Archive for September, 2015
(EVOK) FDA Draft Guidance Consistent w/ Phase 3 Study Design, Endpoint for EVK-001
States Patients With Diabetic Gastroparesis May Have Unpredictable Gastric Emptying and Altered Absorption of Orally-Administered Hypoglycemic Drugs
SOLANA BEACH, Calif., Sept. 15, 2015 — Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that its Phase 3 clinical trial design for EVK-001 (metoclopramide nasal spray) is consistent with the FDA’s recommendations in the recently released draft guidance entitled Gastroparesis: Clinical Evaluation of Drugs for Treatment – Guidance for Industry (Draft Guidance). The new Draft Guidance contains the FDA’s current thinking on trial design and study endpoints for drug development in the treatment of gastroparesis.
“We are pleased to see the recommendations contained in the FDA’s Draft Guidance on gastroparesis are consistent with the feedback we received from the FDA for our Phase 3 study of EVK-001, which gives us further confidence in the design of our ongoing study,” said Dave Gonyer, R.Ph., President and CEO. “Our patented nasal delivery of metoclopramide for the treatment of symptoms associated with diabetic gastroparesis in women is one of only a few products in development for this disease. With a Phase 3 clinical trial design and endpoint that are consistent with the specific recommendations for protocol design, endpoint analysis and disease-specific concerns, we believe there is less regulatory risk with our development program for EVK-001 as it relates to this Draft Guidance.”
“The recommendations in the Draft Guidance are in line with the feedback we received from the FDA during our end of phase 2 meetings regarding the design and plans for the EVK-001 Phase 3 study, which led to our selection of the primary endpoint in the study, which consists of a patient-reported outcome (PRO) instrument for gastroparesis symptoms,” said Marilyn R. Carlson, D.M.D., M.D., RAC, Chief Medical Officer. “This Draft Guidance provides recommendations for the design and endpoints used in gastroparesis clinical trials and outlines the FDA’s expectation that all sponsors will develop a well-defined and reliable PRO instrument consistent with a drug’s mechanism of action for use as the primary efficacy assessment tool in their clinical trials.”
Dr. Carlson continued, “We are further encouraged by specific statements made within the Draft Guidance that acknowledge patients with diabetic gastroparesis may have unpredictable gastric emptying and altered absorption of orally-administered hypoglycemic drugs. Importantly, we believe the FDA’s statements highlight the need for non-oral drugs like EVK-001 to treat the symptoms of gastroparesis. We believe that our intranasal formulation of metoclopramide is the only non-oral and non-injectable product in development and, if approved, may have the distinct advantage of being on the market for several years as the only new treatment approved to address this debilitating disease in these patients with erratic gastric emptying.”
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration. Visit www.EvokePharma.com for more information.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the potential for FDA agreement with our trial design based on feedback we received date and the Draft Guidance; the potential approval and commercialization of EVK-001 as a new and effective treatment for gastroparesis; and the potential of EVK-001 being the only new treatment approved on the market for several years . The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Evoke’s business, including, without limitation: Evoke is entirely dependent on the success of EVK-001, for which it has commenced a Phase 3 clinical trial and male companion trial, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, EVK-001; risks associated with changes in the Draft Guidance or in the FDA’s view on the sufficiency of our trial design; risks that issues with future manufacturing production will arise, whether as a result of noncompliance with CMC requirements or otherwise; Evoke’s reliance on outsourcing arrangements for many of its activities, including clinical development, manufacturing and supply of EVK-001, and Evoke’s current lack of long-term commercial manufacturing agreements; the results observed in female patients with symptoms associated with acute and recurrent diabetic gastroparesis in Evoke’s Phase 2b clinical trial of EVK-001 may not be predictive of the safety and efficacy results in the Phase 3 clinical trial; the inherent risks of clinical development of EVK-001, including continued delays in enrollment and completion of the Phase 3 trial as well as potential delays in any other clinical trials and studies; Evoke will require substantial additional funding to complete the Phase 3 clinical trial and potentially commercialize EVK-001 as well as to finance additional development requirements, and may be unable to raise capital when needed, including to fund ongoing operations; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; the ability of Evoke to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidate and the ability to operate its business without infringing the intellectual property rights of others; competition from other pharmaceutical or biotechnology companies; and other risks detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
CONTACT: Investor Contact: The Ruth Group David Burke Tel: 646-536-7009 dburke@theruthgroup.com Media Contact: The Ruth Group Kirsten Thomas Tel: 646-536-7014 kthomas@theruthgroup.com
(TRCH) Enters Farm-Out Agreement on Its Marcelina Creek Project
PLANO, TX–(September 15, 2015) – Torchlight Energy Resources, Inc. (NASDAQ: TRCH) (“Torchlight” or the “Company”), today announced that the Company has entered into a farm-out agreement with PetroBridge Energy for the Johnson #4 well in its Marcelina Creek Project in Wilson County, TX. The Johnson #4 well is a vertical well producing ~10 Bop/d from the Buda Formation. According to the agreement Torchlight will farm-out a 25% Working Interest in this wellbore in exchange for the cost of drilling and completion for two lateral legs targeting the Austin Chalk formation. The drilling of the new dual horizontal legs is scheduled to commence in the fourth quarter 2015.
“We are very excited about this agreement with PetroBridge and the continued development of our Marcelina Creek assets,” stated Will McAndrew III, COO of Torchlight. “We believe they are the right partner to join us in developing the Austin Chalk potential here which will further unlock value across our asset base. The Johnson #1, also on this lease had a reported initial production of 438 Bop/d from one lateral leg completed in the Austin Chalk and is still producing ~50 Bop/d three years later. The Johnson #1 horizontal section is 2000 feet where the Johnson #4 re-entry will provide for two horizontal legs up to 2400 feet each, providing us with what we expect will be a greatly increased target for completion. This most recent agreement is another example of our ability to extract value from our assets while eliminating Torchlight’s Capex requirements.”
About Torchlight Energy
Torchlight Energy Resources, Inc. (NASDAQ: TRCH), based in Plano, Texas, is a high growth oil and gas Exploration and Production (E&P) company with a primary focus on acquisition and development of highly profitable domestic oil fields. The Company currently holds interests in Texas, Kansas and Oklahoma where their targets are established plays such as the Wolf Penn, Eagle Ford Shale, Mississippi Limestone and Hunton Limestone trends. For additional information on the Company, please visit www.torchlightenergy.com.
Forward-Looking Statement
This news 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. These statements involve risks and uncertainties that could cause actual results to differ materially from those described in such statements. Such forward-looking statements involve known and unknown risks and uncertainties, including risks associated with the Company’s ability to obtain additional capital in the future to fund planned expansion, the demand for oil and natural gas, general economic factors, competition in the industry and other factors that could cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. The Company is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Investor Relations Contact
Derek Gradwell
MZ Group
SVP Natural Resources
Phone: 512-270-6990
Email: dgradwell@mzgroup.us
Web: www.mzgroup.us
(RKDA) to Present at Credit Suisse Small & Mid Cap Conference
Arcadia Biosciences, Inc. (NASDAQ: RKDA), an agricultural technology company that develops and commercializes plant traits and products that improve farm economics and benefit the environment and human health, announced that it will participate in the 6th Annual Credit Suisse Small & Mid Cap Conference at the Waldorf Astoria Hotel in New York City. Roger Salameh, Arcadia’s vice president of business development, is scheduled to present at 2:30 p.m. EDT on Thursday, September 17, 2015.
Mr. Salameh and Tom O’Neil, Arcadia’s chief financial officer, will be available for one-on-one meetings with investors throughout the day. Investors attending the conference may schedule a meeting through their representatives at Credit Suisse.
A copy of Arcadia’s latest investor presentation will be provided at the conference and also will be made available in the Investors section of the company’s website.
About Arcadia Biosciences, Inc.
Based in Davis, Calif., with additional facilities in Seattle, Wash. and Phoenix, Ariz., Arcadia Biosciences (NASDAQ: RKDA) develops agricultural products that create added value for farmers while benefitting the environment and enhancing human health. Arcadia’s agronomic performance traits, including Nitrogen Use Efficiency, Water Use Efficiency, Salinity Tolerance, Heat Tolerance and Herbicide Tolerance, are all aimed at making agricultural production more economically efficient and environmentally sound. Arcadia’s nutrition traits and products are aimed at creating healthier ingredients and whole foods with lower production costs. The company was recently listed in the Global Cleantech 100 and was previously named one of MIT Technology Review’s 50 Smartest Companies. For more information, visit www.arcadiabio.com.
Arcadia Biosciences, Inc.
Jeff Bergau, +1-312-217-0419
jeff.bergau@arcadiabio.com
(JST) Announces Receipt of “Going Private” Proposal at $4.50 Per Share
CARLSTADT, N.J., Sept. 15, 2015 — Jinpan International Limited (Nasdaq: JST), a leading designer, manufacturer, and distributor of cast resin transformers, today announced that its Board of Directors has received a preliminary, non-binding proposal letter dated September 15, 2015 from Li Zhiyuan, the Company’s Chairman of the Board of Directors, President, and Chief Executive Officer, and Forebright Smart Connection Technology Limited (collectively, with Mr. Li, the “Buyer Group”), to acquire all of the outstanding common shares of the Company not currently owned by the Buyer Group in a going private transaction for $4.50 per common share, subject to certain conditions.
According to the proposal letter, an acquisition vehicle will be formed for the purpose of implementing the acquisition, and the acquisition is intended to be financed through a combination of debt and equity capital. Please refer to the enclosed Exhibit A for a copy of the proposal letter.
The Company expects that its Board of Directors will form a special committee consisting of independent directors (the “Independent Committee”) to consider this proposal. The Company also expects that the Independent Committee will retain a financial advisor and legal counsel to assist it in its work. The Company cautions its shareholders and others considering trading in its securities that the Board just received the preliminary, non-binding proposal and no decision has been made with respect to the Company’s response to the proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated.
About Jinpan International Limited
Jinpan International Limited (NASDAQ: JST) designs, manufactures, and markets electrical control and distribution equipment used in demanding industrial applications, utility projects, renewable energy installations, and infrastructure projects. Major products include cast resin transformers, VPI transformers and reactors, switchgears, and unit substations. Jinpan serves a wide range of customers in China and reaches international markets as a qualified supplier to leading global industrial electrical equipment manufacturers. Jinpan is one of the largest manufacturers of cast resin transformers in China by production capacity. Jinpan’s four manufacturing facilities in China are located in the cities of Haikou, Wuhan, Shanghai and Guilin. The Company was founded in 1993. Its principal executive offices are located in Haikou, Hainan, China and its United States office is based in Carlstadt, New Jersey. For more information, visit www.jinpaninternational.com.
Safe Harbor Provision
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and observations and involve known and unknown risks, and uncertainties or other factors not under the Company’s control, which may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors are listed from time-to-time in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 20-F for the period ended December 31, 2014 and our subsequent reports on Form 6-K. Except as required by law, we are not under any obligation, and expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Exhibit A
September 15, 2015
The Board of Directors
Jinpan International Limited
No. 168 Nanhai Avenue (Building No. 7)
Haikou Free Trade Zone
Haikou, Hainan Province, PRC
Dear Sirs:
Zhiyuan Li, Chairman and Chief Executive Officer of Jinpan International Limited (the “Company”) (“Mr. Li” or the “Chairman”), and Forebright Smart Connection Technology Limited (“Forebright”, together with the Chairman, the “Buyer Group”, “we” or “us”), are pleased to submit this preliminary non-binding proposal to acquire all of the outstanding shares of the Company not already owned by the Buyer Group in a going private transaction (the “Acquisition”).
We believe that our proposal provides an attractive opportunity to the Company’s public shareholders. While we have previously made to you a similar proposal on September 21, 2014 and have subsequently withdrawn such proposal due to various reasons, including changes in market conditions, we have re-evaluated the Acquisition and are fully prepared to pursue the Acquisition on a highly expedited basis.
1. The Acquisition. The Buyer Group will form an acquisition vehicle for the purpose of implementing the Acquisition. The Acquisition will be in the form of a merger of the Company with the acquisition vehicle. You should be aware that the Chairman who owns shares of the Company is interested only in pursuing this Acquisition and is not interested in selling his shares in any other transaction involving the Company.
2. Purchase Price. Based on the information available to us, we are prepared to pay US$4.50 in cash per common share in the Acquisition, in each case other than for shares held by the Buyer Group that may be rolled over to the surviving company of the Acquisition. Our proposal represents a premium of 24.3% to the Company’s closing price on September 14, 2015 and a premium of 23.3% and 16.6% to the volume-weighted average closing price during the last 5 and 20 trading days, respectively.
3. Closing Certainty and Funding. We believe that we offer a high degree of closing certainty and are well positioned to negotiate and complete the proposed Acquisition on an expedited basis. We intend to finance the proposed Acquisition with a combination of debt and equity capital and we expect definitive commitments for the required debt and equity funding, subject to terms and conditions set forth therein, to be in place when the Definitive Agreements (as defined below) are signed.
4. Due Diligence. Skadden, Arps, Slate, Meagher & Flom LLP continues to serve as legal advisor to the Buyer Group. We and our legal advisor have significant experience in structuring and consummating transactions of this nature. We expect to complete due diligence on a highly expedited basis, and are prepared and ready to engage in the next stage of discussions.
5. Definitive Agreements. We are prepared to promptly negotiate and finalize mutually satisfactory definitive agreements with respect to the Acquisition and related transactions (the “Definitive Agreements”). The Definitive Agreements will provide for representations, warranties, covenants and conditions which are typical, customary and appropriate for transactions of this type.
6. Process. We recognize that a special committee of independent directors will be formed to evaluate the Acquisition independently before making its determination to endorse it and recommend it to you. Given the involvement of Mr. Li in the Acquisition, we appreciate that the independent members of the Board will proceed to consider the proposed Acquisition and that Mr. Li and his affiliates will recuse themselves from participating in any Board deliberations and decisions related to the Acquisition.
7. Confidentiality. We are sure you will agree that until we have executed Definitive Agreements or terminated our discussions, it is in all parties’ interests to ensure that we proceed in a strictly confidential manner, unless otherwise required by law.
8. About Forebright Smart Connection Technology Limited. Forebright is a special purpose vehicle established by Forebright New Opportunities Fund, a private equity fund managed by Forebright Capital Management Limited (“FCM”). FCM is owned and run by a group of experienced investment professionals who have already successfully completed several going private transactions involving China-based US-listed issuers in recent years, and the market valuation of these privatized companies exceeded, in aggregate, US$ 450 million.
9. No Binding Commitment. This letter constitutes only a preliminary indication of our interest, and does not constitute any binding commitment with respect to the Acquisition. A binding commitment will result only from the execution of Definitive Agreements, and then will be on terms and conditions provided in such documentation.
In closing, each of us would like to personally express our commitment to working together to bring this Acquisition to a successful and timely conclusion. Should you have any questions regarding this proposal, please do not hesitate to contact any of the undersigned at any time. We look forward to speaking with you.
(MXWL) General Motors Becomes First US Auto OEM to Adopt Ultracapacitors for Start-Stop
Continental Voltage Stabilization System with Maxwell Ultracapacitors to Power Cadillac ATS and CTS Vehicles
SAN DIEGO, Sept. 15, 2015 — Maxwell Technologies, Inc. (Nasdaq: MXWL), a leading developer and manufacturer of ultracapacitor-based energy storage and power delivery products, today announced that Continental Automotive Systems’ Maxwell-powered voltage stabilization system (VSS) will be a standard feature on 2016 Cadillac ATS and CTS sedans and ATS coupes, excluding the ATS-V, CTS-V and CT6 models. General Motors is the first North American automotive original equipment manufacturer (OEM) to integrate the Continental ultracapacitor-based voltage stabilization as part of the enhanced start-stop system, which lowers fuel costs, improves performance and reduces emissions, delivering an overall superior owner-driver experience.
In start-stop systems, the internal combustion engine is shut off when the driver stops and the engine is seamlessly restarted when the driver accelerates, which lowers emissions and improves fuel economy. Battery-based start-stop systems augmented with an ultracapacitor-based voltage stabilization system implementation provide burst power needed to restart the engine, thus reducing high currents and repeated cycling that can shorten battery life. The voltage stabilization electronic control results in a smooth start, reduced engine vibration and a superior driving experience. Maxwell’s ultracapacitors, in Continental’s VSS design, also serve as an additional power source for stabilizing the vehicle’s electrical system during periods of high power demand.
“Automotive manufacturers around the world are seeking new ways to improve the performance of their cars while satisfying consumer demands for fuel efficiency,” said Jon Buckles, program manager for hybrid electric vehicles at Continental Automotive Systems. “Continental’s voltage stabilization system uses Maxwell’s ultracapacitors as an affordable option for automakers to create a more positive driving experience for their customers.”
“Performance has always been important to car owners, and Maxwell’s ultracapacitors enable consumers to get the fuel economy they desire without limiting their cars’ performance,” said Dr. Franz Fink, CEO of Maxwell Technologies. “GM’s selection of Continental’s Maxwell-powered VSS is a further affirmation of our ultracapacitor capability for varying applications as the automotive industry continues down its path of vehicle electrification.”
Unlike batteries, which produce and store energy by means of a chemical reaction, ultracapacitors store energy in an electric field. This electrostatic energy storage mechanism enables ultracapacitors to charge and discharge in as little as fractions of a second, perform normally over a broad temperature range (-40 degrees C to +65 degrees C), operate reliably through 1 million or more charge/discharge cycles and resist shock and vibration.
Additional Maxwell Technologies information:
- Maxwell Technologies’ automotive solutions: http://bit.ly/1KaDIU4
- Maxwell Technologies on Twitter: https://twitter.com/Maxwell_Tech
- Maxwell Technologies on Facebook: http://on.fb.me/10e2nPA
- Maxwell Technologies on LinkedIn: http://linkd.in/Z4737Y
- Maxwell Technologies on Google+: https://plus.google.com/+MaxwellTech/
About Maxwell: Maxwell is a global leader in the development and manufacture of innovative, cost-effective energy storage and power delivery solutions. Our ultracapacitor products provide safe and reliable power solutions for applications in consumer and industrial electronics, transportation and telecommunications. Our high-voltage grading and coupling capacitors help to ensure the safety and reliability of electric utility infrastructure and other applications involving transport, distribution and measurement of high-voltage electrical energy. Our radiation-mitigated microelectronic products include power modules, memory modules and single board computers that incorporate powerful commercial silicon for superior performance and high reliability in aerospace applications. For more information, please visit our website: www.maxwell.com.
Maxwell Technologies Contacts:
Media: Sylvie Tse, Metis Communications: +1 (617) 236-0500, maxwell@metiscomm.com
Investor: Amy Wakeham: +1 (858) 503-3359, awakeham@maxwell.com
(CEMP) to Present Data From Antibiotic Drug Development Programs at ICAAC/ICC 2015 Meeting
CHAPEL HILL, N.C., Sept. 10, 2015 — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it will be making multiple presentations on solithromycin and Taksta™ (fusidic acid) at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the International Society of Chemotherapy (ICC) joint meeting in San Diego, September 17-21, 2015.
The ICAAC/ICC presentations are as follows (all times are Pacific Daylight Time):
Friday, September 18
Poster presentations:
Poster Session 008: New Drugs against Resistant Infections (12:00 p.m. – 2:00 p.m., Exhibit Hall F)
- B-088: Solithromycin for the Treatment of Anthrax; A. Sheets, L. Henning, R. Warren, P. Fernandes, G. Meister; Cempra Pharmaceuticals, Inc., Chapel Hill, NC, Battelle, Columbus, OH, BARDA, Washington, DC
Poster Session 013: Antimicrobial Susceptibility Testing Methods and Interpretation for Gram-Negative Pathogens (12:00 p.m. – 2:00 p.m., Exhibit Hall F)
- D-187: MICs and MBCs of Solithromycin for Nontypeable and Typeable Haemophilus influenza; D. Hardy, S. I. Pelton, M. Figueira, K. Keedy, P. Fernandes, D. Vicino; Univ. of Rochester Med. Ctr., Rochester, NY, Boston Med. Ctr., Boston, MA, Cempra, Inc., Chapel Hill, NC
Symposium presentation:
Symposium 038: Approaches for Repurposing or Redesigning Compounds for MDR Microorganisms (4:45 p.m. – 6:45 p.m., Meeting Room 6F, Upper Level)
- Fusidic Acid: An Oral Staphylococcal Antibiotic for Oral, Chronic Treatment; Prabhavathi Fernandes; Cempra Inc., Chapel Hill, NC (4:45 p.m. – 5:15 p.m.)
Saturday, September 19
Poster presentations:
Poster Session 081: Pharmacokinetics/Pharmacodynamics (PK/PD) of Agents against Gram-Positive Bacteria (11:00 a.m. – 1:00 p.m., Exhibit Hall F)
- A-492: Activity of Fusidic Acid (FUS) Alone or in Combination with Daptomycin (DAP), Vancomycin (VAN) and Linezolid (LDZ) (Compared with Each of These Antibiotics Alone) in an in vitro Dynamic Model of Staphylococcus aureus Biofilm; W. Siala, P. Fernandes, P. M. Tulkens, F. Van Bambeke; Univ. Catholique de Louvain, Brussels, Belgium, Cempra Pharmaceuticals Inc., Chapel Hill, NC
Poster Session 085: In Vitro Activities of New Drugs and Inhibitors against Gram-Positives (11:00 a.m. – 1:00 p.m., Exhibit Hall F)
- C-550: Assessment of the Bactericidal Activity of Solithromycin (CEM-101) Against Streptococcus pneumoniae with Known Macrolide-resistance Mechanism and Serotype: S. Magnet, I. Morrissey, P. Fernandes, K. Keedy, S. Hawser; IHMA Europe Sàrl, Epalinges, Switzerland, Cempra, Inc., Chapel Hill, NC
Poster Session 088: New Drugs against Gram-Negatives: In Vitro Activity and Insights (11:00 a.m. – 1:00 p.m., Exhibit Hall F)
- C-622: Activity of Solithromycin Tested Against Pathogens Associated with Community-acquired Bacterial Pneumonia: Global Surveillance Results for 2014; D. J. Farrell, R. K. Flamm, H. S. Sader, R. N. Jones; JMI Lab., North Liberty, IA
Sunday, September 20th
Poster presentations:
Poster Session 159: New Drugs and Approaches to Fight Antimicrobial Resistant Staphylococci (11:00 a.m. – 1:00 p.m., Exhibit Hall F)
- C-1055: Activity of Fusidic Acid against Staphylococci Isolated from Patients in United States Hospitals During 2014; D. J. Farrell, M. Castanheira, R. E. Mendes, R. N. Jones; JMI Lab., North Liberty, IA
Poster Session 162: Antimicrobial Susceptibility Testing-Antibiotic Combinations (11:00 a.m. – 1:00 p.m., Exhibit Hall F)
- D-1123: In vitro Activity of the Combination of Solithromycin and Cephalosporins against Neisseria gonorrhoeae; O. O. Soge, K. Keedy, L. A. Barbee, C. R. Kono, P. Fernandes, M. R. Golden; Univ. of Washington, Seattle, WA, Cempra, Inc., Chapel Hill, NC
Poster Session 163: Clinical Antibacterial Susceptibility Testing and Surveillance (11:00 a.m. – 1:00 p.m., Exhibit Hall F)
- D-1137: Solithromycin MIC and Disk Diffusion Quality Control Ranges, a CLSI Multi-Laboratory M23-A3 Study Design; J. E. Ross, D. J. Farrell, R. K. Flamm, R. N. Jones; JMI Lab., North Liberty, IA
Poster Session 172: Respiratory Tract Infections and Mycobacteria (11:00 a.m. – 1:00 p.m., Exhibit Hall F)
- L-1274: Prevalence of Pneumococcal Serotypes in Adults Enrolled in a Phase 3 Trial that Evaluated the Efficacy and Safety of Oral Solithromycin (CEM-101) versus Moxifloxacin in Adults with CABP; S. Chochua, A. Sheets, K. Keedy, B. Jamieson, D. Oldach, P. Fernandes, K. Klugman, J. E. Vidal; Emory Univ., Atlanta, GA, Cempra, Inc. Chapel Hill, NC
Copies of these posters will be available on the Cempra website following the ICAAC/ICC meeting at http://www.cempra.com.
About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra’s two lead product candidates are currently in advanced clinical development. Solithromycin (CEM-101) is in Phase 3 clinical development for community acquired bacterial pneumonia (CABP) and is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin has also entered a Phase 3 clinical trial for uncomplicated bacterial urethritis caused by Neisseria gonorrhoeae and chlamydia. Taksta™ (CEM-102) is Cempra’s second product candidate, which is being developed for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company has also synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com.
CONTACT: Investor Contact: Robert H. Uhl Westwicke Partners, LLC (858) 356-5932 robert.uhl@westwicke.com Media Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com
(ACTS) Amends Dutch Auction Tender Offer
ZHUHAI, China, Sept. 11, 2015 — Actions Semiconductor Co., Ltd. (Nasdaq: ACTS)(“Actions Semiconductor” or “the Company”), one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics, announced today that it has amended its previously announced self “Dutch auction” tender offer to (1) increase the size of the offer to up to 84,000,000 of its issued and outstanding ordinary shares (“the Shares”) (including Shares represented by ADSs), (2) increase the price range at which it will purchase the issued and outstanding ordinary shares to not greater than $23/60 per Share (or $2.30 per ADS) nor less than $20/60 per Share (or $2.00 per ADS) and (3) extend the expiration date of the tender offer to 5:00 p.m., Eastern Daylight Savings Time, on Tuesday, September 29, 2015. The Company is also reaffirming guidance for third quarter 2015 and fiscal 2015, presented on August 14, 2015. The Company undertakes to provide a further update prior to the closing of the tender offer to the extent there are any material changes to guidance for third quarter 2015 and fiscal 2015.
Information Relating to the Tender Offer Amendment and Extension
Under the terms of the tender offer, the Company invites holders of Shares and ADSs (together, the “Securities”) to tender their Securities at prices specified by such holders within such range of prices described further in the amended offer materials. The Company will select the lowest single per Share purchase price or per ADS purchase price, as applicable, that will allow it to buy up to 84,000,000 issued and outstanding Shares, which represent approximately 24.0% of Actions Semiconductor’s currently issued and outstanding ordinary shares, $0.000001 par value per share at the completion of the tender offer. Tenders of Securities must be made on or prior to the expiration of the tender offer and may be withdrawn at any time on or prior to the expiration of the tender offer. As previously announced, the tender offer will not be conditioned upon any minimum number of shares being tendered. The tender offer is, however, subject to the satisfaction of certain terms and conditions as described in the original Offer to Purchase and the Supplement to the Offer to Purchase. The tender offer was originally made pursuant to the Offer to Purchase, dated August 24, 2015, which was previously filed with the Securities and Exchange Commission (“SEC”) and forwarded to shareholders. A Supplement to the Offer to Purchase and amended letters of transmittal and related materials containing a complete explanation of the amended terms and conditions of the tender offer and revised instructions for tendering the Securities will be promptly filed with the SEC and forwarded to shareholders of record.
Holders who have previously tendered securities, and do not wish to either withdraw the tender of those securities, increase the number of securities tendered or change their indication of a specific price at which Shares (including Shares represented by ADSs) are being tendered, do not need to take any further action. As a result of the increase in the minimum price from US$18/60 per Share (or US$1.80 per ADS) to US$20/60 per Share (or US$2.00 per ADS), any Shares (including Shares represented by ADSs) previously tendered into the tender offer at any price below US$18/60 per Share (or US$1.80 per ADS) will now be deemed to have been tendered at US$20/60 per Share (or US$2.00 per ADS). Holders who have previously tendered securities, and wish either to increase the number of securities tendered or change their indications of a specific price at which Shares (or ADSs) are being tendered, must deliver an amended letter of transmittal to the depositary for the tender offer on or prior to the expiration date.
Neither Actions Semiconductor, its board of directors, dealer managers nor the information agent is making any recommendation to holders of the Securities as to whether to tender or refrain from tendering their Securities or as to the purchase price on any tender. Actions Semiconductor has been advised that none of its directors or executive officers intends to tender any Securities pursuant to the offer. The information agent for the tender offer is Laurel Hill Advisory Group, LLC and the depositary for the tender offer is Laurel Hill Advisory Group Company. Laurel Hill Securities, LLC and Imperial Capital, LLC are acting as the dealer managers for this tender offer.
Reaffirmation of Third Quarter 2015 and Fiscal 2015 Guidance
The Company also reaffirmed its third quarter 2015 and fiscal 2015 guidance previously announced on August 14, 2015. For third quarter 2015, the Company reaffirmed revenue guidance of $13.0 to $14.0 million. For fiscal 2015, the Company reaffirmed that it continues to anticipate revenue growth for the full year 2015 but at a slower pace than previously expected due to declining demand in tablet market and longer than anticipated design and qualification times for SoCs targeting other types of smart devices and hardware.
This announcement is for informational purposes only and does not constitute an offer to purchase or a solicitation of an offer to sell Actions Semiconductor’s Securities. The solicitation of offers to buy Actions Semiconductor’s Securities will only be made pursuant to the offer to purchase, issued in connection with the commencement of the tender offer (as may be amended or supplemented), the related letter of transmittal, and other related documents that Actions Semiconductor intends to send to holders of its Securities. The tender offer materials contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials are being distributed by Actions Semiconductor to the holders of its Securities at no expense to them. In addition, all of the materials (and all other offer documents filed with the SEC) will be available at no charge on the SEC’s website at www.sec.gov and by contacting Laurel Hill Advisory Group, the Information Agent for the Offer, by telephone at (888) 742-1305.
About Actions Semiconductor
Actions Semiconductor is one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics. Actions Semiconductor products include SoCs, firmware, software, solution development kits, as well as detailed specifications of other required components. Actions Semiconductor also provides total product and technology solutions that allow customers to quickly introduce new portable consumer electronics to the mass market in a cost effective way. The Company is headquartered in Zhuhai, China, with offices in Shanghai, Shenzhen, Hong Kong and Taipei. For more information, please visit the Actions Semiconductor website at http://www.actions-semi.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
Statements contained in this release that are not historical facts are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements relating to the Company’s Dutch auction tender offer and its reaffirmation of guidance. Actions Semiconductor uses words like “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project” and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are estimates reflecting current assumptions, expectations and projections about future events and involve significant risks, both known and unknown, uncertainties and other factors that could cause actual results to differ materially and adversely from those expressed in any forward-looking statement. The risks and uncertainties referred to above include, but are not limited to, the trading price of the ADSs, the security holders’ interest in participating in such tender offer, the review of this matter by the SEC, the Company’s proposed cash requirements and future prospects and results of operations, and current market and economic conditions, as well as such other factors described in the Company’s filings with the SEC. In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed in this press release may not occur. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date stated, or if no date is stated, as of the date of this press release. Except as required by law, Actions Semiconductor undertakes no obligation and does not intend to update or revise any forward-looking statement to reflect subsequent events or changed assumptions or circumstances.
Investor Contacts: | |
Elaine Ketchmere, CFA | Ally Xie, CA, CPA |
Compass Investor Relations | Actions Semiconductor |
eketchmere@compassir.com | investor.relations@actions-semi.com |
+1-310-528-3031 | +86-756-3392353*1018 |
(ARWR) Nominates ARC-HIF2 As First RNAi Therapeutic Candidate Using Extrahepatic DPC™
Data to be presented September 27 at the European Cancer Conference 2015 in Vienna
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it has nominated ARC-HIF2 as its first therapeutic candidate delivered using a new Dynamic Polyconjugate™ (DPC™) designed to target tissues outside of the liver. Arrowhead believes that ARC-HIF2, which uses RNA interference to silence transcription factor hypoxia-inducible factor 2α (HIF-2α), is a promising new candidate for the treatment of clear cell renal cell carcinoma (ccRCC). The company will present preclinical data at the European Cancer Congress 2015 (ECC2015) in Vienna on September 27 in a session starting at 16:45 CEST. In a poster titled “HIF-2α targeting with a novel RNAi delivery platform as therapy for renal cell carcinoma,” (abstract #353), Arrowhead scientists will show data suggesting that HIF-2α inhibition through RNA interference may significantly impact late stage ccRCC progression. The company is in the process of manufacturing scale up to allow for initiation of IND-enabling studies. Timing for anticipated regulatory submission will be announced in the future.
“Preclinical data using our new extrahepatic DPC™ delivery system has been very promising. We think the ability to target tissues outside of the liver, including tumors, opens additional opportunities for Arrowhead to develop differentiated RNAi-therapeutics that address numerous diseases without adequate treatment options,” said Christopher Anzalone, Ph.D., Arrowhead’s president and chief executive officer. “This is an important milestone for Arrowhead and we look forward to continued development of the DPC™ delivery platform and product candidates based on it.”
ARC-HIF2 is designed to inhibit the production of HIF-2α, which has been linked to tumor progression and metastasis in ccRCC. ARC-HIF2 employs a novel extrahepatic-targeted DPC™ that comprises a membrane active polymer to promote RNAi trigger endosomal release, an active ligand that targets the DPC™ to tumor cells, reversible masking to prevent polymer activity prior to cellular uptake, and an RNAi trigger to HIF-2α conjugated directly to the DPC™.
Using ARC-HIF2 in a preclinical ccRCC tumor model, mice treated with weekly injections led to greater than 80% knockdown of HIF-2α mRNA in tumors. Furthermore, tumors from treated mice exhibited statistically significant reductions in size and weight, extensive tumor cell death, reduction in the tumor-expressed VEGF-A biomarker, and destruction of the blood vessels feeding the tumors.
Therapies for metastatic ccRCC including agents that target the VEGF/VEGFR or mTor signaling pathways, which are validated cancer targets, have become the standard-of-care and have improved patient outcomes. However, since emergence of resistance to these agents is common, novel therapies targeting alternative pathways are needed for patients with resistant tumors. Arrowhead believes that HIF2α is an attractive target for intervention because over 90% of ccRCC tumors express a mutant form of the Von Hippel-Landau protein that is unable to degrade HIF-2α, leading to its accumulation during tumor hypoxia and promoting tumor growth.
An abstract of the data to be presented at ECC2015 is available on the conference website at www.europeancancercongress.org/.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate™ delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead’s pipeline includes ARC-520 for chronic hepatitis B virus, ARC-AAT for liver disease associated with Alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and thromboembolic diseases, and ARC-HIF2 for renal cell carcinoma.
For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadresearch.com/alerts.cfm.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Research Corporation.
Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
or
Investor Relations:
The Trout Group
Chad Rubin, 646-378-2947
ir@arrowres.com
or
Media:
Russo Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
(APDNW) Acquires Assets of DNA Manufacturer Vandalia Research
Strengthens Large Scale DNA Production and Broadens Market Reach
STONY BROOK, NY–(September 11, 2015) – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology, product genotyping services and product authentication solutions, announced that it has acquired the assets of privately held Vandalia Research, Inc. for $1.5 million in cash.
Vandalia’s core technology and intellectual property portfolio, allow for the large-scale production of specific DNA sequences using polymerase chain reaction (PCR). PCR can amplify a few copies of a piece of DNA, generating millions to billions of copies without the impurities of fermentation.
Vandalia’s Triathlon™ PCR systems are self-contained and modular, can work together in mass production or can be used individually throughout the world, offering the advantage of delivering DNA locally and securely. The enclosed design should facilitate compliance with drug manufacturing guidelines in our quest to DNA mark individual doses as a major initiative in the war against counterfeit drugs. “Expanding our manufacturing capacity through the acquisition of Vandalia’s Triathlon PCR machines is opportune as we move toward converting pilot projects to commercial deployment, and creates, we believe, the world’s largest manufacturing capacity of DNA in bulk using PCR,” said Dr. James Hayward, President and CEO of APDN. “Self-contained production, paired with our On-Site™ DNA Authentication Program that can be done with simple training, opens the opportunity for rapid deployment of DNA marking in response to the anti-counterfeiting needs of the military, border protection, law enforcement agencies and supply chains.”
The acquisition provides APDN with established supply relationships across key companies in the biotechnology, pharmaceutical and diagnostic markets where Vandalia DNA is already used as a business-critical therapeutic, diagnostic and reagent and provides the company the opportunity to cross-sell its DNA-based supply chain security solutions. There will be no lapse in DNA production as we fulfil Vandalia’s current backlog and expected orders through the remainder of the current quarter and beyond.
A new capacity for APDN will be the ability to manufacture longer DNA sequences valuable in gene therapy, DNA vaccines and diagnostics. These types of DNA are distinct from APDN’s security markers and represent a new entry into medical markets, where management believes there are ample opportunities for APDN’s broader platform.
Derek Gregg, former CEO of Vandalia and co-inventor of its Triathlon platform, will join APDN as a consultant focused on the sale of DNA to the biotechnology and drug development industry. The company intends to move the physical assets of Vandalia to its headquarters in Long Island before the end of 2015.
Dr. Hayward continued, “We are in the midst of a coordinated effort to use SigNature DNA to bring supply chain security to pharmaceutics and foods and, as part of this, it is essential that we immediately begin the process of becoming compliant with cGMP (Current Good Manufacturing Practice) guidelines so that we may improve these supply chains just as we have in cotton. We believe that Vandalia’s Triathlon can help us to expedite this process. We look forward to working with our new colleagues from Vandalia, creating demand for DNA and setting new records for its production.”
About Applied DNA Sciences
We make life real and safe by providing botanical-DNA based security and authentication solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. SigNature® DNA describes the platform ingredient that is at the heart of all of our security and authentication solutions. SigNature DNA is at the core of a family of uncopyable products such as DNAnet®, our anti-theft product, SigNature® T and fiberTyping®, targeted toward textiles, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence and can be used to prosecute perpetrators.
Applied DNA Sciences common stock is listed on NASDAQ under the symbol APDN, and its warrants are listed under the symbol APDNW.
Forward Looking Statements
The statements made by APDN in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 15, 2014, as amended on March 6, 2015, and our subsequent quarterly reports on Form 10-Q filed on February 9, 2015, May 11,2015 and August 10, 2015, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.
Investor contact:
Debbie Bailey
631-240-8817
Email contact
Media contact:
Susan Forman
Dian Griesel Int’l.
212-825-3210
Email contact
Web: Email contact
twitter: @APDN
(MRTX) To Present Clinical Data At European Society for Medical Oncology 2015
Company to Present Data from Phase 1/1b Study of MGCD516
SAN DIEGO, Sept. 11, 2015 — Mirati Therapeutics, Inc. (“Mirati”) (NASDAQ: MRTX), an oncology company focusing on genetic and epigenetic drivers of cancer, today announced it will present data on its tyrosine kinase inhibitor, MGCD516, at the ESMO 2015 European Cancer Congress being held in Vienna, Austria from September 25-29, 2015.
Data from the study titled, “A First-in-Human Phase 1/1b Study of Receptor Tyrosine Kinase (RTK) Inhibitor, MGCD516, in Patients with Advanced Solid Tumors” will be presented during the “Early Drug Development” poster session on Sunday, September 27, 2015 from 4:45 – 6:45 PM CEST/7:45 – 9:45 AM PDT at the Messe Wien Exhibition and Congress Centre, Hall C.
“MGCD516 is a potent, orally bioavailable inhibitor of key pathways that drive tumor growth. Specifically, MGCD516 targets driver mutations including RET, Trk and DDR gene alterations, which occur most often in patients with non-small cell lung cancer,” said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. “In this dose escalation phase, MGCD516 was well tolerated and showed favorable PK characteristics in unselected cancer patients. Later this year we will begin treating selected patients with solid tumors, including non-small cell lung cancer.”
About MGCD516
MGCD516 is a tyrosine kinase inhibitor that has demonstrated potent inhibition of a closely related spectrum of tyrosine kinases including RET, Trk and DDR, which are key regulators of signaling pathways that lead to cell growth, survival and tumor progression. These kinases and their key regulatory pathways are genetically altered in multiple cancer indications and act as oncogenic drivers that promote cancer development and progression in solid tumors, including non-small cell lung cancer (NSCLC). MGCD516 is in a Phase 1 dose escalation study in advanced solid tumors with an initial focus on NSCLC. Mirati retains worldwide rights to MGCD516.
About Mirati Therapeutics
Mirati Therapeutics develops molecularly targeted cancer treatments that are intended to inhibit tumor growth. Mirati’s approach combines the three most important factors in oncology drug development, 1) researching and developing drug candidates that target genetic and epigenetic drivers of cancer, 2) designing creative and agile clinical development strategies that select for patients whose tumors are dependent on specific driver alterations, and 3) leveraging a highly accomplished targeted oncology leadership team. The Mirati team uses a blueprint – proven by their prior work – for developing potential breakthrough cancer therapies, with accelerated development paths, in order to improve outcomes for patients. Mirati is advancing three drug candidates through clinical development for multiple oncology indications. More information is available at www.mirati.com.
Forward Looking Statements
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, contain “forward-looking” statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties. For more detailed disclosures and discussions regarding such forward looking statements, please refer to Mirati’s filings with the U.S. Securities and Exchange Commission (“SEC”), including without limitation Mirati’s filings on Forms 10-K, 10-Q, and 8-K. Forward looking statements are based on the current expectations of management and upon what management believes to be reasonable assumptions based on information currently available to it. Such statements can usually be identified by the use of words such as “may,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology, or by statements that certain actions, events or results “may” or “would” be taken, occur or be achieved. Such statements include, but are not limited to, statements regarding Mirati’s development plans and timelines, potential regulatory actions, expected use of cash resources, the timing and results of clinical trials, and the potential benefits of and markets for Mirati’s product candidates. Forward looking statements involve significant risks and uncertainties and are neither a prediction nor a guarantee that future events or circumstances will occur. Such risks include, but are not limited to, potential delays in development timelines or negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks described in Mirati’s filings with the SEC. We are including this cautionary note to make applicable, and to take advantage of, the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The information in this news release is given as of the date above and Mirati expressly disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
Company Contact:
Anne Erickson
Mirati Therapeutics Inc.
Investor Relations and Corporate Communications
858-332-3532
ericksona@mirati.com
Investor Relations and Media Relations:
Jason Spark
Canale Communications
619-849-6005
jason@canalecomm.com
(SMMT) Completes Targeted Enrolment for SMT19969 Phase 2 Trial for C. diff
OXFORD, United Kingdom, Sept. 10, 2015 — Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection (‘CDI’), today announced the completion of patient enrolment into the CoDIFy Phase 2 proof of concept trial of SMT19969 for the treatment of CDI. Patient dosing and follow-up is continuing and top-line results are expected in the fourth quarter of 2015. SMT19969 is a novel, oral antibiotic designed to selectively target C. difficile bacteria while not harming the gut microbiome that is essential in protecting against disease recurrence.
“CDI is now widely accepted to be a major healthcare issue, and with current antibiotics used to treat CDI having high rates of disease recurrence, there is an urgent need to develop new therapies,” said Glyn Edwards, Chief Executive Officer of Summit. “We believe SMT19969 represents an important advance as its potency in killing C. difficile bacteria is complemented by selective targeting that leaves the healthy gut microbiome unharmed. The timely completion of enrolment into our CoDIFy proof of concept trial achieves an important milestone and means we remain on-track to report top-line results in the fourth quarter of this year.”
C. difficile is one of three pathogens that pose an immediate public health threat according to the US Center for Disease Control and Prevention (‘CDC’). CDI has a high economic impact with annual acute care costs estimated at $4.8 billion in the United States alone. The key clinical issue is disease recurrence with approximately 25% of patients suffering recurrence of CDI, a risk that rises to 40% after a first recurrence and over 65% after a second recurrence.
SMT19969 has received Qualified Infectious Disease Product designation (‘QIDP’) and Fast Track status from the US Food and Drug Administration. The development of SMT19969 is being supported by a Wellcome Trust Translational Award.
About CoDIFy Phase 2 Clinical Trial
CoDIFy, is a double-blind, randomized, active control Phase 2 trial evaluating the efficacy of SMT19969 against the current standard of care, vancomycin. CoDIFy is being conducted in the United States and Canada. The trial has enrolled a total of 100 patients, with half receiving ten days of dosing with SMT19969, and half receiving ten days of dosing with vancomycin. The primary endpoint of the trial is sustained clinical response, a composite endpoint which is defined as clinical cure at the test of cure visit with no recurrence of CDI within 30 days after the end of treatment. The trial is also examining a number of secondary endpoints, including the safety and tolerability of SMT19969 and its impact on patients’ gut microbiome.
About SMT19969
SMT19969 is a novel, oral small molecule antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with high levels of antibacterial selectivity. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported, demonstrating that SMT19969 was highly sparing of the gut microbiome.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
For more information, please contact:
Summit Therapeutics | |
Glyn Edwards / Richard Pye (UK office) | Tel: +44 (0)1235 443 951 |
Erik Ostrowski (US office) | +1 617 294 6607 |
Cairn Financial Advisers LLP | |
(Nominated Adviser) | |
Liam Murray / Tony Rawlinson | Tel: +44 (0)20 7148 7900 |
N+1 Singer | |
(Broker) | |
Aubrey Powell / Jen Boorer | Tel: +44 (0)20 7496 3000 |
MacDougall Biomedical Communications | |
(US media contact) | Tel: +1 781 235 3060 |
Michelle Avery | mavery@macbiocom.com |
Peckwater PR | |
(Financial public relations, UK) | Tel: +44 (0)7879 458 364 |
Tarquin Edwards | tarquin.edwards@peckwaterpr.co.uk |
Forward Looking Statements
Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, the timing of initiation, completion and availability of data from clinical trials and expectations regarding the sufficiency of Summit’s cash balance to fund operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “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: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from on-going and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.
(LIFE) Doses First Patient In Long-Term Safety Extension Study Of Resolaris™
Physiocrine-Based Therapy Harnesses Natural Immunomodulation Pathway to Address Rare Genetic Muscular Dystrophy
SAN DIEGO, Sept. 10, 2015 — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe rare diseases, today announced that the first patient has been dosed in a newly initiated long term-safety extension study of Resolaris™ for adult patients with facioscapulohumeral muscular dystrophy (FSHD), a rare and severe genetic myopathy for which there are currently no approved treatments.
The open label study is designed to assess the long-term safety, tolerability and biological activity of Resolaris™ and will include adult patients who are currently enrolled in an ongoing, double-blind, placebo-controlled, multiple ascending dose Phase 1b/2 trial of Resolaris™ in adult patients with FSHD. Data from the Phase 1b/2 study are expected in the fourth quarter of 2015 or first quarter of 2016. The extension study is expected to continue through mid-2016.
“Our Resolaris extension study takes the next step in developing a new class of Physiocrine-based medicines for patients who currently have few options. The trial will also expand our growing safety and tolerability database over a longer treatment period,” said John Mendlein, Ph.D., CEO and executive chairman of aTyr Pharma. “When given in therapeutic doses, we believe Physiocrine-based therapies may productively modulate immune processes by rebalancing the immune systems in chronic rare muscle diseases to provide new options for these severely affected patients.”
Resolaris™ is the first Physiocrine-based therapeutic under investigation for any disease and is based on a naturally occurring protein identified by aTyr Pharma. The Company is also planning trials in additional indications, including early onset FSHD and limb-girdle muscular dystrophy (LGMD) 2B, and both are expected to initiate later this year.
For additional information on this study, please visit www.clinicaltrials.gov.
About Physiocrines
Physiocrines comprise naturally occurring proteins that aTyr believes promote homeostasis, a fundamental process of restoring stressed or diseased tissue to a healthier state. Physiocrines are extracellular signaling regions of tRNA synthetases, an ancient family of enzymes that catalyze a key step in protein synthesis. aTyr is currently focused on Physiocrines that act as endogenous modulators of the immune system. Physiocrines offer the opportunity for modulating biological pathways through newly discovered, naturally occurring mechanisms, many of which may provide advantages over engineered immuno-modulatory therapeutics, including the potential for improved patient outcomes and reduced side effect profiles.
About Resolaris™
aTyr Pharma is developing Resolaris™ as a first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris™ is derived from a naturally occurring protein released in vitro by human skeletal muscle cells. aTyr believes Resolaris™ has the potential to provide therapeutic benefit to patients with rare myopathies with an immune component characterized by excessive immune cell involvement.
About FSHD
Facioscapulohumeral muscular dystrophy (FSHD) is a rare genetic myopathy affecting approximately 19,000 people in the United States for which there are no approved treatments. The primary clinical phenotype of FSHD is debilitating skeletal muscle deterioration and weakness. The symptoms of FSHD develop in a descending pattern, starting with the face and upper body to the lower body and progressing in a “muscle by muscle” fashion. In addition to muscle weakness, FSHD patients often experience debilitating fatigue and chronic pain. The disease is typically diagnosed by the presence of a characteristic pattern of muscle weakness and other clinical symptoms, as well as through genetic testing.
About aTyr Pharma
aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients suffering from severe rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators. The Company’s lead candidate, Resolaris™, is a first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris™ is currently in a Phase 1b/2 clinical trial in adult patients with facioscapulohumeral muscular dystrophy (FSHD). Trials are planned in additional indications, including early onset FSHD and limb-girdle muscular dystrophy (LGMD) 2B. Trials are also planned for indications in interstitial lung disease (ILD). To protect this pipeline, aTyr built an intellectual property estate comprising 45 issued or allowed patents and over 240 pending patent applications that are solely owned or exclusively licensed by aTyr. aTyr’s key programs are currently focused on severe, rare diseases characterized by immune dysregulation for which there are currently limited or no treatment options. For more information, please visit http://www.atyrpharma.com.
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the potential of Resolaris, the ability of the Company to undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals, and the timing of initiation of additional clinical trials reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the discovery, development and regulation of our Physiocrine-based product candidates, as well as those set forth in the prospectus for our recent offering of common stock and our most recent Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
(SGMO) Unanimous Recombinant DNA Advisory Committee Approval Of ZFP Phase 1 Protocol
First Application of Sangamo’s In Vivo Protein Replacement Platform (IVPRP) for Potential Cure of Hemophilia B
RICHMOND, Calif., Sept. 10, 2015 — Sangamo BioSciences, Inc. (Nasdaq: SGMO), a leader in therapeutic genome editing, announced unanimous approval by the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) of a Phase 1 study protocol for a ZFP Therapeutic as a potential curative therapy for hemophilia B. The Factor IX program will be the first clinical study of in vivo genome editing and the first therapeutic application of Sangamo’s In Vivo Protein Replacement Platform (IVPRP).
Sangamo expects to file an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) by the end of 2015 and, pending FDA clearance, plans to initiate a Phase 1 clinical trial in 2016. The Company recently reacquired all of its hemophilia assets from Shire plc as a result of the amendment to the companies’ 2012 collaboration and license agreement.
“Hemophilia B is the first clinical application of our IVPRP which can be applied to many other diseases that are currently treated by protein replacement including hemophilia A and lysosomal storage disorders,” said Geoff Nichol, M.B., Ch.B., Sangamo’s executive vice president of research and development. “Successful review, by the NIH RAC, of the first human in vivo genome editing clinical protocol is a major milestone for Sangamo. We appreciate this careful consideration and unanimous approval of our proposed clinical trial and look forward to the commencement of our Phase 1 study in the near future.”
“We are pleased with the outcome from this thorough review, by the NIH RAC, of our first IVPRP clinical protocol,” said Edward Lanphier, Sangamo’s president and chief executive officer. “We will continue to leverage the potential of this strategy for development of ZFP Therapeutics for other monogenic diseases, and remain on track to file IND applications for the hemophilia B program and the first of our lysosomal storage disorder programs by the end of 2015.”
Sangamo’s IVPRP
The IVPRP approach makes use of the albumin gene locus, a highly expressing and liver-specific genomic “safe-harbor site”, that can be edited with zinc finger nucleases (ZFNs) to accept and express any therapeutic gene. The platform enables the patient’s liver to permanently produce therapeutic levels of a corrective protein product such as factor VIII or IX to treat hemophilia, or replacement enzymes to treat lysosomal storage disorders. With such a large capacity for protein production (approximately 15g/day of albumin), which is in excess of the body’s requirements, targeting and co-opting only a very small percentage of the albumin gene’s capacity is sufficient to produce the needed replacement protein at therapeutically relevant levels with no significant effect on albumin production.
Sangamo
Sangamo BioSciences, Inc. is focused on Engineering Genetic CuresTM for monogenic and infectious diseases by deploying its novel DNA-binding protein technology platform in therapeutic gene regulation and genome editing. The Company has a Phase 2 clinical program to evaluate the safety and efficacy of novel ZFP Therapeutics® for the treatment of HIV/AIDS (SB-728). Sangamo’s other therapeutic programs are focused on monogenic and rare diseases. The Company has formed a strategic collaboration with Shire International GmbH to develop therapeutics for Huntington’s disease, and with Biogen Inc. for hemoglobinopathies, such as sickle cell disease and beta-thalassemia. It has also established strategic partnerships with companies in non-therapeutic applications of its technology, including Dow AgroSciences and Sigma-Aldrich Corporation. For more information about Sangamo, visit the company’s website at www.sangamo.com.
ZFP Therapeutic® is a registered trademark of Sangamo BioSciences, Inc.
This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references to the research and development of novel ZFNs, potential therapeutic applications of its ZFP technology for the treatment of hemophilia A and B, lysosomal storage disorders and other monogenic diseases, the potential therapeutic applications of the IVPRP, the expected timing for filing of IND applications and commencement of clinical trials. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, uncertainties and risks relating to clinical trials, compliance with regulatory and other requirements, the ability of Sangamo to develop commercially viable products and technological developments by our competitors. See the SEC filings, and in particular, the risk factors described in Sangamo’s Annual Reports on Form 10-K and most recent Quarterly Reports on Form 10-Q. Sangamo does not assume any obligation to update the forward-looking information contained in this press release.
(FARM) to Present at the Inaugural B. Riley & Great American Group Consumer Conference
TORRANCE, Calif., Sept. 10, 2015 — Farmer Bros. Co. (“Farmer Brothers”, or the “Company”), a coffee roaster and distributor with a history of more than 100 years, has been invited to present at the Inaugural B. Riley & Great American Group Consumer Conference being held September 16, 2015 at the New York Athletic Club, New York.
Mike H. Keown, President & Chief Executive Officer and Mark J. Nelson, Treasurer and Chief Financial Officer are scheduled to present the corporate overview and strategy, and discuss the Company’s financial results and corporate relocation on Wednesday, September 16 in one‑on‑one meetings held throughout that day from 8:00 a.m. Eastern time.
A copy of the presentation will also be available on the Investor Relations section of the Company’s website at www.farmerbros.com at the time of the presentation.
For more information about the conference or to schedule a one-on-one meeting with Farmer Brothers management, please email conference@brileyco.com.
About Farmer Bros. Co.
Founded in 1912, Farmer Bros. Co. is a manufacturer, wholesaler and distributor of coffee, tea and culinary products. The Company’s customers include restaurants, hotels, casinos, offices, quick service restaurants (“QSRs”), convenience stores, healthcare facilities and other foodservice providers, as well as private brand retailers in the QSR, grocery, drugstore, restaurant, convenience store, and independent coffee house channels. The Company’s product line includes roasted coffee, liquid coffee, coffee-related products such as coffee filters, sugar and creamers, assorted iced and hot teas, cappuccino, cocoa, spices, gelatins and puddings, soup bases, dressings, gravy and sauce mixes, pancake and biscuit mixes, and jellies and preserves. Currently headquartered in Torrance, Calif., Farmer Bros. Co. generated net sales of over $500 million in fiscal 2015 and has approximately 1,800 employees nationwide. The Company’s primary brands include Farmer Brothers™, Artisan Collection by Farmer Brothers™, Superior®, Metropolitan™ , Cain’s™ and McGarvey®. For more information, visit: www.farmerbros.com.
Contact: Farmer Bros. Co. Mark Nelson (310) 787-5241
(ENVI) Ericsson Announces Agreement to Acquire Envivio
Shareholders to Receive $4.10 Per Share in Cash in Transaction Valued at Approximately $125 Million
SAN FRANCISCO, Sept. 10, 2015 — Envivio, Inc. (Nasdaq:ENVI), a leading provider of software-based video processing and delivery solutions, today announced that it has entered into a definitive agreement to be acquired by Ericsson, a provider of communications technology and services.
“The uniting of Envivio’s pioneering software solutions and Ericsson’s strength in the marketplace is a great combination for our customers and stockholders,” said Julien Signès, founder and CEO of Envivio. “Ericsson shares a similar vision for the future of video processing and shift to software defined and virtualized encoding solutions. Ericsson brings tremendous resources, a broad product and solutions portfolio and reach that will accelerate the adoption of Envivio’s software-based video solutions.”
As part of Ericsson’s TV and Media business, Envivio will continue to work with its customers and partners to develop its current software based video solutions for video processing, delivery and monetization. Envivio’s customers will be able to rely on the global stability and scale and the strong commitment of Ericsson in the TV and Media business with access to Ericsson’s full portfolio of products, solutions, and global services expertise.
“Our consumer research clearly shows that viewers are demanding TV on their terms on any device, and expecting experiences that continually evolve,” said Per Borgklint, Senior Vice President and Head of Business Unit Support Solutions at Ericsson. “We are committed to offering our customers a clear path towards fully agile cloud agnostic platforms that delight TV consumers. I look forward to welcoming the market leader in pure software-defined video encoding, processing, and packaging into Ericsson. The combination will strengthen our encoding position with both custom silicon and pure software encoding, delivering performance and flexibility.”
Under the terms of the definitive agreement, Ericsson will commence a cash tender offer to purchase all of Envivio’s outstanding shares, with a merger following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to receive $4.10 per share. Certain of Envivio’s major stockholders, collectively owning approximately 34 percent of Envivio’s outstanding common stock, have entered into a tender and support agreement with Ericsson committing to tender all of their Envivio shares in the tender offer and to vote in favor of the merger. The acquisition is expected to close in the fourth quarter of 2015, subject to customary closing conditions.
The board of directors of Envivio has unanimously agreed to recommend that Envivio’s stockholders tender their shares to Ericsson in the tender offer.
For further information regarding all terms and conditions contained in the definitive merger agreement, please see Envivio’s Current Report on Form 8-K, which will be filed in connection with this transaction.
About Envivio
Envivio (NASDAQ:ENVI) is a global market leader and innovator of video software solutions that are trusted by video service providers and content companies worldwide to power stunning video quality and captivating, personalized experiences to our millions of viewers on any device, over any network. Leveraging our pioneering and technically superior virtualized video delivery solutions, we enable video operators of any size to increase revenues and reduce costs while uniquely providing the best-in-class quality, reliability, efficiency, and scalability to support the new age of video anywhere. Envivio is headquartered in San Francisco, California with offices worldwide in France, China and Singapore. Visit www.envivio.com for more information, or connect with us on LinkedIn.
About Ericsson
Ericsson (NASDAQ:ERIC) is the driving force behind the Networked Society – a world leader in communications technology and services. Our long-term relationships with every major telecom operator in the world allow people, business and society to fulfill their potential and create a more sustainable future.
Our services, software and infrastructure – especially in mobility, broadband and the cloud – are enabling the telecom industry and other sectors to do better business, increase efficiency, improve the user experience and capture new opportunities.
With approximately 115,000 professionals and customers in 180 countries, we combine global scale with technology and services leadership. We support networks that connect more than 2.5 billion subscribers. Forty percent of the world’s mobile traffic is carried over Ericsson networks. And our investments in research and development ensure that our solutions – and our customers – stay in front.
Founded in 1876, Ericsson has its headquarters in Stockholm, Sweden. Net sales in 2014 were SEK 228.0 billion (USD 33.1 billion). Ericsson is listed on NASDAQ OMX stock exchange in Stockholm and the NASDAQ in New York.
Important Additional Information
The tender offer for the outstanding common stock of Envivio has not yet commenced. This communication is for informational purposes only and it is neither an offer to purchase nor a solicitation of an offer to sell shares of Envivio common stock. At the time the tender offer is commenced, Ericsson will file a tender offer statement, containing an offer to purchase, a form of letter of transmittal and other related tender offer documents with the Securities and Exchange Commission (the “SEC”), and Envivio will file a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer with the SEC. Envivio’s stockholders are strongly advised to read these tender offer materials, as well as any other documents relating to the tender offer and the associated transactions that are filed with the SEC, carefully and in their entirety when they become available, and as they may be amended from time to time, because they will contain important information about the tender offer that Envivio’s stockholders should consider prior to making any decisions with respect to the tender offer. Once filed, stockholders of Envivio will be able to obtain a free copy of these documents at the website maintained by the SEC at www.sec.gov or by directing a request to Ericsson, Investor Relations, +46 10 719 00 00 or e-mail: investor.relations@ericsson.com.
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, including statements regarding the anticipated benefits of the proposed acquisition of Envivio by Ericsson, the potential impact to Envivio’s customers of the proposed acquisition of Envivio and other statements relating to the combined entity following the proposed acquisition. Although we attempt to be accurate in making forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. Important factors that could cause results to differ materially from the statements herein include the following, general economic risks; execution risks with acquisitions; closing conditions; risks associated with sales not materializing based on a change in circumstances; disruption to sales following acquisitions; increasing competitiveness in the video processing and delivery market; ability to retain key personnel from the acquisition, unexpected changes in Envivio’s business, the loss of significant customers, changes in capital spending in the markets Envivio serves, the failure of Envivio’s target markets to develop as anticipated, disruption with existing channel partners, unpredictable sales cycles, fluctuations in operating results, failure to develop new and enhanced products in a timely manner, the loss of a key customer or customers, the loss of a key supplier or suppliers, claims of technology infringement, general economic conditions and other risks detailed from time to time in Envivio’s Quarterly Report on Form 10-Q for the three months ended April 30, 2015 and other SEC reports, which can be found at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements herein reflect our opinions only as of the date of this release, and we undertake no obligation, and expressly disclaim any obligation, to update forward-looking statements herein in light of new information or future events.
CONTACT: NMN Advisors Investor Relations Avelina Kauffman ir@envivio.com +1.510.344.2664
(TNDM) Announces FDA Approval of t:slim G4 Insulin Pump with CGM Integration
The First and Only CGM-enabled Touch-Screen Pump
SAN DIEGO, Sept. 9, 2015 — Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced U.S. Food and Drug Administration approval of the t:slim G4™ Insulin Pump, the first and only touch-screen pump with continuous glucose monitoring (CGM) integration, for use by people 12 years of age or older who use insulin. It combines features of the t:slim® Insulin Pump and Dexcom G4® PLATINUM CGM System, devices that have consistently ranked #1 in independent surveys1, into a single device that is simple to use. The t:slim G4 Pump is the only pump that conveniently displays CGM graphs and trend information with current insulin delivery activity together on the home screen to help make informed treatment decisions. Orders for the t:slim G4 Insulin Pump can be placed now with shipments expected to begin in October 2015.
“The t:slim G4 Pump combines our intuitive touch-screen interface and bright color display with Dexcom’s CGM technology, giving the diabetes community a powerful new tool to help simplify therapy management,” said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. “CGM integration has been one of the most requested features since the launch of the t:slim Pump. The addition of t:slim G4 to our product family allows us to address a wider variety of diabetes management needs through the broadest range of insulin pump options available from one company.”
“The integration of Tandem’s touch-screen interface and Dexcom’s G4 PLATINUM CGM product could prove to be a powerful combination for people with diabetes,” said Kupper Wintergerst, MD, pediatric endocrinologist at the University of Louisville and director of the Wendy L. Novak Diabetes Care Center in Louisville, KY. “It’s great to have another integrated option for my patients, particularly one with an age indication for people as young as 12 years old.”
“We believe the t:slim G4 Pump’s touch screen technology and simple user interface are a great combination for Dexcom G4 PLATINUM CGM integration,” said Steve Pacelli, EVP, Strategy and Corporate Development at Dexcom. “CGM-integration is key to future automated insulin delivery technology, and we are pleased to be working with a company like Tandem who is continuously innovating to make diabetes technology simpler to use for people with diabetes.”
The t:slim G4 Pump is the newest addition to the Company’s family of products, which includes the t:slim® and t:flex™ Insulin Pumps. Each pump in the portfolio features a touch-screen with a streamlined, user-friendly interface. This provides people rapid access to frequently used features while eliminating the need for excessive scrolling and button pressing, making these features simple to learn and simple to use. Each Tandem product utilizes modern technology, such as a built-in rechargeable battery and micro-USB port for convenient charging and fast data transfers. They also feature the Company’s Micro-Delivery® technology that allows for basal delivery every 5 minutes in increments as small as 0.001 unit. The t:slim G4 and t:slim Pumps are the slimmest and smallest durable insulin pumps on the market, yet still hold up to 300 units of insulin, and the t:flex offers similar size benefits while holding up to 480 units of insulin.
The t:slim G4 Pump can operate as a stand-alone insulin pump without CGM, or be paired with a Dexcom G4 PLATINUM sensor. When paired with a sensor, the CGM component of the pump closely mimics the interface of the Dexcom system, tracking glucose continuously and displaying color-coded graphs and arrows directly on the Pump’s home screen2. The system also allows users to program personalized information, such as glucose targets and alerts, and has an alarm feature to notify the user if glucose levels rise or fall to dangerous levels.
For additional product and safety information, or to begin the order process, visit www.tandemdiabetes.com/tslimG4
or call (877) 801-6901, Monday – Friday between 6am and 5pm Pacific Time
Download Tandem’s free t:simulator™ App to experience the t:slim G4 Pump’s touch screen interface directly on your mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects more than 29 million people in the United States, or nearly 1 in 10 Americans. Tandem estimates that more than 3 million people in the United States require daily administration of insulin and are candidates for pump therapy. More than 425,000 Americans with type 1 diabetes use an insulin pump, or approximately 27% of the type 1 diabetes population. In addition, approximately 125,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.
Conference Call Details:
The Company will hold a conference call and simultaneous webcast on September 9, 2015 at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss FDA approval of the t:slim G4 Insulin Pump with CGM Integration. To listen to the conference call, please dial (855) 427-4396 (US/Canada) or (484) 756-4261 (International) and use the participant code “37158883”. A link to the webcast will be available on Tandem Diabetes Care’s Investor Center website located at http://investor.tandemdiabetes.com in the “Investor Events” section. An archive of the webcast will be available for 30 days following the event.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with diabetes who use insulin. The Company manufactures and sells the t:slim® Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, the t:flex™ Insulin Pump, the first pump designed for people with greater insulin requirements, and the t:slim G4™ Insulin Pump, the first CGM-enabled pump with touch-screen simplicity. Tandem is based in San Diego, California.
Forward Looking Statement
This press release includes forward-looking statements relating to the anticipated timing of the commercial launch of the t:slim G4 Pump, the anticipated benefits associated with use of the t:slim G4 Pump and the potential advantages of the t:slim G4 Pump over existing insulin pumps. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including: Tandem’s ability to begin commercial scale manufacturing of the t:slim G4 Pump and associated cartridges; the potential that newer products that compete with the t:slim G4 Pump, or other technological breakthroughs for the monitoring, treatment or prevention of diabetes, including potential new products offered by Dexcom, may render the t:slim G4 Pump obsolete or less desirable; the potential that customers may not perceive the anticipated benefits associated with the use of the t:slim G4 Pump when paired with a Dexcom G4 sensor; the potential that customers may not be willing to concurrently use a G4 sensor and the t:slim G4 Pump; and other risks identified in Tandem’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update any forward-looking statement in this press release.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim, #tslimG4, #tflex, #tconnect, and $TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at http://www.linkedin.com/company/tandemdiabetes
t:slim, Micro-Delivery and Tandem Diabetes Care are registered trademarks, and t:slim G4, t:flex, and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G4 PLATINUM are registered trademarks of Dexcom, Inc.
1 dQ&A USA Diabetes Connections Surveys. t:slim Pump: 2013-2014. Dexcom G4 PLATINUM CGM: 2009-2014.
2 A minimum of two finger sticks a day is required for calibration. System may require more.
(CRNT) Large Mobile Operators Expand 4G Services Throughout North America
LITTLE FALLS, New Jersey, September 9, 2015 —
Ceragon Networks Ltd. (NASDAQ: CRNT), the #1 wireless backhaul specialist today announced that three large North American mobile operators, all existing Ceragon customers, are deploying its IP-20 platform for their separate 4G network expansion and modernization projects.
The growing demand for Ceragon’s IP-20 platform in North America is attributed to its high capacity, high availability, high reliability and backwards compatibility capabilities, providing exceptional performance. These mobile operators chose Ceragon’s IP-20 wireless backhaul solution as it enables them to quickly and efficiently modernize the existing networks to 4G and rapidly expand coverage and capacity. The IP-20 platform allows them to meet increasing network traffic demands with its ability to deliver the highest possible capacity under any condition, while ensuring maximal spectral efficiency. By providing uncompromised reliability and redundancy, Ceragon’s IP-20 platform ensures consistent and reliable network performance, hence enabling all three operators to deliver an excellent, uninterrupted mobile experience to their end users.
The Ceragon offering allows these three long standing Ceragon customers to save significant CAPEX and OPEX as they are able to leverage their legacy Ceragon antennas and radios while performing minimal upgrades to sites. The operators additionally enjoy the IP-20 platform’s backwards compatibility capabilities with legacy Ceragon products installed at remote sites, which significantly reduce implementation times and required site visits, ultimately allowing their network to be up and running quickly with minimal service interruptions. With its compact radios, the IP-20 platform also saves operators site and tower real estate costs. The Ceragon high power IP-20 platform delivers operators a complete wireless backhaul solution that enables them to meet their operational efficiency targets.
“We are extremely pleased to see our North American customers embracing the IP-20 platform in their 4G expansion projects,” said Ira Palti, president and CEO of Ceragon. “We appreciate the long term partnerships we have with our customers, and are to continuously providing them with a truly best of breed portfolio of products that meets their current and future needs.”
About Ceragon Networks Ltd.
Ceragon Networks Ltd. (NASDAQ: CRNT) is the #1 wireless backhaul specialist. We provide innovative, flexible and cost-effective wireless backhaul solutions that enable mobile operators and other service providers to deliver 4G/LTE, 3G/2G, and other wireless broadband services to their subscribers with high quality of experience. Our solutions are deployed by public utilities, government and defense organizations for delivering mission critical multimedia and other applications at high reliability and speed. Ceragon’s high-capacity solutions use microwave technology to transfer multimedia, voice and data traffic while maximizing bandwidth efficiency, to deliver more capacity over longer distances under any deployment scenario. Based on our extensive global experience, Ceragon delivers turnkey solutions that support service provider profitability at every stage of the network lifecycle enabling faster time to revenue, cost-effective operation and simple modernization to all-IP networks. As the demand for multimedia services pushes the need for ever-increasing capacity, Ceragon is committed to serve the market with unmatched technology and innovation, ensuring effective solutions for the evolving needs of the marketplace. Our solutions are deployed by more than 430 service providers in over 130 countries.
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Ceragon Networks® and FibeAir® are registered trademarks of Ceragon Networks Ltd. in the United States and other countries. CERAGON ® is a trademark of Ceragon Networks Ltd., registered in various countries. Other names mentioned are owned by their respective holders.
Safe Harbor
This press release contains statements concerning Ceragon‘s future prospects that are “forward-looking statements“ under the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include: projections of capital expenditures and liquidity, competitive pressures, revenues, growth prospects, product development, financial resources, restructuring costs, cost savings and other financial matters. You can identify these and other forward-looking statements by the use of words such as “may,“ “plans,“ “anticipates,“ “believes,“ “estimates,“ “predicts,“ “expects,“ “intends,“ “potential“ or the negative of such terms, or other comparable terminology. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risk that Ceragon will not achieve the benefits it expects from its expense reduction and profit enhancement programs; the risk that Ceragon‘s expectations regarding future revenues and profitability will not materialize; the risk that Ceragon will not comply with the financial or other covenants in its agreements with its lenders; risks associated with doing business in Latin America, including currency export controls and recent economic concerns; risks relating to the concentration of our business in the Asia Pacific region and in developing nations; the risk of significant expenses in connection with potential contingent tax liability associated with Nera‘s prior operations or facilities; and other risks and uncertainties detailed from time to time in Ceragon‘s Annual Report on Form 20-F and Ceragon‘s other filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.
Media Contact:
Matthew Krieger
GK Public Relations
Tel: +1-914-768-4219
matthew@gkpr.com
Company Contact:
Tanya Solomon
Ceragon Networks
Tel: +972-3-543-1163
tanyas@ceragon.com
Investor Contact:
Claudia Gatlin
Tel. +1-(212)-830-9080
claudiag@ceragon.com
(CFRXW) Announces Poster Presentation at the ICAAC/ICC 2015 Meeting for CF-301
First Lysin Allowed by the FDA to Enter Human Clinical Trials
YONKERS, NY–(Sep 9, 2015) – ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, today announced that it will present new preclinical data for its lead compound CF-301 in a poster presentation at the ICAAC/ICC 2015 conference September 17-21, 2015 in San Diego, CA.
The company will present preclinical findings on CF-301, which is currently in Phase I development for the treatment of Staph aureus bloodstream infections, including MRSA. The abstract summarizing the data is published on the ICAAC/ICC website and is available to conference registrants at: http://www.abstractsonline.com/plan/start.aspx
Details of the poster presentation are as below:
Presentation Title: Lysin CF-301 Activates Daptomycin in Pulmonary Surfactant in vitro and Rescues Mice from Lethal Staphylococcal Pneumonia
Session Day & Time: Friday, September 18, 2015 12:00 PM – 2:00 PM PT
Location: Exhibit Hall F/San Diego Convention Center
Poster Number: F-290b
Session Title: New Agents and Approaches Addressing Gram-Positive Pathogens, including Mycobacteria
About CF-301:
CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria. It has specific and rapid bactericidal activity against Staph aureus and does not impact the body’s good bacteria. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm. Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.
About ContraFect:
ContraFect is a clinical-stage biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. ContraFect intends to address drug-resistant infections using its therapeutic product candidates from its lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (drug-resistant staphylococcus bacteria) and influenza.
About the ICAAC/ICC 2015
ICAAC/ICC 2015 is a joint meeting of American Society for Microbiology (ASM)’s Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Society of Chemotherapy (ISC)’s International Congress of Chemotherapy and Infection (ICC). ICAAC, the premier conference on antimicrobial agents and infectious diseases, showcases the latest-breaking science and lectures from top researchers from around the world. With over 60% of its attendees living outside of the United States, ICAAC provides a rare opportunity to bring together the field’s foremost leaders to discuss the state of infection control and prevention on a global scale. Through oral and poster presentations, 10,000 physicians, clinical microbiologists, researchers, and pharmacists will come together to share their research, discover the latest breakthroughs, and work towards fostering global solutions to the problems of infectious diseases and antimicrobial agents.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “potential” or similar references to future periods. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including those detailed in ContraFect’s filings with the Securities and Exchange Commission. Specific forward-looking statements in this release include statements regarding our preclinical data that will be presented at ICAAC/ICC and our ability to address drug-resistant infections using our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses, all of which are subject to certain assumptions, risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
Paul Boni
ContraFect Corporation
Tel: 914-207-2300
Email: Email Contact
Barbara Ryan
Clermont Partners
Tel: 203-274-2825
Email: Email Contact
(WGBS) to Present New Single-Cell System Results at the Single Cell Genomics Meeting
Data Generated From Early Access Program Also to be Presented
FREMONT, Calif., Sept. 9, 2015 — WaferGen Bio-systems, Inc. (Nasdaq:WGBS) will present results from the Company’s single-cell analysis system at the Single Cell Genomics (SCG) Conference on September 16th, 2015, in Utrecht, The Netherlands. The presentation will highlight throughput and performance levels not previously achieved prior to the development of WaferGen’s single-cell research platform (poster abstract code P036). In addition, data generated by the Company’s single-cell early access partners utilizing WaferGen’s technology will also be presented at the conference.
Both the in-house generated results and the data produced by WaferGen’s partners will demonstrate that thousands of individual cells can be isolated and analyzed from heterogeneous cell populations which, when coupled with partitioning the chip into multiple sections, allows for powerful screening of cells for applications including therapeutic dose determination and gene insertion/deletion efficacy studies. WaferGen’s presentation, which will be given by Dr. Maithreyan Srinivasan, the Company’s Chief Technology Officer, will also include a demonstration of a first of its kind software designed specifically for selecting isolated cells for subsequent processing for RNA-Sequencing applications.
“The development of our single-cell analysis platform is progressing extremely well. The system is producing compelling data both in-house and with our world-class early access partners at Genentech, Karolinska Institutet, National Jewish Health, and MD Anderson Cancer Center. We are pleased to present late-breaking results of our program at SCG 2015, and look forward to providing additional details surrounding these results shortly,” said Rollie Carlson, President and CEO of WaferGen.
About WaferGen
WaferGen Bio-systems, Inc. is a biotechnology company that offers innovative genomic technology solutions for single-cell analysis and clinical research. The single cell analysis platform is a revolutionary system which can isolate thousands of single cells and processes specific cells for analysis, including Next Generation Sequencing (NGS). The SmartChip platform can be used for profiling and validating molecular biomarkers, and can perform massively-parallel single-plex PCR for one-step target enrichment and library preparation for clinical NGS. These technologies offer a powerful set of tools for biological analysis at the molecular and single-cell level in the life sciences, pharmaceutical, and clinical laboratory industries.
About SCG 2015
Building on the success of the single cell genomics meeting at the Karolinska Institutet in September 2014 and at the Weizmann Institute in 2013, the third Single Cell Genomics meeting will be held September 16-18, 2015, at the Hubrecht Institute in Utrecht, The Netherlands. Single cell genomics is rapidly emerging as a revolutionary technology transforming many fields of biological research. Through its many applications (single cell genome sequencing, single cell transcriptomics, various single cell epigenetic profiling approaches), researchers can characterize the genetic and functional properties of individual cells in their native conditions, leading to numerous experimental and clinical opportunities.
The conference will bring together many of the pioneers and leading experts in the field for three days of extensive, interdisciplinary and informal discussion. The meeting will include presentations from thirty invited leaders and several selected abstracts, a poster session and many opportunities for interaction. (www.weizmann.ac.il/conferences/SCG2015)
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses, expected cash usage, our expectations regarding our development of future products including single cell analysis technologies and our expectations concerning our competitive position and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
CONTACT: INVESTOR CONTACTS: LifeSci Advisors, LLC Brian Ritchie BRitchie@LifeSciAdvisors.com WaferGen Bio-systems, Inc. Rollie Carlson Rollie.Carlson@wafergen.com
(LATX) NFL Week One Contests Now Available on 360 Fantasy Live.com
360 Fantasy Live Offers $5 in Matching Funds With Promo Code “360LIVE”; Users Have the Chance to Win Big Money
NEW YORK, NY–(Sep 9, 2015) – Latitude 360, Inc. (OTCQB: LATX) (www.latitude360.com), the “ultimate upscale multi-dimensional entertainment eatery,” has kicked-off its highly anticipated daily fantasy football contests for the first week of the 2015 National Football League (NFL) season on 360 Fantasy Live (www.360fantasylive.com).
Based on finalized rosters of NFL teams, 360 Fantasy Live will provide its wide range of daily and weekly NFL contests throughout the entire 2015 season. 360 Fantasy Live players can make their own game plan, choosing from free entry games and wagered games contests as they line up against other players and have the chance to win big money every day. Weekly NFL contests include week long contests as well as daily contests specific to Sunday and Monday night games.
The 360 Fantasy Live platform also includes other exciting sports competitions, including daily Major League Baseball contests, which are also currently available for play.
To celebrate the launch of 360 Fantasy Live, new users are being offered $5 in matching funds for a limited time when they join 360 Fantasy Live and deposit at least $5 within 30 days. New users need to use the promo code “360LIVE” when signing up at www.360fantasylive.com to receive the funds.
In addition to appealing to national fantasy sports enthusiasts, 360 Fantasy Live will be activated within all of Latitude 360’s cutting-edge dining and entertainment venues. Now, in addition to enjoying top-quality entertainment, food and drinks, guests can participate in daily fantasy contests while watching their players perform on huge HD screens.
“We’re excited to enhance our current line of offerings with the launch of 360 Fantasy Live, building on the months-long excitement and competitiveness of the NFL season. Our mission is to continually evolve the Latitude 360 brand to reach more consumers and build customer loyalty once they step into our venues — all part of an overarching vision to empower our brand and exponentially grow shareholder value,” said Brent Brown, CEO of Latitude 360. “By strengthening the entertainment value for sports fanatics, we believe we’re on track to achieve this goal.”
ABOUT LATITUDE 360
Latitude 360 (OTCQB: LATX) is an award-winning pioneer of combining premier upscale casual dining with state-of-the-art entertainment creating a “360 Experience” in its unique venues. The Company develops, constructs and operates cutting-edge Latitude 360 locations (from 50,000-70,000 sq. ft.) that appeal to a broad base of consumers and corporate clients. Current locations can be found in Jacksonville, Pittsburgh, and Indianapolis. Management plans to open three new venues per year for the next four years. Two new locations in Syracuse, NY and Bethlehem, PA are expected to operate as Latitude 360 locations in the fourth quarter of this year.
Latitude 360’s “360 Experience” provides a dining and entertainment experience unlike any concept in the world. Key offerings at each Latitude 360 location include, but are not limited to:
- Latitude 360 Grille, a full-service, upscale casual restaurant and bar
- Latitude LIVE, a Las Vegas-style live entertainment theatre
- 360 Fantasy LIVE, providing daily fantasy sports contests for guests including the ability to wager and win big money while enjoying top quality sports watching on massive HD screens (and continue playing outside the venue via www.360fantasylive.com)
- Axis Bar & Stage, a lush bar featuring the area’s top musicians and/or DJ’s
- Luxury Bowling, a high end lounge for boutique bowling lanes
- Cinegrille, a full service dine-in movie experience
- HD Sports Theater, a state-of-the art HD viewing area with full service dining
- Arcade, an exciting game arcade featuring the most popular video and redemption games available
- Latitude Lit, a luxury Cigar Lounge
Safe Harbor Statement
This press release contains “forward-looking statements.” Such statements include those related to the company’s expectations about future events or financial performance, including the potential acquisition of the Revolutions venues, the anticipated benefits of the potential acquisition, anticipated growth opportunities, a potential listing of the Company’s stock on a securities exchange and access to capital, and are not historical facts. Forward-looking statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements are not guarantees of future performance, are based on certain assumptions, and are also subject to various known and unknown risks and uncertainties, many of which are beyond the control of the company. Actual results may differ materially from the expectations contained in forward-looking statements. The company does not undertake any obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
5W Public Relations
Latitude360@5wpr.com
+1-212-999-5585
(NVIV) Announces Enrollment of Fifth Patient in Pilot Spinal Cord Injury Study
– Communicates Intent to Incorporate Pilot Study into Pivotal Probable Benefit Study –
InVivo Therapeutics Holdings Corp. (NVIV) today announced that the fifth patient has been enrolled in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury at the Keck Hospital of University of Southern California (USC) in Los Angeles.
Patrick Hsieh, M.D., Principal Investigator at this site, performed the fifth-ever Neuro-Spinal Scaffold implantation approximately 69 hours after the injury occurred.
“Enrolling the fifth patient in our first clinical study is a momentous milestone for the company, and we are pleased this accomplishment came ahead of previous guidance,” said Mark Perrin, InVivo’s CEO and Chairman. “We are in productive discussions with the FDA regarding the transition to the pivotal probable benefit study, and our plan is to incorporate the pilot study into the pivotal probable benefit study. We expect to use this single study as the basis for a Humanitarian Device Exemption (HDE) application, which would allow us to dramatically reduce the time to approval and commercialization.”
Mr. Perrin continued, “While we are discussing plans with the FDA for the pivotal probable benefit study and the incorporation of the pilot study, we intend to request expanding the number of patients in the current pilot study beyond five to further compress clinical timelines. We anticipate that we will receive formal approval of this expansion within the next two months. During this interim period, additional eligible patients at participating clinical sites may receive the Neuro-Spinal Scaffold under the Emergency Use Expanded Access Mechanism on a case-by-case basis, and the safety and outcomes data from these patients will be included in the HDE application. We have fostered a collaborative relationship with the FDA, and we are optimistic that we will finalize the pivotal probable benefit study design in the coming months.”
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold™
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the FDA’s approval of a new pivotal study and/or an expansion of the company’s pilot study and the timing of such approvals and the nature of the company’s negotiations with the FDA and the timeline for commercialization of the Neuro-Spinal Scaffold. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the volatility of the trading price of the company’s common stock; the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to modify its pilot trial protocol or to conduct a future study; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
InVivo Therapeutics
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com
(IPXL) Announces Resolution of FDA Warning Letter Related to its Hayward Manufacturing Facility
– Impax to Host Conference Call Today at 8:30 AM ET –
HAYWARD, Calif., Sept. 8, 2015 — Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it received written notice from the United States Food and Drug Administration (FDA) verifying that the Company has successfully addressed all items raised by the FDA in the May 2011 Warning Letter relating to its Hayward, California manufacturing facility.
The FDA notice follows a re-inspection in 2015 by the FDA of the Hayward facility. Receipt of the FDA notice means that pursuant to the Agency’s regulatory practice, the Company’s remediation activities at the Company’s Hayward facility and its quality management and compliance systems of the facility are deemed to be acceptable.
“Resolving the FDA Warning Letter is a testament to the progress we have made toward improving our quality and compliance systems in Hayward, with such initiatives being fully instituted across the Company,” said Fred Wilkinson, President and Chief Executive Officer of Impax. “We want to thank the FDA for working cooperatively with us to resolve the items previously raised by the Agency. We will remain committed to investing in our Quality Improvement Program and maintaining a culture that is focused on continuously improving these key systems.”
“With the resolution of the Warning Letter, we are excited about the potential for approvals and launches of new products from this facility. While we cannot predict the timing of approvals, we are planning to accelerate certain spending initiatives during the remainder of 2015 in order to prepare for these potential events. Despite the increase in costs associated with these activities, we continue to expect that we will remain within the ranges of our previously issued guidance for full year 2015.”
Conference Call Information
The Company will host a conference call with financial analysts at 8:30 a.m. ET today. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The conference ID is 35430606. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (855) 859-2056 (in the U.S.) and (404) 537-3406 (international callers).
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. For more information, please visit the Company’s Web site at: www.impaxlabs.com.
“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the Company’s total revenues derived from sales of a limited number of products; the impact of consolidation of the Company’s customer base; the impact of competition; the Company’s ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company’s manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company’s operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company’s products; the Company’s determinations to discontinue the manufacture and distribution of certain products; the Company’s ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements ; the Company’s ability to successfully conduct clinical trials; the Company’s reliance on third parties to conduct clinical trials and testing; the Company’s lack of a license partner for commercialization of IPX066 outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company’s supply chain; the Company’s policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company’s products; the effect of current economic conditions on the Company’s industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; the Company’s reliance on alliance and collaboration agreements; the Company’s reliance on licenses to proprietary technologies; the Company’s dependence on certain employees; the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company’s government contracts; the Company’s ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company’s ability to manage growth, including through potential acquisitions and investments; the integration of the acquired business of Tower Holdings, Inc. and Lineage Therapeutics Inc. by the Company being more difficult, time-consuming or costly than expected, operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the acquisition, the retention of certain key employees of the acquired business being difficult, the Company’s and the acquired business’s expected or targeted future financial and operating performance and results, the combined company’s capacity to bring new products to market, and the possibility that the Company may be unable to achieve expected synergies and operating efficiencies in connection with the acquisition within the expected time-frames or at all, the restrictions imposed by the Company’s credit facility and indenture; the Company’s level of indebtedness and liabilities and the potential impact on cash flow available for operations; uncertainties involved in the preparation of the Company’s financial statements; the Company’s ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company’s business; the location of the Company’s manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Company Contacts:
Mark Donohue
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com
(CAPN) Acquires Neonatal Pulmonary Resuscitation Solutions From NeoForce Group
Acquisition Strengthens Capnia’s Presence in Neonatology
NeoForce President and Chief Executive Officer to Join Capnia as General Manager of Neonatology
REDWOOD CITY, Calif., Sept. 8, 2015 — Capnia, Inc. (NASDAQ:CAPN), focused on the development and commercialization of novel products based on its proprietary technologies for precision metering of gas flow, today announced that it has acquired substantially all assets from privately-held NeoForce Group, Inc., a developer of innovative pulmonary resuscitation solutions for the inpatient and ambulatory neonatal markets.
Under the terms of the agreement, Capnia will pay to NeoForce a $1.0 million upfront payment, which represents less than one times of NeoForce’s 12-month forward looking revenue, plus a low single-digit royalty on sales of NeoForce products for a period of 36 months. NeoForce’s currently marketed products include the NeoPIP™ Infant T-Piece Resuscitator and the CPRNome Resuscitation Timer. Additionally, NeoForce President and Chief Executive Officer, Otho Boone, will join the Company as General Manager of Neonatology. Mr. Boone, who founded NeoForce in 2005, brings to Capnia over 25 years of medical device sales, operations and product development experience at neonatology focused companies such as Drager, Hill-Rom Air Shields and Ohmeda. Prior to founding NeoForce, Mr. Boone was Vice President of Global Marketing at Drager.
“The acquisition of NeoForce further underscores our commitment to leveraging technology to address unmet medical needs in Neonatology, which is one of the most attractive segments in the healthcare business today,” said Anish Bhatnagar, MD, Chief Executive Officer of Capnia. “As General Manager of Neonatology, Otho brings a depth of expertise and broad relationships with top tier hospitals across the United States which we can leverage to accelerate the adoption of our CoSense® ETCO monitor. Neonatology is a high-growth area, and we believe that the addition of Otho and the NeoForce product line, together with the ongoing commercial rollout of CoSense®, significantly strengthen our presence in this area.”
“I am excited to be joining the Capnia team and advancing the Company’s commercial efforts,” said Otho Boone, President and CEO of NeoForce. “NeoForce is a revenue generating, profitable entity that will benefit greatly from additional commercial manpower to further scale its operations. We also have a number of new products that we would like to bring to the market. Capnia’s expertise is highly complementary, and I look forward to calling on new and existing hospital customers to maximize the potential of our combined platform of products, as well as bring more innovation to the market.”
For additional information on NeoForce, please visit www.neoforcegroup.com.
About Capnia
Capnia, Inc. develops and commercializes novel products based on its proprietary technologies for precision metering of gas flow. Capnia’s lead product CoSense® is based on the Sensalyze™ Technology Platform. It is a portable, non-invasive device that rapidly and accurately measures carbon monoxide (CO) in exhaled breath. CoSense has 510(k) clearance for sale in the U.S. and has received CE Mark certification for sale in the European Union. CoSense is used for the monitoring of CO from internal sources (such as hemolysis, a dangerous condition in which red blood cells degrade rapidly), as well as external sources (such as CO poisoning and smoke inhalation). The initial target market is newborns with jaundice that are at risk for hemolysis, comprising approximately three million births in the U.S. and European Union. Capnia’s proprietary therapeutic technology uses nasal, non-inhaled CO2 and is being evaluated to treat the symptoms of allergies, as well as the trigeminally-mediated pain conditions such as cluster headache, trigeminal neuralgia and migraine.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical trials, that neonatology is a high-growth area, that this acquisition will strengthen our presence in this area and the amount of revenue to be generated from this acquisition in the next 12 months.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-K filed with the Securities and Exchange Commission on March 13, 2015, including under the caption titled “Risk Factors.” Capnia expressly disclaims any intent or obligation to update these forward looking statements, except as required by law.
CONTACT: Investor Relations Contact: Michelle Carroll/Susie Kim Argot Partners (212) 600-1902 michelle@argotpartners.com susan@argotpartners.com
(VTAE) Positive Top-Line Results, Initial Phase 1 Study of RORyt Inhibitor VTP-43742
- Single ascending doses of VTP-43742 safe and generally well-tolerated, demonstrated once-daily pharmacokinetics
- Robust ex vivo biomarker response, suppressing pro-inflammatory IL-17A by more than 90 percent
FORT WASHINGTON, Pa., Sept. 8, 2015 — Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today announced positive top-line results from its Phase 1 single ascending dose clinical study of VTP-43742 in autoimmune disorders. VTP-43742 is Vitae’s first-in-class, wholly owned RORγt inhibitor being developed for the treatment of a range of autoimmune disorders, potentially including psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and irritable bowel disease (IBD), as well as numerous orphan diseases.
In this double-blind, randomized, placebo-controlled study that evaluated the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile of single oral doses of VTP-43742 in 53 healthy human volunteers, VTP-43742 was safe and generally well tolerated at all dose levels across a 60-fold dose range. No serious adverse events were reported and there were no drug-related clinical laboratory or electrocardiogram (ECG) abnormalities.
VTP-43742 was also evaluated in an ex vivo assay for its ability to inhibit the production of pro-inflammatory cytokine IL-17A in blood obtained from study subjects. Subjects receiving VTP-43742 showed a dose-dependent suppression of RORγt dependent IL-17A production by more than 90 percent, with the effect largely sustained over the full 24-hour measurement period.
In animal studies, steady inhibition of RORγt was necessary to achieve full therapeutic efficacy, indicating the importance of a relatively long plasma half-life. The plasma half-life of VTP-43742 was observed to be approximately 30 hours in this clinical trial, supporting the potential for effective once-a-day dosing in humans.
“VTP-43742’s robust and sustained lowering of IL-17A production observed in the ex vivo blood assay, paired with its favorable safety, tolerability and PK profile, demonstrate that this first-in-class drug candidate has the potential to safely and effectively treat a range of autoimmune conditions,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “We are extremely encouraged by the PK and PD data, and look forward to reporting additional clinical results, including top-line proof-of-concept data in psoriasis patients, by the end of the year.”
Vitae is currently conducting a Phase 1 multiple ascending dose clinical trial of VTP-43742, which was initiated in August 2015. This trial includes both healthy human volunteers and patients with moderate to severe psoriasis. The Company plans to begin dosing psoriatic patients in the second half of 2015, with top-line clinical efficacy results expected by the end of 2015.
About Autoimmune Disorders
Autoimmune disorders, where a patient’s own immune system attacks normal tissue, make up a large number of human disorders. Increased activity of a class of lymphocytes called Th17 cells, and the subsequent excess production of pro-inflammatory cytokines, including IL-17, by those cells are critical parts of the pathophysiology of many human autoimmune disorders. RORγt is a nuclear hormone receptor that is essential for the formation and function of Th17 cells. Vitae believes inhibition of excess RORγt activity in immune cells will be beneficial for the treatment of multiple autoimmune disorders, potentially including psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and / or IBD, as well as numerous orphan diseases.
About VTP-43742
VTP-43742 is Vitae’s first-in-class, wholly owned product candidate for the potential treatment of a variety of autoimmune disorders and orphan diseases. In preclinical studies, VTP-43742 inhibited the activity of RORγt and has demonstrated potent inhibition of multiple Th17 cell-dependent pro-inflammatory cytokines, including IL-17. It is highly selective versus other ROR isotypes, and has a plasma half following single oral dosing that is consistent with a once a day dosing schedule. VTP-43742 has demonstrated superior efficacy in an animal model of multiple sclerosis in direct comparison to an IL-17A monoclonal antibody. Vitae initiated Phase 1 testing with VTP-43742 in June of 2015 with this Phase 1 single ascending dose clinical trial in healthy human volunteers. A Phase 1 multiple ascending dose clinical trial in healthy human volunteers was initiated in August 2015.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing first-in-class, small molecule drugs for difficult-to-drug disease targets that can potentially address significant unmet medical needs, including programs in autoimmune disorders, atopic dermatitis, Alzheimer’s disease and diabetes. This robust and growing portfolio of novel product candidates is generated internally by Contour®, Vitae’s proprietary structure-based drug discovery platform.
For additional information, please visit the company’s website at www.vitaepharma.com.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the clinical development of VTP-43742. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “impending” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vitae is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vitae’s forward-looking statements include, among others, the timing and success of preclinical studies and clinical trials conducted by Vitae and its collaborative partners; the ability to obtain and maintain regulatory approval of Vitae’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Vitae’s product candidates; the size and growth of the potential markets for Vitae’s product candidates and the ability to serve those markets; Vitae’s expectations regarding Vitae’s expenses and revenue, the sufficiency of Vitae’s cash resources and needs for additional financing; Vitae’s ability to attract or retain key personnel; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2014 and Vitae’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 which have been filed with the Securities and Exchange Commission (SEC). In addition to the risks described above and in Vitae’s other filings with the SEC, other unknown or unpredictable factors also could affect Vitae’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vitae undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
CONTACT: INVESTORS: Vitae Pharmaceuticals, Inc. Richard S. Morris, CPA Chief Financial Officer (215) 461-2000 rmorris@vitaerx.com Westwicke Partners John Woolford (443) 213-0506 john.woolford@westwicke.com MEDIA: 6 Degrees PR Tony Plohoros (908) 591-2839 tplohoros@6degreespr.com
(AKBA) Announces Positive Top-Line Results from its Phase 2 Study of Vadadustat
-Treatment with Vadadustat Successfully Maintained Mean Hemoglobin Levels Following Conversion from rESA Therapy-
-Vadadustat Demonstrated a Favorable Safety Profile with Once Daily and Three Times per Week Dosing-
-Conference Call at 5:00 PM Eastern Time Today-
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor (HIF), today announced positive top-line results from its Phase 2 study of vadadustat (formerly AKB-6548) in dialysis patients with anemia related to chronic kidney disease (CKD). The study achieved its primary objective, indicating that vadadustat maintained stable hemoglobin (HGB) levels throughout the 16-week treatment period following conversion from recombinant erythropoiesis-stimulating agent (rESA) therapy. Vadadustat demonstrated a favorable safety profile with no drug-related serious adverse events and no deaths. The results highlight the potential of vadadustat, dosed either once daily or three times per week, to safely and predictably manage and sustain HGB levels in CKD patients undergoing dialysis.
The open-label, multi-center, 94 patient study was designed to evaluate the ability of vadadustat to maintain hemoglobin levels in patients undergoing hemodialysis who were previously being treated with rESAs. Patients were assigned to one of three dose cohorts: once daily vadadustat at a starting dose of 300mg, once daily vadadustat at a starting dose of 450mg, or vadadustat three times per week in conjunction with the patient’s hemodialysis schedule at a starting dose of 450mg. The study achieved its primary endpoints of maintaining stable hemoglobin levels over 16 weeks of treatment in all three cohorts of patients converting from rESAs to vadadustat.
Mean Hemoglobin Levels (g/dL)* | Baseline | Week 7/8 | Week 15/16 | |||||||||||||
300mg Daily Dose | 10.4 | 10.4 | 10.3 | |||||||||||||
450mg Daily Dose | 10.6 | 10.3 | 10.5 | |||||||||||||
450mg Three Times per Week Dose | 10.5 | 10.2 | 10.4 | |||||||||||||
* Modified intent-to-treat (MITT) population, n=94 | ||||||||||||||||
Vadadustat was well tolerated among patients in all three dose cohorts. Treatment-emergent adverse events (TEAEs) with vadadustat were balanced across the cohorts. Serious adverse events (SAEs) were reported in 13 subjects (13.8%), well within the expected range for this patient population. There were no drug-related SAEs and no deaths reported in the study.
“This study was a clear success, demonstrating the potential of vadadustat to effectively and safely treat anemia in dialysis patients switching from injectable rESA therapy,” said Brad Maroni, M.D., Chief Medical Officer at Akebia. “We are impressed with the consistency in hemoglobin levels across the duration of the study, which highlights the ability of vadadustat to control and maintain hemoglobin levels in this patient population. Furthermore, the results indicate that daily and three times per week dosing regimens are both viable options for patients on dialysis.”
John P. Butler, President and Chief Executive Officer of Akebia, stated, “These results further confirm vadadustat as a potential best-in-class anemia treatment for CKD patients, and reinforce our confidence in this product candidate as we advance toward our Phase 3 program. Adding these results to the 12 other clinical studies we have completed, we are confident in the potential for vadadustat to treat anemia in a broad array of patients with CKD. We are pleased to have successfully completed this stage of our drug development and look forward to initiating Phase 3 studies.”
Complete efficacy and safety data from this Phase 2 study will be presented at an upcoming medical meeting.
About the Phase 2 Study Design of Vadadustat in Dialysis Patients with Anemia Related to CKD
The Phase 2 multi-center, open-label study evaluated 94 patients over 16 weeks of treatment, at 20 dialysis centers in the United States, including an assessment of HGB response to the starting dose of vadadustat during the first 8 weeks, followed by an assessment of HGB response to algorithm-guided dose adjustments of vadadustat during the subsequent 8 weeks of treatment. The study enrolled three cohorts, each consisting of approximately 30 CKD patients with anemia undergoing dialysis who were switched from injectable rESA therapy to vadadustat. Patients in the first two cohorts received once daily doses of vadadustat, while patients in the third cohort received vadadustat three times per week in conjunction with their hemodialysis schedule.
Conference Call and Webcast | ||||
Date: | September 8, 2015 | |||
Time: | 5:00 PM ET | |||
Telephone Access: | Domestic callers: dial 877-458-0977 | |||
International callers: dial 484-653-6724 | ||||
Please reference the Akebia conference call | ||||
Passcode: 3379-3912 | ||||
Online Access: | Go to the Investor Relations section of the Akebia website and follow instructions for accessing the live webcast. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary. | |||
About Vadadustat (Formerly AKB-6548)
Vadadustat is an oral therapy currently in development for the treatment of anemia related to CKD. Vadadustat is designed to stabilize HIF, a transcription factor that regulates the expression of genes involved with red blood cell (RBC) production in response to changes in oxygen levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme. Vadadustat exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin (EPO) production to increase RBC production and, ultimately, improve oxygen delivery.
As a HIF stabilizer with best-in-class potential, vadadustat raises hemoglobin levels predictably and sustainably, with a dosing regimen that allows for a gradual and controlled titration. Vadadustat has been shown to improve iron mobilization, potentially eliminating the need for intravenous iron administration and reducing the overall need for iron supplementation.
About Anemia Related to CKD
Approximately 30 million people in the United States have CKD, with an estimated 1.8 million of these patients suffering from anemia. Anemia results from the body’s inability to coordinate RBC production in response to lower oxygen levels due to the progressive loss of kidney function, which occurs in patients with CKD. Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality. Renal anemia is currently treated with injectable rESAs, which are associated with inconsistent hemoglobin responses and well-documented safety risks.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through HIF biology. The company has completed Phase 2 development of its lead product candidate, vadadustat, an oral therapy for the treatment of anemia related to CKD in both non-dialysis and dialysis patients.
Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements include those about Akebia’s strategy, future plans and prospects, including statements regarding the potential indications, dosing and benefits of vadadustat, the development plan for vadadustat, plans for presenting a more detailed analysis of the data from the Phase 2 study, and the initiation of the Phase 3 program. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia’s product candidates and operate the company, and the actual expenses associated therewith; the cost of our Phase 3 studies and the availability of financing to cover such cost; the timing and content of decisions made by the FDA and other regulatory authorities; the acceptance of Akebia’s abstract for presentation at a medical meeting; the actual time it takes to prepare for and initiate Phase 3 clinical studies; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; and Akebia’s ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Investors:
Akebia Therapeutics, Inc.
Ed Joyce, 617-844-6130
ejoyce@akebia.com
or
Media:
Argot Partners
Eliza Schleifstein, 917-763-8106
Eliza@argotpartners.com
(ISCO) Announces Next Phase of Research Collaboration With Rohto Pharma
CARLSBAD, CA–(September 08, 2015) – International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com, ISCO or the Company), a California-based biotechnology company developing novel stem cell-based therapies, announced today that it had entered into the second phase of the existing Research Agreement with Rohto Pharmaceutical Co., Ltd. (“Rohto”), a global Japanese pharmaceutical company. After successfully completing preliminary studies of ISCO’s human parthenogenetic neural stem cells (hpNSCs) Rohto acknowledged that ISCO’s proprietary cells demonstrate consistent high quality and are suitable for further use in Rohto’s research. If Rohto successfully demonstrates hpNSCs’ efficacy in rodent models, which could lead to a possible treatment of a variety of degenerative eye disorders, Rohto will enter into negotiations of a definitive license agreement with ISCO in order to license ISCO’s proprietary technology for therapeutic and commercial use.
“Based on hpNSCs known performance in various animal models we expect that in the next four months Rohto will be able to demonstrate the efficacy of these stem cells in treating retinal degenerative disorders,” said Ruslan Semechkin, Ph.D., Chief Scientific Officer of ISCO.
About Rohto Pharmaceutical Company, Ltd.
Founded in 1899, Rohto Pharmaceutical is the second-largest consumer health company in Japan, and is a world leader in the manufacturing and marketing of pharmaceuticals, cosmetics, and skincare and healthcare products. Rohto has global operations and its products are available in more than 110 countries.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell
Safe harbor statement
Statements pertaining to anticipated developments, expected clinical studies (including timing and results), progress of research and development, and other opportunities for the company and its subsidiaries, 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, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, 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 company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
Contacts:
International Stem Cell Corporation
Ruslan Semechkin, Ph.D.
Chief Scientific Officer
Phone: 760-940-6383
Email: ir@intlstemcell.com
Media:
Christopher R. Hippolyte
Phone: +1-646-942-5634
Email: chris.hippolyte@russopartnersllc.com
Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com
(GWGH) to Present at the 4th Annual Liolios Gateway Conference on September 9, 2015
MINNEAPOLIS, Sept. 4, 2015 — GWG Holdings (NASDAQ:GWGH) a specialty finance company and a leader in the life insurance secondary market, has been invited to present at the 2015 Liolios Gateway Conference being held on September 9-10, 2015 at the Four Seasons Hotel San Francisco.
GWG CFO William Acheson is scheduled to present on Wednesday, September 9 at 1:30 p.m. Pacific time, with one-on-one meetings held throughout the conference.
Acheson will discuss GWG’s value proposition for consumers and investors:
- GWG, through its subsidiaries, purchases life insurance policies from seniors who no longer want, need or can afford their policies
- GWG offers a fixed income, non-correlated security for income investors seeking attractive yields
- GWG offers high growth equity stock for growth investors
The presentation will be webcast live and available for replay in the Investor Relations section of GWG’s website at www.gwglife.com or on the Gateway Conference website at www.gateway-conference.com/presenters.
To receive additional information, request an invitation or to schedule a one-on-one meeting, please email gateway@liolios.com.
About the Gateway Conference
The 4th Annual Gateway Conference is an invite-only conference presented by Liolios, a comprehensive financial communications firm. Gateway was designed to bring together the most compelling companies with the nation’s top institutional investors and analysts. This year’s event features more than 90 companies from a number of growth industries, including technology, business and financial services, consumer, digital media, clean technology and life sciences. The format has been designed to give attendees direct access to senior management via company presentations, Q&A sessions and one-on-one meetings. For more information, visit www.gateway-conference.com or www.liolios.com.
About GWG Holdings
GWG Holdings, Inc. (NASDAQ:GWGH) is a specialty finance company and a leader in the life insurance secondary market. GWG, through its subsidiaries, purchases life insurance policies from seniors who no longer want, need or can afford their policies. Since 2006, GWG has purchased more than $1.7 billion in life insurance policy benefits and paid seniors over $291 million for their policies – approximately $274 million more than the surrender or lapse value offered by insurance carriers. GWG’s strategy is to originate and manage a diverse portfolio of life insurance policies that generate yields that exceed the costs to finance the policies (in aggregate). GWG finances the purchase and maintenance of a portfolio of policies primarily through a fixed income alternative investment product that is offered through independent broker-dealers and registered investment advisors nationwide. GWG’s goal is to generate financial returns for GWG’s investors and shareholders while providing valuable post-retirement financial solutions to seniors.
CONTACT: Rubenstein Associates Stefan Prelog Senior Vice President Tel: (212) 843-8076 Email: sprelog@rubenstein.com GWG Holdings, Inc. Rose Reifsnyder Director of Communications and Media Relations Tel: (612) 840-7204 Email: rreifsnyder@gwglife.com
(RLYP) Announces New Employment Inducement Grants
REDWOOD CITY, Calif., Sept. 4, 2015 — Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that on September 1, 2015, the compensation committee of the company’s board of directors granted 14 new employees options to purchase an aggregate of 80,800 shares of the company’s common stock with a per share exercise price of $22.54, the closing trading price on the grant date, and 12,700 restricted stock units. The stock options and restricted stock units were granted pursuant to the Relypsa, Inc. 2014 Employment Commencement Incentive Plan, which was approved by the company’s board of directors in June 2014 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the company.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. The company’s lead product candidate is Patiromer for Oral Suspension for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood. A two-part pivotal Phase 3 trial of Patiromer for Oral Suspension has been completed and the primary and secondary endpoints were met. A New Drug Application for Patiromer for Oral Suspension for the treatment of hyperkalemia was accepted by the U.S. Food and Drug Administration and is currently under review. Patiromer for Oral Suspension has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.
CONTACT: Charlotte Arnold Vice President, Corporate Communications 650.421.9352 IR@relypsa.com
(SKYW) to Present at Upcoming Investor Conferences
Executive leadership scheduled at Cowen and Co., Deutsche Bank and Imperial
SAINT GEORGE, Utah, Sept. 4, 2015 — SkyWest, Inc. (NASDAQ: SKYW) will participate in a number of upcoming investor conferences, including:
- Cowen and Company 8th Annual Global Transportation Conference in Boston on Wednesday, Sept. 9
- Deutsche Bank Airline Day in New York on Thursday, Sept. 10
- Imperial Capital 9th Annual Global Opportunities Conference on Thursday, Sept. 17
Rob Simmons, SkyWest’s Chief Financial Officer, and Eric Woodward, SkyWest’s Chief Accounting Officer, are scheduled to present at Cowen and Deutsche Bank. SkyWest, Inc. President, Chip Childs, will present with Eric Woodward at Imperial Capital. SkyWest has a redesigned, user-friendly website with additional SkyWest information at inc.skywest.com.
About SkyWest, Inc.
SkyWest, Inc. was named one of “America’s Best Employers” by Forbes in 2015 and was Air Transport World’s Regional Airline of the Year in 2014. SkyWest, Inc. is the holding company for two scheduled passenger airline operations and an aircraft leasing company and is headquartered in St. George, Utah. SkyWest’s airline companies provide commercial air service in cities across the United States, Canada, Mexico and the Caribbean with more than 3,200 daily flights and a fleet of 664 aircraft. SkyWest Airlines operates through partnerships with United Airlines, Delta Air Lines, American Airlines and Alaska Airlines. ExpressJet Airlines operates through partnerships with United Airlines, Delta Air Lines and American Airlines. SkyWest is headquartered in St. George, Utah, and continues to set the standard for excellence in the regional industry with unmatched value for customers, shareholders and its nearly 20,000 employees. This press release and more information about SkyWest can be found at inc.skywest.com.
(ICLD) Announces a New Cloud Data Disaster Recovery Services Agreement
InterCloud Continues to Expand on the Over $2.6M in Services With JBFCS
SHREWSBURY, N.J., Sept. 4, 2015 — InterCloud Systems, Inc. (Nasdaq:ICLD) (the “Company” or “InterCloud”), announced today it has been selected by The Jewish Board of Family and Children’s Services (“The Jewish Board”) to provide disaster recovery cloud services. InterCloud will provide key value add elements including geographic data redundancy to guard critical customer data against any colossal failure, natural disaster or human error. In addition, InterCloud will provide a total turnkey implementation including set-up, maintenance and managed services, as they deploy industry-leading next generation network solutions.
Uday Madasu, CIO of The Jewish Board, stated, “We are excited to start this new project with InterCloud Systems. Our goal is to further protect our critical data with a high quality, resilient solution, with a partner that has executed successfully for The Jewish Board in the past. In addition, InterCloud’s unique positioning in the marketplace will allow for a smooth migration as we look to take advantage of the cloud for our business disaster recovery initiatives.”
Joseph Scotti, Vice President of Sales for InterCloud Systems, stated, “We are pleased to report the broadening of our relationship with The Jewish Board. The additional InterCloud cloud disaster recovery services are expected to be provisioned immediately and will safeguard The Jewish Board critical data against any unforeseen events.”
About The Jewish Board of Family and Children’s Services
For 140 years, as the largest health and human services agency in New York City, The Jewish Board of Family and Children’s Services has been helping New Yorkers realize their potential and live as independently as possible. With hope and resilience guiding our work, we promote recovery by addressing all aspects of an individual’s life, including mental and physical health, family, housing, employment and education. Inspired by Jewish values, The Jewish Board brings the ideals of Jewish service to all New Yorkers. Visit us at www.jbfcs.org.
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a leading provider of cloud networking orchestration and automation, for Software Defined Networking (SDN) and Network Function Virtualization (NFV) cloud environments to the communications service provider and corporate enterprise markets, through cloud solutions and professional services. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
Forward-looking statements:
The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as “anticipate,” “appear,” “believe,” “could,” “estimate,” “expect,” “hope,” “indicate,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “will,” “would,” and other variations or negative expressions of these terms, including statements related to expected market trends and the Company’s performance, are all “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances, and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.
CONTACT: Investor Relations InterCloud Systems, Inc. 561-988-1988
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