Archive for June, 2017
$KTNNF Sully Project Exploration Update on E3
VANCOUVER, BRITISH COLUMBIA–(June 16, 2017) – Kootenay Zinc Corp. (the “Company“) (CSE:ZNK)(CSE:ZNK.CN)(CNSX:ZNK)(OTCQB:KTNNF)(FRANKFURT:KYH) provides the following update on exploration activities and upcoming drill testing at the Sully project.
Field programs have continued through May and early June and the project team has completed a number of activities at the site, with a specific focus on the E3 Target: detailed gravity surveying, interpretation and mass modeling, prospecting and mapping, soil geochemistry sampling, drilling preparations and road/access preparations.
Excel Geophysics has recently completed interpretation and mass modeling of the new data collected at E3. The work resulted in a well-defined, sizeable and discreet anomaly at this target location. As compared to measurements and analysis at E1, the data suggest that E3 is not as dissected or disturbed, making it a more attractive target for drilling. At the time of planning exploration at E1, permits to drill E3 had not yet been received. The necessary exploration permits have since been granted. Brian Jones, principle of Excel stated, “E3 has emerged as a strong geophysical target. Now it needs to be tested.” A drill site has been identified and preparations are underway to mobilize FB Drilling of Cranbrook, BC.
The project team has also completed new prospecting and sampling over the EAST anomaly area and has collected outcrop samples from a number of sites for assay. Many new outcrop locations were identified and visible sphalerite was found disseminated in irregular patches at one of the outcrops. This style of mineralization is reminiscent of mineralization in rocks two to three kilometres south of the Sullivan deposit on North Star Hill. A total of 17 outcrop samples were sent for analysis. Samples from two of these sites returned zinc values greater than 10,000 ppm (roughly 1%); one of these sites is 100 metres south of the surface projection of the E3 gravity anomaly.
A soil geochemical survey extended previous coverage to complement existing property-wide geological mapping. Thirty-four samples were collected along the base of the slope, including below E3. Several samples returned anomalous zinc in the 150 to 300 ppm range with higher zinc values in general proximity to the E3 drill target.
The Company is excited to drill test E3 to determine the source of the gravity anomalies at Sully and will provide further updates on progress and results.
About the Company
Kootenay Zinc Corp. is a mineral exploration and development company based in Vancouver, British Columbia that is presently targeting the Sully Property. The Company is focused on discovering large-scale sedimentary-exhalative (“SEDEX“) deposits.
The Sully Property comprises 1,375 hectares located approximately 30 kilometres east of Kimberley, B.C., and overlies rocks of similar age and origin as those which host the world-class Sullivan deposit, owned by Teck Resources Ltd. Sullivan was discovered in 1892, and is known to be one of the largest SEDEX deposits in the world. Over its 100-year lifetime, Sullivan produced approximately 150 million tonnes of ore, including approximately three hundred million ounces of silver, eight million tonnes of zinc and eight million tonnes of lead. The equivalent level of strata as at Sullivan and that formed on the margin of that same basin are present at the Sully Property. The Company cautions that past results or discoveries on proximate land are not necessarily indicative of the results that may be achieved on the Sully Property.
The scientific and technical information contained in this news release has been reviewed and approved by the Company’s Project Manager, Paul Ransom, P.Geo., a “Qualified Person” as defined in National Instrument 43-101 – Standards of Disclosure for Mineral Projects.
Forward Looking Information
This news release includes certain statements that constitute “forward-looking information” within the meaning of applicable securities law, including without limitation, statements that address the Sully Property, comments regarding the timing and content of upcoming work programs, geological interpretations, costs and timing of future exploration and development, requirements for additional capital, other statements relating to the financial and business prospects of the Company. Forward-looking statements address future events and conditions and are necessarily based upon a number of estimates and assumptions. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects” or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “estimates” or “intends”, or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved), and variations of such words, and similar expressions are not statements of historical fact and may be forward-looking statements. Forward-looking statement are necessarily based upon a number of factors that, if untrue, could cause the actual results, performances or achievements of the Company to be materially different from future results, performances or achievements express or implied by such statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of zinc and other metals, anticipated costs and the ability to achieve goals.
While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Forward-looking statements are subject to a variety of risks and uncertainties, which could cause actual events, level of activity, performance or results to differ materially from those reflected in the forward-looking statements, including, without limitation: (i) risks related to zinc, base metal and other commodity price fluctuations; (ii) risks and uncertainties relating to the interpretation of exploration results; (iii) risks related to the inherent uncertainty of exploration and cost estimates and the potential for unexpected costs and expenses; (iv) that resource exploration and development is a speculative business; (v) that the Company may lose or abandon its property interests or may fail to receive necessary licences and permits; (vi) that environmental laws and regulations may become more onerous; (vii) that the Company may not be able to raise additional funds when necessary; (viii) the possibility that future exploration, development or mining results will not be consistent with the Company’s expectations; (ix) exploration and development risks, including risks related to accidents, equipment breakdowns, labour disputes or other unanticipated difficulties with or interruptions in exploration and development; (x) competition; (xi) the potential for delays in exploration or development activities or the completion of geologic reports or studies; (xii) the uncertainty of profitability based upon the Company’s history of losses; (xiii) risks related to environmental regulation and liability; (xiv) risks associated with failure to maintain community acceptance, agreements and permissions (generally referred to as “social licence”); (xv) risks relating to obtaining and maintaining all necessary government permits, approvals and authorizations relating to the continued exploration and development of the Company’s projects; (xvi) risks related to the outcome of legal actions; (xvii) political and regulatory risks associated with mining and exploration; (xix) risks related to current global financial conditions; and (xx) other risks and uncertainties related to the Company’s prospects, properties and business strategy. These risks, as well as others, could cause actual results and events to vary significantly.
There can be no assurance that planned exploration will be completed as proposed or at all, or that economic resources will be discovered or developed at the Sully Property. Accordingly, actual results may differ materially from those currently anticipated in such statements. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, the loss of key directors, employees, advisors or consultants, equipment failures, failure of counterparties to perform their contractual obligations and fees charged by service providers. Investors are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements. The forward-looking statements included in this news release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities legislation. Neither the Canadian Securities Exchange nor its regulation services provider accepts responsibility for the adequacy or accuracy of this news release.
Kootenay Zinc Corp.
Hugh Rogers
Director
info@kootenayzinc.com
$SELB Reports Data from Ongoing Phase 2 Trial of Lead Candidate, SEL-212
WATERTOWN, Mass., June 15, 2017 — Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, today announced data from its ongoing Phase 2 trial of SEL-212 (SVP-Rapamycin in combination with the uricase enzyme pegsiticase), which is being developed for patients with chronic severe gout.
Key observations and findings based upon the clinical data generated through June 12, 2017 from the 60 patients currently enrolled in this open-label, dose ranging Phase 2 trial include:
- Mitigated anti-drug antibodies (ADAs) after repeat monthly administrations of SEL-212 – The prevention of ADAs in a dose-dependent manner resulted in durable control of serum uric acid (sUA) levels (defined as sUA <6 mg/dl). The clinical data demonstrate a correlation between the prevention of ADAs and the maintenance of pegsiticase activity and serum uric acid control.
- Demonstrated induction of immune tolerance – A majority of patients in the minimum effective dose group maintained sUA control following three monthly injections of SEL-212 and two monthly “challenge” injections of pegsiticase alone. Maintenance of sUA in the challenge portion of the trial provides evidence at this stage that the use of SVP-Rapamycin is enabling immune tolerance, meaning a prevention of ADAs to pegsiticase, which is typically immunogenic when administered alone.
- Reduced rate of gout flares with SEL-212 – In the control cohorts receiving pegsiticase alone, within the first month of treatment, 50% of patients reported experiencing a gout flare, which is a sudden and severe attack of pain, inflammation and tenderness of the joints. By comparison, only 15% of patients receiving SEL-212 reported a gout flare in the first month of treatment, with reports declining further in subsequent months. These data also appear to be in contrast with the increased incidence of flares reported in clinical trials involving other urate lowering therapies.
- Identified minimum effective dose of SEL-212 – A key objective of the Phase 2 trial was to determine a minimum effective monthly dose of the two components of SEL-212 (i.e. pegsiticase and SVP-Rapamycin) through an ascending dose matrix design. A majority of the initial patients dosed with 0.4 mg/kg of pegsiticase in combination with 0.08 mg/kg of SVP-Rapamycin maintained sUA control beyond five treatments. As a result, the company has determined this to be a minimum monthly effective dose of SEL-212. Additional patients are now being added to this cohort, and higher dose levels of SVP-Rapamycin are being tested to further determine the dose regimens that may be taken forward into Phase 3.
- SEL-212 generally well tolerated – Consistent with the expected reduction in immunogenicity of pegsiticase when SVP-Rapamycin doses increase, SEL-212 has been generally well tolerated at clinically active doses. There have been a total of eight serious adverse events (SAEs) reported in the trial through June 12, 2017. Seven were infusion reactions, four of which occurred in the cohorts receiving pegsiticase alone or the lowest dose of SVP-Rapamycin and two of which were due to dosing errors. One additional SAE, cholecystitis, was determined to not be related to the study drug. All of the SAEs were successfully treated and resolved without further issues.
“The implications of these trial data are profound for both SEL-212 and for the development of Selecta’s immune tolerance platform,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “First and foremost, the clinical data demonstrate SEL-212’s potential to address substantial unmet needs for patients with chronic severe gout, a debilitating disease that has been associated with both increased morbidity and mortality. We believe that a reduction of serum uric acid levels to near zero during treatment, a reduction in the incidence of flares and the convenience of safe monthly dosing with SEL-212 would prove to be a compelling treatment option. Leveraging these data, we are beginning to prepare for a Phase 3 program that we plan to initiate in 2018 following further dialogue with the U.S. Food and Drug Administration. Importantly, we also believe that our technology has shown for the first time in a clinical setting the potential to induce tolerance to a highly immunogenic biologic, which helps to inform the continued development of our other proprietary novel biologic programs.”
These and other data are being reported today at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid, Spain and at the Federation of Clinical Immunology Societies’ Annual Meeting (FOCIS 2017) in Chicago, IL. The company also has posted a presentation to its website entitled “Selecta June 2017 Phase 2 Trial Presentation” that can be accessed by clicking here.
Conference Call Reminder
At 8:30 a.m. ET today, Selecta will host a conference call to discuss the data. Those interested can access a live and archived webcast of this call via the Investors & Media section of the company’s website, http://selectabio.com. Individuals may also participate in the live call via telephone by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10108095.
About Chronic Severe Gout, SEL-212 and Selecta’s Ongoing Phase 2 Trial
According to market research, more than 500,000 gout patients in the U.S. are treated by rheumatologists and approximately 160,000 of these patients have chronic severe gout. These patients typically have an inflammatory build-up of uric acid deposits called tophi in their joints and tissue that causes pain, inflammation of joints and debilitating flares. If untreated, these deposits also can potentially exacerbate kidney and cardiovascular disease and increase morbidity. In fact, a study published in 2016 involving more than 600 patients diagnosed with tophaceous gout showed a 60% increased risk of mortality when compared to more than 2,800 patients without tophi.1
Published data show that uricase enzymes have the unique ability to rapidly eliminate uric acid crystal deposits and tophi in patients with chronic severe gout.2 However, since these are biologic enzymes that are recognized as “foreign” by the immune system, anti-drug antibodies (ADAs) are induced in most patients early in their treatment, compromising efficacy and safety as well as preventing further administrations.
SEL-212 (SVP-Rapamycin in combination with the uricase enzyme pegsiticase) is designed to be the first monthly uricase treatment and the first uricase treatment that avoids immunogenicity. It is intended to remove the patient’s uric acid burden through a short induction treatment cycle, thereby improving acute symptoms such as pain, inflammation of joints and debilitating flares. Selecta also envisions that additional SEL-212 treatment cycles could be re-administered if severe gout symptoms were to recur.
In the fourth quarter of 2016, Selecta began enrolling patients with symptomatic gout and elevated serum uric acid levels in an open-label, multiple ascending dose Phase 2 clinical trial of SEL-212. The primary and secondary endpoints for this trial include safety, tolerability, pharmacokinetics, reduction of serum uric acid levels and reduction of ADA levels. Data also are being collected regarding flares and other patient-related observations. Patients are being enrolled in multiple ascending dose cohorts to enable the identification of the optimal dose ratio of SVP-Rapamycin and pegsiticase, the minimal effective dose level of SEL-212 for repeat monthly administration, and the dose regimen to take forward into Phase 3. More information about the trial (NCT02959918) is available at www.clinicaltrials.gov.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP™) to a range of biologics for rare and serious diseases that require new treatment options. The company’s current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.
Forward-Looking Statements
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the ability of SEL-212 to avoid unwanted immune responses, the ability of SVP-Rapamycin to induce immune tolerance against pegsiticase, the ability of SEL-212 to improve acute symptoms during a short induction cycle, the ability of SEL-212 to be re-administered if severe gout symptoms recur, whether the company will determine an appropriate dose of SEL-212 for a Phase 3, whether the company will advance to a Phase 3 for SEL-212 at all, whether the Phase 2 clinical data of SEL-212 demonstrate the potential of SEL-212 to address a substantial unmet need for gout patients, the company’s ability to unlock the full potential of biologic therapies, the company’s plan to apply its SVP platform to a range of biologics for rare and serious diseases, the potential treatment applications for products utilizing the SVP platform in areas such as enzyme therapy, gene therapy, oncology therapy, vaccines and treatments for allergies and autoimmune diseases, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, the potential of the company’s two gene therapy product candidates to enable repeat administration, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the unproven approach of the company’s SVP technology, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares have recently become eligible to be sold into the market, and other important factors discussed in the “Risk Factors” section of the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 11, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.
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1 Vincent Z et al, Predictors of Mortality in People with Recent Onset of Gout: A Prospective Observational Study, ACR, Sept. 2016
2 Araujo E, Bayat S, Petsch C, Matthias E, Faustini F, Kleyer A, Hueber A, Cavallaro A, Lell M, Dalbeth N, et al. June 2015. Tophus resolution with pegloticase: a prospective dual-energy CT study. Rheumatic & Musculoskeletal Diseases.
Contact Information: Jason Fredette Selecta Biosciences, Inc. 617-231-8078 jfredette@selectabio.com
$ATNM Announces Appointment of Nitya Ray, Ph.D. as Executive Vice-President
– Dr. Nitya Ray joins Actinium Executive Team with 30 years of radiopharmaceutical and biologics product development, manufacturing and strategic planning experience
– Also announced is the recent hiring of Dr. Ramesh Kashi and Mr. Vimal Patel who bring deep expertise in product development and manufacturing to enable expansion of operations
NEW YORK, June 15, 2017 — Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today the expansion of its product development, manufacturing, and supply chain capabilities with the appointment of Dr. Nitya Ray as a Corporate Officer and Executive Vice-President. Dr. Ray will be the Head of Product Development, Manufacturing, and Supply Chain and will be responsible for leading and managing all product development, manufacturing, and supply chain activities to support Actinium’s clinical development and commercialization scale-up. In addition, the Company also announced the recent hiring of Dr. Ramesh Kashi as Senior Director of Process Development and Vimal Patel as Manager of Pharmaceutical Development.
Sandesh Seth, Actinium’s Chairman and CEO said, “We are pleased to welcome Dr. Ray to the Actinium Executive Team. Dr. Ray is a leader with decades of relevant experience which includes development of antibodies, antibody drug conjugates, radiopharmaceuticals and small-molecule drugs. His proven track record with drug development, clinical and commercial manufacturing, supply chain management, and strategic planning expertise provides Actinium with the right blend of skills and experience that will not only enable the success of our current clinical trials but also help set the stage for our commercial operations. In this endeavor, he will be ably supported by his entire team which also includes recent hires Dr. Ramesh Kashi and Mr. Vimal Patel. We have added decades of invaluable knowledge and experience to Actinium’s product development capabilities. Given the late stage of development of Iomab-B and the ambitious plans we have for our Actimab drug candidates and alpha particle technology platform, we could not be more excited to welcome these new team members. I am delighted in our ability to recruit such strong talent as evidenced by these most recent additions and look forward to the contributions they will make to Actinium.”
Dr. Nitya Ray said, “I have spent virtually all of my career in radiopharmaceutical and antibody therapeutics drug development. Actinium’s radioimmunotherapies represent significant progression for the field and have the potential to dramatically improve outcomes for patients, especially in patients with hematologic malignancies, which are known to be radiosensitive. I could not think of a better time to join Actinium as my experience and knowledge can be applied to product development, manufacturing, and supply chain efforts to support Actinium’s late stage clinical development and to prepare for commercial manufacturing. Actinium has assembled a strong team that is growing rapidly and I look forward to working with my colleagues to build a leading radioimmunotherapy company.”
Dr. Ray joins Actinium from CytoDyn, Inc. where he was Sr. Vice President of Manufacturing and CMC Team Leader. At CytoDyn Dr. Ray developed robust and cost effective manufacturing processes for an antibody therapeutic drug candidate, currently in two Phase 3 clinical studies intended to treat and prevent HIV infection. Dr. Ray led a successful regulatory meetings with the FDA while simultaneously developing strategies for process development, scale-up, validation, commercial manufacturing, and supply chain to support potential commercialization of the CytoDyn’s HIV therapeutic drug candidate. Prior to CytoDyn, Dr. Ray spent 15 years at Progenics Pharmaceuticals, Inc., a radiopharmaceutical therapeutic and diagnostic company, most recently as Senior Vice President, Manufacturing. At Progenics, Dr. Ray led the development of scalable manufacturing processes and achieved order-of-magnitude cost reduction through improved productivity and scale. In addition, Dr. Ray built process and product development teams for Progenics’ small molecule, biologics, and radiopharmaceuticals that developed innovative processes for various phases of clinical development and commercial manufacturing. Dr. Ray supported in-house cGMP biologics manufacturing for Phase 1–3 clinical development and managed relationships with Contract Development and manufacturing Organizations (CDMO’s) on a global basis. Dr. Ray also worked at Hoffman-La Roche with a focus on biopharmaceuticals and Verax Corporation in roles of increasing responsibility. Dr. Ray has a Ph.D. in Biochemical Engineering and an M.S. in Chemical and Biochemical Engineering from Rutgers University and a B.S. in Chemical Engineering from Jadavpur University.
Dr. Ramesh Kashi joins Actinium from Merck & Co. where he led a functional group that performed formulation development, scale-up and technology transfer to enable good manufacturing practices (GMP) of clinical supplies for two antibody therapeutics. He also supported formulation development of Keytruda, a PD-1 inhibitor, other checkpoint inhibitors and therapeutic proteins. In addition, Dr. Kashi supported initiation of Phase 1 to 3 global clinical trials and provided chemistry, manufacturing and controls (CMC) related support on regulatory matters. Prior to Merck, Dr. Kashi worked at Agenus, Inc. in the Protein Support and Formulation Department where he worked on protein based therapeutics at R&D and manufacturing scales and supported biologic license application (BLA) efforts. In addition, Dr. Kashi has worked at Baxter Bioscience/Healthcare Corp., Diagnostics Products Corporation (acquired by Siemens) and Biogen, Inc. Dr. Kashi has a Ph.D. in Biochemistry from the Indian Institute of Science and completed Post-Doctoral research at Massachusetts General Hospital, Harvard Medical School and the New England Medical Center, Tufts Medical School. Dr. Kashi is also the author of several issued patents, pending patents and research publications.
Mr. Patel comes to Actinium from Pfizer where he was most recently a Senior Scientist focused on clinical and commercial processes for antibody drug conjugates (ADCs) and payloads. Mr. Patel supported processes for six ADCs and supported in-house manufacturing as well as outsourced manufacturing through CMOs. Prior to Pfizer, Mr. Patel was a Senior Scientist at Progenics Pharmaceuticals, Inc. where supported cGMP manufacturing of biologics for Phase 1 – 3 clinical development and optimized processes for antibody drug conjugation. Previously, Mr. Patel worked at SibTech as a Research Scientist where he worked on radiopharmaceuticals. Mr. Patel has a M.S. in Biotechnology from the University of Connecticut and a B.S. in Chemical Engineering from Sardar Patel University.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium’s proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company’s lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company’s second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. In addition, Actinium is developing Actimab-M, which is being studied in patients with relapsed or refractory multiple myeloma in a Phase 1 clinical trial. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contact: Actinium Pharmaceuticals, Inc. Steve O'Loughlin Vice President, Finance and Corporate Development soloughlin@actiniumpharma.com Marek Ciszewski, J.D. Liolios Group, Inc. 949.574.3860 ATNM@liolios.com
$SKLN Announces CE Mark for the STREAMWAY® System
MINNEAPOLIS, June 15, 2017 — Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces that its European Authorized Representative, Emergo Europe B.V., has notified the Dutch Competent Authority that the Company’s STREAMWAY System meets all requirements and can now be affixed with the CE mark and marketed in 32 European countries.
“Receipt of the CE mark is an important milestone for Skyline Medical and we are very excited to be able to expand the reach of our STREAMWAY System to Europe,” said Dr. Carl Schwartz, chief executive officer of Skyline Medical. “We have already held preliminary discussions with a few European distributors, and with the CE mark in hand we can now advance those negotiations while beginning dialogues with others.
“We are optimistic that we can record our first product sale under the CE mark before year-end, and ramp up STREAMWAY’s availability throughout Europe by early 2018. Europe presents a rich market opportunity we are eager to pursue,” Dr. Schwartz added.
About the STREAMWAY System
Skyline’s revolutionary, FDA-cleared STREAMWAY System is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids. As of March 31, 2017, Skyline Medical customers have installed 103 STREAMWAY Systems in 52 facilities across 20 states, and in Canada.
The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. Furthermore, the STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S. For a demonstration please visit www.skylinemedical.com or call 855-785-8855.
About Skyline Medical
Skyline Medical produces a fully automated, patented, FDA-cleared waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods that require hand carrying and emptying filled fluid canisters present an exposure risk and potential liability. Skyline Medical’s STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers; 2) improve compliance with OSHA and other regulatory agency safety guidelines; 3) improve efficiency in the operating room, and radiology and endoscopy departments, thereby leading to greater profitability; and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills each year in the U.S. For additional information, please visit www.skylinemedical.com.
Forward-looking Statements
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company’s business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company’s financial position. See the Company’s most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.
Contact: Investors LHA Investor Relations Kim Sutton Golodetz (212) 838-3777 kgolodetz@lhai.com
$EKSO Centers of Robotic Excellence Collab. w/ Rehabilitation Facilities for Mobility Impaired
RICHMOND, Calif., June 15, 2017 — Ekso Bionics Holdings, Inc. (NASDAQ:EKSO), an industry leader in exoskeleton technology for medical and industrial use, today announced a collaboration with four leading rehabilitation facilities to establish Centers of Robotic Excellence to help further advance the use of innovative exoskeleton technology for mobility impaired patients.
As early adopters of state-of-the-art exoskeleton technology, the centers have committed to provide peer-to-peer support as reference sites to train other facilities interested in becoming proficient in innovative approaches to rehabilitation.
The centers include:
- Barrow Neurological Institute, Phoenix, Arizona
- Good Shepherd Rehabilitation Network, Allentown, Pennsylvania
- Marianjoy Rehabilitation Hospital, part of Northwestern Medicine, Wheaton, Illinois
- “Villa Beretta” Centro di Riabilitazione, Costa Masnaga (LC), Italy (Northeast of Milan)
“Collaborating with leaders in the rehabilitation community is key to building clinical support on the benefits of exoskeletons to aid early mobility for stroke & spinal cord injury,” said Thomas Looby, president and chief executive officer of Ekso Bionics. “We are proud to work with these visionaries who are dedicated to helping patients with recovery and to provide quantifiable insights into the strides they’re making walking with an exoskeleton.”
Christina Kwasnica, M.D., medical director for the Barrow Neuro Rehabilitation Center, notes, “The robotic device allows us to get patients up on their feet earlier. The gains we see are overwhelming and the positive effects on a patient’s mood and motivation is unbelievable.”
Each center will also work with Ekso Bionics to aid in research and development efforts. The Centers of Excellence will gather clinical evidence and measurable results on rehabilitation with EksoGTTM and create research protocols for proving standard of care for exoskeletons for rehabilitation.
“As an early adopter of the EksoGT, we look forward to mentoring our peers and sharing our knowledge so that more patients can benefit from this life-changing technology,” said Frank Hyland, M.S., P.T., executive director of Good Shepherd Rehabilitation Network and administrator of Good Shepherd Rehabilitation Hospital. “Good Shepherd has experienced the economic advantage firsthand with a significant return on investment, increased market share growth, and a value proposition that also benefits patients and payers. EksoGT is now the cornerstone of our rehabilitation program and has helped our patients take 3 million steps and counting.”
To learn more about the Centers of Excellence and the EksoGT, visit http://eksobionics.com/eksohealth/centers-of-excellence/.
About Ekso Bionics®
Ekso Bionics is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical, industrial and defense applications. Founded in 2005, the company continues to build upon its unparalleled expertise to design some of the most cutting-edge, innovative wearable robots available on the market. Ekso Bionics is the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe, to providing research for the advancement of R&D projects intended to benefit U.S. defense capabilities. The company is headquartered in the Bay Area and is listed on the Nasdaq Capital Market under the symbol EKSO. For more information, visit: www.eksobionics.com.
About Ekso GT™
Ekso GT™ is the first exoskeleton cleared by the FDA for use with stroke and spinal cord injuries from L5 to C7. The EksoGT with SmartAssist™ software is the only exoskeleton available for rehabilitation institutions that can provide adaptive amounts of power to either side of the patient’s body, challenging the patient as they progress through their continuum of care. The suit’s patented technology provides the ability to mobilize patients earlier, more frequently and with a greater number of high intensity steps. To date, this device has helped patients take more than 70 million steps in over 130 rehabilitation institutions around the world.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) estimates or projection of financial results, financial condition, capital expenditures, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain adequate financing to fund the Company’s operations and necessary to develop or enhance our technology, the significant length of time and resources associated with the development of the Company’s products, the Company’s failure to achieve broad market acceptance of the Company’s products, the failure of our sales and marketing organization or partners to market our products effectively, adverse results in future clinical studies of the Company’s medical device products, the failure to obtain or maintain patent protection for the Company’s technology, failure to obtain or maintain regulatory approval to market the Company’s medical devices, lack of product diversification, existing or increased competition, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. To learn more about Ekso Bionics please visit us at www.eksobionics.com. The Company does not undertake to update these forward-looking statements.
The photo is also available at Newscom, www.newscom.com, and via AP PhotoExpress.
Media Contact: Carrie Yamond 917-371-2320 cyamond@lazarpartners.com Investor Contact: David Carey 212-867-1768 investors@eksobionics.com
$ADMP Receives FDA Approval for Its Epinephrine Pre-Filled Syringe
SAN DIEGO, June 15, 2017 — Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (“PFS”) for the emergency treatment of allergic reactions (Type I) including anaphylaxis. The FDA has also approved the PFS trade name of Symjepi™.
Symjepi provides two single dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods (such as nuts), drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We are very excited by this approval, and at the same time, are already preparing to submit our second NDA to the FDA. This second submission is for the junior version of Symjepi. We are committed to helping patients by providing them with additional therapeutic choices. With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market. We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset. In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year.”
About Anaphylaxis
Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. According to information published by industry sources, up to 8% of U.S. children under the age of 18 have a food allergy, and approximately 38% of those with a food allergy have a history of severe reactions. Anaphylaxis requires immediate medical treatment, including an injection of epinephrine. The number of prescriptions for epinephrine products has grown annually, as the risk of anaphylaxis and allergic reactions have become more widely understood. The company estimates that sales of prescription epinephrine products in 2016 were at least $1 billion, based on industry data.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease and allergy. The company’s current specialty pharmaceutical products and product candidates include Epinephrine Injection pre-filled syringe product for use in the emergency treatment of acute allergic reactions, including anaphylaxis; albuterol (APC-2000) and fluticasone (APC-4000) dry powder inhaler products for the treatment of bronchospasm and asthma; and beclomethasone (APC-1000), a metered dose inhaler product for the treatment of asthma.
The Company’s U.S. Compounding, Inc. subsidiary, which is registered as a drug compounding outsourcing facility under Section 503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug Quality and Security Act, provides prescription compounded medications, including compounded sterile preparations and non-sterile compounds, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States. USC’s offerings broadly include, among others, injectable corticosteroids, hormone replacement therapies, hospital outsourcing formulations, urological preparations, ophthalmic preparations, topical compounds for pain and men’s and women’s health formulations.
Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future results of operations, including, but not limited to the following statements: the company’s beliefs concerning the timing and outcome of any future New Drug Application (NDA) that the company may submit to the FDA relating to lower dose version of its Epinephrine PFS product; the company’s beliefs concerning the ability of its product candidates to compete successfully in the market; the company’s beliefs concerning the safety and effectiveness of its product candidates; the company’s beliefs concerning its commercialization strategies; and the company’s beliefs concerning the anticipated timing of a commercial launch of its Symjepi product. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis’ actual results to be materially different from these forward-looking statements. There can be no assurances regarding the commercialization options that the company will pursue, that the company’s Symjepi product will be launched by the end of the year, that the product will be able to compete successfully in the market, or concerning the timing of a submission to the FDA of an NDA relating to a lower dose version of the product or the timing or outcome of the FDA’s review of any such submission. Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC’s web site at http://www.sec.gov. Except to the extent required by law, any forward-looking statements in this press release speak only as the date of this press release, and Adamis expressly disclaims any obligation to update any forward-looking statements.
Contact Adamis: Mark Flather Senior Director, Investor Relations & Corporate Communications (858) 412-7951 mflather@adamispharma.com
$PTOTF NetworkNewsWire Publication Highlights Innovative Global Defense Solutions
NEW YORK, NY–(Jun 15, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring Patriot One Technologies, Inc. (TSX VENTURE: PAT) (OTCQB: PTOTF), a client of NNW that is leveraging seven years of development to create powerful technologies that mitigate security risks by detecting concealed weapons via novel radar technology.
The publication, entitled, “Fighting Terror: Innovative Companies Take Aim at Fresh Solutions for Global Defense,” discusses innovative, alternative solutions being brought to market by companies on a mission to help solve the world’s security problems.
To view the full publication visit: https://www.networknewswire.com/fighting-terror-innovative-companies-take-aim-fresh-solutions-global-defense/
“Engaged in creating powerful solutions that minimize security risks, Patriot One employs novel radar technology for the detection of concealed weapons. The company’s disruptive PATSCAN technology, the first system of its kind and the next-generation version of the company’s award-winning NForce CMR1000 software and radar solution, is an innovative cognitive microwave radar system designed to instantly detect concealed weapons–even on moving targets.
“PATSCAN identifies individuals who are carrying weapons–including guns, knives or suicide vests–by analyzing metal content and then relating that content to a database of known weapon signatures. The system’s detection is real-time and fully computer-based, and because the solution is small, it can be covertly placed in doorways or hallways as a preventative measure against attacks in public places, such as stadiums, concert venues, schools, airports and more.
“Unlike other weapons detection technology on the market, with Patriot One’s products, subject compliance ceases to be an issue, since individuals don’t know they are being scanned. Additionally, privacy concerns are eliminated since the solution does not generate an image of those it scans. Wherever PATSCAN is deployed, security personnel are automatically alerted if an active threat enters the premises, and the system has an impressive overall accuracy rate of 93 percent.”
About Patriot One Technologies, Inc.
Patriot One has developed PATSCAN CMR™ the next generation of its award-winning Patriot One Technologies™ NForce CMR1000 software and radar solution. PATSCAN CMR is a first-of-its-kind Cognitive Microwave Radar concealed weapons detection system as an effective tool to combat active shooter threats before they occur. Designed for cost-effective deployment in weapon-restricted buildings and facilities, the Patriot One software solution and related hardware can be installed in hallways and doorways to covertly identify weapons and to alert security of an active threat entering the premises. Owner/operators of private and certain public facilities can now prominently post anti-weapons policies with compliance assured. The company’s motto Deter, Detect and Defend is based on the belief that widespread use of its technology will act as an effective deterrent, thereby diminishing the epidemic phenomena of active shooters across the globe.
For more information, visit: https://patriot1tech.com
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides to users (1) access to our news aggregation and syndication servers, (2) enhanced press release services, and (3) a full array of social communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
For more information, visit: https://NetworkNewsWire.com
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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.
NNW Contact:
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$EPZM Positive Interim Data Phase 2 Tazemetostat
Data Presented During Plenary Session at International Conference on Malignant Lymphoma
Conference Call to be Held Today at 10:30 a.m. ET
CAMBRIDGE, Mass., June 14, 2017 — Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, today announced positive interim efficacy data from the company’s ongoing Phase 2 clinical trial of tazemetostat, a first-in-class, oral EZH2 inhibitor, as a single-agent treatment for relapsed or refractory patients with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) grouped by EZH2 mutational status. The data were presented today during a plenary session at the International Conference on Malignant Lymphoma (ICML), which is being held June 14-17, 2017 in Lugano, Switzerland. In addition, data from a 62-gene panel biomarker study of tazemetostat in patients with various subtypes of non-Hodgkin lymphoma will be presented during a poster session at the conference.
Interim data as of June 1, 2017 show that tazemetostat treatment resulted in a clinically meaningful benefit in patients with FL. The subset of FL patients with EZH2 activating mutations have a 92 percent objective response rate (ORR). Patients with FL with EZH2 wild-type have an ORR of 26 percent and 22 percent of patients with stable disease are still on study. Promising activity was also observed in DLBCL patients with EZH2 mutations, which includes recently enrolled patients, with an ORR of 29 percent. As the size of the mutation study groups increase and patients remain on study, Epizyme expects the data will continue to evolve. In addition, tazemetostat continues to demonstrate a favorable safety profile across all patient populations in this study.
“I believe that tazemetostat may play a significant role in disease management for my patients, and am particularly excited by the impact observed in patients with follicular lymphoma,” said Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Régional Universitaire de Lille, France, and lead investigator of the Phase 2 study. “I am also encouraged by the level of activity in DLBCL patients with EZH2 mutations, especially in light of the bleak prognosis associated with advanced disease. Tazemetostat has demonstrated a uniquely tolerable safety profile, and I look forward to further exploring its full benefit in patients with relapsed or refractory FL and DLBCL as the data mature.”
“These interim data findings represent an important step forward for our tazemetostat program, with anti-tumor activity observed across all groups of the study,” said Rob Bazemore, chief executive officer of Epizyme. “The activity we have observed in patients with an EZH2 mutation exceeds what we have seen so far with wild-type EZH2, consistent with our scientific hypothesis, and we are encouraged by both the objective responses and durability of responses in FL and DLBCL. Our focus is on continuing to increase enrollment of patients with an EZH2 mutation, and engaging with FDA in the second half of the year to determine potential registration paths to bring tazemetostat to patients as quickly as we can.”
Follicular Lymphoma Efficacy Data
FL, an indolent form of non-Hodgkin lymphoma (NHL), is considered to be incurable with existing treatments and is characterized by cycles of relapse that become increasingly difficult to treat with each disease progression. Approximately 25,000 patients in the U.S. and major European countries are diagnosed with FL every year1, of which an estimated 15 to 20 percent have an EZH2 mutation. There are no approved treatments indicated for patients with FL with an EZH2 mutation. In April 2017, Epizyme was granted Fast Track designation for FL regardless of EZH2 mutational status.
As of June 1, 2017, Epizyme enrolled 19 FL patients with EZH2 activating mutations in the Phase 2 trial, of which 13 are evaluable for efficacy. Enrollment of FL patients with EZH2 wild-type was completed in late 2016 with a total of 54 patients, all of which are evaluable for efficacy. More than 75 percent of evaluable FL patients had three or more prior treatments, and approximately 50 percent of patients in each group were refractory to their last prior therapy.
Key interim efficacy findings are as follows:
FL with EZH2 MT | FL with EZH2 WT | |
Evaluable for efficacy on June 1, 2017 | n =13 | n =54 |
Objective Response Rate (CR + PR) | 12 (92%) | 14 (26%) |
Complete Response (CR) | 1 (8%) | 3 (6%) |
Partial Response (PR) | 11 (85%) | 11 (20%) |
Stable Disease (SD) | 1 (8%) | 23 (43%) |
SD study drug ongoing | 1 (8%) | 12 (22%) |
Progressive Disease | 0 | 13 (24%) |
No Data, Unknown (UNK) | 0 | 4 (7%) |
Time to first Response (weeks) median (range) |
11.9 (6.9 – 35.9) |
15.2 (8.1 – 32.1) |
The activity of tazemetostat across FL patients is encouraging, and when combined with the well-tolerated safety profile, supports its potential utility as both as monotherapy and a combination agent. Combination treatment has become the evolving standard-of-care for FL, and Epizyme plans to begin investigating tazemetostat as a combination agent in FL this year.
Diffuse Large B-Cell Lymphoma Efficacy Data
DLBCL is an aggressive form of NHL that once diagnosed, typically requires immediate treatment. Approximately 45,000 patients are diagnosed with DLBCL in the U.S. and major European countries every year2. Among patients with germinal center DLBCL, an estimated 15 to 20 percent have an EZH2 mutation. Forty to 50 percent of patients will relapse on their first-line treatment, which is most commonly the chemotherapy regimen R-CHOP, and there are few treatment options for patients who relapse or become refractory to chemotherapy. In November 2016, Epizyme was granted Fast Track designation for DLBCL with EZH2 mutations.
As of June 1, 2017, Epizyme had enrolled 22 DLBCL patients with EZH2 mutations, and efficacy was assessed on 17 patients. Enrollment of DLBCL patients with EZH2 wild-type (germinal center and non-germinal center) was completed in early 2017 with 120 patients, of which 119 were evaluable for efficacy. Patients with DLBCL with EZH2 activating mutations represent the most advanced and severely ill patients in the study, with 82 percent having been previously treated with at least three therapeutic regimens and refractory to their last treatment.
Key interim efficacy findings are as follows:
DLBCL EZH2 MT | DLBCL EZH2 WT | |
Evaluable for efficacy on June 1, 2017 | n = 17 | n = 119 |
Objective Response Rate (CR + PR) | 5 (29%) | 18 (15%) |
Complete Response (CR) | 0 | 10 (8%) |
Partial Response (PR) | 5 (29%) | 8 (7%) |
Stable Disease (SD) | 6 (35%) | 22 (18%) |
SD study drug ongoing | 1 (6%) | 4 (3%) |
Progressive Disease | 6 (35%) | 60 (50%) |
No Data, Unknown (UNK) | 0 | 19 (16%) |
Time to first Response (weeks) median (range) |
8.3 (4.6 – 48.1) |
8.5 (5.3 – 24.7) |
Epizyme believes that activity is likely to be enhanced for wild-type disease through combination treatment. The company has a robust combination program underway in DLBCL evaluating tazemetostat in an immuno-oncology combination with atezolizumab and a steroid combination with prednisolone. In addition, tazemetostat is being evaluated in the front-line setting in combination with R-CHOP in newly diagnosed, high-risk DLBCL patients.
Tazemetostat Safety Profile
Safety data from patients in this Phase 2 trial (n=210), as of the data cutoff, demonstrate a favorable tolerability profile, consistent with the experience observed in a nearly 400-patient safety database from tazemetostat clinical trials to date. Across all cohorts of this trial, dose reductions and discontinuations due to treatment-related adverse events are low, at only three and two percent, respectively.
The majority of treatment-emergent adverse events are grade 1 or 2, with only 18 percent of grade 3 or higher being considered treatment-related. Treatment-emergent adverse events, regardless of attribution and affecting more than five percent of patients, are nausea (20%); thrombocytopenia (19%); anemia (16%); cough (14%); fatigue (12%); diarrhea (11%); asthenia, neutropenia, pyrexia and vomiting (10% each); bronchitis (7%); and constipation, decreased appetite, upper respiratory infection, abdominal pain, headache and urinary tract infection (6% each).
Poster Presentation Information
Data from a 62-gene panel biomarker study of tazemetostat in patients with various subtypes of NHL will also be presented in a poster by Stephen Blakemore Ph.D., titled “Preliminary evidence of a molecular predictor of tazemetostat response, beyond EZH2 mutation, in NHL patients via characterization of archive tumor and circulating tumor DNA” on June 14, 2017 (Poster Board No.: 154).
The data in the poster detail both potential positive and negative predictors of response to tazemetostat. In the case of positive predictors, both EZH2 and MYD88 are mutations that appear to enhance patients’ sensitivity to tazemetostat. The company has also detected EZH2 mutations by circulating tumor DNA in patient serum, indicating the potential future use of a tube of blood for patient identification of EZH2 mutations rather than testing patient’s archival tumor samples.
Conference Call Information
Epizyme will host a conference call and audio webcast today at 10:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 15855261. The webcast, and accompanying slides for the call, will be accessible under “Events and Presentations” in the Investor Relations section of the Company’s website at http://www.epizyme.com/.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for both relapsed/refractory follicular lymphoma and DLBCL with EZH2 activating mutations, as well as Orphan Drug designation for malignant rhabdoid tumors.
About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to rewriting cancer treatment through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy and in relapsed and front-line disease. Using the Company’s proprietary platform, Epizyme has pioneered the identification and development of small molecule inhibitors of chromatin modifying proteins (CMPs), such as tazemetostat. CMPs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of CMPs, which can allow cancer cells to grow and proliferate. By focusing on the genetic drivers of cancers, Epizyme’s science seeks to match targeted medicines with the specific patients that need it. For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future studies; whether interim data from clinical studies such as the data reported in this presentation will be indicative of the final results of the study; whether results from clinical studies will warrant meetings with regulatory authorities or submissions for regulatory approval; whether submissions for regulatory approval will be made when anticipated or at all and whether these submissions will be reviewed under the accelerated approval framework; whether the Company will receive will receive regulatory approvals to conduct trials or to market products; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the “Risk Factors” section of the Company’s most recent Form 10-Q filed with the SEC and in the Company’s other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.
1 Decision Resources, 2017
2 Decision Resources, 2017
Contacts: Cheya Pope, Epizyme, Inc. media@epizyme.com 617-229-7561 Monique Allaire, THRUST IR monique@thrustir.com (617) 895-9511
$MTBC Announces Launch of New Platform to Support Continued Growth
SOMERSET, NJ–(Jun 14, 2017) – MTBC (NASDAQ: MTBC) (NASDAQ: MTBCP), a leading industry consolidator and provider of proprietary, cloud-based healthcare IT solutions, today announced the initial launch of MTBC WebSoft™, the newest addition to its leading cloud-based healthcare IT platform which will further support scalability, acquisition integration, and margin expansion.
“MTBC WebSoft leverages state of the art technology — ASP.NET MVC framework and AngularJS 2.0 — to optimize performance, empower us to scale with increasing efficiency, and enable us to further streamline the integration of newly acquired customer bases,” said Hadi Chaudhry, Vice President of Global Operations. He continued, “As a top consolidator in our space that has grown year-over-year revenues by more than 60% during the most recent two quarters, this is precisely the type of tool we need to ensure that we remain ahead of the industry for many years to come as we continue our expansion into new markets.”
The healthcare revenue cycle management market is highly fragmented and MTBC estimates that there are more than 1,500 revenue cycle management companies, the overwhelming majority of which do not have a proprietary healthcare IT platform or scalable infrastructure. During the last five years, MTBC has acquired the customer bases of more than a dozen competing revenue cycle management companies, which lacked the type of proprietary platform, expertise, and scale required to support the needs of their existing and prospective customers. In conjunction with its acquisitions, MTBC leverages its proprietary technology platform and team of more than 1,800 individuals — including approximately 250 IT professionals — to add value to the newly acquired customer relationships and expand in the local market.
MTBC WebSoft, which has been in development for a year and a half and will ultimately replace MTBC’s legacy management information system, leverages the newest ASP.NET Model-View-Controller (MVC) framework and the power of AngularJS 2.0. The beta launch of MTBC WebSoft began on June 1, 2017 and the company expects MTBC WebSoft to be fully deployed within 60 days.
About MTBC
MTBC is a healthcare information technology company that provides a fully integrated suite of proprietary web-based solutions, together with related business services, to healthcare providers throughout the United States. Our integrated Software-as-a-Service (SaaS) platform helps our customers increase revenues, streamline workflows and make better business and clinical decisions, while reducing administrative burdens and operating costs. MTBC’s common stock trades on the NASDAQ Capital Market under the ticker symbol “MTBC,” and its Series A Preferred Stock trades on the NASDAQ Capital Market under the ticker symbol “MTBCP.”
For additional information, please visit our website at www.mtbc.com.
Forward-Looking Statements
This press release contains various forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. These statements relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements by terminology such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “goals”, “intend”, “likely”, “may”, “plan”, “potential”, “predict”, “project”, “will” or the negative of these terms or other similar terms and phrases.
Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Forward-looking statements in this press release include, without limitation, statements reflecting management’s expectations for future financial performance and operating expenditures, expected growth, profitability and business outlook, increased sales and marketing expenses, and the expected results from the integration of our acquisitions.
Forward-looking statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. These factors include, but are not limited to, the company’s ability to manage growth; integrate acquisitions; effectively migrate and keep newly acquired customers and other important risks and uncertainties referenced and discussed under the heading titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission. Although we believe that the expectations reflected in the forward-looking statements contained in this press release are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.
The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not assume any obligations to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.
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732-873-5133
$WBKC & $HBNC Sign Merger Agreement
MICHIGAN CITY, Ind. and MIDLAND, Mich., June 14, 2017 — Horizon Bancorp (NASDAQ:HBNC) (“Horizon”) and Wolverine Bancorp, Inc. (NASDAQ:WBKC) (“Wolverine”), today announced they have executed a definitive agreement whereby Horizon will acquire Wolverine and its wholly-owned subsidiary, Wolverine Bank.
Under the terms of the merger agreement, shareholders of Wolverine will receive 1.0152 shares of Horizon common stock and $14.00 in cash for each share of Wolverine common stock, which based upon the June 13, 2017 Horizon closing price of $27.50 per share would result in an implied price of $41.92 per share of Wolverine common stock.
Originally chartered in 1933 and headquartered in Midland, Michigan, Wolverine, through its wholly-owned subsidiary Wolverine Bank, serves the Great Lakes Bay Region of Michigan with three full-service banking offices. Importantly, Wolverine services the State of Michigan with additional emphasis in the Metro Detroit, Greater Lansing, and Grand Rapids regions. As of March 31, 2017, Wolverine had total assets of approximately $379.3 million and total equity of $62.5 million, translating to an equity to asset ratio of 16.48%.
Horizon is a community bank holding company headquartered in Michigan City, Indiana with total assets of $3.2 billion as of March 31, 2017. Horizon’s wholly-owned subsidiary, Horizon Bank, NA (“Horizon Bank”), still operates under its original charter dating back to 1873, with fifty-nine offices extending throughout northern and central Indiana; southwestern and central Michigan and central Ohio. Horizon has filed an application with the Indiana Department of Financial Institutions to change charters from a national bank to a state non-member bank. We anticipate approval and completion for the charter conversion by the end of the second quarter of 2017.
“We are enthusiastic about this merger, as it allows Horizon to extend our reach into Michigan while remaining true to our values as we partner with this like-minded institution,” said Horizon’s Chairman and Chief Executive Officer, Craig M. Dwight. “Wolverine Bank’s foundation is to contribute to the success of their customers by offering creative financial solutions based upon sound financial advice while being mindful of the communities they serve. This stems from their goal to preserve the values of community banking. We expect that our complementary product offerings and commitment to the local communities will result in success for the shareholders of the combined company, employees, customers and communities at large.” Horizon also has a track record of establishing local advisory boards to ensure it remains connected to, and informed about, trends and needs of the local community. Dwight indicated that such an advisory board will be established for the Great Lakes Bay Region following the merger. In addition, one director from Wolverine’s Board will be appointed to Horizon’s board of directors immediately after the closing of the merger.
Dwight explained that the Wolverine merger provides an excellent opportunity to expand Horizon’s current market presence into Michigan’s Great Lakes Bay Region. This expansion also complements Horizon’s locations in East Lansing and its most recent full-service office opening in Grand Rapids, Michigan. “We believe that establishing a significant presence in these larger markets and regions of Michigan will provide Horizon with substantial growth opportunities, a key component to our future success,” Dwight commented.
David H. Dunn, President and Chief Executive Officer of Wolverine Bank, stated, “This partnership with Horizon Bank will provide us new opportunities to increase the depth of products and services we can offer to our customers, while providing significant value to our shareholders. Importantly, Horizon shares our commitment to community banking and understands the value we provide to the communities we serve. We have great history and pride in being a strong and trusted resource for our customers and communities, and we feel that will continue as we join together with Horizon.”
The transaction is expected to be completed by the late third quarter or early fourth quarter of 2017, subject to approval by bank regulatory authorities and the shareholders of Wolverine, as well as the satisfaction of other customary closing conditions. Wolverine Bank will be merged into Horizon Bank, and the combined operations will be continued under the Horizon Bank name.
Horizon was advised by Raymond James & Associates, Inc. and the law firm of Barnes & Thornburg, LLP. Wolverine was advised by Keefe, Bruyette & Woods, Inc. and the law firm of Luse Gorman, PC.
About Horizon Bancorp
Horizon Bancorp is an independent, commercial bank holding company serving northern and central Indiana, southwest and central Michigan and central Ohio through its commercial banking subsidiary Horizon Bank, NA. Horizon also offers mortgage-banking services throughout the Midwest. Horizon Bancorp may be reached online at www.horizonbank.com. Its common stock is traded on the NASDAQ Global Select Market under the symbol HBNC.
About Wolverine Bancorp, Inc.
Originally chartered in 1933 and headquartered in Midland, Michigan, Wolverine Bancorp, through its wholly-owned subsidiary Wolverine Bank, serves the Great Lakes Bay, Metro Detroit, Greater Lansing and Grand Rapids regions. Wolverine Bank may be reached online at www.wolverinebank.com. Its common stock is traded on the NASDAQ Capital Market under the symbol WBKC.
Additional Information
This communication is being made with respect to the proposed transaction involving Horizon and Wolverine. This material is not a solicitation of any vote or approval of the Wolverine shareholders and is not a substitute for the proxy statement/prospectus or any other documents that Wolverine may send to its shareholders in connection with the proposed merger.
In connection with the proposed merger, Horizon will file with the SEC a Registration Statement on Form S-4 that will include a Proxy Statement of Wolverine and a Prospectus of Horizon, as well as other relevant documents concerning the proposed transaction. Shareholders and investors are urged to read the registration statement and the proxy statement/prospectus regarding the merger when it becomes available and any other relevant documents filed with the SEC, as well as any amendments or supplements to those documents, because they will contain important information.
The proxy statement/prospectus and other relevant materials (when they become available), and any other documents Horizon has filed with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents Horizon has filed with the SEC from Horizon at www.horizonbank.com under the tab “About Us – Investor Relations – Documents – SEC Filings.” Alternatively, these documents, when available, can be obtained free of charge from Horizon upon written request to Horizon Bancorp, attention: Dona Lucker, Shareholder Relations Officer, 515 Franklin Square, Michigan City, Indiana 46360 or by calling (219) 874-9272. The information available through Horizon’s website is not and shall not be deemed part of this press release or incorporated by reference into other filings Horizon makes with the SEC. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities.
Investors and security holders also may obtain free copies of the documents Wolverine has filed with the SEC from Wolverine at www.wolverinebank.com under the tab “Investor Information – SEC Filings.” Alternatively, these documents, when available, can be obtained free of charge from Wolverine upon written request to Wolverine Bancorp, attention: Rick A. Rosinski, Chief Operating Officer, 5710 Eastman Avenue, Midland, Michigan 48460 or by calling (989) 631-4280. The information available through Wolverine’s website is not and shall not be deemed part of this press release or incorporated by reference into other filings Wolverine makes with the SEC. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities.
Horizon and Wolverine and certain of their directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Wolverine in connection with the proposed merger. Information about the directors and executive officers of Horizon is set forth in Horizon’s Annual Report on Form 10-K filed with the SEC on February 28, 2017, and in the proxy statement for Horizon’s 2017 annual meeting of shareholders, as filed with the SEC on March 17, 2017. Information about the directors and executive officers of Wolverine is set forth in Wolverine’s Annual Report on Form 10-K filed with the SEC on March 31, 2017, and in the proxy statement for Wolverine’s 2017 annual meeting of shareholders, as filed with the SEC on April 17, 2017. Additional information regarding the interests of these participants and any other persons who may be deemed participants in the transaction may be obtained by reading the proxy statement/prospectus regarding the proposed merger when it becomes available. Free copies of this document may be obtained as described in the preceding paragraph.
Forward Looking Statements
This press release may contain forward-looking statements regarding the financial performance, business prospects, growth and operating strategies of Horizon and Wolverine. For these statements, Horizon and Wolverine each claims the protections of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Statements in this press release should be considered in conjunction with the other information available about Horizon and Wolverine, including the information in the filings each of us makes with the Securities and Exchange Commission. Forward-looking statements provide current expectations or forecasts of future events and are not guarantees of future performance. The forward-looking statements are based on management’s expectations and are subject to a number of risks and uncertainties. Each of us has tried, wherever possible, to identify such statements by using words such as “anticipate,” “estimate,” “project,” “intend,” “plan,” “believe,” “will” and similar expressions in connection with any discussion of future operating or financial performance.
Although management believes that the expectations reflected in such forward-looking statements are reasonable, actual results may differ materially from those expressed or implied in such statements. Risks and uncertainties that could cause actual results to differ materially include risk factors relating to the banking industry and the other factors detailed from time to time in Horizon’s and Wolverine’s reports filed with the Securities and Exchange Commission, including those described in their Forms 10-K and the following: the possibility that the merger does not close when expected or at all because required regulatory, shareholder or other approvals and other conditions to closing are not received or satisfied on a timely basis or at all; the risk that the benefits from the transaction may not be fully realized or may take longer to realize than expected, including as a result of changes in general economic and market conditions, interest and exchange rates, monetary policy, laws and regulations and their enforcement, and the degree of competition in the geographic and business areas in which Horizon and Wolverine operate; the ability to promptly and effectively integrate the businesses of Horizon Bank and Wolverine Bank; the reaction of the companies’ customers, employees and counterparties to the transaction; and the diversion of management time on merger-related issues. Undue reliance should not be placed on the forward-looking statements, which speak only as of the date hereof. Neither Horizon nor Wolverine undertakes, and specifically disclaims any obligation, to publicly release the result of any revisions that may be made to update any forward-looking statement to reflect the events or circumstances after the date on which the forward-looking statement is made, or reflect the occurrence of unanticipated events, except to the extent required by law.
Horizon Contact Information: Craig M. Dwight Chairman and Chief Executive Officer Phone: (219) 873-2725 Fax: (219) 874-9280 Mark E. Secor Chief Financial Officer Phone: (219) 873-2611 Fax: (219) 874-9280 Wolverine Contact Information: David H. Dunn President and Chief Executive Officer Phone: (989) 839-8760 Fax: (989) 631-7610 Rick A. Rosinski Chief Operating Officer Phone: (989) 839-8771 Fax: (989) 631-7610
$AEMD To Present Clinical Study Results at The BIO International Convention
SAN DIEGO, June 14, 2017 — Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health and biodefense, announced today that Company Chairman and CEO, Jim Joyce will present at the 2017 BIO International Convention (BIO 2017) on June 21, 2017 at 11:15 AM Pacific Time. BIO 2107, which is being held at the San Diego Convention Center, attracts more than 16,000 biotechnology industry executives from 76 countries. Mr. Joyce will present virus capture data from a recently concluded FDA-approved feasibility study that was designed to assess the safety of the Aethlon Hemopurifier® in health-compromised individuals infected with a viral pathogen.
The presentation will be live audio webcast through a link available in the upcoming events section of the company’s website at https://www.aethlonmedical.com/news-media/events.
The Aethlon Hemopurifier® is a first-in-class medical device designed for the single-use removal of viral pathogens from the circulatory system of infected individuals.
The Hemopurifier® is a candidate treatment countermeasure to address a broad-spectrum of viruses that are not addressed with antiviral drug therapies, including natural occurring pandemic threats and agents of bioterrorism. Additionally, the device provides a strategy to augment the benefit of approved antiviral drug regimens.
Aethlon believes the Hemopurifier® can achieve the U.S. Government’s broad-spectrum treatment goal against emerging viral threats. More specifically, the Company is advancing the Hemopurifer® to fulfill the U.S. Department of Health and Human Services (HHS) initiative to manufacture and procure medical countermeasures, including non-pharmaceutical therapies, that can address multiple high-priority bioterror and pandemic threats, yet may also have commercial viability in other markets. To date, the Hemopurifier® has been validated to capture 16 different viral threats and has been the subject of multiple human studies. .
About Aethlon Medical, Inc.
Aethlon Medical develops immunotherapeutic technologies to combat infectious disease and cancer. To augment the body’s natural immune defenses, the Aethlon Hemopurifier® reduces the presence of circulating viruses in infected individuals. The technology provides a first-line candidate defense against viruses that are not addressed with proven drug therapies, including natural occurring pandemic threats and agents of bioterrorism. The Hemopurifier® can also be deployed as a strategy to improve the benefit of approved antiviral drug regimens. At present, the Hemopurifier® is being advanced in the United States under an FDA approved clinical study. Aethlon Medical is also investigating the potential use of the Hemopurifier® to reduce the presence of tumor-derived exosomes, which contribute to immune-suppression and the spread of metastasis in cancer patients. Aethlon Medical is also the majority owner of Exosome Sciences, Inc. (ESI), which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders, including Alzheimer’s disease (AD) and Chronic Traumatic Encephalopathy (CTE). ESI’s TauSome™ biomarker is being clinically evaluated as the basis for a blood-based test to identify CTE in living individuals. Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com. You can also connect with us on Twitter, LinkedIn, Facebook and Google+.
Forward Looking Statements
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 Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company’s ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, including any diagnostic products, that the FDA will not approve the initiation or continuation of the Company’s clinical programs or provide market clearance of the Company’s products, including clearance through the 21st Century Cures Act, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the Company’s ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the Company’s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2016, and in the Company’s other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 extension 3300
Jfrakes@aethlonmedical.com
Investor Relations:
John Marco
CORE IR
516 222 2560
johnm@coreir.com
$CIIX Launches CBD Biotechnology Inc. in British Columbia, Canada
SAN GABRIEL, California, June 14, 2017 —
ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announces that it has incorporated CBD Biotechnology Inc. in British Columbia, Canada. CBD Biotechnology Inc. will focus on research, development and distribution of health products, including hemp-derived cannabidiol (“CBD”) products, as well as hemp-based food and beverage products.
In April 2017, fulfilling a campaign pledge, Prime Minister Justin Trudeau introduced legislation to legalize the recreational use of marijuana in Canada by the middle of 2018. Canada will become the second country to completely legalize marijuana as a consumer product. The law will require purchasers to be at least 18 years old, and it will limit the amount they can carry at any one time to 30 grams. While the federal government will license and regulate growers, each of Canada’s provinces will need to decide exactly how the drug will be distributed and sold within its boundaries.
“I am delighted about the incorporation of CBD Biotechnology Inc.,” says Warren Wang, founder and CEO of CIIX. “CBD Biotechnology Inc. is strategically located in British Columbia, Canada, known to be a cannabis friendly province. The British Columbia cannabis industry produces 40 percent of all Canadian cannabis, making cannabis among the most valuable cash crops in the province. While CIIX has been laying the groundwork to enter the legal cannabis market for some time, the complete legalization of cannabis in Canada provides another great opportunity for CIIX to enter the market.”
“The incorporation of CBD Biotechnology Inc. is a promising step forward towards CIIX’s goals to enter the medical marijuana industry. Through its expansion into Canada, CIIX aims generate significant revenues through sales of CBD-based health products, while helping the nearly one million Chinese in Canada to improve their overall health,” concludes Wang.
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)
New York, New York
http://www.NetworkNewsWire.com
+1-212-418-1217 Office
Editor@NetworkNewsWire.com
$GNMX to Present at the JMP Securities Life Sciences Conference
PHILADELPHIA, June 13, 2017 — Aevi Genomic Medicine, Inc. (NASDAQ: GNMX) (the Company) announced today that Michael F. Cola, President and Chief Executive Officer, will be a participant on the Emerging Landscape of Orphan / CNS Disorders Panel at the JMP Securities Life Sciences Conference at 1:00 PM EDT in New York, NY on Tuesday, June 20, 2017 at the St. Regis New York.
About Aevi Genomic Medicine, Inc.
Aevi Genomic Medicine, Inc. is dedicated to unlocking the potential of genomic medicine to translate genetic discoveries into novel therapies. Driven by a commitment to patients with pediatric onset life-altering diseases, the company’s research and development efforts leverages an internal genomics platform and an ongoing collaboration with the Center for Applied Genomics (CAG) at The Children’s Hospital of Philadelphia (CHOP).
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
CONTACT:
Aevi Genomic Medicine, Inc.
Brian Piper
Brian.Piper@aevigenomics.com
Westwicke Partners
Chris Brinzey
339-970-2843
Chris.brinzey@westwicke.com
$HDP & $IBM Expand Partnership
— Companies combine IBM Data Science Experience and Machine Learning with Hortonworks Data Platform; — New fast and easy on-ramp for developers to access data science and cognitive tools and create intelligent apps; — Companies to propel Apache open source projects with new code
SAN JOSE, Calif., June 13, 2017 — (DataWorks Summit/Hadoop Summit) — IBM (NYSE: IBM) and Hortonworks (NASDAQ: HDP) today announced an expansion to their relationship focused on extending data science and machine learning to more developers and across the Apache Hadoop ecosystem. The companies are combining Hortonworks Data Platform (HDP®) with IBM Data Science Experience and IBM Big SQL into new integrated solutions designed to help everyone from data scientists to business leaders better analyze and manage their mounting data volumes and accelerate data-driven decision-making.
“The combination of IBM’s data science and Hortonworks’ open and connected data platforms will benefit not only our respective clients, but also the Apache open source community because of our combined investment and collaboration,” said Rob Bearden, CEO, Hortonworks. “We’re excited about the inevitable acceleration in technical innovations that this relationship is being designed to foster, the result being smarter and more agile businesses.”
“This partnership will provide an integrated and open data science and machine learning platform that lets teams easily collaborate and operationalize data science,” said Rob Thomas, General Manager, IBM Analytics. “Incorporating advanced machine learning and deep learning capabilities, the combination of Hortonworks Data Platform with IBM’s Data Science Experience and the IBM Machine Learning platform can help clients achieve improved analytic results faster and at scale.”
The news builds on the long-standing relationship between the companies and includes the following:
- Hortonworks will resell the IBM Data Science Experience with HDP, a leading Hadoop distribution, and adopt it as its strategic data science platform, giving developers a fast on-ramp to data science capabilities including machine learning, advanced analytics and statistics. Also, Hortonworks and IBM will create new solution bundles that integrate HDP with IBM Big SQL, IBM’s SQL engine for Hadoop, giving Hortonworks’ legions of clients and users a familiar method of managing their data.
- IBM is adopting HDP for its Hadoop distribution and will fully integrate it with Data Science Experience and Machine Learning. As a result, this solution will combine for users the rich data security, governance and operations functionality provided by HDP, and the advanced analytics and management of the Data Science Experience. IBM will migrate existing IBM BigInsights users to HDP.
IBM Data Science Experience provides a set of critical tools and a collaborative environment through which analysts and developers can create new analytic models quickly and easily. For example, IBM Machine Learning, found in the Data Science Experience, can speed the time it takes to build and deploy analytic models for application development by two-times, according to IBM testing.
In addition to the companies’ numerous product collaborations, IBM and Hortonworks are also founding members of the Open Data Platform Initiative (ODPi). Launched in February 2015, ODPi is comprised of industry leaders working collaboratively to define and promote a set of standard open source technologies and increase compatibility among big data platforms.
The expanded partnership also builds on an existing partnership and joint solutions including HortonWorks Data Platform (HDP) for IBM’s Power Systems and Spectrum Scale Storage. Customers can benefit from fast access to data and a cost-effective platform for running their big data and cognitive workloads.
Earlier this week Hortonworks announced Hortonworks DataFlow (HDFTM) for IBM Power Systems. HDF, the industry’s only data ingest, stream processing and streaming analytics platform built entirely on open source software, is designed to enable customers to collect, curate, analyze and act on all data in real-time, across the data center and cloud. Combined with IBM Power Systems, customers can gain access to industry-leading performance and efficiency for streaming analytics. HDF is complementary to HDP and is designed to accelerate the flow of data in motion into HDP to support full fidelity analytics.
Partnering On Apache
As part of their wide-ranging partnership, the companies will also team to advance the development of Unified Governance (IBM BigIntegrate, IBM BigQuality and IBM Information Governance Catalog) on the Apache Atlas open platform. Atlas provides a scalable governance platform for Enterprise Hadoop which is designed to help developers model new business processes and data assets quickly and easily. Through their work, both companies plan to help advance Atlas from its current Incubator status to Apache Top Level Project status, where projects are typically released for open development and deployment.
In addition to Atlas, the companies will also partner on the advancement of Apache Spark, the open source framework for processing and analyzing large data sets across clustered environments. The companies will also collaborate to advance the Apache Hadoop framework itself, working to unify access to multi-vendor, heterogeneous data environments across data warehouses and databases – ultimately aiming to simplify the environment for better value from all data.
IBM – A Leader in Gartner Data Science Magic Quadrant
IBM was recently named a Leader in the February 2017 Gartner Magic Quadrant for Data Science Platforms. The report, which evaluated data science platforms from 16 analytics vendors, describes data science platforms as “products that organizations use to build machine-learning solutions themselves, as opposed to outsourcing their creation or buying ready-made solutions.”
About Hortonworks
Hortonworks is an industry-leading innovator that creates, distributes and supports enterprise-ready open data platforms and modern data applications that deliver actionable intelligence from all data: data-in-motion and data-at-rest. Hortonworks is focused on driving innovation in open source communities such as Apache Hadoop, Apache NiFi and Apache Spark. Along with its 2,100+ partners, Hortonworks provides the expertise, training and services that allow customers to unlock transformational value for their organizations across any line of business.
Hortonworks, HDP and HDF are registered trademarks or trademarks of Hortonworks, Inc. and its subsidiaries in the United States and other jurisdictions. All other trademarks are the property of their respective owners. For more information, please visit www.hortonworks.com.
About IBM
For more about IBM Analytics visit www.ibm.com/analytics.
Contact
Mike Zimmerman
IBM Media Relations
mrzimmerman@us.ibm.com
(585) 698-9974
Michelle Lazzar
Hortonworks Media Relations
comms@hortonworks.com
(408) 828-9681
$AST Patients with Complete Paralysis Show Additional Recovery
Third patient recovers two motor levels; three of six (50%) patients in AIS-A 10 million cell cohort have now recovered two motor levels on at least one side
FREMONT, Calif., June 13, 2017 — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that new 9-month follow-up data from the AIS-A 10 million cell cohort in the company’s ongoing SCiStar Phase 1/2a clinical trial shows three of six (50%) patients have now recovered two levels of motor function and previously-announced improvements in arm, hand and finger function at 3-months and 6-months following administration of AST-OPC1 have been confirmed and further increased at 9-months.
“The new efficacy results show that previously reported meaningful improvements in arm, hand and finger function in the 10 million cell cohort treated with AST-OPC1 cells have been maintained and in some patients have been further enhanced even 9 months following dosing,” stated Dr. Edward Wirth III, Chief Medical Officer. “Gains in motor function, such as the improvements observed in the SCiStar study to date, have been shown to increase a patient’s ability to function independently following complete cervical spinal cord injuries. We are increasingly encouraged by these continued positive results, which are remarkable compared with spontaneous recovery rates observed in a closely matched untreated patient population.”
Jane S. Lebkowski, Ph.D., Asterias’ President of R&D and Chief Scientific Officer, will present the 9-month efficacy and safety data on the AIS-A 10 million cell cohort later today during the International Society for Stem Cell Research (ISSCR) 2017 Annual Meeting held in Boston, MA. The full slide presentation will be available at http://asteriasbiotherapeutics.com/inv_events_presentations.php.
9-Month Follow-up Results
Improvements in upper extremity motor function are being measured using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, widely used to quantify functional status of patients with spinal cord injuries. Both subjects and physicians consistently report that improvements in upper extremity motor function are the most desirable functional improvement target in the quadriplegic population, as they can have a significant impact on functional independence, quality of life and cost of care from even relatively modest changes. The SCiStar study is monitoring two separate ISNCSCI measurements of upper extremity motor function. The upper extremity motor score (UEMS), is a linear scale used to quantify motor function at each of five upper extremity muscle groups driving arm and hand function; these scores are also used to determine “motor levels”, which define the level within the cord above which a subject has normal function. As suggested by existing research, patients with severe spinal cord injuries that show two motor levels of improvement on at least one side may regain the ability to perform daily activities such as feeding, dressing and bathing, which significantly reduces the overall level of daily assistance needed for the patient and associated healthcare costs.
A total of six patients were enrolled and dosed in the AIS-A 10 million-cell cohort, with five of six patients completing a 9-month follow-up visit. The results include the following highlights:
- Motor Level Improvement – Additional motor level improvement was seen in the AIS-A 10 million cell cohort at 9 months.
- Three of six patients (50%) achieved two motor levels of improvement over baseline on at least one side as of their latest follow-up visit through 9 months. This compares to two of six patients (33%) that had improved two motor levels on at least one side through 3- and 6-months of follow-up.
- In addition, all six patients (100%) achieved at least one motor level of improvement on at least one side as of their latest follow-up through 9-months.
- Upper Extremity Motor Score – Additional improvement in the average UEMS score for this cohort was observed at 9 months. The average UEMS improvement at 9 months was 11.2 points, compared to 9.7 points at 6 months.
- Matched Historical Control Data – The 9 month results show a meaningful improvement in the motor function recovery in the AIS-A patients receiving 10 million AST-OPC1 cells compared to a historical control group of 62 closely matched patients from the EMSCI database. In the historical matched control 29% of patients recovered two motor levels on at least one side 12 months after baseline compared to the 50% of the AIS-A patients receiving AST-OPC1 that have recovered two motor levels on at least one side 9 months after baseline.
- Safety – The trial results to date continue to indicate a positive safety profile for AST-OPC1. There have been no serious adverse events related to AST-OPC1 and data from the study indicate that AST-OPC1 can be safely administered to patients in the subacute period after severe cervical spinal cord injury.
As previously reported, Asterias will report 12-month efficacy and safety data from the AIS-A 10 million cell cohort sometime late in the third quarter 2017 after the 12-month results are collected for the entire cohort.
Each year in the U.S. more than 17,000 people suffer a severe, debilitating spinal cord injury. These injuries can be devastating to quality of life and ability to function independently. Lifetime healthcare costs for these patients can often approach $5 million. Improvements in arm, hand and finger functional capabilities in these patients can result in lower healthcare costs, significant improvements in quality of life, increased ability to engage in activities of daily living, and increased independence.
About the SCiStar Trial
The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.
The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University.
Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.
Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).
About AST-OPC1
AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.
In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with AST-OPC1. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries, which represents the first targeted population for registration trials.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.
$OMER FDA Grants Breakthrough Therapy Designation in IgA Nephropathy
– Omeros’ Second Phase 3 Clinical Program for OMS721 Slated to Begin this Year –
Omeros Corporation (NASDAQ: OMER) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
Breakthrough therapy designation was granted based on data from Omeros’ Phase 2 clinical trial evaluating OMS721 in patients with IgA nephropathy and other kidney diseases. The data were recently presented at the 54th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Madrid. Proteinuria is an important marker for disease progression in patients with IgA nephropathy, and improvement in proteinuria is associated with improved clinical outcomes. The clinical trial data show unprecedented improvement in proteinuria following only 12 weeks of OMS721 treatment, with a 77-percent mean reduction in urine albumin-to-creatinine ratios (p = 0.026) and a 73-percent mean reduction in 24-hour urine protein levels (p = 0.013). In response, many physicians attending ERA-EDTA in Madrid and representing centers across Europe, the U.S. and Asia that manage large numbers of IgA nephropathy patients asked to participate in Omeros’ planned Phase 3 clinical trial. These physicians have been added to the ongoing clinical site evaluation for the Phase 3 clinical program.
FDA’s breakthrough therapy designation enables expedited development and review of a drug candidate for the treatment of a serious or life-threatening disease. Preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies is required. Benefits of breakthrough therapy designation include the eligibility for priority review of the application and rolling submission of portions of the application. FDA personnel, including senior management, provide guidance to the company to determine the most efficient route to approval. OMS721 is the only drug candidate in development for the treatment of IgA nephropathy that has been granted breakthrough therapy designation by FDA.
“We are pleased that FDA has granted breakthrough designation to OMS721 for IgA nephropathy and appreciate the Agency’s recognition of the potential importance of OMS721 in the treatment of this disease,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “OMS721 appears to be helping IgA nephropathy patients with a rapidity and magnitude not previously seen with any other therapy, and we look forward to working closely with the FDA to accelerate its development.”
There is no approved treatment for IgA nephropathy. The most common primary glomerulopathy globally, it accounts for up to 10 percent of all dialysis patients. In the U.S. alone, an estimated 120,000 to 180,000 patients have this disease. Approximately 40 percent of IgA nephropathy patients develop end-stage renal disease, a life-threatening condition, within 20 to 30 years following diagnosis.
OMS721 is also being evaluated in a Phase 3 clinical program for atypical hemolytic uremic syndrome and in a Phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
About Omeros’ MASP Programs
Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 is the effector enzyme of the lectin pathway, one of the principal complement activation pathways. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. OMS721 is Omeros’ lead human MASP-2 antibody.
Following discussions with both the FDA and the European Medicines Agency, a Phase 3 program for OMS721 in atypical hemolytic uremic syndrome (aHUS) is in progress. Also, two Phase 2 trials are ongoing. One is evaluating OMS721 in glomerulonephropathies, which has generated positive data in patients with immunoglobulin A (IgA) nephropathy and with lupus nephritis; the other has reported positive data both in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA) and in those with aHUS. One or more additional OMS721 Phase 3 clinical programs are planned to initiate this year in IgA nephropathy and in stem cell transplant-associated TMA. OMS721 can be administered intravenously, and Omeros also expects to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection. In parallel, Omeros is developing small-molecule inhibitors of MASP-2. Based on requests from treating physicians, Omeros has established a compassionate-use program for OMS721, which is active in both the U.S. and Europe. The FDA has granted OMS721 breakthrough therapy designation for IgA nephropathy, orphan drug status for the prevention (inhibition) of complement-mediated TMAs and fast track designation for the treatment of patients with aHUS.
Omeros also has identified MASP-3 as responsible for the conversion of pro-factor D to factor D and as a critical activator of the human complement system’s alternative pathway. The alternative pathway is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the company is advancing its development of antibodies and small-molecule inhibitors against MASP-3 to block activation of the alternative pathway. Omeros is preparing to initiate manufacturing scale-up of its MASP-3 antibodies in advance of clinical trials.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Part of its proprietary PharmacoSurgery® platform, the company’s first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary G protein-coupled receptor (GPCR) platform and controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
Forward-Looking Statements
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 Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor and Media Relations
360.668.3701
jennifer@cwcomm.org
$PTOTF Marks 3-Months of Global PATSCAN Sales with $2.7M in Signed Agreements
Concealed Weapons Detection System Maker Exceeds 90% of 2017 Order Target
TORONTO, ON–(Jun 13, 2017) – Patriot One Technologies Inc. (TSX VENTURE: PAT) (OTCQB: PTOTF) (FRANKFURT: 0PL) (“Patriot One” or the “Company”), developer of the award-winning PATSCAN CMR™ concealed weapons detection system, is pleased to report that in the three months since product marketing began during the lead up to the ISC West trade show in Las Vegas, confirmed sales commitments now top $2.7 million.
Patriot One sales efforts are currently focused on categories including houses of worship, academic institutions, event centres, casinos, commercial offices, hotel properties, government agencies and other locations at high risk of terrorist attack. Orders have been received from locations spanning four continents, and new territorial opportunities are opening as reseller influence grows.
Patriot One President and CTO Dinesh Kandanchatha notes, “Our roll-out program initially conceived finalizing our engineering in early spring in order to meet Industry Canada and FCC certification requirements by late summer. This timing also aligns with our go-to-market packaging initiative and expectation that we will begin shipments to end-user installations by Q4 of this year.”
As a result of recent sales performance, as well as new agreements with resellers in Canada, the US, the UK, and South Africa, Patriot One is now receiving requests to employ special waivers allowing for the immediate deployment of PATSCAN CMR to users that have a demonstrated need under certification exemption guidelines.
“We have informed our supply chain partners of the accelerating demand, and I am confident that our scalable manufacturing processes will be well equipped to fulfil our orders,” says Kandanchatha. “It means a lot of work ahead, but it is a highly positive and not wholly unanticipated situation at this phase of our strategic growth plan.”
Martin Cronin, Patriot One CEO, notes, “Proving out demand is a key factor for any early stage company with an exciting new product. The surge we are experiencing reflects the outcomes of repeated successful demonstrations of the system’s capability. The word on Patriot One’s weapons detection solution is spreading rapidly.”
Cronin adds, “All of us at Patriot One Technologies are honoured to have the opportunity to deploy a product with such value as a catalyst for positive change. To have an opportunity to improve public safety and to save lives as a basis for a successful business venture is something we all are very proud of.”
ON BEHALF OF THE BOARD
“Martin Cronin”
CEO & Director
About Patriot One Technologies, Inc. (TSX VENTURE: PAT) (OTCQB: PTOTF) (FRANKFURT: 0PL):
Patriot One has developed PATSCAN CMR™ the next generation of its award-winning Patriot One Technologies™ NForce CMR1000 software and radar solution. PATSCAN CMR is a first-of-its-kind Cognitive Microwave Radar concealed weapons detection system as an effective tool to combat active shooter threats before they occur. Designed for cost-effective deployment in weapon-restricted buildings and facilities, the Patriot One software solution and related hardware can be installed in hallways and doorways to covertly identify weapons and to alert security of an active threat entering the premises. Owner/operators of private and certain public facilities can now prominently post anti-weapons policies with compliance assured. The Company’s motto Deter, Detect and Defend is based on the belief that widespread use of its technology will act as an effective deterrent, thereby diminishing the epidemic phenomena of active shooters across the globe. For more information, visit: www.patriot1tech.com. Patriot One Technologies are proud winners of the 2017 Anti-Terrorism / Force Protection category of the Security Industry Association’s New Product Showcase at ISC West.
CAUTIONARY DISCLAIMER STATEMENT:
No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For further information, please contact:
Patriot One Inquiries
+1 (888) 728-1832
info@patriot1tech.com
www.patriot1tech.com
$MBII California Cannabis Growers Now Have Access to Safe and Effective Biopesticides
Marrone Bio Innovations Biopesticides Approved for Use in Calfornia Cannabis Market
DAVIS, Calif., June 12, 2017 — Marrone Bio Innovations, Inc. (NASDAQ:MBII), (MBI) a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, today announced that three MBI active ingredients are now legal for use on cannabis crops in the California market.
Inclusion of these ingredients of products developed and owned by MBI on California Department of Pesticide Regulation’s newest posting of “Legal Pest Management Practices for Cannabis Growers in California,” (http://marronebioinnovations.com/wp-content/uploads/delightful-downloads/MC-mgmt-practices-092916-DPR-Cannabis-Approved-List.pdf) has made four MBI products with proven track records in many of California’s conventional and organic food crops, available to cannabis growers in California.
“We are pleased to meet the demand by the fast growing number of cannabis growers in California and many other states,” said Dr. Pam Marrone, Founder and Chief Executive Officer, Marrone Bio Innovations. “We are also currently working with industry experts around the country to develop cannabis-specific ‘special local need’ labels in states where it is currently legal to market and sell medicinal and/or adult use cannabis. Where allowed by state governments, these labels will provide product use information that is more detailed to cannabis cultivation practices.”
Marrone added, “We have seen the cannabis industry quickly emerge as an important segment for MBI. Our products are transforming cannabis production through the reduction of toxic chemicals and pesticide residues that are harmful to both the environment and to people.”
Natalie Darves, CEO of Cougar Acres Consulting and Lead Outdoor Horticulture Instructor, Oaksterdam University, commented, “California cannabis growers strive to produce a high quality and safe product. Since MBI products on the new CADPR listing are tolerance exempt, use of these pest management tools will help minimize crop rejection. Proposed cannabis testing standards prohibit unsafe pesticide residues from unapproved uses of synthetic pesticides. Since MBI products do not contain live microbes as active ingredients, I have been able to significantly reduce crop rejection. Most microbial pesiticides residues will not pass the stringent microbial contamination testing standards that exceed standard food safety testing. These various testing standards are the forefront of policy issues affecting California cannabis growers today. The MBI products approved for use on cannabis are valuable and welcome new tools for California growers.”
Reynoutria sachalinensis extract is the active component of Regalia biofungicide, bringing outstanding levels of control of diseases like powdery mildew and leaf spots. Chromobacterium subtsugae strain PRAA41T is the active ingredient in Grandevo bioinsecticide and Burkholderia spp. strain A396 is the active ingredient in Venerate XC bioinsecticide. These two bioinsecticides provide outstanding control of insects such as thrips, aphids, mites and white flies. Burkholderia spp. strain A396 is also the active element in Majestene bionematicide.
MBI products are safe for cannabis growers, their customers and the environment, and are approved for use in organic production. Further, these products are exempt from Maximum Residue Limits (MRL) and offer the flexibility to be used through point of harvest.
According to recent studies, the legal cannabis industry in the U.S. could grow to $50 billion in the next decade. It could expand to more than eight times its current size, as lawful cannabis suppliers gain new customers and convert consumers from the illicit market. The recent legalization of cannabis for adult use in California, where it was already permitted for medical use, is expected to triple the size of the country’s current $6 billion legal cannabis industry.
About Marrone Bio Innovations
Smart. Natural. Solutions.
Marrone Bio Innovations, Inc. (NASDAQ:MBII) strives to lead the movement to a more sustainable world through the discovery, development and promotion of biological products for pest management and plant health. Our effective and environmentally responsible solutions help customers operate more sustainably while controlling pests, improving plant health, and increasing crop yields. We have five products for agriculture on the market (Regalia®, Grandevo®, Venerate®, Majestene®, and Haven™), and also distribute Bio-tam 2.0® for Isagro USA in the western U.S. MBI also markets Zequanox® for invasive mussels for water markets. We have a proprietary discovery process, a rapid development platform, and a robust pipeline of pest management and plant health product candidates. At Marrone Bio Innovations we are dedicated to pioneering better biopesticides that support a better tomorrow for users around the globe. For more information, please visit www.marronebio.com.
Marrone Bio Innovations Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertain-ties. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations and plans, including assumptions underlying such statements, are forward-looking statements, and should not be relied upon as representing MBI’s views as of any subsequent date. Examples of such statements include statements regarding sales of the Company’s products, the potential benefits of the Company’s products, and MBI’s efforts with respect to expansion of its product labels in cannabis or other markets. Such forward-looking statements are based on information available to the Company as of the date of this release and involve a number of risks and uncertainties, some beyond the Company’s control, that could cause actual results to differ materially from those anticipated by these forward-looking statements, including consumer, regulatory and other factors affecting demand for the Company’s products, any difficulty in marketing MBI’s products for cannabis, competition in the market for pest management products, lack of understanding of bio-based pest management products by customers and growers, and adverse decisions by regulatory agencies and other relevant third parties. Additional information that could lead to material changes in MBI’s performance is contained in its filings with the SEC. MBI is under no obligation to, and expressly disclaims any responsibility to, update or alter forward-looking statements contained in this release, whether as a result of new information, future events or otherwise.
Marrone Bio Innovations Contact: Keith Pitts, Senior VP Regulatory and Government Affairs and Chief Sustainability Officer Andre Trepanier Product Manager, Fungicides and New Products Telephone: +1 (530) 750-2800 Email: Info@marronebio.com MBI Investor Contacts: MZ Group Main: 949-385-6449 Greg Falesnik greg.falesnik@mzgroup.us
$FCSC Rare Pediatric Disease Designation from FDA for FCX-013
Gene Therapy Candidate under Control of RheoSwitch Therapeutic System® Technology is Potential First-in-Class Treatment for Chronic Disease with High Unmet Need
EXTON, Pa., June 12, 2017 — Fibrocell Science, Inc., (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to FCX-013, Fibrocell’s gene therapy candidate for the treatment of moderate to severe localized scleroderma—a chronic autoimmune disease characterized by thickening of the skin and connective tissue. The Rare Pediatric Disease Designation augments the Orphan Drug Designation previously granted by the FDA to FCX-013 for the treatment of localized scleroderma, which includes linear scleroderma.
“We are pleased the FDA has awarded Rare Pediatric Disease Designation to FCX-013, which in addition to its Orphan Drug Designation provides important incentives to Fibrocell for developing therapies for rare pediatric diseases,” said John Maslowski, Chief Executive Officer of Fibrocell. “Moderate to severe forms of localized scleroderma, including the linear subtype, can result in significant morbidity, including pain, restricted motion, disfigurement and developmental issues. With no FDA-approved therapies available, we believe controlled gene therapy through FCX-013 offers promise to address this high unmet medical need of patients suffering from this chronic and often debilitating disease.”
FCX-013 is Fibrocell’s second gene therapy candidate awarded Rare Pediatric Disease Designation. The Company also received this designation for FCX-007, its clinical-stage gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Upon market approval, both candidates are eligible to receive a Priority Review Voucher.
Fibrocell continues to make progress in the pre-clinical development of FCX-013, and expects to submit an investigational new drug application (IND) to the FDA in the fourth quarter of 2017.
FCX-013 and FCX-007 are being developed in collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology.
About Rare Pediatric Disease Designation
The FDA defines a “rare pediatric disease” as a disease that affects fewer than 200,000 individuals in the U.S. that is a serious or life-threatening disease affecting individuals primarily aged from birth to 18 years. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, upon the approval of a qualifying new drug application (NDA) or biologics license application (BLA) for the treatment of a rare pediatric disease, the sponsor of such application would be eligible for a Rare Pediatric Disease Priority Review Voucher that can be used to obtain priority review for a subsequent NDA or BLA. The Priority Review Voucher may be sold or transferred an unlimited number of times.
About FCX-013
Fibrocell is in pre-clinical development of FCX-013, its gene therapy candidate for the treatment of linear scleroderma, a form of localized scleroderma. FCX-013 incorporates Intrexon’s proprietary RheoSwitch Therapeutic System® (RTS®), a biologic switch activated by an orally administered compound to control future protein expression once the initial fibrosis has been resolved. FCX-013 is designed to be injected under the skin at the location of the fibrosis where the genetically-modified fibroblast cells will produce a protein to break down excess collagen accumulation. The patient takes an oral compound to facilitate protein expression. Once the fibrosis is resolved, the patient will stop taking the oral compound which will stop further production of the subject protein by FCX-013.
About Localized Scleroderma
Localized scleroderma is a chronic autoimmune skin disorder that manifests as excess production of extracellular matrix, collagen resulting in thickening of the skin and connective tissue. The localized areas of skin thickening may extend to underlying tissue and muscle in children which can impair growth and development. Lesions appearing across joints can be painful, impair motion and may be permanent. Current treatments for localized scleroderma, which include systemic or topical corticosteroids, UVA light therapy and physical therapy, only address the symptoms of the disorder. We estimate that there are approximately 40,000 patients in the U.S. who have the linear scleroderma subtype of localized scleroderma over a major joint and exhibit severe joint pain.
About Fibrocell
Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue. Fibrocell’s most advanced product candidate, FCX-007, is the subject of a Phase 1/2 trial for the treatment of recessive RDEB. Fibrocell is in pre-clinical development of FCX-013, its product candidate for the treatment of linear scleroderma. Fibrocell’s gene therapy portfolio is being developed in collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology. For more information, visit http://www.fibrocell.com or follow Fibrocell on Twitter at @Fibrocell.
Trademarks
Fibrocell, the Fibrocell logo and Fibrocell Science are trademarks of Fibrocell Science, Inc. and/or its affiliates. All other names may be trademarks of their respective owners.
Forward-Looking Statements
This press release contains, and our officers and representatives may from time to time make, statements that are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: Fibrocell’s expected initiation of a toxicology/biodistribution study and submission of an IND for FCX-013 in 2017; the potential benefits of Orphan Drug Designation and Rare Pediatric Disease Designation; the potential advantages of FCX-013 and Fibrocell’s other product candidates; the sufficiency of the Company’s cash and cash equivalents to fund operations into the second quarter of 2018 and other statements regarding Fibrocell’s future operations, financial performance and financial position, prospects, strategies, objectives and other future events.
Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated herein including, among others: uncertainties and delays relating to the initiation, enrollment and completion of pre-clinical studies and clinical trials; whether pre-clinical study and clinical trial results will validate and support the safety and efficacy of Fibrocell’s product candidates; unanticipated or excess costs relating to the development of Fibrocell’s gene therapy product candidates; Fibrocell’s ability to obtain additional capital to continue to fund operations; Fibrocell’s ability to maintain its collaboration with Intrexon Corporation; and the risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” in Fibrocell’s most recent Form 10-K filing and Form 10-Q filings. As a result, you are cautioned not to place undue reliance on any forward-looking statements. While Fibrocell may update certain forward-looking statements from time to time, Fibrocell specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise.
Investor & Media Relations Contact: Karen Casey 484-713-6133 kcasey@fibrocell.com
$GDEN to Acquire American Casino & Entertainment Properties for $850 Million
Four Casino Acquisition Includes the Iconic Stratosphere Casino, Hotel & Tower and Two Arizona Charlie’s Casinos in Las Vegas as well as the Market-leading Aquarius Casino Resort in Laughlin
Acquisition to Significantly Increase Revenues and EBITDA, Expected to be Immediately Accretive to Cash Flow and Earnings per Share
Golden Entertainment Inc. (NASDAQ:GDEN) (“Golden” or the “Company”), announced today that it has entered into a definitive agreement to acquire American Casino & Entertainment Properties LLC (“American”), which owns three properties in Las Vegas including the Stratosphere Casino, Hotel & Tower, Arizona Charlie’s Decatur and Arizona Charlie’s Boulder, as well as its fourth property, the Aquarius Casino Resort in Laughlin. American is expected to generate approximately $413 million of net revenues and $103 million of EBITDA in 2017, and Golden expects to achieve approximately $18 million of annual run-rate synergies post-closing. The purchase price of $850 million includes working capital cash estimated to be approximately $28 million at closing.
The purchase consideration will consist of $781 million cash plus approximately four million shares of Golden stock issued to American’s current owner, Whitehall Street Real Estate Partners 2007 (“Whitehall”), a real estate private equity fund managed by the Merchant Banking Division of Goldman Sachs. The number of shares issued to Whitehall was determined based on Golden’s 10-day volume weighted average price of $17.05 as of June 9, 2017. Upon closing, Whitehall will own approximately 15% of Golden’s diluted shares outstanding. The transaction is expected to be immediately accretive to Golden’s operating results, increasing free cash flow and earnings per share significantly. Based on American’s estimated 2017 EBITDA, the acquisition represents an 8.0x pre-synergies multiple and a 6.8x post-synergies multiple.
Upon completion of the transaction, Golden will operate over 15,800 slot machines, 114 table games and more than 5,100 hotel rooms across eight casino properties and almost 1,000 distributed gaming locations including the largest branded tavern portfolio in Nevada. Pro forma for the completion of the transaction, the combined company would generate approximately $847 million of net revenues in 2017 and approximately $180 million of EBITDA in 2017, including $18 million of estimated run-rate synergies.
The transaction is not subject to a financing condition. Golden has received committed financing totaling $1.1 billion from JPMorgan Chase Bank, N.A., Credit Suisse, Macquarie Capital and Morgan Stanley & Co. LLC to fund the cash consideration as well as to refinance Golden’s existing credit facilities. The financing commitment includes a $100 million revolving credit facility to support Golden’s future organic and strategic growth initiatives.
Blake L. Sartini, Chairman and Chief Executive Officer of Golden, commented, “This is a transformational event for our Company, creating a significant gaming portfolio centered around Nevada-based casinos that, in addition to our Pahrump properties, will include two well-known Las Vegas locals casinos, a destination resort in Laughlin, and the iconic Stratosphere property on the Las Vegas Strip. Our market leading distributed gaming businesses in Nevada and Montana, as well as our Casino Resort in Maryland, present several opportunities to cross-market and promote these new assets that we welcome to the Golden family. As with our existing businesses, we believe the American properties are poised to benefit tremendously from anticipated continued economic growth in Nevada, particularly from the continued strength in the Las Vegas market.”
Mr. Sartini further stated, “The American properties represent an ideal complement to our existing operations as they strengthen our presence in the Las Vegas locals market while providing us with an iconic destination property on the Las Vegas Strip. Our proven strategy of focusing on guest service, quality food and beverage offerings and effective player marketing will complement the strong existing operations currently at all of American’s properties. In addition, given the recent investment activity focused on the north end of the Las Vegas Strip, we see future potential to develop the approximately 15 acres of excess real estate surrounding the Stratosphere. This acquisition supports our goals for growth in many ways, including the potential to use our increased free cash flow and financial scale to pursue distributed gaming opportunities in existing or potential new markets.”
Charles Protell, Chief Financial Officer of Golden, concluded, “This transaction significantly increases the size of our operations and allows us to access the capital markets more efficiently while enhancing our ability to further expand our leading presence in distributed gaming. At closing, we anticipate our funded total debt to be approximately $1 billion resulting in a net leverage ratio of less than 5.5x. Post-closing, we anticipate leverage will be reduced by operating cash flow of the combined businesses. In addition, we expect that our new credit facility will provide us with the flexibility and liquidity to pursue future organic and strategic opportunities.
“With the acquisition of American, we will improve our position to benefit from Nevada’s strong economic trends which are driving gaming, room, and F&B revenues on the Las Vegas Strip, in the Las Vegas locals and in other Nevada gaming markets. Despite the significance of our Nevada casino portfolio after closing this transaction, we intend to continue to invest in the expansion of our industry leading distributed gaming business including our planned tavern developments in Las Vegas as well as our pursuit of potential distributed gaming operations in new jurisdictions.”
The transaction is subject to customary regulatory approvals and is expected to close by the end of 2017.
J.P. Morgan Securities LLC, Credit Suisse, Macquarie Capital, and Morgan Stanley & Co. LLC are acting as co-financial advisors and Latham & Watkins LLP is acting as legal counsel to Golden in connection with the proposed transaction. Macquarie Capital has also provided a Fairness Opinion to Golden’s board of directors in connection with the transaction. Goldman Sachs & Co. LLC is acting as financial advisor to American and Sullivan & Cromwell LLP is acting as its legal counsel.
Conference Call, Webcast, Investor Presentation
Golden will host a conference call today, Monday, June 12 at 4:30 p.m. ET to review the transaction. To access the conference call, interested parties may dial 866/394-1484 or 213/660-0701 for international callers. The Conference ID Number is 38250490. Participants can also listen to a live webcast of the call from Golden’s website at “Investors”. During the conference call and webcast, management will review a presentation summarizing the proposed transaction which can be accessed from Golden’s website at “Presentation”. A webcast replay will be available for 90 days following the live event at “Investors”. Please call five minutes in advance to ensure that you are connected. For the webcast, please allow 15 minutes to register, download and install any necessary software.
About American Casino & Entertainment Properties LLC
American owns and operates four gaming and entertainment properties in Nevada which in aggregate feature 3,879 slot machines, 89 table games and 4,895 hotel rooms:
- The Stratosphere Casino, Hotel & Tower features the 1,149-foot Stratosphere Tower, one of the most iconic landmarks on the North Las Vegas Strip and the tallest freestanding observation tower in the U.S., offering views of the city, award-winning fine dining and lounges, specialty retailers, the world’s highest thrill rides and SkyJump Las Vegas. The property features an 80,000 sq. ft. casino with 743 slot machines, 42 table games, 2,427 guestrooms and suites, 13 restaurants, nine bars, two pools and entertainment venues.
- The Aquarius Casino Resort, located in Laughlin, Nevada, is an award-winning destination resort located on the banks of the Colorado River. The largest casino operations and hotel in Laughlin, Aquarius features 1,227 slot machines, 33 table games, and 1,906 guestrooms and suites offering river, mountain and desert views. Guests enjoy over 57,000 sq. ft. of casino floor space, eight restaurants, three bars, an entertainment Pavilion and a range of outdoor and sports amenities.
- Arizona Charlie’s Hotel & Casino – Decatur is located just off the Las Vegas Strip. The property features 1,060 slot machines, seven table games, 259 hotel rooms, a Poker Room, a Race & Sportsbook, the city’s only 24-hour bingo room, live Keno, fine dining and a café and buffet.
- Arizona Charlie’s Hotel & Casino – Boulder is located on Boulder Highway, just off the U.S. 95 freeway. The property features 849 slot machines, seven table games, 303 hotel rooms, a full service casino with a hotel and RV park; the property also features a 24-hour bingo room, and fine and casual dining options.
About Golden Entertainment Inc.
Golden currently owns and operates gaming properties across two divisions – distributed gaming and resort and casino operations. Golden operates approximately 12,000 gaming devices and 25 table games in Nevada, Maryland and Montana. The Company owns four casino properties, 56 taverns and operates almost 1,000 distributed gaming locations in multiple jurisdictions. Golden is focused on maximizing the value of its portfolio by leveraging its scale, leadership position, and proven management capabilities across its two divisions. For more information, visit www.goldenent.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding future events and our future results, including statements regarding the proposed transaction and the ability to consummate the proposed transaction, that are subject to the safe harbors created under the Securities Act of 1933 and the Securities Exchange Act of 1934. Forward-looking statements can generally be identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “potential,” “seek,” “should,” “think,” “will,” “would” and similar expressions, or they may use future dates. Forward-looking statements in this press release include, without limitation, statements regarding: the planned completion of the transaction; the benefits of the transaction; estimated future financial and operating results, including the Company’s, American’s and the pro forma combined companies’ 2017 net revenues, 2017 EBITDA and run-rate synergies, and the expected accretive effect of the transaction on the Company’s operating results including its cash flows and earnings per share; the Company’s plans, objectives, expectations and intentions; and the expected timing of completion of the transaction. It is important to note that the Company’s goals and expectations are not predictions of actual performance. These forward-looking statements are subject to assumptions, risks and uncertainties that may change at any time, and readers are therefore cautioned that actual results could differ materially from those expressed in any forward-looking statements. Factors that could cause actual results to differ include, among other things: the ability to obtain required regulatory approvals for the transaction (including the approval of gaming and antitrust authorities necessary to complete the transaction), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions that could materially adversely affect the Company, American and the expected benefits of the transaction; the risk that a condition to closing of the transaction may not be satisfied on a timely basis or at all, the failure of the transaction to close for any other reason and the risk of liability to the Company in connection therewith; access to available financing (including financing for the acquisition) on a timely basis and on reasonable terms; the effects of disruption caused by the transaction making it more difficult for the Company to execute its operating plan effectively or to maintain relationships with employees, vendors and other business partners; failure to realize the anticipated cost savings, synergies and other benefits of the transaction; stockholder litigation in connection with the transaction; the Company’s ability to successfully integrate American’s businesses, and other acquired businesses; changes in national, regional and local economic, political and market conditions; legislative and regulatory matters (including the cost of compliance or failure to comply with applicable laws and regulations); increases in gaming taxes and fees in the jurisdictions in which the Company operates; litigation; increased competition; the Company’s ability to renew its distributed gaming contracts; reliance on key personnel (including our Chief Executive Officer, Chief Operating Officer and Chief Strategy and Financial Officer); the level of the Company’s indebtedness and the Company’s ability to comply with covenants in its debt facilities; terrorist incidents; natural disasters; severe weather conditions; the effects of environmental and structural building conditions; the effects of disruptions to the Company’s information technology and other systems and infrastructure; factors affecting the gaming, entertainment and hospitality industries generally; and other risks and uncertainties discussed in the Company’s filings with the SEC, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. The Company undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
Investor Relations
JCIR
Joseph Jaffoni, Richard Land, James Leahy
212-835-8500
gden@jcir.com
or
Media Relations
Golden Entertainment Inc.
Howard Stutz, 702-526-1822
Vice President Corporate Communications
hstutz@goldenent.com
$GTXI Positive Prelim Results from Ongoing Phase 2
GTx, Inc. (Nasdaq: GTXI) today announced release of preliminary clinical data from its ongoing, open-label, Phase 2 clinical trial of enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence (SUI). An abstract entitled “Kegels In A Bottle”: Preliminary Results Of A Selective Androgen Receptor Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal Women, summarizing clinical data from the first seven patients completing 12 weeks of treatment with enobosarm, is now available on the International Continence Society’s website. This proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI.
In this ongoing Phase 2 clinical trial, enobosarm 3 mg is being given to post-menopausal women who have demonstrated SUI symptoms for more than six months, with 3 to 15 reported SUI episodes per day averaged over a three-day period, and a positive bladder stress test. The primary endpoint is the number of SUI episodes per day on the 3-day voiding diary at 12 weeks, compared to base line. The clinical findings from the first seven patients enrolled in the study following their completion of treatment, as outlined in the abstract, are summarized below.
- Each of the women treated with enobosarm showed a clinically significant reduction in incontinence episodes per day:
- Mean stress leaks decreased by 80.9 percent from baseline over 12 weeks
- Stress leaks decreased from a mean of 5.7 leaks/day at baseline, to 1.1 leaks/day at Week 12
- All patients saw at least a 65 percent reduction in number of stress leaks
- Reductions in incontinence episodes were sustained well beyond the stopping of study drug at Week 12:
- Patients demonstrated continued reduction in incontinence episodes for up to five months
- Women reported improved quality of life in the Patient Global Impression of Improvement (PGI-I) and Female Sexual Function Index (FSFI)
- At Week 12, all seven patients showed improved PGI-I scores and 5 of 7 patients showed improvement in FSFI
- Reported adverse events are minimal with none above Grade I
“With approximately half the women in the United States experiencing symptoms of SUI, there is a growing need for an effective oral therapy to treat women with stress urinary incontinence,” said Kenneth M. Peters, M.D., Professor and Chairman of Urology, Oakland University William Beaumont School of Medicine. “I am very encouraged by the consistency and strength of these early results, and I look forward to presenting more detailed clinical data from this ongoing clinical trial at the upcoming International Continence Society (ICS) meeting.”
“What caught our attention was the fact that the first seven patients dosed in this study saw impressive positive results. We subsequently added two additional clinical trial sites, and we look forward to presenting data from additional patients from this study at the ICS meeting in September,” said Robert J. Wills, Ph.D., Executive Chairman of GTx. “We believe SUI represents a near-term commercial opportunity in a potentially large population of women whose treatment options are currently limited to non-pharmacologic or invasive treatments.”
About the Phase 2 Proof-of-Concept Clinical Trial
Enrollment in the Phase 2 proof-of-concept clinical trial of 3 mg of enobosarm in women with SUI is ongoing. This is the first clinical trial to evaluate a SARM for SUI. The Company believes that developing an oral therapy to potentially treat the large number of women who face a diminished quality of life from stress urinary incontinence presents a unique commercial opportunity, especially since current therapies may sometimes involve invasive procedures. In the Phase 2 clinical trial, 3 mg of GTx−024 is being given daily for 12 weeks to post−menopausal women. The primary endpoint is the number of stress incontinence episodes per day on the 3-day voiding diary. Secondary endpoints include: pad weights, bladder stress test, and quality of life instruments including the Female Sexual Function Index (FSFI) and Patient Global Impression of improvement (PGI-I). More information about the clinical trial can be found here.
About Enobosarm and SUI
Enobosarm, a selective androgen receptor modulator (SARM), has been evaluated in 24 completed or ongoing clinical trials enrolling over 1,700 subjects, of which approximately 1,200 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated.
The rationale for evaluating enobosarm as a treatment for SUI is supported by preclinical in vivo data demonstrating increases in pelvic floor muscle mass following treatment with GTx’s SARM compounds, including enobosarm, and data from the Company’s on-going Phase 2 clinical trial continues to validate the use of enobosarm as a potential treatment for SUI.
About Stress Urinary Incontinence
Stress urinary incontinence (SUI) refers to the unintentional leakage of urine during activities that increase abdominal pressure such as coughing, sneezing or physical exercise. SUI, the most common type of incontinence suffered by women, affects up to 50 percent of adult women in the United States. There are a variety of treatments that are used to treat SUI in women, such as behavioral modification and pelvic floor physical therapy, especially as initial treatment options. As the condition worsens however, bulking agents and surgical procedures are often the most widely used treatments.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx’s current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTx’s ongoing clinical development of enobosarm (GTx-024) for the treatment of stress urinary incontinence (SUI). GTx’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that the Phase 2 proof-of-concept study being conducted by GTx for the treatment of SUI may not be completed on schedule; (ii) that additional clinical development of enobosarm for the treatment of SUI will be required beyond the ongoing study; and (iii) any future development of enobosarm as a treatment for SUI is contingent on obtaining sufficient additional capital to permit such development, which it may be unable to do. In addition, GTx will continue to need additional funding and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs and potentially cease operations. GTx’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx’s quarterly report on Form 10-Q for the quarter ended March 31, 2017, contains under the heading, “Risk Factors”, a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170612005351/en/
GTx, Inc.
Investors:
Lauren Crosby, 901-271-8622
lcrosby@gtxinc.com
or
Media:
Red House Consulting
Denise Powell, 510-703-9491
denise@redhousecomms.com
$IGC Acquires Exclusive Rights to THC-based treatment for Alzheimer’s Disease
BETHESDA, Md., June 12, 2017 — India Globalization Capital, Inc. (NYSE MKT:IGC) is pleased to announce that it has entered into a definitive license agreement with the University of South Florida making IGC the exclusive licensee of the U.S. patent filing entitled “THC as a Potential Therapeutic Agent for Alzheimer’s Disease.” By acquiring this patent filing, IGC is protecting a potential cannabis-based blockbuster treatment for America’s most expensive disease.
Alzheimer’s Disease Market Overview
In 2017 Medicare and Medicaid alone are expected to spend $175 billion on patients diagnosed with Alzheimer’s. There are currently over 5.3 million Americans with Alzheimer’s (AD). The cost of Alzheimer’s has increased significantly and is expected to continue to surge higher. The number of patients is expected to double over the next 20 years and the direct costs are expected to exceed $450 billion per year in the next 12 years. There is still no accepted cure for Alzheimer’s Disease.
The Patent
THC has several known molecular pathways by which it interacts with the human body, including binding to the CB1 receptor, anti-oxidative effects, and others. The patent filing claims discovery of a new pathway: low doses of THC bind to amyloid beta plaques and prevent those plaques from aggregating on neurons, which is what occurs in Alzheimer’s disease and causes cognitive decline. If the patent is granted and proven, IGC will own a significant therapeutic pathway by which THC interacts with the human body. The pathway has incredible potential in treating Alzheimer’s disease and is now a burgeoning research area. Acquiring this patent further supports IGC in protecting its proprietary formulation IGC-AD1, which includes low-doses of THC and is intended to disrupt the buildup of amyloid beta plaques and alleviate some of the worst symptoms of Alzheimer’s disease.
Next Steps
“Securing this licensing agreement from the University of South Florida represents a major turning point for IGC as we now look to prepare several of our key products for clinical trials,” explained Ram Mukunda, CEO of IGC. “We have worked hard to assemble a strong development team and a primary pipeline of four major products addressing large markets and possible blockbuster indications utilizing cannabis-based therapies. We are putting the finishing touches on our products, which may include filing additional patents, and we very much expect to start pursuing clinical trials for our Alzheimer’s product and others this year.” IGC also expects in the near future to share some data that supports its formulation, the patent application, and the transition to clinical trials as well as details of commercialization initiatives.
About IGC
India Globalization Capital Inc. is engaged in the development of cannabis-based therapies to treat cachexia, nausea, vomiting, Parkinson’s Disease, Alzheimer’s Disease, epilepsy, PTSD and other life altering conditions in humans and animals. In support of this mission, IGC has assembled a portfolio of patent filings for its phytocannabinoid-based treatments. The company is based in Bethesda, Maryland.
For more information, visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/
Forward-looking Statements, Statistics, and Risk Factors
Please see cautionary statements related to Safe Harbor, forward-looking statements, and risk factors discussed in India Globalization Capital, Inc.’s Form 10-K for fiscal year ended March 31, 2016, and in subsequent reports, including the June 12, 2017 report on Form 8-K, filed with the U.S. Securities and Exchange Commission. Statistics on Alzheimer’s Disease are cited from the website of the Alzheimer’s Association (alz.org).
Contact Info: Claudia Grimaldi 301-983-0998
$GSBC Announces Early Termination of FDIC Loss Sharing Agreements
Early termination related to 2012 FDIC-assisted acquisition of Inter Savings Bank in Maple Grove, Minn.
SPRINGFIELD, Mo., June 9, 2017 — Great Southern Bancorp, Inc. (NASDAQ:GSBC), announced today that its wholly owned subsidiary, Great Southern Bank, has entered into an agreement with the Federal Deposit Insurance Corporation (FDIC) that terminates the Bank’s loss sharing agreements related to the Bank’s 2012 acquisition of certain assets and assumption of all deposits of Maple Grove, Minn.-based Inter Savings Bank through an FDIC-assisted transaction.
The agreement requires the FDIC to pay $15.0 million to the Bank to settle all outstanding items related to the terminated loss sharing agreements. As a result of entering into the agreement, assets that were covered by the terminated loss sharing agreements, including covered loans in the amount of $138.8 million and covered other real estate owned in the amount of $2.9 million as of March 31, 2017, have been reclassified as non-covered assets, effective June 9, 2017. Accordingly, in the second quarter of 2017, the Company expects to realize a one-time after-tax gain of approximately $0.35 per diluted common share, inclusive of the write-off of the remaining indemnification asset, other receivables from the FDIC and the Bank’s clawback liability due to the FDIC. There will be no future effects on the Company’s non-interest income (expense) related to adjustments or amortization of the indemnification asset and the related clawback liability for Inter Savings Bank. The remaining accretable yield adjustments that affect interest income are not changed by this transaction and will continue to be recognized for all of the Bank’s FDIC-assisted transactions in the same manner as they have been previously.
The termination of the loss sharing agreements for the Inter Savings Bank transaction will have no impact on the yields for the loans that were previously covered under this agreement. All future recoveries, gains, losses and expenses related to these previously covered assets will now be recognized entirely by Great Southern Bank since the FDIC will no longer be sharing in such gains or losses. Accordingly, the Company’s future earnings will be positively impacted to the extent the Company recognizes gains on any sales or recoveries in excess of the carrying value of such assets. Similarly, the Company’s future earnings will be negatively impacted to the extent the Company recognizes expenses, losses or charge-offs related to such assets. At June 9, 2017, the Company has discounts related to the loan pools totaling approximately $14.0 million which are available to absorb charge-offs. Any future charge-offs exceeding that aggregate amount would impact the Company’s allowance for loan losses.
This agreement terminates the last outstanding loss sharing agreements related to the Bank’s four FDIC-assisted acquisitions from 2009 through 2012. In April 2016, the Company executed an agreement with the FDIC to terminate loss sharing agreements related to the FDIC-assisted acquisitions of TeamBank, Vantus Bank and Sun Security Bank. More information about that agreement can be found in the Company’s Form 10-Q for the quarter ended March 31, 2016.
Headquartered in Springfield, Mo., Great Southern offers a broad range of banking services to customers. The Company operates 104 retail banking centers and more than 200 ATMs in Missouri, Arkansas, Iowa, Kansas, Minnesota and Nebraska and commercial lending offices in Chicago, Ill., Tulsa, Okla., and Dallas.
Forward-Looking Statements
When used in this press release and documents filed or furnished by the Company with the Securities and Exchange Commission (the “SEC”), in the Company’s other press releases or other public or stockholder communications, and in oral statements made with the approval of an authorized executive officer, the words or phrases “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” “intends” or similar expressions are intended to identify “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks and uncertainties, including, among other things, (i) non-interest expense reductions from Great Southern’s banking center consolidations might be less than anticipated and the costs of the consolidation and impairment of the value of the affected premises might be greater than expected; (ii) expected revenues, cost savings, earnings accretion, synergies and other benefits from the Company’s merger and acquisition activities (including the Fifth Third branch acquisition in 2016) might not be realized within the anticipated time frames or at all, and costs or difficulties relating to integration matters, including but not limited to customer and employee retention, might be greater than expected; (iii) changes in economic conditions, either nationally or in the Company’s market areas; (iv) fluctuations in interest rates; (v) the risks of lending and investing activities, including changes in the level and direction of loan delinquencies and write-offs and changes in estimates of the adequacy of the allowance for loan losses; (vi) the possibility of other-than-temporary impairments of securities held in the Company’s securities portfolio; (vii) the Company’s ability to access cost-effective funding; (viii) fluctuations in real estate values and both residential and commercial real estate market conditions; (ix) demand for loans and deposits in the Company’s market areas; (x) the ability to adapt successfully to technological changes to meet customers’ needs and developments in the marketplace; (xi) the possibility that security measures implemented might not be sufficient to mitigate the risk of a cyber attack or cyber theft, and that such security measures might not protect against systems failures or interruptions; (xii) legislative or regulatory changes that adversely affect the Company’s business, including, without limitation, the Dodd-Frank Wall Street Reform and Consumer Protection Act and its implementing regulations, and the overdraft protection regulations and customers’ responses thereto; (xiii) changes in accounting principles, policies or guidelines; (xiv) monetary and fiscal policies of the Federal Reserve Board and the U.S. Government and other governmental initiatives affecting the financial services industry; (xv) results of examinations of the Company and the Bank by their regulators, including the possibility that the regulators may, among other things, require the Company to increase its allowance for loan losses or to write-down assets; (xvi) costs and effects of litigation, including settlements and judgments; and (xvii) competition. The Company wishes to advise readers that the factors listed above and other risks described from time to time in documents filed or furnished by the Company with the SEC could affect the Company’s financial performance and could cause the Company’s actual results for future periods to differ materially from any opinions or statements expressed with respect to future periods in any current statements.
The Company does not undertake-and specifically declines any obligation- to publicly release the result of any revisions which may be made to 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.
$MHLD Assigns Issue Credit Rating to Maiden Holdings Ltd.’s Series D Preference Shares
A.M. Best has assigned a Long-Term Issue Credit Rating of “bb+” to $150 million, 6.70% Series D preference shares recently announced by Maiden Holdings Ltd. (MHLD)(NASDAQ:MHLD) (Hamilton, Bermuda). This Credit Rating (rating) has been assigned a stable outlook.
The proceeds from the issuance of the shares will be used to repay the 8.00% senior notes due 2042 of MHLD’s subsidiary, Maiden Holdings North America, Ltd., and for other corporate purposes. Upon issuance of the shares and redemption of these notes, Maiden’s adjusted debt to total capital ratio will measure 21.1%, within A.M. Best’s guidelines for the rating. While interest coverage for 2016 was below expectations, improvement is anticipated in 2017 and consistently favorable operating cash flows and available liquidity are offsetting considerations.
This press release relates to Credit Ratings that have been published on A.M. Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see A.M. Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Understanding Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and A.M. Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and A.M. Best Rating Action Press Releases.
A.M. Best is the world’s oldest and most authoritative insurance rating and information source. For more information, visit www.ambest.com.
Copyright © 2017 by A.M. Best Rating Services, Inc. and/or its subsidiaries. ALL RIGHTS RESERVED.
A.M. Best
Jennifer Marshall, CPCU, ARM, +1-908-439-2200, ext. 5327
Director
jennifer.marshall@ambest.com
or
Michael J. Lagomarsino, CFA, FRM, +1-908-439-2200, ext. 5810
Senior Director
michael.lagomarsino@ambest.com
or
Christopher Sharkey, +1-908-439-2200, ext. 5159
Manager, Public Relations
christopher.sharkey@ambest.com
or
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Director, Public Relations
james.peavy@ambest.com
$OMNT DubLi.com Website Launches New Luxury Brands Category
Attracts New Customer Base, Makes Luxury Brands Available Plus Cash Back
Ominto, Inc. (Nasdaq:OMNT), a global leader in online Cash Back shopping, today announced that it has launched a new page on its DubLi.com website, targeted at customers who enjoy shopping for luxury brands. The Luxury Brands page offers DubLi.com customers easy access for finding their favorite luxury brands while earning Cash Back from a wide variety of stores.
When shopping through the Luxury Brands page, DubLi.com customers can earn Cash Back at their favorite luxury stores and/or brands on every purchase. Finding great deals is now easier than ever as shoppers can stack specials, coupons and free shipping offers with Cash Back to maximize savings. This gives customers the ability to save significantly on luxury brands, without sacrificing style for savings. Ominto’s Founder and CEO, Michael Hansen, expressed his thoughts on the new Luxury Brands page stating, “The addition of this powerful new page, growing our list of beneficial new features, is tailored to a new base of shoppers. Simplifying the ease of access to luxury brands offers superior shopping and savings opportunities for our customers who prefer this type of shopping experience.”
DubLi.com is designed to accommodate the interests of a wide variety of shopping preferences and global cultures. The addition of this new page is tailored to those shoppers with a taste for the finer things who are, simultaneously, cost conscious. This new feature lets high-end shoppers earn Cash Back when shopping at luxury brands from affiliated stores such as Casadei, Diane Von Furstenberg, GILT, Forzieri and more. Updates on the latest sales and discounts are available via email sign-up so shoppers can be the first to hear about the latest available special offers.
This new feature is one of several recently announced for DubLi.com. In April, the new VIP Lounge launched, providing members with multiple ways to save on hotel rooms, travel, flights, local shopping, dining services, entertainment and leisure activities – all from one convenient location. The new Luxury Brands page is another avenue for making smart shopping easier. In addition to discounts and savings offers, VIP Lounge members are also entitled to earn an additional 2% Cash Back on purchases made from the Luxury Brands page, increasing their savings. The Luxury Brands page has launched exclusively in the US, Saudi Arabia, Italy, and the UAE with rollout to other countries planned for the future.
About DubLi.com
DubLi.com is an online shopping website that offers shoppers discounts and Cash Back on their purchases. Shopping smarter is easier than ever with additional discounts, deals, and memberships for those looking to save more. The simple and personalized shopping site allows shoppers to choose from over 12,000 stores in 10 languages, and multiple currencies making for a stress-free shopping experience. Be smart, save more, shop DubLi.
About Ominto, Inc.
Ominto, Inc. is a global e-commerce leader and pioneer of online Cash Back shopping, delivering value-based shopping and travel deals through its primary shopping platform and affiliated Partner Program websites. At DubLi.com or at Partner sites powered by Ominto.com, consumers shop at their favorite stores, save with the best coupons and deals, and earn Cash Back with each purchase. The Ominto.com platform features thousands of brand name stores and industry-leading travel companies from around the world, providing Cash Back savings to consumers in more than 120 countries. Ominto’s Partner Programs offer a white label version of the Ominto.com shopping and travel platform to businesses and non-profits, providing them with a professional, reliable web presence that builds brand loyalty with their members, customers or constituents while earning commission for the organization and Cash Back for shoppers on each transaction.
For more information, please visit Ominto’s corporate website http://inc.ominto.com.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. These include statements about Ominto’s expectations, beliefs, intentions or strategies for the future, which are indicated by words or phrases such as “anticipate,” “expect,” “intend,” “plan,” “will,” “believe,” “projects,” “could,” “would,” and similar expressions. You can also identify them by the fact that they do not relate strictly to historical or current facts. The forward-looking statements reflect Ominto’s current view about future events and are subject to risks, uncertainties and assumptions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Ominto may not actually achieve the expectations disclosed in the forward-looking statements and you should not place undue reliance on Ominto’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results or events to differ materially from the expectations disclosed in the forward-looking statements, including, but not limited to: risks related to our ability to continue as a going concern being in doubt; Ominto’s inability to generate enough customers or enough purchasing activity for our shopping websites; Ominto’s inability to establish and maintain a large growing base of Business Associates; Ominto’s failure to adapt to technological change; increased competition; increased operating costs; changes in legislation applicable to Ominto’s business; Ominto’s failure to improve our internal controls; and Ominto’s inability to generate sufficient cash flows from operations or to secure capital to enable us to maintain our current operations or support our intended growth; along with other risks and potential factors that could affect Ominto’s business and financial results identified in Ominto’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended September 30, 2016.
Ominto, Inc.
Michael Hansen
investors@ominto.com
$GST Declares Monthly Cash Dividend on 8.625% Series A
HOUSTON, June 9, 2017 — Gastar Exploration Inc. (NYSE MKT: GST) (“Gastar”) announced today that it has declared monthly cash dividends on its 8.625% Series A Preferred Stock (“Series A Preferred Stock”) and its 10.75% Series B Preferred Stock (“Series B Preferred Stock”) for June 2017.
The dividend on the Series A Preferred Stock is payable on June 30, 2017 to holders of record at the close of business on June 19, 2017. The June 2017 dividend payment will be an annualized 8.625% per share, which is equivalent to $0.1796875 per share, based on the $25.00 per share liquidation preference of the Series A Preferred Stock. The Series A Preferred Stock is currently listed on the NYSE MKT and trades under the ticker symbol “GST.PRA.”
The dividend on the Series B Preferred Stock is payable on June 30, 2017 to holders of record at the close of business on June 19, 2017. The June 2017 dividend payment will be an annualized 10.75% per share, which is equivalent to $0.2239584 per share, based on the $25.00 per share liquidation preference of the Series B Preferred Stock. The Series B Preferred Stock is currently listed on the NYSE MKT and trades under the ticker symbol “GST.PRB.”
About Gastar
Gastar Exploration Inc. is a pure play Mid-Continent independent energy company engaged in the exploration, development and production of oil, condensate, natural gas and natural gas liquids. Gastar’s principal business activities include the identification, acquisition, and subsequent exploration and development of oil and natural gas properties with an emphasis on unconventional reserves, such as shale resource plays. Gastar holds a concentrated acreage position in the normally pressured oil window of the STACK Play, an area of central Oklahoma which is home to multiple oil and natural gas-rich reservoirs including the Meramec and Osage formations within the Mississippi Lime, the Oswego limestone, the Woodford shale and Hunton limestone formations. For more information, visit Gastar’s website at www.gastar.com.
Forward-Looking Statements
This news release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements give our current expectations, opinion, belief or forecasts of future events and performance. A statement identified by the use of forward-looking words including “may,” “expects,” “projects,” “anticipates,” “plans,” “believes,” “estimate,” “will,” “should,” and certain of the other foregoing statements may be deemed forward-looking statements. Although Gastar believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties that may cause actual future activities and results to be materially different from those suggested or described in this news release. These include risks inherent in oil and natural gas drilling and production activities, including risks with respect to continued low or further declining prices for oil and natural gas that could result in further downward revisions to the value of proved reserves or otherwise cause Gastar to further delay or suspend planned drilling and completion operations or reduce production levels, which would adversely impact cash flow; risks relating to the availability of capital to fund drilling operations that can be adversely affected by adverse drilling results, production declines and continued low or further declining prices for oil and natural gas; risks of fire, explosion, blowouts, pipe failure, casing collapse, unusual or unexpected formation pressures, environmental hazards, and other operating and production risks, which may temporarily or permanently reduce production or cause initial production or test results to not be indicative of future well performance or delay the timing of sales or completion of drilling operations; delays in receipt of drilling permits; risks relating to unexpected adverse developments in the status of properties; risks relating to the absence or delay in receipt of government approvals or third-party consents; risks relating to Gastar’s ability to realize the anticipated benefits from acquired assets; and other risks described in Gastar’s Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission (“SEC”), available at the SEC’s website at www.sec.gov. By issuing forward-looking statements based on current expectations, opinions, views or beliefs, Gastar has no obligation and, except as required by law, is not undertaking any obligation, to update or revise these statements or provide any other information relating to such statements.
Contacts:
Gastar Exploration Inc.
J. Russell Porter, Chief Executive Officer
713-739-1800 / rporter@gastar.com
Investor Relations Counsel:
Lisa Elliott / lelliott@DennardLascar.com
Dennard-Lascar Associates: 713-529-6600
$LXRX Reports Positive Top-Line Results In Phase 3 inTandem3 Study
Sotagliflozin Demonstrates Statistically Significant Benefit in Primary Endpoint Results Support a Unique Drug Profile as an SGLT1 and SGLT2 Inhibitor
THE WOODLANDS, Texas, June 9, 2017 — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced positive top-line results from its Phase 3 inTandem3 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of patients with type 1 diabetes on any background insulin therapy. The study met its primary endpoint, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA) after randomization.
Sotagliflozin demonstrated a generally well tolerated safety profile during a 24-week treatment period, with rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs that were consistent with rates seen in two prior pivotal Phase 3 studies, inTandem1 and inTandem2, including a similar rate of severe hypoglycemia for the sotagliflozin arm compared to placebo during the 24-week treatment period (2.4% for placebo compared to 3.0% for sotagliflozin 400 mg) and a slightly higher rate of DKA during the 24-week treatment period for sotagliflozin 400 mg (3.0%) than placebo (0.6%).
A full analysis of the results from inTandem3, including safety data, will be submitted for publication in a peer-reviewed journal.
“The results achieved with sotagliflozin in the inTandem3 study are scientifically and clinically important and significant,” said Satish Garg, M.D., lead investigator of inTandem3 and Professor of Medicine and Pediatrics, and Director Adult Program at the Barbara Davis Center for Diabetes, University of Colorado Denver and Editor-in-Chief, Diabetes Technology and Therapeutics. “If approved, sotagliflozin may potentially be the first option as an adjunct to insulin to improve glycemic control for patients with type 1 diabetes.”
“These positive results represent an important milestone, further supporting sotagliflozin’s differentiated profile as a novel, oral anti-diabetic agent with potential to benefit people with type 1 diabetes,” said Lonnel Coats, Lexicon’s president and chief executive officer. “Sotagliflozin is the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase 3 clinical trials in this population.”
“These compelling results speak to the potential long-term benefits that sotagliflozin may bring to people with type 1 diabetes,” said Jorge Insuasty, senior vice president, head of global development, Sanofi. “There are more than 1 million adults with type 1 diabetes in the United States alone, and the majority of these are not at their A1C goal of 7 percent. The need for diabetes therapies that help adults with type 1 diabetes control their blood sugar with fewer complications is clear, and sotagliflozin added to insulin therapy can potentially help meet that need. We look forward to pursuing regulatory submissions for the treatment of type 1 worldwide and to continuing to study the use of sotagliflozin in adults with type 2 diabetes.”
About inTandem3
The Phase 3 study known as inTandem3 was a global, randomized, double-blind, placebo-controlled, parallel-group, multicenter study of 1,402 patients with type 1 diabetes on continuous subcutaneous insulin infusion or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. Patients had a confirmed diagnosis of type 1 diabetes and inadequate glycemic control on insulin therapy alone. The study evaluated 400 mg of sotagliflozin taken once daily before the first meal of the day, against placebo. The primary objective of the study was to demonstrate the superiority of sotagliflozin 400 mg versus placebo in the proportion of patients with glycosylated A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization.
About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is a first-in-class, oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.
Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and retains an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan).
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its recently-launched product for carcinoid syndrome diarrhea, XERMELO™ (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s and its licensees’ clinical development of and regulatory filings for sotagliflozin and the results and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that clinical studies of sotagliflozin may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
$CIIX Has an Edge in Lucrative Hemp Oil Industry — CFN Media
SEATTLE, WA–(Jun 9, 2017) – CFN Media Group, the leading creative agency and digital media network dedicated to legal cannabis, announces the publication of an article discussing ChineseInvestors.com Inc. (OTCQB: CIIX) and its recent expansion into the multi-billion dollar legal hemp industry.
Building a Strong Core
ChineseInvestors.com was founded in 1999 by Mr. Wang Warren for Chinese-speaking investors in the United States and China. In the past, Mr. Warren participated in the initial placement and funding of Shopping.com that was later acquired and returned his investors 300% in three years. Later, he was instrumental in developing the marijuana consulting firm, Medicine Man of Denver, and returned investors 500% in three years.
Chief Technology Officer Kevin GE has also been working with ChineseInvestors.com since its incorporation in 1999. GE has over 18 years of experience in the IT industry and extensive experience in project development and management. He previously served as a Senior Programmer for Dynamic Systems and a Senior Consultant for yDebts Inc. And finally, independent director Paul Dickman brings a wealth of finance experience into the fold.
The company’s core operations include real-time market commentary, analysis, and educational services in Chinese language for retail investors. In addition, the company provides consulting services to private companies considering going public, including advertising, public relations, and related support services. These activities have resulted in a database of approximately 100,000 registered high net worth native Chinese speaking investors worldwide
Expansion into the Hemp Industry
The U.S. hemp-based cannabidiol (CBD) market is projected to grow from $90 million in 2015 to $450 million by 2020, according to The Hemp Business Journal, making it one of the largest subsets of the legal cannabis industry. This growth is driven by the combination of increasingly health-conscious consumers and a growing body of research showing the potential benefits of CBD oil in addressing a wide range of medical conditions.
The company believes that China’s hemp-based CBD industry could be even larger with more than 1.4 billion people and a historical preference for traditional medicines. In January, the company formed a wholly-owned subsidiary, CBD Biotechnology Co., Ltd., to operate ChineseCBDOil.com, added ChineseHempOil.com in April to operate online and retail sales of hemp-based health products in the U.S., and aims to open its first wellness center in June.
The company announced plans to further these efforts by partnering with a well known venture building firm, Launch Haus LLC, to develop a multi-level marketing platform and recruit top producers in the direct sales industry. Launch Haus has a strong presence in the direct-selling industry and its principals have a proven track record having built sales organizations with an excess of $1.5 billion in commissionable volume over the last 10 years. Concurrently, Chineseinvestors.com is launching a media campaign on the largest U.S. Chinese TV (PSTV), the largest Chinese portal in the U.S. (SINA), and various social media and print publications to raise awareness and increase sales.
Please follow the link to read the full article: http://www.cannabisfn.com/chineseinvestors-com-ciix-edge-lucrative-hemp-oil-industry/
Learn how to become a CFN Media featured company, brand or entrepreneur: http://www.cannabisfn.com/become-featured-company/
Download the CFN Media iOS mobile app to access the world of cannabis from your smart phone: https://itunes.apple.com/us/app/cannabisfn/id988009247?ls=1&mt=8
Or visit our homepage and enter your mobile number under the Apple App Store logo to receive a download link text on your iPhone: http://www.cannabisfn.com
About CFN Media
CFN Media (CannabisFN) is the leading creative agency and media network dedicated to legal cannabis. We help marijuana businesses attract investors, customers (B2B, B2C), capital, and media visibility. Private and public marijuana companies and brands in the US and Canada rely on CFN Media to grow and succeed.
Disclaimer:
Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Emerging Growth LLC, which owns CFN Media and CannabisFN.com, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. Emerging Growth LLC may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. Emerging Growth LLC may be compensated for its services in the form of cash-based compensation or equity securities in the companies it writes about, or a combination of the two. For full disclosure please visit: http://www.cannabisfn.com/legal-disclaimer/.
Contact:
Frank Lane
President
CFN Media
flane@cannabisfn.com
206.369.7050
$ONCS Granted Orphan Drug Designation in Melanoma
SAN DIEGO, June 8, 2017 — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pIL-12, otherwise known as tavokinogene telsaplasmid, for the treatment of unresectable metastatic melanoma. Tavokinogene telsaplasmid is the active biologic agent in OncoSec’s lead product candidate, ImmunoPulse® IL-12. The Orphan Drug status will provide OncoSec with eligibility for certain development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.
“This is an important regulatory milestone for OncoSec as we advance ImmunoPulse® IL-12 toward commercialization,” said Punit Dhillon, CEO and President of OncoSec. “We are diligently working to address a significant unmet medical need in melanoma patients who are progressing or have progressed after treatment with anti-PD-1.”
OncoSec is initiating the registration-directed PISCES trial, to evaluate the safety and efficacy of ImmunoPulse® IL-12 and the approved anti-PD-1 agent, pembrolizumab, in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the U.S. at any given time. For a drug to qualify for orphan drug designation both the drug and the disease must meet certain criteria specified in Section 525 of the Federal Food, Drug, and Cosmetic Act (21 USC 360aa). The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.
About PISCES
PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a Phase II multicenter study of ImmunoPulse® IL-12 in combination with KEYTRUDA® in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. Eligible patients will be those with Stage III/IV metastatic melanoma who are progressing or have progressed on an approved anti-PD-1 therapy. The primary endpoint for this registration-directed trial is 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. In Phase I and II clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors as well as 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 non-responsive to anti-PD-1/PD-L1 therapies. In addition to ImmunoPulse® IL-12, 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.
CONTACT:
Investor Relations
OncoSec Medical Incorporated
855-662-6732
investors@oncosec.com
Media Relations
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
$NCTY The9 Limited Signs Definitive Agreements Regarding Private Placements
SHANGHAI, June 8, 2017 — The9 Limited (the “Company” or “The9”) (NASDAQ: NCTY), an online game operator, today announced that it has entered into a definitive agreement with each of Ark Pacific Special Opportunities Fund I, L.P., an exempted limited partnership organized under the laws of the Cayman Islands acting by its general partner, Ark Pacific Investment Management Limited (“Ark Pacific”), and Incsight Limited, a company incorporated under the laws of the British Virgin Islands wholly owned by Mr. Jun Zhu, the chairman and chief executive officer of The9 (“Incsight”), for the issuance and sale of a total of 25,000,000 ordinary shares of the Company, each with par value US$0.01, to Ark Pacific and Incsight for a total consideration of US$30 million, or US$1.2 per share (the sale to each of Ark Pacific and Incsight, a “Transaction”). Each of Ark Pacific and Incsight will subscribe for 50% of the total shares to be issued (i.e. 12,500,000 shares) under the Transaction with cash.
Pursuant to the definitive agreement with each of Ark Pacific and Incsight, the shares to be subscribed by Ark Pacific and Incsight will be subject to a redemption right. The parties agreed that if the rolling volume weighted average price of the Company’s ADS market price for any given 30 consecutive trading day period is below US$4 during the second year after completion of the Transaction, each of Ark Pacific and Incsight can exercise its redemption right. The proceeds from the Transaction with Ark Pacific (but not Incsight) will be deposited at a bank account held under the name of a Hong Kong subsidiary of the Company, which will be used to secure the Company’s payment of redemption price upon any exercise of the redemption right.
The completion of each Transaction is subject to customary closing conditions and will take place in two stages, whereby The9 will first deliver its shares to Ark Pacific and Incsight, respectively, followed by receipt of the relevant consideration from Ark Pacific and Incsight, respectively, within a specified period of time thereafter. The Transaction with Incsight will additionally be subject to a closing condition that Incsight has obtained approval from the relevant Chinese regulatory authority in relation to the Transaction.
About The9 Limited
The9 Limited is an online game developer and operator in China. The9 develops and/or operates, directly or through its affiliates, its proprietary mobile games and web games, including CrossFire new mobile game, Audition AR and Soul Awake. The9’s joint venture has also obtained an exclusive license for publishing and operating CrossFire 2, which is under development by a third-party game developer, in China. The9 also engages in mobile advertising and mobile app education businesses.
About Ark Pacific
Ark Pacific is an alternative asset manager in Asia with a focus on Greater China. Through innovative and flexible approach to capital structure, Ark Pacific invests with entrepreneurs and management teams to create long-term value. Ark Pacific manages Ark Pacific Special Opportunities Fund I, L.P., which is a private equity special situations fund.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, statements about the potential transactions may constitute forward-looking statements. Statements that are not historical facts, including statements about The9’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to, political and economic policies of the Chinese government, the laws and regulations governing the online game industry, information disseminated over the Internet and Internet content providers in China, intensified government regulation of Internet cafes, The9’s ability to retain existing players and attract new players, The9’s ability to license, develop or acquire additional online games that are appealing to users, The9’s ability to anticipate and adapt to changing consumer preferences and respond to competitive market conditions, and other risks and uncertainties outlined in The9’s filings with the U.S. Securities and Exchange Commission, including its annual reports on Form 20-F. The9 does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
For further information, please contact:
Ms. Connie Sun
Investor Relations Manager
The9 Limited
Tel: +86 (21) 5172-9990
Email: IR@corp.the9.com
Website: http://www.corp.the9.com/
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