to approximately $75 million) based on the successful completion of certain development and sales milestones.
Mallinckrodt expects dilution from the acquisition to adjusted diluted earnings per share by $0.25 to $0.35 annually beginning in 2018, assuming the expected 2017 close. Guidance on the impact of the acquisition to the company’s GAAP14 diluted earnings per share has not been provided due to the inherent difficulty of forecasting the timing or amount of items that would be included in calculating such impact. Subject to customary closing conditions, the company estimates the transaction will close in the fourth quarter of 2017.
ABOUT OCERA
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous (IV) and oral formulations. OCR-002 is an ammonia scavenger and has been granted Orphan Drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy (HE) in patients with acute liver failure and acute-on-chronic liver disease.
Ocera’s HE clinical development efforts include a recently completed Phase 2b clinical trial, STOP-HE, which evaluated the safety and efficacy of intravenously-administered OCR-002 in resolving neurocognitive symptoms of acute HE in hospitalized patients with elevated ammonia. Ocera is preparing to meet with the FDA later this year to review the IV program and discuss potential development paths forward.
Ocera is currently evaluating its oral tablet form of OCR-002 in a Phase 2a study in patients with cirrhosis as a chronic use option to maintain remission of HE. Results of this study are expected to be published by the end of 2017. For additional information, please see www.ocerainc.com.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products. The company’s core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company’s Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
NON-GAAP FINANCIAL MEASURES
This press release references adjusted diluted earnings per share, which is considered a “non-GAAP” financial measure under applicable SEC rules and regulations.
Adjusted diluted earnings per share represent adjusted net income divided by the number of diluted shares. Adjusted net income represents amounts, prepared in accordance with accounting principles generally accepted in the U.S. (GAAP), adjusted for certain items (on an after-tax basis) that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include restructuring and related charges, net; amortization and impairment charges; discontinued operations; acquisition-related expenses, changes in fair value of contingent consideration obligations; inventory step-up expenses; significant legal and environmental charges; pension settlement charges; recurrent cash tax payments to the U.S. Internal Revenue Service associated with internal installment sales transactions; and other items identified by the company.
The company has provided these adjusted financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate the company’s operating performance. In addition, the company believes that they will be used by certain investors to measure Mallinckrodt’s operating results. Management believes that presenting these adjusted measures provides useful information about the company’s performance across reporting periods on a consistent basis by excluding items that the company does not believe are indicative of its core operating performance.
These adjusted measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The company’s definition of these adjusted measures may differ from similarly titled measures used by others.
Because adjusted financial measures exclude the effect of items that will increase or decrease the company’s reported results of operations, management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety.
Cautionary Statements Related to Forward-Looking Statements
Statements in this document that are not strictly historical, including the proposed acquisition of Ocera Therapeutics, Inc., the expected timetable for completing the transaction, statements regarding future financial condition and operating results, economic, business, market opportunity, competitive and/or regulatory factors affecting Mallinckrodt’s and Ocera’s businesses and any other statements regarding events or developments that the companies believe or anticipate will or may occur in the future, may be “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: general economic conditions and conditions affecting the industries in which Mallinckrodt and Ocera operate; Ocera’s ability to obtain regulatory approval to market its product or the timing of such approval process; the commercial success of Mallinckrodt’s products and Ocera’s product; the parties’ ability to satisfy the acquisition agreement conditions and complete the Ocera acquisition on the anticipated timeline or at all; Mallinckrodt’s ability to realize anticipated growth, synergies and cost savings from acquisitions (including the Ocera acquisition); conditions that could necessitate an evaluation of Mallinckrodt’s goodwill and/or intangible assets for possible impairment; changes in laws and regulations; Mallinckrodt’s ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings (including with respect to the Ocera acquisition); Mallinckrodt’s and Mallinckrodt’s licensers’ ability to successfully develop or commercialize new products; Mallinckrodt’s and Mallinckrodt’s licensers’ ability to protect intellectual property rights; Mallinckrodt’s ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; customer concentration; Mallinckrodt’s reliance on certain individual products that are material to its financial performance; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; the reimbursement practices of a small number of public or private insurers; pricing pressure on certain of Mallinckrodt’s products due to legal changes or changes in insurers’ reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; limited clinical trial data for H.P. Acthar® Gel; complex reporting and payment obligations under healthcare rebate programs; Mallinckrodt’s ability to navigate price fluctuations; future changes to U.S. and foreign tax laws; Mallinckrodt’s ability to achieve expected benefits from restructuring activities; complex manufacturing processes; competition; product liability losses and other litigation liability; ongoing governmental investigations; material health, safety and environmental liabilities; retention of key personnel; conducting business internationally; the effectiveness of information technology infrastructure; and cybersecurity and data leakage risks.
These and other factors are identified and described in more detail in the “Risk Factors” sections of Mallinckrodt’s Annual Report on Form 10-K for the fiscal year ended September 30, 2016, as well as such sections of Ocera’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt and Ocera do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Additional Information and Notice to Investors
This communication is for informational purposes only and does not constitute an offer to purchase nor a solicitation of an offer to sell any securities of Ocera Therapeutics. The tender offer for the shares of Ocera Therapeutics common stock described in this communication has not yet commenced. The solicitation and offer to purchase shares of Ocera Therapeutics common stock will only be made pursuant to a tender offer statement on Schedule TO and related exhibits, including the offer to purchase, letter of transmittal, and other related documents. Upon commencement of the tender offer, Mallinckrodt plc and its wholly-owned subsidiaries, MAK LLC and MEH Acquisition Co., will file with the SEC a tender offer statement on Schedule TO and related exhibits, including the offer to purchase, letter of transmittal, and other related documents. In addition, Ocera will file with the SEC a tender offer solicitation/recommendation statement on Schedule 14D-9 with respect to the tender offer. These documents will contain important information, including the terms and conditions of the tender offer. Investors and security holders are urged to read each of these documents and any amendments to these documents carefully when they are available prior to making any decisions with respect to the tender offer. Investors and security holders will be able to obtain free copies of these materials (when available) and other documents filed with the SEC through the web site maintained by the SEC at www.sec.gov. Copies of the documents filed by Mallinckrodt plc, MAK LLC and MEH Acquisition Co. with the SEC will also be available free of charge on the Investor Relations section of its website at www.mallinckrodt.com and copies of the documents filed by Ocera with the SEC will be available free of charge on Ocera’s website at www.ocerainc.com.
CONTACTS
Mallinckrodt plc
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
Ocera Therapeutics, Inc.
Michael Byrnes
Chief Financial Officer
650-475-0150
mbyrnes@ocerainc.com
Susan Sharpe
Senior Director, Corporate Communications
919-328-1109
ssharpe@ocerainc.com
1 Presentation at The Liver Meeting® the annual meeting of the American Association for the Study of Liver Diseases, held Oct. 20-24. https://liverlearning.aasld.org/aasld/2017/thelivermeeting/201404/stanley.bukofzer.ocr-002.28ornithine.phenylacetate29.is.a.potent.ammonia.html?f=topic=1572*media=3
2 https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm
3 U.S. Patent and Trademark Office
4 American Liver Foundation, Clinical Gastroenterology and Hepatology, 2011;9:524‐530 Zobair et al
5 Clin Liver Dis (2012) 73‐89 Khungar et al
6 West Haven score
7 Presentation at The Liver Meeting® the annual meeting of the American Association for the Study of Liver Diseases, held Oct. 20-24. https://liverlearning.aasld.org/aasld/2017/thelivermeeting/201404/stanley.bukofzer.ocr-002.28ornithine.phenylacetate29.is.a.potent.ammonia.html?f=topic=1572*media=3
8 HCUP, company estimate
9 Int J Gen Med 2015 Saab et al
10 Company market research
11 Pharmacotherapy (2010) Neff
12 Clin Gastroenterology and Hepatology 2012 Stepanova et al
13 Clin Liver Dis (2012) 73-89 Khungar et al
14 Accounting principles generally accepted in the U.S.
$NBEV Signs Agreement With Unified Strategies Group
DENVER, CO–(Nov 1, 2017) – New Age Beverages Corporation (NASDAQ: NBEV) the Colorado-based leading all-natural and organic healthy functional beverage company today announced that the Company has signed an agreement with Unified Strategies Group (USG) to expand distribution to USG’s more than 1,000,000 vending machines, 5,000 micro markets and over 1,800 client dining facilities throughout the United States.
New Age Beverages has developed a portfolio of better-for-you beverages over the past year that includes XingTea®, Aspen Pure® Probiotic water, Búcha® Live (organic) Kombucha, Marley® (coffee, relaxation drinks and organic yerba mate), Coco-Libre® (coconut waters and sparkling coconut waters), and a number of impending products for the medical channel through their Health Sciences Division including PediaAde™, Enhanced Recovery™ (Recovery After Surgery Beverage), and others.
Unified Strategies Group is the leading US purchasing cooperative servicing independently owned vending, office coffee service, micro market, and food service companies. USG consists of about 2,000 member companies operating in all 50 states. USG generates over $5 billion in annual revenue and currently distributes leading brands including Kraft Heinz, Frito Lay, Mars, Nestle, Kellogg’s, and others. Their system reaches 75,000 workplace locations a day and will now be offering the New Age Beverages portfolio throughout their system.
Michael Cunningham, Senior Vice President of Sales for New Age commented, “Over the past few months, New Age has almost doubled their previous traditional retailer penetration in grocery and convenience. New Age’s portfolio of healthy functional beverages is now taking hold with major retail partners, major distributors and consumers. The expansion with USG is the next step in our evolution to new channels whose customers are also seeking a full portfolio of organic, natural, and better-for-you alternatives. We are excited to work with USG and are confident it will be a very mutually beneficial partnership.”
Since uplisting onto the NASDAQ Exchange in February the Company has eliminated virtually all debt, completed three additional acquisitions, developed a number of new products on its acquired platforms and expanded retail distribution by over 15,000 new outlets. In addition to those developments, New Age recently signed an agreement with Advantage Solutions, one of the leading sales and marketing agencies in the United States to expand traditional key account penetration, and completed a partnership with Dot Foods, the largest food redistributor in the United States to penetrate new channels including foodservice, offices, hospitals and others.
About Unified Strategies Group (USG)
Unified Strategies Group is the leading US purchasing cooperative servicing independently owned vending, office coffee service, micro market and food service companies. USG consists of about 2,000 member companies operating in all 50 states, generating over $5 billion in annual revenue via more than 1,000,000 vending machines, 5,000 micro markets and over 1,800 client dining facilities. USG operates as a non-profit corporation, headquartered in Arlington Heights, IL. USG successfully drives cost savings to its membership through rebate based supplier programs, manufacturer volume discounts and off-invoice allowances. To its supplier partners, USG offers national scale, volume, product trials and sales performance.
About New Age Beverages Corporation (NASDAQ: NBEV)
New Age Beverages Corporation is a Colorado-based, leading all-natural and organic healthy functional beverage company that was founded in 2003. The Company competes in the fast-growing healthy functional beverage segments including Ready to Drink (RTD) Tea, RTD Coffee, Kombucha, Energy Drinks, Relaxation Drinks, Coconut Waters and Functional Waters with the brands XingTea®, Marley One Drop®, Búcha® Live Kombucha, XingEnergy®, Marley Mellow Mood®, Marley Mate™, Coco-Libre®, PediaAde™, and Aspen Pure® PH and Aspen Pure® Probiotic Water. The Company’s brands are sold across all 50 states within the US and in more than 10 countries internationally across all channels via direct and store door distribution systems. The company operates the websites http://newagebev.us, http://newagehealth.us, www.mybucha.com, www.xingtea.com, www.aspenpure.com, www.drinkmarley.com, www.cocolibre.com, and https://shop.newagebev.us.
New Age has exclusively partnered with the world’s 5th largest water charity, WATERisLIFE, to end the world water crisis with the most innovative technologies available. Donate at WATERisLIFE.com to help us #EnditToday.
Safe Harbor Disclosure
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statement reflecting management’s current expectations regarding future results of operations, economic performance, financial condition and achievements of the Company including statements regarding New Age Beverage’s expectation to see continued growth. The forward-looking statements are based on the assumption that operating performance and results will continue in line with historical results. Management believes these assumptions to be reasonable but there is no assurance that they will prove to be accurate. Forward-looking statements, specifically those concerning future performance are subject to certain risks and uncertainties, and actual results may differ materially. New Age Beverages competes in a rapidly growing and transforming industry, and other factors disclosed in the Company’s filings with the Securities and Exchange Commission might affect the Company’s operations. Unless required by applicable law, NBEV undertakes no obligation to update or revise any forward-looking statements.
For investor inquiries about New Age Beverages Corporation please contact:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com
$VRML Major Coverage Milestone – A 27% Increase in Covered Lives for OVA1
AUSTIN, Texas, Nov. 1, 2017 — ASPiRA Labs, a Vermillion company (NASDAQ: VRML) and the exclusive distributor of OVA1 (Multivariate Index Assay) (MIA), today announced that it has substantially expanded positive policy coverage with the addition of 14 key managed care providers. This positive coverage is a transition from negative policy to positive policy for many of these plans.
“ASPiRA Labs has increased positive coverage for OVA1 with 14 providers totaling over 26 million lives,” stated Fred Ferrara, Chief Operating Officer of Vermillion, Inc. “Two policies totaling approximately 3.8 million covered lives are effective as of October 1, 2017, with the remainder being effective January 2018. This positive policy coverage is the first step to in-network contracts and market adoption. We are finishing this year strong with managed care rapidly increasing support of OVA1 to over 123 million lives, as of January 2018. OVA1 provides the only pelvic mass risk assessment product proven to get patients to the highest standard of care for ovarian cancer treatment.”
These recent positive coverage policies specify that OVA1 is medically necessary for the below plans:
- BlueCross BlueShield (BCBS) plans associated with a national plan, Health Care Service Corporation (HCSC) that include Illinois, Montana, New Mexico, Oklahoma and Texas (approximately 14.8 million covered lives)
- Horizon BCBS plans in New Jersey (approximately 3.7 million covered lives)
- Highmark BCBS plans that include Pennsylvania, West Virginia and Delaware (approximately 3.2 million covered lives)
- Wellcare: Government sponsored managed care across the U.S. (approximately 2.9 million covered lives)
- Other Plans:
- Health Alliance Medical Plans, Oscar and Prominence Health Plans (together, approximately 1.0 million covered lives)
- 1199 SEIU Benefits in New York (approximately 351,000 covered lives)
- Health New England (approximately 191,000 covered lives)
OVA1 is the most comprehensive risk assessment test that can stratify women at risk for ovarian cancer in all ages, stages and subtypes. These new policies will bring the total number of covered lives for OVA1 to more than 123 million, as of January 2018.
We expect the 2018 Centers for Medicare and Medicaid Services (CMS) pricing for OVA1 and Overa to be finalized in the fourth quarter of 2017, based on Protecting Access to Medicare Act of 2014 (PAMA) calculated rates. In addition, we expect that OVA1 will be also listed on the 2018 Clinical Lab Fee Schedule (CLFS), effective January 1, 2018, with a PAMA assigned price. We believe these prices will further support our value to the healthcare system.
Each year in the US, there is a 5-10% lifetime risk for women undergoing surgery for a suspected ovarian neoplasm. The majority of the masses are benign and, as a result, triaging the low and high risk masses is vital to improved patient outcomes. Today, more than 60% of the ovarian cancer patients do not receive National Comprehensive Cancer Network (NCCN) guideline treatment, which includes surgical treatment by a gynecologic oncologist, and, as a result, the survival rate is reduced by 30-40%. OVA1 helps ensure that rare ovarian cancer is triaged appropriately to the gynecological oncologist and benign cysts are managed by the general practitioner in the most cost effective and efficient way. Our goal is to have the right patient managed by the right specialist with the right treatment the first time.
Links to our complete list of payer coverage and multiple clinical studies showing OVA1’s strong performance compared to existing technologies, such as CA125 and ROMA, can be found on our website:
http://vermillion.com/providers/ova-1/clinical-validation-studies/.
About Vermillion
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases. The company’s initial in vitro diagnostic test, OVA1® (MIA), was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016, Vermillion received FDA clearance for Overa™, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.
Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements regarding the number of covered lives for OVA1 as of January 2018, CMS pricing of OVA1 and Overa, inclusion of OVA1 on the CLFS and the anticipated impact of expected pricing on Vermillion’s value to the healthcare system. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on Vermillion’s expectations as of the date of this press release. A variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements, including changes to interpretations of existing laws and regulations and other factors that are described in Vermillion’s Form 10-K for the year ended December 31, 2016 and Form 10-Q for the quarter ended March 31, 2017 as filed with the Securities and Exchange Commission. Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
mwood@lifesciadvisors.com
$CPAH Awarded Patent Leveraging Presence and Location for Mobile and IP Networks
Presence and location will drive how embedded communications are used in everyday life across businesses, advertising, social networking and other consumer services
VANCOUVER, British Columbia, Nov. 01, 2017 — CounterPath Corporation (NASDAQ:CPAH) (TSX:PATH), a global provider of award-winning, over-the-top (OTT) Unified Communications (UC) solutions for enterprises and carriers, today announced that it has been awarded patent No. US 9,774,695 by the U.S. Patent and Trademark Office. Titled “Enhanced Presence Detection For Routing Decisions,” this patent optimizes the routing of calls, messages and other communication based upon a user’s real time presence information from both broadband and mobile networks.
While user presence detection from a single network is not new, maintaining a presence status for both types of broadband and mobile networks, and making decisions on where to send messages or request updates when that user is potentially attached to both networks, is novel. Originally, single network, non-data phones would attach to the mobile network and signal that the phone was available to take calls, receive texts and authorize it to make the same. Today our smart phones can attach to both IP and mobile networks simultaneously.
Presence status has also evolved to be more richly composed of details, such as where the person is located via GEO inclusion fields, whether they wish to be disturbed, and if so, by which select group of priority individuals. This richness of presence information leads to a multitude of product features that may be offered. For example, one scenario is using a smartphone’s calendar to expose meeting information over the broadband network, which informs the routing engine not to disturb the user with cellular or VoIP calls during the user’s meetings. Alternatively, a list of priority individuals may be permitted to interrupt the meeting or send messages to the individual. This allows users to remain reachable where urgent conditions are met, or remain undisturbed for less important communications.
“CounterPath has been building software for the communication market for more than 10 years. The relevance of this technology and its underlying patent has even greater significance today,” said Donovan Jones, President and CEO of CounterPath. Communications networks are being meshed and inextricably intertwined with social networks. Increasingly, users are always connected to one or more social networks with their identity and location increasingly public. Seamlessly moving calls based on presence and location is a game changer.”
For more information on CounterPath, please visit http://www.counterpath.com.
About CounterPath
CounterPath Unified Communications solutions are changing the face of telecommunications. An industry and user favorite, Bria softphones for desktop, tablet and mobile devices, together with Stretto Platform™ server solutions, enable operators, OEMs and enterprises large and small around the globe to offer a seamless and unified over-the-top (OTT) communications experience across both fixed and mobile networks. The Bria and Stretto combination enables an improved user experience as an overlay to the most popular UC and IMS telephony and applications servers on the market today. Standards-based, cost-effective and reliable, CounterPath’s award-winning solutions power the voice and video calling, messaging, and presence offerings of customers such as AT&T, Avaya, BroadSoft, BT, Cisco Systems, GENBAND, Metaswitch Networks, Mitel, NEC, Network Norway, Nokia, Rogers and Verizon. Visit www.counterpath.com.
Contacts
Ragi Mahil
Vice President of Marketing
e-mail: rmahil@counterpath.com
Investor Relations
e-mail: ir@counterpath.com
$CIIX Announces Board of Directors Appointments
SAN GABRIEL, California, November 1, 2017 —
ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announced that it has appointed Delray Wannemacher and Patrick Leung as Independent Directors and Keevin Gillespie as an Executive Director effective November 1, 2017. Mr. Wannemacher and Mr. Leung will also serve on the Company’s Audit Committee along with its recently appointed Chief Financial Officer, Paul Dickman.
“We are extremely pleased to welcome Delray, Patrick and Keevin to the ChineseInvestors.com, Inc.’s Board of Directors,” stated Warren Wang, Chief Executive Officer of ChineseInvestors.com, Inc. “Their financial and industry experience make these gentlemen excellent choices for the Company’s Board as we continue to grow our Financial Services/Media Division and further develop our Consumer Retail Division. We also look forward to Delray’s and Patrick’s service on the Company’s Audit Committee alongside CFO Paul Dickman.”
Mr. Wannemacher has more than 20 years of experience helping build and finance both private and public emerging growth companies. As the current CEO for First Look Equities, he sets the strategic vision for the company’s national and global operations. Mr. Wannemacher also has extensive experience building investment communities by leveraging technology and services to streamline the capital formation process. His experience covers a wide variety of sectors including internet, software, finance, crowdfunding portals, media, communications, EB5 projects, global investments and trade. Through his efforts, Mr. Wannemacher has helped a variety of public and private companies to raise hundreds of millions of dollars. More info http://www.firstlookequites.com/about.
Mr. Wannemacher also serves on the Executive Board at The World Trade Center of Atlanta where he is the Vice President of Business Development responsible for developing corporate partnerships and sponsorships. In addition, Mr. Wannemacher currently serves as the Vice Chair for World Trade Day which focuses on global trade and investments. More info: http://www.wtcatlanta.com/about/ and http://www.worldtradeday.com.
Mr. Leung, has over 20 years’ experience as a Certified Public Accountant and is a member of CPA Australia, the Hong Kong Institute of Certified Public Accountants, and the Association of International Professional Accountants. Mr. Leung has also held several Board seats including his current positions as an Independent Director at Daisho Microline Holdings Limited, where he also serves as the Chairman of the Audit Committee and is a member of the Remuneration and Nomination Committee; an Executive Director and Secretary for Kirin Group Holdings Limited, where he acts as a liaison between the company and its auditors, financial advisors, lawyers and regulators; and an Independent Director at Biostar Pharmaceuticals, Inc. where he is also Chairman of the Audit Committee, Nomination and Compensation Committee.
Mr. Gillespie is President of ChineseInvestors.com, Inc.’s wholly owned subsidiary, ChineseHempOil.com, Inc. Prior to that he served as Vice President of sales for the Company and was integral in helping Mr. Wang to build ChineseInvestors.com, Inc. into what it is today. Prior to joining ChineseInvestors.com, Inc. and ChineseHempOil.com, Inc., Mr. Gillespie served as Vice President of Sales, Branch Manager, HR Director/Recruiter, and Senior Account Executive at various investment firms where he managed the placement of several initial public offerings and private placements.
About ChineseInvestors.com (OTCQB: CIIX)
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online and direct sales of hemp-based products and other health related products.
For more information visit ChineseInvestors.com.
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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.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776
Investor Relations:
Alan Klitenic
+1-214-636-2548
Corporate Communications:
NetworkNewsWire (NNW)
+1-212-418-1217 Office
Editor@NetworkNewsWire.com
$PBIO Initiates Aggressive Marketing and Sales Strategy to Expand in China
Professor Tiannan Guo’s Laboratory at Westlake Institute for Advanced Study Named First PBI Center of Excellence in China — Four Barocycler Instruments Purchased to Support Collaborative Effort
SOUTH EASTON, MA–(Nov 1, 2017) – Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” and the “Company”), a leader in the development and sale of innovative, broadly enabling, pressure-based instruments and related consumables for the worldwide life sciences industry, today announced that Professor Tiannan Guo’s laboratory at Westlake Institute for Advanced Study (“WIAS”) has been named the Company’s first Center of Excellence (“CoE”) in China. Professor Guo, M.D., Ph.D. and internationally-recognized proteomics expert Professor Ruedi Aebersold (ETH-Zurich, Switzerland) are the co-developers of PCT-SWATH, a major breakthrough in high throughput proteomic sample analysis.
PCT-SWATH is a novel proteomics method that combines the unique capabilities of PBI’s patented pressure cycling technology (“PCT”) platform for sample preparation (a critical step in the research process) with the cutting-edge analytical capabilities of SCIEX’s mass spectrometry SWATH method. SCIEX, a global leader in life sciences analytical technologies, signed an exclusive co-marketing agreement with PBI in early 2016 to improve protein quantitation in complex samples. Data strongly indicate that PCT-SWATH allows scientists to reproducibly extract, identify, and quantify more proteins from complex samples types in a shorter period of time than current methods, potentially facilitating the path to earlier and superior biological insights and discoveries.
Professor Guo said: “I am honored that our laboratory at WIAS was chosen to be PBI’s first CoE in China. Having worked with this novel, enabling technology platform for many years, I believe strongly that PCT will have a significant impact in helping research scientists in China and around the world make new discoveries in multiple fields, including proteomics, genomics, lipidomics, and metabolomics.”
Professor Guo continued: “As head of the Center of Excellence in China, I look forward to being a source of information on the features and benefits of the PCT platform, in helping my colleagues to develop new uses and applications for PCT, and in being a site where others can come and learn about PCT and PCT-SWATH. I am excited about the tasks ahead — to help educate research scientists and broaden the use of the PCT platform in China, as well as in other countries in Asia and worldwide.”
Dr. Nate Lawrence, VP of Marketing and Sales at PBI, said: “We are very pleased that Professor Guo will be leading the effort to establish and then direct our first CoE in China. This Center is the first of its kind in Asia and joins our other Centers of Excellence in Europe and Australia as an important pillar in our global marketing and sales strategy. We believe Professor Guo’s vast experience with the PCT platform, his expertise in proteomics and lipidomics, and his fluency in both Chinese and English will be invaluable in helping PBI quickly and successfully expand into the large life sciences market in China.”
Dr. Lawrence continued: “We believe the Guo Center of Excellence will quickly evolve into a powerful resource for our exclusive distributor in China, Powertech Technology Company, Ltd. With the support of Professor Guo and his team, we believe that Powertech will flourish and soon become an even stronger distributor of PBI products throughout all of China.”
Mr. Richard T. Schumacher, President and CEO of PBI, said: “Although the initial purchase of four instruments and related consumables from WIAS is greatly appreciated, it is the potential impact of having our Barocycler instruments in a laboratory at one of China’s premier research institutes, led by one of the most innovative and knowledgeable PCT users in the world, that is most exciting to us. The Chinese life sciences market is one of the largest and fastest-growing in the world. We expect to rapidly expand into this critical market with help from our colleagues at WIAS. Together with our recent expansion into Europe and the hiring of our own field sales team in the U.S., we believe our marketing strategy will result in significant revenue increases, driven by a larger and more diversified global customer base.”
About Westlake Institute for Advanced Study
Westlake Institute for Advanced Study (“WIAS”) is a non-profit research institute dedicated to the advancement of natural sciences and the frontiers of engineering disciplines. Located in the beautiful Cloud Town of Xihu District, Hangzhou, China, WIAS strives to represent the scientific strength of China, to influence the nation’s future, and to promote inclusive development and progress. Laying the foundation for the future Westlake University, WIAS aims at establishing a top-level research-oriented global university. At WIAS, scientific knowledge and technological advancement are utilized to have a real life impact on the world and to benefit human beings. Leading talent with innovative spirit and capabilities are trained to become the driving force of China’s development.
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or “PCT”) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug development and design, bio-therapeutics characterization, soil & plant biology, forensics, and counter-bioterror applications. Major new focal market opportunities are emerging in the use of our patented, scalable, high-efficiency Ultra Shear Technology (“UST”) to create stable nanoemulsions of otherwise immiscible fluids (such as oils and water), and to prepare higher quality, homogenized, extended shelf-life or room temperature stable, low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.
Forward Looking Statements
Statements contained in this press release regarding PBI’s intentions, hopes, beliefs, expectations, or predictions of the future are “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based upon the Company’s current expectations, forecasts, and assumptions that are subject to risks, uncertainties, and other factors that could cause actual outcomes and results to differ materially from those indicated by these forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law.
For more information about PBI and this press release, please click on the following website link: http://www.pressurebiosciences.com
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Investor Contacts:
Pressure BioSciences, Inc.
Richard T. Schumacher
President & CEO
Nathan P. Lawrence, Ph.D.
VP of Marketing and Sales
(508) 230-1828 (T)
$GERN Fast Track Designation Granted to Imetelstat for Myelodysplastic Syndromes
Expanded Part 1 of IMerge is Open for Patient Enrollment
MENLO PARK, Calif., Oct. 31, 2017 — Geron Corporation (Nasdaq:GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are non-del(5q) and who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA). Imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech, Inc. (Janssen) on a worldwide basis. Janssen sponsored the application for Fast Track designation utilizing preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS.
The FDA’s Fast Track Program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and supported by data that demonstrate the potential to address an unmet medical need. Fast Track designation provides opportunities for frequent interactions with FDA review staff, including meetings to discuss the drug’s development plan and to ensure the collection of appropriate data needed to support approval. Through the Fast Track Program, a product candidate may be eligible for priority review, if supported by the clinical data, and for the ability to submit completed sections of a New Drug Application (NDA) on a rolling basis as data become available prior to completion of the full application.
Imetelstat Clinical Development in MDS
Imetelstat is being evaluated in an ongoing Phase 2/3 clinical trial (IMerge) in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an ESA. IMerge is designed in two parts: Part 1 is a Phase 2, open-label, single-arm design and Part 2 is designed to be a Phase 3, randomized, controlled trial.
As previously announced, 32 patients were enrolled in Part 1 of IMerge, of which a subset of 13 patients had not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and did not have a del(5q) chromosomal abnormality. As of May 2017, the 13-patient subset showed an increased durability and rate of red blood cell (RBC) transfusion independence (TI) compared to the overall trial population (≥8-week RBC-TI: 53.8% vs 34.4%). Based on these data, Part 1 is being expanded to enroll approximately 20 additional patients who are non-del(5q) and naïve to HMA and lenalidomide treatment to increase the experience and confirm the benefit-risk profile of imetelstat in this refined target patient population. Janssen has opened the expanded Part 1 for patient enrollment. For more information about IMerge, please visit https://clinicaltrials.gov/ct2/show/NCT02598661.
Results for the original 32 patients in Part 1 of IMerge, including hematologic improvement and rate of RBC-TI lasting at least 24 weeks, as well as duration of response and safety information, are expected to be presented at an upcoming major medical conference.
About Imetelstat
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat might have disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Imetelstat has not been approved for marketing by any regulatory authority.
About the Collaboration with Janssen
On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) continued conduct by Janssen of IMerge and any future clinical trials of imetelstat; (ii) expanding enrollment to Part 1 of IMerge in a refined target patient population; (iii) the timing for enrollment to begin for the expanded Part 1 of IMerge; (iv) any future presentation of data from current clinical trials of imetelstat by Janssen at a major medical conference; (v) potential outcomes of any data reviews conducted by Janssen for IMerge; (vi) the safety and efficacy of imetelstat; (vii) that approximately 20 additional patients in IMerge will be sufficient for decision-making; (viii) potential receipt by Geron of additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, and royalties from sales of imetelstat; and (ix) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) whether Janssen decides to continue to conduct IMerge; (ii) whether imetelstat is safe and efficacious and will succeed in IMerge by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (iii) whether the FDA or other health authorities permit IMerge to continue to proceed under the existing protocols or any amendments thereto; (iv) Janssen’s ability to collect additional and more mature data from current clinical trials of imetelstat; (v) Geron’s dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the collaboration agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the collaboration agreement with Janssen and the clinical development or commercialization of imetelstat could be delayed or terminated; (vi) whether any future efficacy or safety results from any clinical trial of imetelstat may cause the benefit/risk profile of imetelstat to become unacceptable; and (vii) whether patent coverage of imetelstat enables Janssen to successfully commercialize imetelstat. Additional information on the above-stated risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended June 30, 2017. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
CONTACT:
Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
investor@geron.com
media@geron.com
$RESN Availability of Full-Band, Band 41 TDD Filter ISN Design In SAW
GOLETA, CA–(October 31, 2017) – Resonant Inc. (NASDAQ: RESN), a designer of filters for radio frequency, or RF, front-ends that specializes in delivering designs for difficult bands and complex requirements, today announced that a licensee has produced a state-of-the-art Full-Band, Band 41 Time Division Duplex (TDD) filter that is required for all handset vendors addressing the China market, using a Resonant Surface Acoustic Wave (SAW) design. Resonant’s licensee has also made this Band 41 filter available for sale and is currently sampling to OEMs.
The Band 41 TDD filter is a highly technical and complex design, widely regarded as one of the most difficult filters to design. Typically, in high frequency operation (the maximum passband frequency is 2.69GHz), these designs are restricted to small feature sizes, while the filter must handle high LTE powers because of TDD operation. In addition, this specialized design requires extremely large bandwidth at 194MHz, as well as the rejection of neighboring WiFi bands to prevent interference.
“Not only were we able to create this very complex Band 41 filter design in less than our stated time frame of 12-18 months for an ISN Pilot design, but we did it on a SAW platform, which we believe is the first of its kind in the market,” said George Holmes, CEO of Resonant Inc. “We expect this to be a high-volume filter, with the potential for rapid growth due to its use in Asia for LTE. Our customers require increasing complexity and rapidly evolving technology, which Resonant has delivered in the Band 41 filter design using our innovative software, intellectual property, and the capabilities of our experienced team.”
“This design is yet another example of how we are focusing on our core business and reducing execution risk as we drive towards royalty revenues,” Holmes added. “We continue to collaborate with our customers to reduce the time it takes to bring our designs to market, in an effort to accelerate our receipt of royalty revenues.”
The Company believes that the superior performance of Resonant’s Band 41 filter design offers several key advantages over competitive filters:
- Full band operation (194MHz) – One part can accommodate all of the Band 41 carriers globally. This is a significant improvement, given that most of the commercially available filters are sub-band, while full band parts are traditionally processed in BAW and FBAR, which is much more expensive.
- WiFi co-existence filter – This filter design results in high rejection to WiFi ( > 35dB). In addition, it allows for operation of TDD cellular and WiFi simultaneously, while also reducing interference.
- Small footprint – With measurements of only 1.3 mm x 1.1 mm, the size of this design translates to less material and lower production costs, which can be passed on to customers.
- HPUE capable – High Performance User Equipment (HPUE) is designed to improve the performance of TDD-LTE Band 41 networks around the world, by allowing higher power operation and therefore improved coverage. This is a current requirement of China Mobile.
Figure 1 compares the measured passband performance of Resonant’s Band 41 filter design as compared to the best publicly available Band 41 filter. Lower insertion loss (IL) represents higher performance.
The improved performance over BAW is validation of the capabilities of Resonant’s ISN platform. In particular, the accuracy with which the measured performance matches the simulation prior to fabrication (see Figure 2), allows optimization of performance without the need for multiple fabrication iterations.
About Resonant Inc.
Resonant is creating software tools and IP & licensable blocks that enable the development of innovative filter designs for the RF front-end, or RFFE, for the mobile device industry. The RFFE is the circuitry in a mobile device responsible for the radio frequency signal processing and is located between the device’s antenna and its digital baseband. Filters are a critical component of the RFFE that selects the desired radio frequency signals and rejects unwanted signals and noise. For more information, please visit www.resonant.com.
About Resonant’s ISN® Technology
Resonant can create designs for difficult bands and complex requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. The Company’s large suite of proprietary mathematical methods, software design tools and network synthesis techniques enable it to explore a much bigger set of possible solutions and quickly derive the better ones. These improved filters still use existing manufacturing methods (i.e. SAW) and can perform as well as those using higher cost methods (i.e. BAW). While most of the industry designs surface acoustic wave filters using a coupling-of-modes model, Resonant uses circuit models and physical models. Circuit models are computationally much faster, and physical models are highly accurate models based entirely on fundamental material properties and dimensions. Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is eased because its models speak the “fab language” of basic material properties and dimensions.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements, which include the following subjects, among others: the capabilities and expected sales volumes of Resonant’s Band 41 filter design. Forward-looking statements are made as of the date of this document and are inherently subject to risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, without limitation, the following: our limited operating history; our ability to complete designs that meet customer specifications; market demand for filters utilizing our designs; the ability of our customers (or their manufacturers) to fabricate our designs in commercial quantities; the ability of our designs to significantly lower costs compared to other designs and solutions; the risk that the intense competition and rapid technological change in our industry renders our designs less useful or obsolete; our ability to find, recruit and retain the highly skilled personnel required for our design process in sufficient numbers to support our growth; our ability to manage growth; and general market, economic and business conditions. Additional factors that could cause actual results to differ materially from those anticipated by our forward-looking statements are under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent Annual Report (Form 10-K) or Quarterly Report (Form 10-Q) filed with the Securities and Exchange Commission. Forward-looking statements are made as of the date of this release, and we expressly disclaim any obligation or undertaking to update forward-looking statements.
Investor Relations Contact:
Greg Falesnik
MZ North America
1-949-385-6449
Greg.Falesnik@mzgroup.us
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