Archive for October, 2017
$PZRX Announces Corporate Restructuring and Review of Strategic Alternatives
SEATTLE, Oct. 13, 2017 — PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its board of directors has made a determination to conduct a restructuring of operations to reduce short term operating costs and delay the development of its lead product candidate PRX-OTC. This reorganization includes a reduction in PhaseRx’s workforce by 10 employees, including some executive officers. These efforts are aimed at preserving the company’s cash resources. As of June 30, 2017, PhaseRx had cash and equivalents of $8.4 million and a total of 20 employees.
The board of directors has also begun a review of strategic alternatives, including but not limited to a potential merger transaction. The company has not set a timetable for this process. No decision has been made as to whether the company will engage in a transaction or transactions and there can be no assurance that the review of strategic alternatives will result in a transaction, or the terms or timing of any potential transaction that may take place.
The company does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or otherwise determined that further disclosure is appropriate.
About PhaseRx
PhaseRx is a biopharmaceutical company dedicated to developing mRNA products for the treatment of children with inherited enzyme deficiencies in the liver using intracellular enzyme replacement therapy (i-ERT). PhaseRx’s initial product development focus is on urea cycle disorders, a group of rare genetic diseases that generally present before the age of twelve and are characterized by the body’s inability to remove ammonia from the blood with potentially devastating consequences for patients. The company’s i-ERT approach is enabled by its proprietary Hybrid mRNA Technology™ platform. PhaseRx is headquartered in Seattle. For more information, please visit www.phaserx.com.
Safe Harbor Statement
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the fact that the company has incurred significant losses since its inception and anticipates that it will continue to incur significant losses for the foreseeable future, (ii) the company being dependent on technologies it has licensed and that it may need to license in the future, (iii) the fact that the company will need to raise substantial additional funding to develop its planned products, (iv) the fact that the company’s Hybrid mRNA Technology has not previously been tested beyond company preclinical studies, and that mRNA-based drug development is unproven, (v) the fact that all of the company’s programs are in preclinical studies or early stage research and it is uncertain that any company product candidates will receive regulatory approval or be commercialized, (vi) the fact that development of the company’s product candidates will be expensive, time-consuming and subject to regulatory approval, (vii) the company expecting to continue to incur significant research and development expenses, (viii) the company becoming dependent on collaborative arrangements for the development and commercialization of its products, (ix) the company’s ability to adequately protect its proprietary technology from legal challenges, infringement or alternative technologies and (x) the biotechnology and pharmaceutical industries being intensely competitive. More detailed information about the company and the risk factors that may affect the realization of forward looking statements is set forth in the company’s filings with the Securities and Exchange Commission (SEC), including the most recent annual report on Form 10-K and its quarterly reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contacts:
Corporate Communications Contact:
Jason Spark
Canale Communications
Senior Vice President
jason@canalecomm.com
619-849-6005
Investor Contact:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
robert.uhl@westwicke.com
858.356.5932
$NETE Announces Growth in North America Transactions Solutions Segment
Electronic commerce and value-added integrated transaction volumes increased by 134% during the first half of 2017 over the same period in 2016
MIAMI, FL–(Oct 13, 2017) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a global financial technology and value-added solutions group that supports electronic payments acceptance in an omni-channel environment spanning across point-of-sale (POS), e-commerce and mobile devices, today reported significant growth in Unified Payments, its North America Transactions Solutions Segment division.
Total e-commerce volumes for the first half of 2017 increased by 33% from the first half of 2016. Transactions processed for the first half of 2017 increased by 34% over the same period in 2016. New e-commerce merchants for the first half of 2017 increased by 37% over the same period in 2016.
Total volumes for electronic commerce and value-added integrated services such as Aptito and Unified m-POS increased by 134% during the first half of 2017 over the same period in 2016. Transactions processed for the first half of 2017 increased by 84% over the same period in 2016. New merchants for the first half of 2017 increased by 43% over same period in 2016.
“Unified Payments continues gaining market-share by delivering competitive e-commerce, mobile point of sale and integrated value added services through easy-to-use technology such as Apple iOS and Android apps while providing exceptional customer service, technical support and fast merchant on-boarding,” commented Oleg Firer, Chief Executive Officer of Net Element. “We are confident in our ability to continue executing our growth strategy and are excited about the Company’s future.”
About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US it aims to grow transactional revenue by innovating SME productivity services such as its cloud based, restaurant and retail point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Net Element was named in 2016 by South Florida Business Journal as one of the fastest growing technology companies. Further information is available at www.netelement.com.
Forward-Looking Statements
Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to whether the Company will be successful in its delisting appeal with Nasdaq, its expansion and growth endeavors and in entering into new partnerships; and even if it is successful in any or all of these endeavors, whether this will positively impact the Company or result in improved shareholder value. Additional examples of such risks and uncertainties are : (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Net Element, Inc.
media@netelement.com
+1 (786) 923-0502
$CIIX A First Mover in CBD Skin Care
- China is the second-largest global cosmetics consumer, representing $30 billion annually
- Savvy industry veteran recruited for vast untapped CBD skin care market
- 100% of cannabis skin care product market in China up for grabs
It comes as little surprise that cannabidiol (CBD) likely possesses skin healing properties. Found in the marijuana plant, CBD is one of over 80 natural compounds in marijuana that have been used for centuries as natural medicines and therapeutics. Cannabis is a known anti-inflammatory, containing antioxidants and anti-aging elements, while hemp seed oil contains both omega-3 and omega-6 fatty acids.
In spite of vast anecdotal evidence, science has not yet definitively settled on the positive effects of CBD skin care. However, the recent article “The Role of Cannabinoids in Dermatology,” published in the prestigious Journal of American Academy of Dermatology, suggests efficacy in CBD use for the treatment of several dermatologic conditions, including pruritus, inflammatory skin disease and…
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$POLA Multi-Unit Purchase Order of DC Power Systems for Puerto Rico
Initial 57 Unit Purchase Order to be Shipped Over Next Two Weeks to Hurricane-Affected Telecom Sites on Puerto Rico
GARDENA, CA–(October 12, 2017) – Polar Power, Inc. (NASDAQ: POLA), a global provider of prime and backup DC power solutions, has received a multi-unit purchase order of its 15 kilowatt (kW) back-up diesel DC generator set from its new Tier-1 wireless carrier customer in the United States. The initial 57 units will be shipped over the next two weeks to hurricane-affected telecom sites on the island of Puerto Rico.
Hurricane Maria, which lingered over Puerto Rico for 10 days in early to mid-September, caused extensive destruction and a humanitarian crisis in the region. Of the 3.6 million people who reside on the island, the vast majority have no power. According to the FCC, 91% of cellular sites are out of service and according to Wired.com, of the 1,600 cellular sites, at least 1,300 are out of service. Of the four fiber-optic providers in Puerto Rico, one is mostly broken and one is completely down. Roughly 75 percent of fiber coverage, including cellular service, isn’t working, and neither is about 40 percent of the wired network.
“We are pleased to receive our first material, multi-unit purchase order with our newly signed Tier-1 wireless carrier customer in the United States,” said Polar Power CEO, Arthur Sams. “It comes at a time when over 3.5 million U.S. citizens are without some form of access to cellular phone or data to communicate with family and friends.
“We look forward to continuing our collaboration with all of our Tier-1 wireless carrier customers as we work together to provide solutions to aid in the redevelopment of Puerto Rico’s wireless networks. We’ve seen an increase in inbound RFP requests due to the recent hurricanes and look forward to working with our partners to implement innovative solutions to restore service to areas hardest hit by these natural disasters,” concluded Sams.
About Polar Power, Inc.
Gardena, California-based Polar Power, Inc. (NASDAQ: POLA), designs, manufactures and sells direct current, or DC, power systems, lithium battery powered hybrid solar systems for applications in the telecommunications market and, in other markets, including military, electric vehicle charging, cogeneration, distributed power and uninterruptable power supply. Within the telecommunications market, Polar’s systems provide reliable and low-cost energy for applications for off-grid and bad-grid applications with critical power needs that cannot be without power in the event of utility grid failure. For more information, please visit www.polarpower.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
With the exception of historical information, the matters discussed in this press release including, without limitation, Polar Power’s expectation that its new customers will commence ordering products during the next two weeks and beyond; Polar Power’s belief that customers will make major purchases in the fourth quarter of 2017; and Polar Power’s belief that RFP’s will turn into purchase orders are forward-looking statements and considerations that involve a number of risks and uncertainties. The actual future results of Polar Power could differ from those statements. Factors that could cause or contribute to such differences include, but are not limited to, adverse economic and market conditions, including demand for DC power systems; raw material and manufacturing costs; changes in governmental regulations and policies; and other events, factors and risks previously and from time to time disclosed in Polar Power’s filings with the Securities and Exchange Commission including, specifically, those factors set forth in the “Risk Factors” section contained in Polar Power’s Form 10-Q/A filed with the Securities and Exchange Commission on July 11, 2017.
Media and Investor Relations:
Chris Tyson
Managing Director
MZ North America
Direct: 949-491-8235
ir@polarpowerinc.com
www.mzgroup.us
Company Contact:
Polar Power, Inc.
249 E. Gardena Blvd.
Gardena, CA 90248
Tel: 310-830-9153
ir@polarpowerinc.com
www.polarpower.com
$AMPE Accepted Publication of Pooled Ampion™ Clinical Results in Severe Osteoarthritis
ENGLEWOOD, Colo., Oct. 12, 2017 — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that a manuscript titled: “LMWF-5A For The Treatment Of Severe Osteoarthritis Of The Knee: Integrated Analysis Of Safety And Efficacy” was accepted for publication in Orthopedics, an international peer-reviewed journal in the field of Orthopedics. Ampion™ is the Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A).
Ampio’s Chief Scientific Officer, Dr. David Bar-Or described the study as follows: “This was a combined analysis of all completed single-injection Ampion™ randomized placebo-controlled trials to date, focusing on the subset of patients with severe (Kellgren-Lawrence [KL] grade 4) osteoarthritis of the knee (OAK). The objective of the study was to examine the safety and efficacy of an intra-articular injection of Ampion™ compared to a saline placebo control in patients with severe OAK. Safety and efficacy measurements, subject eligibility, treatment, randomization and blinding, were identical across all trials.”
Dr. Brian Cole, who co-authored the article, explained, “417 patients is thought to be the largest study treating the KL grade 4 population to be published. This pooled analysis demonstrated that a single-injection of Ampion™ was safe and well tolerated across all trials. Patients treated with Ampion™ were also significantly more likely to respond to treatment and with a longer duration of response as compared to saline. These results are clinically important and provide support for Ampion™ for the indication of pain due to severe OAK. The KL grade 4 population is an unmet medical need.”
Ampion™ is in late-stage development to treat the signs and symptoms of severe OAK. Based on FDA guidance, Ampio recently completed enrollment in the 12-week pivotal trial of Ampion™, which enrolled patients with severe OAK (KL grade 4) to evaluate the efficacy of Ampion™ for the treatment of pain, function, and Patient Global Assessment (PGA). The primary study endpoint is the OMERACT-OARSI responder criteria.
About Osteoarthritis
Osteoarthritis (OA) is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, obesity, and diabetes, this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
Forward-Looking Statements
Ampio’s statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s scientific publications on our Ampion™ product. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact
Tom Chilcott
Chief Financial Officer
Phone: (720) 437-6500
tchilcott@ampiopharma.com
$INFI Announces IPI-549 Late-Breaking Presentation at SITC Annual Meeting
– Clinical and Translational Data from Monotherapy Dose-Escalation Component of Ongoing Phase 1/1b Study of IPI-549 in Patients with Advanced Solid Tumors to be Reported During an Oral Session –
CAMBRIDGE, Mass., Oct. 12, 2017 — Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that an abstract describing new data for IPI-549, an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), has been selected as a late-breaking presentation during an oral session at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting taking place in National Harbor, MD, November 10 – 12. Additionally, a clinical trials in progress poster will also be presented on the Phase 1/1b clinical study which is ongoing to explore the safety and activity of IPI-549 both as a monotherapy and in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors. IPI-549 is believed to be the only PI3K-gamma inhibitor in clinical development.
Details of the presentations are as follows:
Updated Phase 1/1b Data
Title: Monotherapy dose escalation clinical and translational data from first-in-human study in advanced solid tumors of IPI-549, an oral, selective, PI3K-gamma inhibitor targeting tumor macrophages
Abstract number: O43
Oral session: Clinical Trials – New Agents
Oral session date and time: Friday, November 10, 2017, from 1:45 p.m. –3:30 p.m. ET
Lead author: David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Additionally, an identically titled poster will be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET.
Clinical Trials in Progress
Title: Phase 1/1b, first-in-human study of the PI3K-gamma inhibitor IPI-549 as monotherapy and combined with nivolumab in patients with advanced solid tumors
Abstract number: P219
Poster session: Clinical trials in progress
Presentation time: Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET
Lead author: Antoni Ribas, M.D., Ph.D., Parker Institute Center Director at the University of California, Los Angeles (UCLA)
About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.
A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin in the second half of 2017.
The combination expansion component includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion will also include a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.S.4,5
IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Infinity
Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is developing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study in patients with advanced solid tumors is ongoing. For more information on Infinity, please refer to Infinity’s website at www.infi.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 including those regarding the company’s expectations about the timing and type of data presentations, the therapeutic potential of PI3K-gamma inhibition and of IPI-549, alone or in combination with other agents, and clinical trial plans regarding IPI-549. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations, including, for example, that there is no guarantee that IPI-549 will successfully complete necessary preclinical and clinical development phases, or gain regulatory approval, and other risks described in greater detail under the caption “Risk Factors” included in Infinity’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 3, 2017, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
OPDIVO® is a registered trademark of Bristol-Myers Squibb.
Contact:
Jaren Irene Madden, Senior Director, Investor Relations and Corporate Communications
617-453-1336 or Jaren.Madden@infi.com
____________________________
1 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3Kγ is a molecular switch that controls immune suppression. Nature, 2016 Nov;539:437-442.
2 De Henau, O., Rausch, M., Winkler, D., Campesato, L., et al. Overcoming resistance to checkpoint blockade therapy by targeting PI3Kγ in myeloid cells. Nature, 2016 Nov;539:443-447.
3 www.clinicaltrials.gov, NCT02637531.
4 American Cancer Society, Cancer Facts and Statistics 2017, http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index and http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics, Last Accessed September 19, 2017.
5 Conquer Cancer Foundation, Head and Neck Cancer Statistics, http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics, Last Accessed September 19, 2017.
$IGC NYSE American Extends India Globalization Capital Compliance Plan Period
BETHESDA, Md., Oct. 12, 2017 — India Globalization Capital Inc. (NYSE American:IGC) announces that on October 11, 2017 it received notice from NYSE American LLC (“the Exchange”) that it has accepted the Company’s plan to regain compliance with the Exchange’s continued listing standards by November 8, 2017.
The Exchange reviewed the Company’s timeline submitted on October 10, 2017, which commits to an annual meeting on November 8, 2017, and agreed to extend the deadline for IGC to regain compliance with Section 704 to November 8, 2017, as the Company will resolve the noncompliance by holding its annual meeting on such date.
The Company is diligent in its effort to ensure compliance with Exchange requirements within the period granted, subject to periodic review by the Exchange.
IGC invites its shareholders to its Annual Shareholders Meeting to be held on November 8, 2017 at 11:00 am as disclosed on the Definitive Proxy on Form 14A filed with the SEC on October 10, 2017.
About IGC
India Globalization Capital is engaged in the development of cannabis-based therapies to treat pain, PTSD, seizures, cachexia, chronic and terminal neurological and oncological diagnoses, and other life altering conditions. In support of this mission, IGC has assembled a portfolio of patent filings for its phytocannabinoid-based treatments. The company is based in Bethesda, Maryland.
For more information visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/
Forward-looking Statements
Please see forward-looking statements as discussed in detail in IGC’s Form 10-K for fiscal year ended March 31, 2017, and in subsequent reports filed with the U.S. Securities and Exchange Commission.
Contact Info:
Claudia Grimaldi
301-983-0998
$STLHF NetworkNewsWire Releases Exclusive Audio Interview
NEW YORK, NY–(Oct 12, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions for business, today announces the online availability of its interview with Standard Lithium Ltd. (TSX VENTURE: SLL) (FRANKFURT: S5L) (OTCQX: STLHF), a Canadian-based energy exploration and development company building one of the largest portfolios of high-quality lithium brine assets in the United States.
The interview can be heard at http://NNW.fm/STLHF-October-2017
Standard Lithium CEO and Director Robert Mintak shares company news and insights with NNW’s Stuart Smith in an interview that delves into the opportunities presented by the world’s changing energy demands.
“I’ve been working in the lithium sector for the better part of the last decade, and the team that has joined me has been working extensively in the lithium space as well, at the cutting edge of new lithium processing technologies,” Mintak says. “We’ve been at the forefront of applying new technologies and new processing applications to really look at unlocking resources that haven’t been viewed through the right lens.”
Standard Lithium has partnered with National Chloride Corporation of America at its Bristol Lake project in San Bernardino County, California. Everything about the 25,000-plus acre project fit nicely into the company’s criteria, Mintak says, pointing out the area has seen almost a century of industrial mineral production from brines.
“We’re able to immediately begin working on the important processing work that any lithium project has to do,” he says. “Lithium projects aren’t traditional mining projects, they’re more chemistry projects.”
Standard Lithium’s team of experts is bringing an enviable amount of extremely valuable experience in the resource development and processing side of the lithium space. The company’s drive to provide battery-grade lithium materials is buoyed by a belief in the transformative state of the world’s energy marketplace.
“We’re at the early stages of a new economy and lithium is at the heart of that economy,” Mintak says. “It’s all about energy storage now with the adoption of electric vehicles just starting to take hold. We’re seeing news coming out of China, saying they’re looking at banning internal combustion engines, and we’ve heard similar stories coming out of England and France. That’s going to mean a massive demand for lithium.”
The global lithium compounds market is projected to reach U.S. $5.87 billion by 2020 at a compound annual growth rate of 13.22% between 2015 and 2020. Lithium-ion batteries are the fastest growing segment of the market.
“We believe it’s going to exceed that, so the lithium space, the electric metal space, is one of the most attractive and exciting spaces to be in for a mining, mineral exploration company,” Mintak concludes.
About Standard Lithium Ltd.
Standard Lithium Ltd. (TSX VENTURE: SLL) (FRANKFURT: S5L) (OTCQX: STLHF), is a Canadian-based energy exploration and development company with a value-driven strategy of acquiring a diverse and highly prospective portfolio of large-scale domestic lithium-bearing brine resources. Led by an innovative and results-oriented management team with a strong focus on technical skills, Standard Lithium is currently focused on the exploration of its Bristol Lake Brine Project in the Mojave region of San Bernardino County, California.
For more information, visit www.StandardLithium.com
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
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$IMNP Announces Presentation at The Liver Meeting 2017
ENGLEWOOD CLIFFS, N.J.
Poster demonstrates activity of anti-eotaxin-1 antibodies in an animal model of immune-mediated hepatitis
Immune Pharmaceuticals, Inc. (NASDAQ: IMNP) a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today announced that the results of a study investigating the therapeutic effect of oral and parenteral administration of anti-eotaxin-1 antibodies in an animal model of immune-mediated hepatitis will be presented at The Liver Meeting 2017 – the 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place October 20-24, 2017 in Washington, DC. Dr. Yaron Ilan, Professor of Medicine, and Director, Department of Medicine at Hebrew University’s Hadassah Hospital in Jerusalem, Israel, and an Immune Pharmaceuticals collaborator, will present the data in a poster.
The poster (#350), entitled “Oral administration of anti-eotaxin-1 monoclonal antibody is biologically active in the gut and alleviates immune-mediated hepatitis: A novel personalized therapy for immune-associated liver diseases” (#350) will be presented Friday, October 20 between 12:00 and 1:30 PM ET at the “Autoimmune and Cholestatic Liver Disease” session. The study aimed to evaluate the biological activity and immunomodulatory effect of oral and parenteral administration of anti-eotaxin-1 antibodies in the concanavalin A (ConA) mouse model of immune hepatitis. Anti-eotaxin-1 antibodies, administered two hours prior to the induction of hepatitis, lowered eotaxin-1 levels and prevented the development of hepatitis compared to controls.
Dr. Ilan commented, “These experiments showed that blocking eotaxin-1 can have a profound impact on the development of hepatic inflammation. Anti-eotaxin-1 antibodies lowered eotaxin-1 levels and were effective at blocking liver injury whether administered parenterally or orally. These results have obvious implications for the potential use of bertilimumab in liver diseases in which chronic inflammation plays a role, including NASH.”
Elliot Maza, President and Chief Executive Officer of Immune Pharmaceuticals, stated, “Our collaboration with Dr. Ilan has been fruitful and yielded results suggesting that blocking eotaxin-1 can have a beneficial effect in liver diseases. We will continue to explore the development of bertilimumab in liver diseases, further to our strategic business plan of focusing our resources on this first-in-class antibody.”
About Immune Pharmaceuticals
Immune Pharmaceuticals is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Our lead program, bertilimumab, is a first-in-class, fully human monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation. By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions. Currently, we are conducting two phase 2 clinical trials to test bertilimumab in patients suffering from bullous pemphigoid and ulcerative colitis, respectively. Bertilimumab may have application in other diseases, including NASH, atopic dermatitis, immune and inflammatory hepatitis, and asthma.
Safe Harbor Statements Regarding Forward Looking Statements
The statements in this news release made by representatives of Immune Pharmaceuticals, Inc. relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Immune’s product candidates and the sufficiency of Immune’s cash and other capital resources, the continued development by Immune of bertilimumab or its determination to seek Orphan Drug designation for the pharmaceutical product of bertilimumab are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Immune’s ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. In addition, there can be no assurance that the Company will ever successfully complete its anticipated corporate restructuring, or that the Company will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. The Company may, at any time and for any reason until the proposed spin-off is complete, abandon the spin-off or modify its terms and conditions, or consider competing, alternate or complimentary transactions or offers by third parties at the discretion of Immune’s board of directors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Immune’s filings with the Securities and Exchange Commission, including those discussed in Immune’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q periodic reports filed on Form 8-K.
Immune Pharmaceuticals Inc.
Elliot Maza
investors@immunepharma.com
$AKTX Announces Further Clinical Progress
- Completion of enrollment into COBALT, the Phase II PNH trial of Coversin™
NEW YORK and LONDON, Oct. 11, 2017 — Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid system and the bioamine system for the treatment of rare and orphan diseases, announces that three additional patients have been enrolled in the ongoing Phase II COBALT clinical trial of Coversin™ in patients with paroxysmal nocturnal hemoglobinuria (PNH).
COBALT, the Phase II 90-day, open label single arm clinical trial, has enrolled a total of eight patients, four of whom have completed the trial and were reported on at the European Hematology Association conference in June 2017. These four patients have all moved into Akari’s long-term safety study, CONSERVE. One of the initial five patients enrolled in the COBALT trial, with a suspected co-morbidity unrelated to the treatment, was withdrawn from the study on day 43.
Three new patients were enrolled pursuant to an amended protocol based on a revised dosing regimen which included changing the maintenance phase from a single dose of 30mg every 24 hours to a single dose of 45mg every 24 hours. The three newly enrolled patients on the revised dosing regimen have now completed approximately 8, 3 and 2 weeks, respectively. The primary endpoint in this clinical trial is reduction in serum LDH (lactate dehydrogenase; an indication of hemolysis) to ≤1.8 times the ULN (upper limit of normal) for the investigator’s reference laboratory or 500 I U/L, whichever is the lower from day 1 (pre-dose) to day 28. The first of the three patients had a LDH value of 1.5 times the ULN at day 28. The other two patients have not yet reached the primary endpoint measurement date. To date, there have been no drug-related serious adverse events. The data reported is taken from the current electronic case report forms.
Akari plans to provide an update on all PNH patients currently enrolled at the American Society of Hematology Annual Meeting to be held December 9-12, 2017.
Akari plans to advance Coversin towards Phase III clinical trials beginning with CAPSTONE in Q1 2018, a Phase III clinical trial of Coversin in naïve PNH patients.
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid system and the bioamine system for the treatment of rare and orphan diseases, in particular those where the complement system or leukotrienes or both complement and leukotrienes together play a primary role in disease progression. Akari’s lead drug candidate Coversin is a C5 complement inhibitor currently being evaluated in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate Coversin in two conditions, the skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4 may be beneficial. Akari is also developing other tick derived proteins, including long acting versions.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 20-F filed on March 31, 2017. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
For more information
Investor Contact:
Peter Vozzo
Westwicke Partners
(443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Mary-Jane Elliott / Sukaina Virji
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com
$RGSE Selected as Exclusive Installer for Solarize New Haven Campaign
Kick-off Workshop on Wednesday, October 18th
DENVER, Oct. 11, 2017 — RGS Energy (NASDAQ:RGSE), the nation’s original solar company since 1978, has been selected by Solarize New Haven, a community-based residential solar purchasing cooperative, to bring solar electricity to homes and business owners in New Haven, Connecticut.
Solarize Connecticut is a community-supported buying program that uses discounted pricing, town supported education and outreach, competitively selected installers and access to flexible financing to significantly reduce the cost of solar for New Haven’s more than 14,000 owner occupied homes. The campaign and sign up period will commence on October 18, 2017 and run through March 7, 2018.
Marketing support for the campaign will be provided by SmartPower, the nation’s leading non-profit marketing firm dedicated to promoting energy efficiency and renewable energy and which has extensive experience with hundreds of community-based energy campaigns and Solarize projects across the country.
“We are thrilled to be joining forces with Solarize Connecticut once again for what we believe will be another successful Solarize program,” said Tom Champlin, Director of sales at RGS Energy. “We will provide our exceptional service to New Haven, supported by our 31 local Connecticut employees, based out of our 10,000 square foot, centrally located, warehouse in Bloomfield.”
According to Brian F. Keane, President of SmartPower: “Solar just makes sense for homeowners throughout New Haven. We now know that solar ownership increases the property value of our homes, it’s a smart way to control energy costs over the long term and is a good personal investment. So, it’s a real win-win-win for the homeowner. Let’s Solarize!”
Toni Harp, Mayor of New Haven, commented: “The City is bringing Solarize New Haven to residents as part of my administration’s ongoing commitment to increase the adoption of clean energy within this community. It’s important that efforts be made at every level to reduce emissions contributing to climate change. The City has pledged to use 100% renewable energy in its operations and we hope residents will consider doing the same in their homes. I encourage everyone to determine whether or not their home is suitable for solar over the next 20 weeks while the discounted pricing is being offered.”
To learn more about the Solarize New Haven campaign, visit SolarizeCT.com/New-Haven.
About RGS Energy
RGS Energy (NASDAQ:RGSE) is America’s Original Solar Company providing solar, storage and energy services, whose mission is to provide clean energy savings. The company sells, designs, installs solar systems for residential homeowners and small business companies. The company is also the exclusive manufacturer of POWERHOUSE™, an innovative in-roof solar shingle using technology developed by The Dow Chemical Company.
For more information, visit RGSEnergy.com, RGSPOWERHOUSE.com, on Facebook at www.facebook.com/rgsenergy and on Twitter at www.twitter.com/rgsenergy. Information on such websites is not incorporated by reference into this press release.
RGS Energy is the Company’s registered trade name. The company files periodic and other reports with the Securities and Exchange Commission under its official name “Real Goods Solar, Inc.”
Forward-Looking Statements and Cautionary Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements regarding the RGS Energy’s results of operations and financial positions, and RGS Energy’s business and financial strategies. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they provide our current beliefs, expectations, assumptions, forecasts, and hypothetical constructs about future events, and include statements regarding our future results of operations and financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. The words “plan,” “future,” “believe,” “may,” “will” and similar expressions as they relate to us are intended to identify such forward-looking statements.
Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward looking statements. Therefore, RGS Energy cautions you against relying on any of these forward-looking statements.
Key risks and uncertainties that may cause a change in any forward-looking statement or that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include: the level of demand for RGS Energy’s solar energy systems; the increase in property value from solar ownership; our ability to generate sales and make installations under the Solarize Connecticut program; and our ability to assist residents of the Town of New Haven to help achieve their renewable energy objectives.
You should read the section entitled “Risk Factors” in our 2016 Annual Report on Form 10-K, as amended, and in our Quarterly Report on Form 10-Q/A for the quarter ended June 30, 2017, each of which has been filed with the Securities and Exchange Commission, which identify certain of these and additional risks and uncertainties. Any forward-looking statements made by us in this press release speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We do not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
POWERHOUSE™ is a trademark of The Dow Chemical Company, used under license.
Investor Relations Contact
Ron Both
Managing Partner, CMA
Tel 1-949-432-7566
RGSE@cma.team
$ARDX Pivotal Phase 3 Study of Tenapanor for IBS-C Hits Primary, & All Secondary Endpoints
Six of 12-week combined responder rate shows clear benefit in treated patients with consistent response throughout 26 weeks Best-in-class, nine of 12-week combined responder rate demonstrates ability to normalize patients’ bowel function Conference call to be held today at 4:30 p.m. ET
FREMONT, Calif., Oct. 11, 2017 — Ardelyx, Inc. (NASDAQ: ARDX) today reported positive results from T3MPO-2, its second Phase 3 study of tenapanor for irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements. The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients (36.5% vs. 23.7%, p<0.001) had at least a 30 percent reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period. In addition, tenapanor achieved statistical significance for the CSBM and abdominal pain responder rates in the six of 12 and nine of 12-treatment weeks, with a consistent response across the 26 weeks of the study. Tenapanor was well-tolerated in treated patients.
“These results are a game-changer for patients with IBS-C, their treating physicians and for Ardelyx as a company,” said Mike Raab, president and chief executive officer of Ardelyx. “They demonstrate the significant benefit tenapanor can have for patients with IBS-C, importantly, leading to a normalization of bowel movements for many patients. These results show that tenapanor has significant potential in the market and bolsters our commitment to identify the ideal collaboration partner to help ensure that we reach the most patients possible who would benefit from therapy.”
“IBS-C is a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States, and often preventing them from engaging in day-to-day activities, such as going to work, exercising and even meeting socially with family and friends,” said William Chey, M.D., University of Michigan. “Based on tenapanor’s unique mechanism of action, which relies upon the inhibition of sodium absorption, and the exciting data reported today, tenapanor has the potential to be an important advancement and a new treatment option for patients suffering from IBS-C.”
T3MPO-2 Trial Design
T3MPO-2 is a 26-week, double-blind, placebo-controlled, multi-center, randomized trial. The trial was conducted in a total of 593 patients meeting the ROME III criteria for the diagnosis of IBS-C. Patients were randomized one-to-one to receive either 50 mg of tenapanor (n=293) or placebo (n=300) twice-daily. The trial included a two-week screening period, during which patients with active disease, based on bowel movement frequency and abdominal pain score recorded in a daily phone diary, were randomized into the trial.
T3MPO-2 Top-line Efficacy Results
During the two-week screening period, the baseline scores were well-balanced between the tenapanor and placebo groups. The mean weekly CSBMs were 0.11 and the mean abdominal pain score was 6.26 (on a 0 – 10 scale where 0 was no pain and 10 was very severe). Key data are as follows:
Table 1 | |||
6 of 12 Treatment Week Results | Tenapanor | Placebo | P value |
Combined responder (primary endpoint) (abdominal pain and CSBM responder) |
36.5% | 23.7% | p<0.001 |
CSBM responder (increase ≥ 1 CSBM from baseline) |
47.4% | 33.3% | p<0.001 |
Abdominal pain responder (≥ 30% abdominal pain reduction) |
49.8% | 38.3% | p=0.004 |
Table 2 | |||
9 of 12 Treatment Week Results | Tenapanor | Placebo | P value |
Combined responder (abdominal pain and CSBM responder) |
18.4% | 5.3% | p<0.001 |
CSBM responder (increase ≥ 1 CSBM from baseline and ≥3 CSBM/week) |
22.2% | 6.0% | p<0.001 |
Abdominal pain responder (≥ 30% abdominal pain reduction) |
35.8% | 26.7% | p=0.015 |
Table 3 | |||
Durable Responder Results (9 of 12 and >3 of last 4 treatment weeks) |
Tenapanor | Placebo | P value |
Combined responder (abdominal pain and CSBM responder) |
18.1% | 5.0% | p<0.001 |
CSBM responder (increase ≥ 1 CSBM from baseline and ≥3 CSBM/week) |
21.2% | 5.7% | p<0.001 |
Abdominal pain responder (≥ 30% abdominal pain reduction) |
34.8% | 26.7% | p=0.028 |
T3MPO-2 Safety Results
Tenapanor was well-tolerated, consistent with the experience across previous clinical trials. The only adverse events observed in more than two percent of patients in the tenapanor-treated group that were also greater than placebo were diarrhea (16.0% vs. 3.7%), flatulence (3.1% vs. 1.0%), nasopharyngitis (4.4% vs. 3.7%) and abdominal distension (3.4% vs. 0.3%). The placebo adjusted discontinuation rate due to diarrhea was 5.8 percent.
Based on positive results from two positive Phase 3 trials, Ardelyx is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for tenapanor for the treatment of IBS-C in the second half of 2018. Final, detailed results from the study are expected to be presented at a medical meeting in 2018.
T3MPO-3
Patients who have completed T3MPO-1 and T3MPO-2 are eligible to enter T3MPO-3, Ardelyx’s open-label, long-term safety trial where patients can continue to receive tenapanor for up to one year. T3MPO-3 is fully enrolled and expected to conclude in late 2017. The results of the trial will be included in the NDA submission for tenapanor for the treatment of patients with IBS-C.
T3MPO-2 Primary and Secondary Endpoint Definitions
Primary Endpoint:
- Combined responder rate (6/12 week): A six of 12-week combined responder is a CSBM responder and an abdominal pain responder during the same week for six of 12 weeks.
Secondary Endpoints:
- CSBM responder rate (6/12 week): A six of 12-week CSBM responder is a patient that has an increase of at least one CSBM from baseline during a week for six of 12 weeks.
- Abdominal pain responder rate (6/12 week): A six of 12-week abdominal pain responder is a patient that has at least a 30 percent decrease in abdominal pain from baseline during a week for six of 12 weeks.
- Combined responder rate (9/12 week): A nine of 12-week combined responder is a nine of 12 week CSBM responder and an abdominal pain responder during the same week for nine of 12 weeks.
- CSBM responder rate (9/12 week): A nine of 12-week CSBM responder is a patient that has an increase of at least one CSBM from baseline and at least three CSBMs during a week for nine of 12 weeks. Normal bowel function is characterized by at least three bowel movements a week up to three bowel movements a day.
- Abdominal pain responder rate (9/12 week): A nine of 12-week abdominal pain responder is a patient that has at least a 30 percent decrease in abdominal pain from baseline during a week for nine of 12 weeks.
- Durable responder rates (9/12 week): All three durable responder endpoints – combined responder rate, CSBM responder rate and abdominal pain responder rate – are identical to the nine of 12-week responder endpoints, except the response must also occur in three of the last four treatment period weeks.
Conference Call Information
The company will host a conference call today, October 11, 2017 at 4:30 p.m. ET to discuss the T3MPO-2 results. To participate in the conference call, please dial (855) 296-9612 (toll-free) or (920) 663-6277 (toll) and reference call ID number 98932908. A webcast of the call and reference slides that will be used during the call, can be accessed by visiting the Investor page of the company’s website www.ardelyx.com, and will be available on the website for 60 days following the call.
About Tenapanor
Tenapanor, invented and developed by scientists at Ardelyx, is a first-in-class, proprietary, minimally absorbed, oral, experimental medication in late-stage clinical development. It has a unique mechanism of action that, in IBS-C, acts by inhibiting, or blocking, the NHE3 transporter in the gastrointestinal (GI) tract to reduce the absorption of dietary sodium. Blocking NHE3 results in an increase in the amount of sodium in the gut. This increased sodium in the gut leads to an increase of fluid in the gut, loosening stool and helping to relieve constipation. We have also seen a desired benefit in the abdominal pain component of IBS-C in our studies to-date.
Tenapanor is also in Phase 3 development for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis. In hyperphosphatemia, tenapanor blocks the NHE3 sodium transporter in the GI tract, reducing the absorption of dietary sodium and resulting in increased protons within the cells. The increase in protons causes a preferential reduction in phosphate uptake by tightening junctions or pores that regulate phosphate absorption in the GI tract. We have not observed this impact on other ions, nutrients or macromolecules in our clinical trials, suggesting that this effect is preferential for phosphate.
About IBS-C
Irritable bowel syndrome with constipation, or IBS-C, is a gastrointestinal disorder characterized by significant abdominal pain and constipation. Ardelyx estimates that approximately 11 million people in the United States suffer from IBS-C. This condition significantly impacts the health and quality of life of affected patients. The cause of IBS-C is unknown.
About Ardelyx, Inc.
Ardelyx is a late-stage company focused on enhancing the way patients with cardiorenal and gastrointestinal (GI) diseases are treated by using the gut as the gateway to delivering medicines that matter. The company has established unique cardiorenal and GI business portfolios aimed at bringing new, effective medicines with distinct safety and dosing advantages to underserved patients. Ardelyx’s cardiorenal portfolio includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and the Phase 3 development of RDX7675 for the treatment of people with hyperkalemia. The company’s GI portfolio includes the Phase 3 development of tenapanor for the treatment of people with irritable bowel syndrome with constipation (IBS-C) and RDX8940, the company’s TGR5 agonist. For more information, please visit http://www.ardelyx.com/ and connect with us on Twitter @Ardelyx.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for tenapanor in treating patients with IBS-C; Ardelyx’s expectations regarding the timing for the completion of T3MPO-3; Ardelyx’s expectations regarding the filing of an NDA for tenapanor for the treatment of IBS-C; and Ardelyx’s ability to establish collaboration partnerships in the future. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx’s product candidates or Ardelyx’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in research and the clinical development process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx’s business in general, please refer to Ardelyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2017, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
$CIIX Launches Bitcoin Multimillionaire, the First Daily Video Cryptocurrency Newscast in Chinese
SAN GABRIEL, California, October 11, 2017 —
ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announces that the Company has launched the first cryptocurrency daily video newscast in the Chinese language, entitled Bitcoin Multimillionaire, broadcast from the NYSE. The video newscast covers timely information and analysis regarding all aspects of the emerging digital currency world, including specific cryptocurrencies, such as Bitcoin and Ethereum, industry trends, price movement, blockchain technology, and sector-related stocks and ETFs listed on major exchanges and the OTC market.
“Many Chinese investors are seeking information and education related to the cryptocurrency sector,” says Warren Wang, Founder and CEO of CIIX. “Moreover, in response to the growing popularity of cryptocurrencies and ICOs, governments around the world, including but not limited to, the United States, China, Japan, South Korea and Switzerland are weighing in and/or enacting regulatory policies regarding cryptocurrencies and ICOs. In the United States, Goldman Sachs Group Inc. recently announced that it is considering a new trading operation dedicated to bitcoin and other digital currencies.”
In addition, CIIX also has plans to launch a new cryptocurrency website under the domain name newcoin168.com to serve Chinese cryptocurrency investors. The site, expected to launch next month, will endeavor to be a leader in digital media and cryptocurrency and blockchain technology education providing straightforward explanations of cryptocurrency basics, trading guidelines, real-time market commentary and analysis regarding currency mining, blockchain technology, industry hotspots, sector-related stock trends and ETFs, and other strategies and opportunities to capitalize on the bitcoin market.
“After the recent launch of our Bitcoin Multimillionaire daily video newscast, the Company has decided to further expand its presence in the digital currency sector,” says Wang. “Similar to U.S. stocks, as the price of digital currency, such as Bitcoin, continues to increase, Chinese people all over the world are taking notice and seeking access to timely information regarding market trends, news, and analysis. We look forward to being the premier source for this information.”
About ChineseInvestors.com (OTCQB: CIIX)
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online and direct sales of hemp-based products and other health related products.
For more information visit ChineseInvestors.com
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Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776
Investor Relations:
Alan Klitenic
+1-214-636-2548
Corporate Communications:
NetworkNewsWire (NNW)
New York
+1-212-418-1217 Office
Editor@NetworkNewsWire.com
$PTSI Commences Self Tender Offer to Purchase up to 400,000 Shares
TONTITOWN, Ark., Oct. 10, 2017 — P.A.M. Transportation Services, Inc. (NASDAQ:PTSI) today announced the commencement of a modified “Dutch auction” tender offer to purchase up to 400,000 shares, or about 6.3%, of its outstanding common stock at a price of not less than $27.00 and not more than $30.00 per share. The tender offer will expire at 5:00 p.m., Eastern Time, on November 7, 2017, unless extended or withdrawn. The Company anticipates paying for the shares tendered in the offer from its available cash and cash equivalents and from funds borrowed under its existing line of credit. The Board of Directors determined that it is in the Company’s best interest to repurchase shares at this time given P.A.M.’s financial condition and stock price.
A modified “Dutch auction” tender offer allows stockholders to indicate how many shares and at what price(s) they wish to tender their shares within the specified price range. Based on the number of shares tendered and the prices specified by the tendering stockholders, the Company will determine the lowest price per share within the range that will allow it to purchase up to 400,000 shares of its common stock, or a lower amount depending on the number of shares properly tendered and not properly withdrawn. Stockholders whose shares are purchased in the offer will receive the determined purchase price per share in cash, without interest, after the expiration of the offer period, subject to the conditions of the tender offer, including the provisions relating to proration. All shares tendered at prices higher than the purchase price will not be purchased and will be promptly returned to stockholders. The tender offer is not conditioned upon any minimum number of shares being tendered; however, the tender offer is subject to a number of other terms and conditions. Specific instructions and an explanation of the terms and conditions of the tender offer are contained in the Offer to Purchase and related materials that are being mailed to stockholders.
P.A.M. Transportation has retained Computershare Trust Company, N.A. as the depositary for the tender offer and Georgeson LLC as the information agent.
Copies of the Offer to Purchase, the related Letter of Transmittal and the Notice of Guaranteed Delivery are being mailed to the Company’s stockholders. Additional copies of the Offer to Purchase, the related Letter of Transmittal or the Notice of Guaranteed Delivery may be obtained at the Company’s expense from the information agent at (800) 248-7690 (toll free). Questions regarding the tender offer should be directed to the information agent at (800) 248-7690 (toll free).
P.A.M. Transportation Services, Inc. is a leading truckload dry van carrier transporting general commodities throughout the continental United States, as well as in the Canadian provinces of Ontario and Quebec. The Company also provides transportation services in Mexico through its gateways in Laredo and El Paso, Texas under agreements with Mexican carriers.
Certain Information Regarding the Tender Offer
The information in this press release describing P.A.M. Transportation’s tender offer is for informational purposes only and does not constitute an offer to buy or the solicitation of an offer to sell shares of P.A.M. Transportation’s common stock in the tender offer. The tender offer is being made only pursuant to the Offer to Purchase and the related materials that P.A.M. Transportation is distributing to its stockholders, as they may be amended or supplemented. Stockholders should read such Offer to Purchase and related materials carefully and in their entirety because they contain important information, including the various terms and conditions of the tender offer. Stockholders of P.A.M. Transportation may obtain a free copy of the Tender Offer Statement on Schedule TO, the Offer to Purchase and other documents that P.A.M. Transportation is filing with the Securities and Exchange Commission from the Securities and Exchange Commission’s website at www.sec.gov. Stockholders may also obtain a copy of these documents, without charge, from Georgeson LLC, the information agent for the tender offer, toll free at (800) 248-7690. Stockholders are urged to carefully read all of these materials prior to making any decision with respect to the tender offer. Stockholders and investors who have questions or need assistance may call Georgeson LLC, the information agent for the tender offer, toll free at (800) 248-7690.
Note Regarding Forward-Looking Statements
Certain information included in this document contains or may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may relate to expected future financial and operating results or events, and are thus prospective. Such forward-looking statements are subject to risks, uncertainties and other factors which could cause actual results to differ materially from future results expressed or implied by such forward-looking statements. Potential risks and uncertainties include, but are not limited to, excess capacity in the trucking industry; surplus inventories; recessionary economic cycles and downturns in customers’ business cycles; increases or rapid fluctuations in fuel prices, interest rates, fuel taxes, tolls, license and registration fees; the resale value of the Company’s used equipment and the price of new equipment; increases in compensation for and difficulty in attracting and retaining qualified drivers and owner-operators; increases in insurance premiums and deductible amounts relating to accident, cargo, workers’ compensation, health, and other claims; unanticipated increases in the number or amount of claims for which the Company is self-insured; inability of the Company to continue to secure acceptable financing arrangements; seasonal factors such as harsh weather conditions that increase operating costs; competition from trucking, rail, and intermodal competitors including reductions in rates resulting from competitive bidding; the ability to identify acceptable acquisition candidates, consummate acquisitions, and integrate acquired operations; a significant reduction in or termination of the Company’s trucking service by a key customer; and other factors, including risk factors, included from time to time in filings made by the Company with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise. In light of these risks and uncertainties, the forward-looking events and circumstances discussed above and in company filings might not transpire.
Allen W. West
(479) 361-9111
$PPHM and SW Investment Additional Nomination to Board of Peregrine Pharmaceuticals
Biotech Industry Veteran James (Jamie) J. Egan Joins Slate of Four Highly Qualified Candidates for Election at Upcoming 2017 Annual Meeting Ronin Calls on Peregrine to Hold 2017 Annual Meeting without Further Delay
CHICAGO, Oct. 10, 2017 — Ronin Trading, LLC and SW Investment Management LLC (together with the other participants in their solicitation, “Ronin” or “we”), collectively the second largest stockholder of Peregrine Pharmaceuticals, Inc. (“Peregrine” or the “Company”) (NASDAQ:PPHM), with aggregate beneficial ownership of approximately 8.9% of the Company’s outstanding shares of common stock, today issued the following statement with respect to Peregrine.
We are excited to announce our additional nomination of James (Jamie) J. Egan, a 30-year biotech veteran, for election to Peregrine’s Board of Directors (the “Board”) at the Company’s 2017 annual meeting of stockholders (the “2017 Annual Meeting”). We believe Mr. Egan’s deep understanding of antibodies, history of senior operations roles at reputable companies in the biotech industry, and proven ability to execute large deals with major pharmaceutical firms make him ideally suited for the Board and a great complement to our previously announced slate of nominees (Gregory P. Sargen, Brian W. Scanlan and Saiid Zarrabian). Mr. Egan’s qualifications are discussed in greater detail below.
Ronin has put forth a slate of highly qualified candidates that we believe are capable of delivering stockholder value. Therefore, we are extremely frustrated that the Board continues to needlessly delay the 2017 Annual Meeting, an action that we believe benefits insiders at the expense of stockholders. It has been over ten weeks since Peregrine announced its intention to expand the size of the Board “from four to up to seven members through the addition of new highly-qualified independent directors,” yet incredibly, the Board still has not announced a single independent candidate for its slate of nominees. Stockholders should not be punished for the Board’s inability to identify qualified independent directors. Furthermore, we are dismayed that Peregrine’s first new director candidate, Dr. Roger Lias, is a Company insider rather than an independent member. Not only is it inappropriate for two Company insiders to serve on the Board, but this appointment directly contradicts Peregrine’s own statement about adding “independent” directors. We feel these actions are yet more evidence of the extraordinarily poor corporate governance practices at the Company and highlight the need for an overhaul of Peregrine’s leadership.
Considering that Peregrine’s past 15 annual meetings were held in October, it is blatantly obvious to us that the Company is stalling as a means to entrench the incumbents and insulate them from the will of Peregrine’s stockholders. To the extent the Company fails to promptly call the 2017 Annual Meeting, we intend to file suit in accordance with Delaware law to compel the holding of the meeting so we can continue this process of change.
James J. Egan (“Jamie”) currently serves as a strategic advisor to Numab AG, a Swiss biotech company that develops antibody-based therapeutics. From 2009 – 2012, Jamie was the Chief Operating Officer of Sucampo Pharmaceuticals, Inc., a publicly-traded global pharmaceutical company, during which time he worked closely with the company’s manufacturing partners. Prior to that, Mr. Egan served as Chief Business Officer of ESBATech AG, a privately held Swiss biotechnology company, from 2006 until its acquisition by Alcon S.A. for $589 million in 2009, which Mr. Egan facilitated. From 2001 – 2006, Jamie was Senior VP of Licensing and Corporate Development for biopharmaceutical company Idenix Pharmaceuticals, Inc. (“Idenix”), where he played an instrumental role in Novartis AG’s $255 million investment in the company as part of a strategic alliance that allowed Idenix to go public in 2004. Idenix was later acquired by Merck & Co. in 2014 for nearly $3.9 billion. Mr. Egan has also held senior operations roles at pharmaceutical company G.D. Searle & Co. and global healthcare company Abbott Laboratories in the 1980’s and 1990’s. Prior to becoming a biotech executive, Mr. Egan was a foreign services officer at the US embassy in Tokyo and an attorney with the Department of Justice. Mr. Egan is fluent in Japanese.
CERTAIN INFORMATION CONCERNING THE PARTICIPANTS
Ronin Trading, LLC, together with the other participants named herein (collectively, “Ronin”), has filed a preliminary proxy statement and an accompanying proxy card with the Securities and Exchange Commission (“SEC”) to be used to solicit votes for the election of its slate of four highly qualified director nominees at the 2017 annual meeting of stockholders Peregrine Pharmaceuticals, Inc., a Delaware corporation (the “Company”).
RONIN STRONGLY ADVISES ALL STOCKHOLDERS OF THE COMPANY TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS WILL BE AVAILABLE AT NO CHARGE ON THE SEC’S WEB SITE AT HTTP://WWW.SEC.GOV. IN ADDITION, THE PARTICIPANTS IN THIS PROXY SOLICITATION WILL PROVIDE COPIES OF THE PROXY STATEMENT WITHOUT CHARGE, WHEN AVAILABLE, UPON REQUEST.
The participants in the solicitation are Ronin Trading, LLC (“Ronin Trading”), John S. Stafford, III, SWIM Partners LP (“SWIM Partners”), SW Investment Management LLC (“SW Management”), Stephen White, James J. Egan, Gregory P. Sargen, Brian W. Scanlan and Saiid Zarrabian.
As of the date hereof, Ronin Trading directly beneficially owned 3,310,652 shares of the Company’s common stock, $0.001 par value per share (“Common Stock”), including 137,260 shares of Common Stock that may be acquired upon the conversion of 115,299 shares of the Company’s 10.50% Series E Convertible Preferred Stock, $0.001 par value per share (“Series E Preferred Stock”). Mr. Stafford, as the Manager of Ronin Trading, may be deemed to beneficially own the 3,310,652 shares of Common Stock beneficially owned directly by Ronin Trading. As of the date hereof, SWIM Partners directly beneficially owned 510,333 shares of Common Stock, including 10,333 shares of Common Stock that may be acquired upon the conversion of 8,680 shares of Series E Preferred Stock. As of the date hereof, an account separately managed by SW Management (the “SW Account”) held 203,714 shares of Common Stock, including 3,714 shares of Common Stock that may be acquired upon the conversion of 3,120 shares of Series E Preferred Stock. SW Management, as the general partner and investment adviser of SWIM Partners and the investment adviser of the SW Account, may be deemed to beneficially own the 714,047 shares of Common Stock beneficially owned in the aggregate by SWIM Partners and held in the SW Account. Mr. White, as the Manager of SW Management, may be deemed to beneficially own the 714,047 shares of Common Stock beneficially owned in the aggregate by SWIM Partners and held in the SW Account. As of the date hereof, Messrs. Egan, Sargen, Scanlan and Zarrabian did not beneficially own any securities of the Company.
Investor Contact:
Stephen White
SW Investment Management LLC
(312) 765-7033
$KALV Announces Collaboration with $MRK
CAMBRIDGE, Mass.
– Covers Development of Investigational Plasma Kallikrein Inhibitors for Treatment of Diabetic Macular Edema –
– $37 Million Upfront Fee Plus Potential Milestone Payments and Sales Royalties –
– Merck Acquires 9.9% Stake in KalVista in Private Placement –
– Investigational Intravitreal DME Candidate KVD001 Phase 2 Clinical Trial Still Planned to Initiate in 2017 –
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced that it has entered into a collaboration agreement with Merck, known as MSD outside the United States and Canada, through a subsidiary, for KVD001, the Company’s investigational intravitreal (IVT) injection candidate currently in development for potential treatment of diabetic macular edema (DME), as well as future oral DME compounds based upon plasma kallikrein inhibition.
“We are pleased to collaborate with Merck for the continuing development of KVD001 and future oral programs for patients with DME,” said Andrew Crockett, Chief Executive Officer of KalVista. “Plasma kallikrein inhibition is a novel approach to the treatment of DME that we believe may offer benefit to a significant number of patients, and an oral therapy particularly would represent a groundbreaking advance for treatment of this indication. We have always believed that development and commercialization of our DME therapies would require the resources of a large pharmaceutical company, and we believe Merck has the wherewithal and resources to help us advance development of our DME drug candidates. Importantly for KalVista, this collaboration also meets our strategic objectives of maintaining control of our oral HAE portfolio that we plan to develop independently. We look forward to providing more details about the Phase 2 trial for KVD001 in DME patients as the trial commences.”
Under the terms of the agreement, KalVista has granted to Merck certain rights including an option to acquire KVD001 through a period following completion of the Phase 2 proof-of-concept trial that KalVista intends to commence later this year. KalVista also has granted to Merck a similar option to acquire investigational orally delivered molecules for DME that KalVista will continue to develop as part of its ongoing research and development activities. As consideration for the agreement, Merck will pay to KalVista a $37 million non-refundable upfront fee. KalVista is further eligible to receive payments associated with the exercise of the options by Merck and the achievement of milestones for each program that potentially total up to $715 million. KalVista also will receive tiered royalties on net sales for therapeutic candidates commercialized under this agreement. KalVista will fund and retain control over the planned Phase 2 clinical trial of KVD001 as well as development of the investigational oral DME compounds through Phase 2, unless Merck exercises its options earlier.
In addition to the collaboration, KalVista has entered into a separate $9.1 million private placement transaction with Merck under which Merck has acquired 1,070,589 shares of KalVista, representing a 9.9% ownership stake, at a price of $8.50 per share. This private placement closed concurrent with execution of the Option Agreement.
“The KalVista team has already made important progress in advancing this candidate into the clinic. At Merck, we look forward to the opportunity to apply our expertise and resources upon the achievement of proof of concept for KVD001,” said Ben Thorner, senior vice president and Head of Business Development & Licensing Merck Research Laboratories. “Merck is seeking to collaborate on the development of candidates that we believe have the potential to transform practice in areas where there is a clear need for new and improved therapeutic options.”
The agreement with Merck covers only the investigational IVT and oral plasma kallikrein inhibitor programs for DME. KalVista retains full rights to its oral hereditary angioedema (HAE) portfolio, and will have the opportunity to select and develop future oral HAE compounds. KalVista intends to continue to aggressively pursue its efforts to develop a best-in-class oral therapy for HAE, as well as additional programs focused on other proteases.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body’s inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors from which it plans to select multiple drug candidates to advance into clinical trials for HAE. The first candidate of this planned portfolio, KVD818, is currently in a first-in-human study and additional program candidates are in preclinical development. KalVista’s most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, has successfully completed its first-in-human study in patients with DME and is being prepared for Phase 2 studies in 2017.
For more information, please visit www.kalvista.com.
Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding and future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 27, 2017, our most recent Quarterly Report on Form 10-Q, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
KalVista Pharmaceuticals, Inc.
Leah Monteiro, 857-999-0808
Director, Corporate Communications & Investor Relations
leah.monteiro@kalvista.com
$ANAB ANB020 in Atopic Dermatitis Positive Topline Data from Phase 2a Clinical
- 83 Percent of Patients Achieved EASI-50 at Day 29 Following a Single Dose of ANB020
- EASI-50 was Observed Early and Persisted Through Day 57
- Management to Host Conference Call Today at 8:30 a.m. EDT
SAN DIEGO, Oct. 10, 2017 — AnaptysBio, Inc. (Nasdaq:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced positive proof-of-concept data for ANB020, its investigational anti-IL-33 therapeutic antibody, in an ongoing Phase 2a clinical trial in adult patients with moderate-to-severe atopic dermatitis. After a single dose of ANB020, 75 percent of patients achieved an Eczema Area Severity Index (EASI) score improvement of 50 percent relative to enrollment baseline (EASI-50) at day 15, 83 percent of patients achieved EASI-50 at day 29 and 75 percent of patients achieved EASI-50 at day 57. All 12 patients achieved EASI-50 at one or more timepoints through Day 57 post-ANB020 administration. ANB020 was generally well tolerated in all patients as of this interim analysis.
“Moderate-to-severe atopic dermatitis is a serious disease associated with chronic skin inflammation and debilitating pruritus, with a clear unmet medical need,” said Dr. Graham Ogg, professor of dermatology at University of Oxford and primary investigator of the Phase 2a study. “The rapid and sustained benefit observed in patients after a single dose of ANB020 is an encouraging interim result from this trial. I look forward to the continued development of ANB020 as a potential future therapeutic option for patients suffering from this disease.”
Phase 2a Trial Design
The Phase 2a proof-of-concept trial enrolled 12 moderate-to-severe adult atopic dermatitis patients, who were initially administered a single intravenous dose of placebo within 14 days of enrollment, followed by a single intravenous 300mg dose of ANB020 one week subsequent to placebo. Clinical response was assessed by the improvement of each patient’s EASI score, a tool used to measure the extent and severity of atopic dermatitis, at key time points following ANB020 administration relative to their enrollment baseline. Pruritus, also known as itchiness, as measured by the 5-D pruritus scale score, was also assessed for each patient. Exploratory mechanistic biomarkers included granulocyte infiltration and cytokine levels in localized skin lesions measured five days after placebo administration and five days after ANB020 administration.
Interim Analysis
An interim analysis conducted after all 12 patients had reached day 57 following ANB020 single administration, indicates the following:
- The average baseline EASI score upon enrollment was 32. The average EASI score reduction and pruritus score reduction at seven days post-placebo administration was four percent and 10 percent, respectively. All 12 patients were inadequately controlled by topical corticosteroids and seven were treated with systemic non-biologic anti-inflammatory therapy prior to the screening washout period of this trial.
- Rapid clinical response was observed at day 15 post-ANB020 administration with nine of 12 patients (75 percent) achieving EASI-50, of which three patients (25 percent) also achieved EASI score improvement of 75 percent relative to baseline (EASI-75). The average EASI score reduction at day 15 was 58 percent and the average pruritus reduction was 28 percent relative to baseline.
- At day 29 post-ANB020 administration, 10 of 12 patients (83 percent) achieved EASI-50, of which four patients (33 percent) also achieved EASI-75. The average EASI score reduction at this time point was 61 percent and the average pruritus reduction was 32 percent relative to baseline.
- Sustained clinical response was observed at day 57 post-ANB020 administration, with nine of 12 patients (75 percent) achieving EASI-50, of which five patients (42 percent) also achieved EASI-75. Average EASI reduction was 62 percent and the average pruritus reduction was 21 percent relative to baseline.
- Exploratory biomarker assessment indicated reduction of granulocyte infiltration into localized skin lesions by an average of 30 percent amongst all patients and 60 percent among the 10 patients achieving EASI-50 at 29 days post-ANB020 administration, while exploratory cytokine biomarker levels were below detection limit and therefore inconclusive.
- ANB020 was generally well-tolerated by all patients and no severe adverse events have been reported to date. The most frequent treatment-emergent adverse events reported were mild dizziness in two patients subsequent to placebo dosing, and mild headache in two patients post-ANB020 administration.
“We are very encouraged by the efficacy results to date in this Phase 2a study, which exemplify our strategic focus on developing first-in-class anti-inflammatory antibody therapeutics to help patients suffering from debilitating inflammatory diseases,” said Hamza Suria, president and chief executive officer of AnaptysBio. “We look forward to further advancing the development of ANB020 for the treatment of patients with atopic diseases.”
The Phase 2a study is currently ongoing and EASI scores will be assessed for each patient up to 140 days post-ANB020 treatment. The company plans to report full data from this trial at a medical conference following study completion.
During the first half of 2018, AnaptysBio plans to initiate a Phase 2b randomized, double-blinded, placebo-controlled study in 200-300 adult patients with moderate-to-severe atopic dermatitis to evaluate multi-dose subcutaneous administration of ANB020, with data expected in 2019.
AnaptysBio also continues to advance its ongoing ANB020 Phase 2a studies in adults with severe peanut allergy with topline data expected in the fourth quarter of 2017, and adults with severe eosinophilic asthma with topline data expected in the first half of 2018.
Conference Call & Webcast Information
The AnaptysBio management team will host a conference call and live webcast with slides with the investment community today, Tuesday, October 10, 2017, at 8:30 a.m. EDT to discuss the information in this press release.
When: October 10, 2017, 8:30 a.m. EDT
Dial-in: (833) 696-8361 (domestic) or (430) 775-1625 (international)
Conference ID: 93436997
The live webcast and accompanying slides can be accessed under the investor relations section of AnaptysBio’s website at www.anaptysbio.com. A replay of the conference call will be archived under the investor relations section of the AnaptysBio website for 30 days shortly after the call.
About ANB020
ANB020 is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, including asthma, food allergies and atopic dermatitis. Following completion of a healthy volunteer Phase 1 trial of ANB020, AnaptysBio is continuing clinical development of ANB020 into Phase 2a studies for moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and severe adult eosinophilic asthma.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (ANB020) for the treatment of moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and severe adult eosinophilic asthma; its anti-IL-36R antibody (ANB019) for the treatment of rare inflammatory diseases, including generalized pustular psoriasis and palmo-plantar pustular psoriasis; and a portfolio of checkpoint receptor agonist antibodies for the treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated and have demonstrated efficacy in an animal model of graft-versus-host disease. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation (SHM) platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO and an inflammation partnership with Celgene, including an anti-PD-1 antagonist antibody (TSR-042), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), which are currently under clinical development with TESARO, and an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the clinic with Celgene.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the anticipated timing of the release of data from AnaptysBio’s clinical trials, including ANB020’s Phase 2a clinical trials for the treatment of moderate-to-severe adult atopic dermatitis, severe peanut allergy and severe adult eosinophilic asthma and planned Phase 2b clinical trial of ANB020 for the treatment of moderate-to-severe adult atopic dermatitis, AnaptysBio’s ability to launch a Phase 2b clinical trial of ANB020 for the treatment of moderate-to-severe adult atopic dermatitis and the anticipated timing thereof, the potential of ANB020 as an effective future therapeutic option for patients with moderate-to-severe adult atopic dermatitis and AnaptysBio’s ability to further advance the development of ANB020 for the treatment of patients with atopic diseases. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ materially from those expressed or implied in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Contacts:
Monique Allaire
THRUST Investor Relations
617.895.9511
monique@thrustir.com
Chelcie Lister
THRUST Investor Relations
910.777.3049
chelcie@thrustir.com
$STLHF Update on Exploration and Process Testing Program at Bristol Dry Lake
VANCOUVER, British Columbia, Oct. 10, 2017 — Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSX-V:SLL) (FRA:S5L) (OTCQX:STLHF) is pleased to provide an update on the exploration and process testing program at the Company’s Bristol Dry Lake lithium brine project located in the Mojave Desert, California.
Building on the promising results of its recently completed large-scale geophysical surveys, the Company has commenced a resource definition drill program on its approximately 25,000 acre Bristol Dry Lake lithium brine project. The objectives of the intrusive exploration program are to establish the lithium grade of the subsurface brine across Standard’s extensive landholdings within the large salar; to determine depth and lateral extent of the brine; and also to define key geological and hydrogeological data that will be required in order to develop a maiden resource estimate. The Company has received all required permits and approvals from Federal and County regulators to conduct the exploration drilling program. Two drill rigs have commenced work on site and the Company’s team of senior geologists and hydrogeologists are supervising all work.
In addition to the geophysical and intrusive exploration programs, the Company has collected and shipped bulk raw brine samples from Bristol Dry Lake to several leading lithium brine assessment and process technology firms across North America. These firms have begun a series of lab-scale process testing studies of the Bristol Dry Lake brine and will begin determining the most efficient and effective process technologies to optimize lithium recovery from this important U.S. mineral brine bearing resource. The Company has also completed preliminary evaporation pond process testing work at the Bristol Dry Lake project site. The initial test work consisted of taking raw brines gathered from near-surface test pits (depth to lithium brine at the project is typically 5-20 ft (1.5-6 m)) and pumping the brine into three shallow plastic-lined ponds that were partially buried to avoid heating effects on the walls of the ponds. Brine samples and field parameters were taken on a weekly schedule, and samples were sent for chemical analysis to a qualified laboratory in Sparks, NV. The data from this first round of evaporation pond testing showed that the raw brine pumped from the near-surface test-pit contained an average concentration of 146 mg/L lithium, and that within a period of 4 weeks, the brine was concentrated by passive solar evaporation to an average lithium concentration of 556 mg/L (max. 717 mg/L). These short-duration evaporation tests will be repeated several times throughout the year, so that seasonal effects can be quantified. Data developed from this short-duration evaporation pond work will be incorporated into the ongoing process-testing work being conducted by leading North American process technology firms.
Standard Lithium’s President and COO, Dr. Andy Robinson commented, “Standard’s exploration and process-testing programs are now fully underway and being completed in parallel by our highly experienced resource assessment and chemical engineering teams. The amount of work that we’ve been able to complete in such a short period of time is evidence of our fast-track development philosophy, and speaks volumes to the constructive relationships that we have in place with the existing fully-permitted brine producers in operation at Bristol Dry Lake. All of the work being completed right now will be used to support the maiden 43-101 resource estimate for the Bristol Dry Lake lithium brine project, estimated for the first half of 2018”.
Quality Assurance
Raymond Spanjers, Certified Professional Geologist (SME No. 3041730), is a qualified person as defined by NI 43-101, and has supervised the preparation of the scientific and technical information that forms the basis for this news release. Mr. Spanjers is not independent of the Company as he is an officer in his role as Vice President, Exploration and Development.
About Standard Lithium
Standard’s value creation strategy encompasses acquiring a diverse and highly prospective portfolio of large-scale domestic brine resources, led by an innovative and results-oriented management team with a strong focus on technical skills. The Company is currently focused on the immediate exploration and development of the Bristol Dry Lake Lithium Project located in the Mojave region of San Bernardino County, California; the location has significant infrastructure in-place, with easy road and rail access, abundant electricity and water sources, and is already permitted for extensive brine extraction and processing activities. The Company is also commencing due diligence and resource evaluation on 33,000 acres of lithium brine leases located in the Smackover Formation.
Standard Lithium is listed on the TSX Venture under the trading symbol “SLL”; quoted on the OTCQX under the symbol “STLHF”; and on the Frankfurt Stock Exchange under the symbol “S5L”. Please visit the Company’s website at www.standardlithium.com.
For further information, contact Anthony Alvaro at 604.240.4793.
On behalf of the Board,
Standard Lithium Ltd.
Robert Mintak, CEO & Director
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release may contain certain “Forward-Looking Statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. When used in this news release, the words “anticipate”, “believe”, “estimate”, “expect”, “target, “plan”, “forecast”, “may”, “schedule” and other similar words or expressions identify forward-looking statements or information. These forward-looking statements or information may relate to future prices of commodities, accuracy of mineral or resource exploration activity, reserves or resources, regulatory or government requirements or approvals, the reliability of third party information, continued access to mineral properties or infrastructure, fluctuations in the market for lithium and its derivatives, changes in exploration costs and government regulation in Canada and the United States, and other factors or information. Such statements represent the Company’s current views with respect to future events and are necessarily based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social risks, contingencies and uncertainties. Many factors, both known and unknown, could cause results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements. The Company does not intend, and does not assume any obligation, to update these forward-looking statements or information to reflect changes in assumptions or changes in circumstances or any other events affections such statements and information other than as required by applicable laws, rules and regulations.
Neither the Company, nor National Chloride makes any representations as to the value of lease rights associated with National Chloride’s Bristol Lake mineral claims (the “Property”), the availability of any particular resource or minerals on the Property, or the merits of any proposed exploration work to be completed on the Property. National Chloride expressly disclaims any responsibility for the adequacy or accuracy of disclosure made by the Company in respect of the Property. Readers are cautioned that a “Qualified Person”(as that term is defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects) has not done sufficient work to specify any mineral resource or reserve on the Property.
$CGEN First-in-Class Novel Cancer Therapy? New Immunomodulatory Target Discovered
Supportive data generated as part of collaboration with the Johns Hopkins University School of Medicine Multi-year research collaboration with Johns Hopkins University School of Medicine extended for additional targets
HOLON, Israel, Oct. 9, 2017 — Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, disclosed new data demonstrating the potential of CGEN-15032 as a target for the development of first-in-class cancer therapy. CGEN-15032 is a novel myeloid and epithelial immuno-oncology target, which may serve as an immuno-suppressive target within the tumor microenvironment. Addressing the immuno-suppressive environment of the tumor through myeloid drug targets has the potential for developing treatments that may expand the patient population responsive to current treatments.
The data, demonstrating the target’s immunomodulatory effect and its effect on tumor growth, were generated as part of the research collaboration with the Johns Hopkins University School of Medicine (JHU), under the direction of Prof. Drew Pardoll, MD, PhD, Director of the Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins and Chairman of Compugen’s Scientific Advisory Board.
Compugen also announced today the extension of its multi-year immuno-oncology research collaboration with JHU. The research collaboration, originally announced in December 2014 is now expanded to include new additional targets discovered by Compugen which have the potential to serve as a basis for the development of cancer immunotherapy treatments. This highly valuable collaborative research provides ongoing assessment of the biology and mechanisms of action of Compugen’s novel immune checkpoint proteins and expedites their expected translation towards the clinic.
Anat Cohen-Dayag, PhD, President and CEO of Compugen said, “The data we achieved with CGEN-15032, together with JHU exemplifies the tremendous value of our collaboration, providing us with access to world-class immuno-oncology knowledge and expertise to successfully develop our immuno-oncology programs, and accelerate their path towards future human testing.”
CGEN-15032 was discovered by the Company’s immune checkpoint discovery platform, which also served as the cornerstone for the identification of TIGIT and PVRIG – two novel immune checkpoints which are currently in preclinical development by Compugen. Tumor growth in CGEN-15032-deficient mice (knock-out mice) is reduced relative to wild-type mice, and treatment of CGEN-15032-deficient mice with an anti-PD-L1 antibody further reduced tumor growth as compared with anti-PD-L1 treated wild-type mice. Together, these data suggest that CGEN-15032 may serve as an immuno-suppressive component of the tumor microenvironment, and that drugs inhibiting CGEN-15032 either alone or in combination with checkpoint inhibitors may activate anti-cancer immune responses.
CGEN-15032 was the subject of both an oral and a poster presentation at the 3rd annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference, in Mainz/Frankfurt, Germany. The poster is available on the Publications page of Compugen’s website.
About Compugen
Compugen is a therapeutic discovery and development company utilizing its broadly applicable predictive discovery infrastructure to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. The Company’s therapeutic pipeline consists of immuno-oncology programs against novel drug targets it has discovered, including T cell immune checkpoints and myeloid target programs. Compugen’s business model is to selectively enter into collaborations for its novel targets and related drug product candidates at various stages of research and development. The Company is headquartered in Israel, with R&D facilities in both Israel and South San Francisco, CA. Compugen’s shares are listed on NASDAQ and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen’s corporate website at http://www.cgen.com.
Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of terminology such as “will,” “may,” “expects,” “anticipates,” “believes,” “potential,” “plan,” “goal,” “estimate,” “likely,” “should,” and “intends,” and describe opinions about possible future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: Compugen’s business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model. Moreover, the development and commercialization of therapeutic candidates involve many inherent risks, including failure to progress to clinical trials or, if they progress to or enter clinical trials, failure to receive regulatory approval. These and other factors are more fully discussed in the “Risk Factors” section of Compugen’s most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Company contact:
Elana Holzman
Director, Investor Relations and Corporate Communications
Compugen Ltd.
E-mail: elanah@cgen.com
Tel: +972(3)765-8124
$ICHR Enters into Substantial Agreement to Produce Liquid Delivery Systems
FREMONT, Calif.
Ichor Holdings, Ltd. (NASDAQ:ICHR) today announced that the company has entered into a substantial agreement to produce liquid delivery systems for one of its key customers.
The agreement provides for design and manufacturing of Ichor’s proprietary Liquid Delivery Systems to be integrated with semiconductor process equipment for one of Ichor’s key customers. “These systems incorporate our unique design which reduces the footprint required on our customer’s equipment and significantly reduces the cost,” said Phil Barros, Chief Technology Officer for Ichor. “We are excited to enter into this relationship and look forward to expanding into other applications with this customer as well as other customers who have expressed interest in our technology.”
He added, “Being able to collaborate with our customers has been the single most important factor in us helping to make them successful. We will continue to follow that approach and expect to realize significant growth as we continue to provide our customers the value they need to compete in the marketplace.”
About Ichor Holdings
Ichor is a leader in the design, engineering and manufacturing of critical fluid delivery subsystems for semiconductor capital equipment. Our primary offerings include gas and chemical delivery subsystems, collectively known as fluid delivery subsystems, which are key elements of the process tools used in the manufacturing of semiconductor devices. Our gas delivery subsystems deliver, monitor and control precise quantities of the specialized gases used in semiconductor manufacturing processes such as etch and deposition. Our chemical delivery subsystems precisely blend and dispense the reactive liquid chemistries used in semiconductor manufacturing processes such as electroplating and cleaning. We also manufacture certain components for internal use in fluid delivery systems and for direct sales to our customers. This vertically integrated portion of our business is primarily focused on metal and plastic parts that are used in gas and chemical systems, respectively. Ichor is headquartered in Fremont, CA. www.ichorsystems.com.
Safe Harbor Statement
This press release contains forward-looking statements that may state Ichor’s or its management’s intentions, beliefs, expectations or predictions for the future. Such forward-looking statements are subject to certain risks, uncertainties and assumptions, and typically can be identified by the use of words such as “will,” “expect,” “estimate,” “anticipate,” “forecast,” “plan,” “believe,” and similar terms. Although Ichor believes that its expectations are reasonable, it can give no assurance that these expectations will prove to have been correct, and actual results may vary materially. Factors that could cause actual results to differ materially from those contemplated above include, among others, risks and uncertainties related to the capital markets. Any forward looking information presented herein is made only as of the date of this press release, and Ichor does not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise.
Ichor Holdings, Ltd.
Norm Haas, 1-510-897-5200
IR@ichorsystems.com
$INTT Research Coverage Initiated by Dougherty & Company and Sidoti & Company
MOUNT LAUREL, N.J., Oct. 09, 2017 — inTEST Corporation (NYSE MKT:INTT), a designer and manufacturer of temperature management products and semiconductor automatic test equipment (ATE) interface solutions, today announced the initiation of coverage by two Wall Street research firms: Dougherty & Company LLC and Sidoti & Company, LLC.
Dougherty & Company, LLC
Dougherty & Company, LLC, initiated research coverage on inTEST in a detailed report published on October 6, 2017. The report was recently disseminated to customers of Dougherty. Distribution and reproduction of the report in any form is solely at the discretion of Dougherty. Interested investors can obtain a copy of the firm’s research by contacting their Dougherty sales person.
Sidoti & Company, LLC
Sidoti & Company, LLC, initiated research coverage on inTEST in a detailed report published on September 5, 2017. inTEST’s research by Sidoti is part of the firm’s Company Sponsored Research. The report was disseminated to customers of Sidoti. A copy of the initiation report is available on the IR page of inTEST’s website: http://investor.shareholder.com/intest/analyst.cfm. Updates to the report will be published on the site as the firm issues them.
Disclaimer
inTEST Corporation neither verifies, affirms nor endorses the analysis, estimates, valuation, conclusions, opinions, ratings, or financial models published by any third party firms and individuals. inTEST does not by its reference or distribution imply its endorsement of or concurrence with such information, conclusions or recommendations. All of the views, opinions and conclusions expressed as part of any third party reports are strictly the personal views of the author and/or the publishing firm, and therefore may not be consistent with those of inTEST, its management team and its Board of Directors. inTEST recommends that all investors carefully read the public disclosures, risk factors and filings made by the Company through its SEC filings and/or public newswire services.
About inTEST Corporation
inTEST Corporation designs and manufactures engineered solutions for ATE and other electronic test, as well as industrial process applications. Our products are used by semiconductor manufacturers to perform development, qualifying and final testing of integrated circuits (ICs) and wafers, and for other electronic test across a range of industries including the automotive, defense/aerospace, energy, industrial and telecommunications markets. We offer induction heating products for joining and forming metals in a variety of industrial markets, including automotive, aerospace, machinery, wire & fasteners, medical, semiconductor, food & beverage, and packaging. Specific products include temperature management systems, induction heating products, manipulator and docking hardware products, and customized interface solutions. We have established strong relationships with our customers globally, which we support through a network of local offices. For more information visit www.intest.com.
CONTACTS:
Hugh T. Regan, Jr.
Treasurer and Chief Financial Officer
inTEST Corporation
Tel: 856-505-8999
Laura Guerrant-Oiye, Principal
Guerrant Associates
lguerrant@guerrantir.com
Tel: (808) 960-2642
$CLNT Exclusivity Agreement with Inspirit Studio Regarding Potential Acquisition
HONG KONG, Oct. 9, 2017 — Cleantech Solutions International, Inc. (“Cleantech Solutions” or “the Company”) (NASDAQ: CLNT) today announced that its wholly-owned subsidiary, Sharing Economy Investment Limited (“SEI”), has entered into an exclusivity agreement with Inspirit Studio, regarding a potential acquisition by SEI of not less than 51% of Inspirit Studio.
Inspirit Studio develops and runs a sharing economy mobile platform called Anyway, which allows people to provide courier delivery services during their commuting times. Anyway connects senders and freelance couriers who are willing to deliver parcels/letters for senders in return for income. It is a low cost and fast delivery solution which allows freelance couriers to earn income by sharing their journeys. “Anyway resolves problems that the current courier services have,” said Kurt Tam, CEO of Inspirit Studio. “With Anyway, senders can get speedy responses to contact with our freelance couriers who are in close proximity to the senders. There is no limitation on service area and business hours. With a five-month pilot program in Hong Kong, we have signed up over 2,000 freelance couriers, with over successful 6,000 transactions.”
“Anyway is a true sharing solution that can also bridge with many sharing economy platforms that we are developing,” said Parkson Yip, COO of Cleantech Solutions. “We are excited to work with Anyway to further fine tune their solution and integrate with other sharing economy platforms. Peer-to-peer courier services can play a big role in communities where we often want helpers to run errands, or simply bring items home from other locations, without taking the extra time out of our schedules. We look forward to making peer-to-peer courier services available globally.”
According to iimediaResearch, the number of users participating in the peer-to-peer delivery sharing market in China has grown from 124 million in 2014 to 231 million in 2016, and experts expect it to grow to 353 million by 2018. Approximately 1.4 billion transactions were recorded in the first quarter of 2017.
About Cleantech Solutions International
Cleantech Solutions, through its affiliated companies, designs, manufactures and distributes a line of proprietary high and low temperature dyeing and finishing machinery to the textile industry. The Company’s latest business initiatives are focused on targeting the technology and global sharing economy markets, by developing online platforms and rental business partnerships that will drive the global development of sharing through economical rental business models.
About Inspirit Studio
Inspirit Studio has been engaging in developing a mobile app platform which provides instant errand services in peer to peer model. Its vision is to create an innovative consumption pattern and improve life quality by effectively reallocating idle resources in communities. Income is mainly generated from commission charged on each errand service transaction, apart from that, it will diversify its revenue stream by introducing advertising business and big data analytic. The upcoming mission is to expand its errand network, continuously optimize its business model, integrate into the ecosystem of the Group and join together into a global network.
Safe Harbor Statement
This release contains certain “forward-looking statements” relating to the business of the Company and its subsidiary and affiliated companies and certain potential transactions that they may enter into. These forward looking statements are often identified by the use of forward looking terminology such as “believes,” “expects” or similar expressions. Such forward looking statements involve known and unknown risks and uncertainties that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website, including factors described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K for the year ended December 31, 2016 and in our Form 10-Q for the quarter ended June 30, 2017. All forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by these factors other than as required under the securities laws. The Company does not assume a duty to update these forward-looking statements.
Company Contacts:
Cleantech Solutions International, Inc.
Parkson Yip, COO
E-mail: parkson.yip@cleantechsolutionsinternational.com
+852-31060372
Web: www.cleantechsolutionsinternational.com
Compass Investor Relations
Elaine Ketchmere, CFA
Email: eketchmere@compass-ir.com
+1-310-528-3031
Web: www.compassinvestorrelations.com
$CIIX SeeThruEquity Issues Update on ChineseInvestors.com Inc. (OTCQB: CIIX)
NEW YORK, NY / October 9, 2017 / SeeThruEquity, the leading independent equity research firm focused on smallcap and microcap public companies, today announced it has issued an update note on ChineseInvestors.com, Inc. (OTCQB: CIIX).
The report is available here: CIIX October 2017 Update Note.
ChineseInvestors.com, Inc. (OTCQB: CIIX, “CIIX”) is a relatively undiscovered specialized investment services company with several intriguing business lines high growth potential and a compelling valuation based on previous peak cycle earnings. With headquarters in Los Angeles, CA, and offices in Shanghai and New York, CIIX offers a range of intriguing consulting services, information products, and web-based tools for investor education, including real-time market commentary, analysis and education in Chinese language character sets. In the last year, CIIX has also begun to make several announcements that will position the company to operate in the global cannabis industry, a new and quickly growing market with large potential. CIIX will initially be focused on the Cannabidiol (CBD) market, one of the fastest growing segments of the legal cannabis market. The company has launched what management believes is the first CBD health products online store in the Chinese Language, and a Chinese language Yelp-style mobile application that will contain a location-enabled database of recreational and medical marijuana dispensaries, as well as a platform to review and discuss various cannabis products.
Highlights from the update are as follows:
CIIX announces FY 2017 results with 75.9% growth
On September 12, 2017, CIIX announced its full year fiscal 2017 (ended May 31, 2017) results. The company reported revenue growth of 75.9% over 2016, with revenues rising sharply in both its Investor Relations segment as well as its Subscriptions services segment. Management attributed the growth to prudent actions taken last year to elevate the quality of investor relations clients, as well as increased focus on new products and better execution in its subscription businesses. Key initiatives in CIIX’s financial services news and subscription businesses include an upgrade to the company’s Chinese language US stocks live video platform, as well as the improvements to the “real-money trading” platform for paid VIP subscribers. Additionally, on August 14, 2017, CIIX announced a new cryptocurrency education and trading subscription service for Chinese-speaking investors, which will provide news, video and analysis covering the emerging digital currency market.
CIIX advances growth plans for cannabidiol (CBD) health products
CIIX continues to establish businesses focused on the emerging market for cannabidiol (CBD). On September 18, 2017, the company announced that its wholly owned foreign subsidiary CBD Biotechnology Co. Ltd., completed the record filing process with the China Food & Drug Administration (‘CFDA’) for its first line of non-industrial hemp-infused skin care products. CIIX has high expectations for its new “CBD Magic Hemp” skin care line. Indeed data from Euromonitor estimated that retail sales of skincare products and make-up products in China reached RMB169.1 billion and RMB28.3 billion respectively in 2016, with Skincare representing the fastest growing sector of the cosmetics market. In the announcement, management stated that it has already engaged a large processing factory in Shanghai with more than 14 years of experience in cosmetics production, and that it expects to begin its commercial launch prior to the end of 2017.
Price target unchanged at $3.75
We are leaving the price target unchanged at this time for CIIX. The price target reflects the significant growth potential from the company’s legal CBD initiatives in the US and the hemp CBD-infused skin care products in China, in addition to growth from its existing financial services businesses.
Please review important disclosures at www.seethruequity.com.
About ChineseInvestors.com, Inc.
ChineseInvestors.com, Inc., (CIIX), headquartered in Los Angeles, with offices in New York City and Shanghai China, is a Company that engages in providing a wide range of products, services, and information for the global Chinese speaking population. Founded in 1999, CIIX endeavors to be an innovative company providing (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) support services to various partners; (c) consultative services to smaller private companies considering becoming a public company; (d) advertising and public relation related support services; and (e) other services we may identify having the potential to create value or partnership opportunity with our existing services. http://www.Chinesefn.com.
The Company is now beginning to change its focus of solely being a premier Internet information provider by expanding into retail and online sales of CBD products via its new website: http://www.ChineseCBDoil.com.
Information on CIIX can be found at http://www.ChineseInvestors.com.
About SeeThruEquity
Since its founding in 2011, SeeThruEquity has been committed to its core mission: providing impactful, high quality research on underfollowed smallcap and microcap equities. SeeThruEquity has pioneered an innovative business model for equity research that is not paid for and is unbiased. SeeThruEquity is the host of acclaimed investor conferences that are the ultimate event for publicly traded companies with market capitalizations less than $1 billion.
SeeThruEquity is approved to contribute its research reports and estimates to Thomson One Analytics (First Call), the leading estimates platform on Wall Street, as well as Capital IQ and FactSet. SeeThruEquity maintains one of the industry’s most extensive databases of opt-in institutional and high net worth investors. The firm is headquartered in Midtown Manhattan in New York City.
For more information visit www.seethruequity.com.
Contact:
SeeThruEquity
info@seethruequity.com
$SBPH Two Presentations at the 2017 AASLD Conference in D.C.
HOPKINTON, Mass., Oct. 06, 2017 – Spring Bank Pharmaceuticals, Inc. (NASDAQ:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced two presentations at the annual American Association for the Study of Liver Disease (AASLD) conference (The Liver Meeting®) being held in Washington, D.C. on October 20-24, 2017. The first is an oral presentation entitled: “SB 9200 an oral selective immunomodulator is safe and efficacious in treatment-naïve, non-cirrhotic HBV patients: Results from Cohort 1 of the ACHIEVE trial,” and the second is a late-breaker poster presentation entitled: “Novel anti-viral activity of SB 9200, a RIG-I agonist; results from Cohort 1 of the ACHIEVE trial.”
“SB 9200 is a novel and exciting potential oral therapy with promising antiviral activity, and we are excited to see Professors Yuen and Locarnini, leaders in the field of clinical Hepatology and Virology, present data at this prestigious conference from the first low dose cohort of the ACHIEVE trial showing promising results of SB 9200 in patients with hepatitis B,” said Nezam Afdhal, M.D., D.Sc., Chief Medical Officer, Spring Bank Pharmaceuticals.
The annual AASLD conference will highlight the latest liver diseases research and discuss treatment outcomes with physicians, researchers and healthcare practitioners involved in the science and practice of hepatology. The abstracts will be presented at the conference as follows:
Title: | SB 9200 an oral selective immunomodulator is safe and efficacious in treatment-naïve, non-cirrhotic HBV patients: Results from Cohort 1 of the ACHIEVE trial |
Author: | M.F. Yuen et al |
Session: | Parallel Session 5: Hepatitis B New Therapies |
Date: | October 22, 2017 |
Time: | 10:30 am – 10:45 am |
Title: | Novel anti-viral activity of SB 9200, a RIG-I agonist; results from Cohort 1 of the ACHIEVE trial |
Author: | S. Locarnini et al |
Session: | Late-Breaking Poster Session |
Date: | October 23, 2017 |
Time: | 12:30 pm – 2:00 pm |
About Spring Bank
Spring Bank Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleic acid hybrid (SMNH) chemistry platform. SMNH compounds are small segments of nucleic acids that the company designs to selectively target and modulate the activity of specific proteins implicated in various disease states. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases, including hepatitis B virus (HBV) and other SMNH product candidates, including SB 11285, the Company’s lead immunotherapeutic agent for the treatment of selected cancers through the activation of the STimulator of INterferon Genes, or STING, pathway.
Forward-Looking Statements
Statements in this press release about Spring Bank’s future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may 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 whether Spring Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Spring Bank’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Spring Bank’s product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Spring Bank’s Annual Report on Form 10-K for the year ended December 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on February 14, 2017, Spring Bank’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, which was filed with the SEC on July 31, 2017, and in other filings Spring Bank makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Spring Bank’s views as of the date hereof. Spring Bank anticipates that subsequent events and developments will cause Spring Bank’s views to change. However, while Spring Bank may elect to update these forward-looking statements at some point in the future, Spring Bank specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spring Bank’s views as of any date subsequent to the date hereof.
Contacts
For investor inquires:
Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993
LifeSci Advisors, LLC
Andrew McDonald
(646) 597-6987
Andrew@lifesciadvisors.com
$GSM Provides Update on Trade Cases in the United States and Canada
LONDON, Oct. 06, 2017 — Ferroglobe PLC (NASDAQ:GSM) (“Ferroglobe” or the “Company”) has received news this week on two significant trade cases in which it is involved: the Department of Commerce’s (“DOC”) preliminary determinations imposing antidumping duties on silicon metal imports into the United States, and the Canada Border Services Agency’s (“CBSA”) final decision on anti-dumping and subsidy duties against silicon imports into Canada.
United States
On October 5, 2017, the United States’ Department of Commerce announced preliminary determinations in the antidumping investigations on silicon metal. The DOC initiated its antidumping investigations in response to a petition filed earlier this year by the leading United States producer of silicon metal, Globe Specialty Metals, Inc., a subsidiary of Ferroglobe, against these three countries. The DOC determined antidumping duty rates of:
Country | Producer | Dumping Rate | |||
Australia | Simcoa | 20.79% | |||
All others | 20.79% | ||||
Brazil | Dow Corning | 56.78% | |||
LIASA | 134.92% | ||||
All others | 56.78% | ||||
Norway | Elkem | 3.74% | |||
All others | 3.74% | ||||
The resulting cash deposit requirements will go into effect when the preliminary determinations are published in the Federal Register and will apply to silicon metal imported into the United States on or after that date. The determinations are likely to be published next week.
Globe Specialty Metals filed trade actions targeting two different types of unfair practices. In addition to the antidumping cases against imports from Australia, Brazil, and Norway (which address unfairly low import pricing), the Company filed countervailing duty cases against imports from Australia, Brazil, and Kazakhstan (which address unfair government subsidization). The DOC made affirmative preliminary determinations in the countervailing duty cases on August 7, 2017. On a combined basis, the preliminary duty rates resulting from the antidumping and countervailing duty cases are as follows:
Country | Producer | Total rate | |||
Australia | All exporters | 37.02% | |||
Brazil | Dow Corning | 59.93% | |||
LIASA | 186.45% | ||||
All others | 59.93% | ||||
Kazakhstan | All exporters | 120% | |||
Norway | All exporters | 3.74% | |||
Based on official United States import data for 2016, more than 63% of silicon metal imports into the U.S. will now be subject to cash deposit requirements.
Canada
On October 3, 2017, the CBSA issued its final decision on anti-dumping and subsidy duties for silicon metal imports into Canada. The CBSA’s final decision is consistent with the preliminary determinations issued in July 2017, with a few changes. While the CBSA terminated the dumping investigation against Brazilian silicon metal producer, RIMA Industrial S.A. it has now imposed a dumping margin against Polymet Alloys Inc., which has a longstanding commercial relationship with RIMA. Further, while the CBSA terminated the dumping finding against Elkem, it has made a positive finding of subsidization against it.
Based on the import data from Statistics Canada, for 2016, more than 95% of silicon metal imports into Canada are now subject to anti-dumping and countervailing duties. The CBSA confirmed final antidumping and countervailing duty rates of:
Country | Producer | Dumping Rate | Subsidy Rate | Total rate | ||||||||
Brazil | LIASA | 27.8% | 7.2% | 35.0% | ||||||||
RIMA | 0.0% | 2.7% | 2.7% | |||||||||
Polymet Alloys | 27.8% | 2.8% | 30.6% | |||||||||
All others | 27.8% | 6.0% | 33.8% | |||||||||
Kazakhstan | Tau-Ken Temir | 18.2% | 40.3% | 58.5% | ||||||||
All others | 86.5% | 269.7% | 356.2% | |||||||||
Laos | All exporters | 85.2% | n.a. | 85.2% | ||||||||
Malaysia | All exporters | 85.2% | 10.6% | 95.8% | ||||||||
Norway | Elkem | n.a. | 2.8% | 2.8% | ||||||||
Thailand | SICA | 51.0% | n.a. | 51.0% | ||||||||
All others | 85.2% | n.a. | 85.2% | |||||||||
The Canadian International Trade Tribunal (CITT) is continuing its inquiry and will make an order or finding by November 2, 2017. Provisional duties will continue to apply to imports of subject goods originating in or exported from Brazil, Kazakhstan, Laos, Malaysia, Norway and Thailand until the CITT order or finding.
Ferroglobe’s Executive Chairman, Javier López Madrid, commented, “These cases demonstrate our commitment to protecting our investments and our workers so that they can enjoy a stable work environment and fair wages and we can compete with foreign producers on a level playing field. We appreciate the dedicated work of the Department of Commerce of the United States and the Canada Border Service Agency, essential to achieving such level playing field for Ferroglobe and its stakeholders in the United States and Canada, respectively. With the measures taken by the DOC and CBSA, a significant portion of the imports into North America are now subject to a duty and the potential for subsequent review for all subject parties is also an important outcome. We look forward to working with the trade authorities as they continue their investigations over the coming months.”
The DOC’s full statement regarding the preliminary determinations will be published at: https://www.commerce.gov/news/press-releases
The CBSA’s full statement regarding the final decisions are published at: http://www.cbsa-asfc.gc.ca/sima-lmsi/
INVESTOR CONTACT:
Ferroglobe PLC
Joe Ragan, US: +1 917 2098581, UK: +44 (0) 7827 227 688
Chief Financial Officer
Email: jragan@ferroglobe.com
$XXII Phase III Study Century’s SPECTRUM® Research Cigarettes
CLARENCE, N.Y.
“Minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy”
22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that Dr. Dorothy Hatsukami, at the Vermont Center on Behavior and Health’s 5th Annual Conference on Tobacco Regulatory Science, revealed the fundamental findings of a highly anticipated 1,250-patient, 20-week study that compared smokers who were assigned to: i) an immediate reduction to Very Low Nicotine cigarettes; ii) gradual reduction in reduced nicotine content cigarettes; or iii) normal nicotine content cigarettes. Designed to determine which approach produces the most optimal outcomes for smokers, the announcement of the results of the seminal phase III study comes only weeks after the United States Food and Drug Administration (FDA) announced that the Agency is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine – at non-addictive levels – in all combustible cigarettes sold in the United States.
Dr. Hatsukami, who is the Co-Director of the Center for the Evaluation of Nicotine in Cigarettes and Professor of Psychiatry and Director of the Tobacco Research Programs at the University of Minnesota, led the ground-breaking phase III study that was conducted in 10 cities across the United States and included participants from all demographics.
22nd Century was the exclusive provider of the Very Low Nicotine and other SPECTRUM research cigarettes that were used in Dr. Hatsukami’s 1,250-participant trial and in more than 16 other clinical trials. In fact, 22nd Century is the only company in the world capable of growing tobacco with nicotine levels of just 0.4mg per gram of tobacco, which is more than a 95% reduction in nicotine as compared to tobacco in conventional cigarettes. Many scientists around the world believe that tobacco with this very low level of nicotine is minimally or non-addictive.
Though the details of Dr. Hatsukami’s phase III study are still under peer review, Dr. Hatsukami divulged the answer to the study’s core question of whether an immediate or a gradual reduction in nicotine is the best approach. Dr. Hatsukami clearly and confidently declared in her panel presentation at the Vermont Conference that “an immediate approach [to nicotine reduction] is most likely to lead to less harm.” Further, Dr. Hatsukami pointed out that the study data indicates compensatory smoking is less likely to occur with an immediate reduction in nicotine, and that the there was a “greater likelihood of more rapid smoking cessation” with the immediate approach to nicotine reduction.
Following Dr. Hatsukami’s discussion, Dr. Stephen T. Higgins, Director of the University of Vermont Tobacco Center of Regulatory Science took the podium and announced to the conference attendees: “I will present evidence that reducing nicotine content lowers the addiction potential of smoking among those with psychiatric conditions or socioeconomic disadvantage consistent with prior evidence in samples from the general adult smoker population.” In addition to finding reduced evidence of addiction in smokers of 22nd Century’s Very Low Nicotine Content (VLNC) cigarettes, Dr. Higgins found that: “VLNCs did not produce evidence of compensatory smoking.” [emphasis added]
Dr. Jonathan Foulds of Penn State College of Medicine also delivered a powerful call to action at the conference, challenging the attending scientists to deny the tobacco industry any diversions or strategies that could be used to delay the FDA’s planned mandate to reduce nicotine in cigarettes to very low, non-addictive levels. Dr. Foulds then pointed out the stakes involved: “Such a move [by FDA to reduce nicotine content of cigarettes] could result in one of the largest single improvements in public health ever [seen] in this country.”
“Considering the results of numerous phase II and phase III studies that have been conducted with VLN cigarettes, there is now compelling and conclusive evidence that Very Low Nicotine cigarettes decrease cigarette dependence, reduce the number of cigarettes smoked per day, and increase smokers’ quit attempts,” explained Henry Sicignano III, President and CEO of 22nd Century Group. “With the power to save millions of lives and to prevent a new generation of young people from becoming dependent on tobacco, minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.
Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 8, 2017, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
22nd Century Group
James Vail, 716-270-1523
Director of Communications
jvail@xxiicentury.com
$FLXN FDA Approval of Zilretta™ for Osteoarthritis Knee Pain
- Innovative, non-opioid, intra-articular therapy, proven to deliver meaningful analgesia over 12 weeks in patients with moderate to severe OA knee pain
- Product label also includes positive data from type 2 diabetes study
- Commercial supply expected to be available by late October following recent completion of manufacturing process validation
- Conference call scheduled for Monday, October 9, 2017, at 8:00 a.m. ET
BURLINGTON, Mass., Oct. 06, 2017 — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology to provide proven pain relief over 12 weeks.
“The approval of Zilretta marks a major advancement in the treatment landscape for managing OA knee pain,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “It comes at a time when our society is in urgent need of non-addictive therapies to help the millions of Americans who suffer from this condition.” Dr. Clayman added, “We believe that Zilretta has the potential to be a transformative medicine for the more than five million patients who receive an intra-articular injection for OA knee pain each year.”
The FDA approval of Zilretta is based upon data from Flexion’s pivotal Phase 3 clinical trial. The randomized, double-blind study enrolled 484 patients at 37 centers worldwide.
Commenting on the approval, Andrew Spitzer, M.D., Co-Director, Joint Replacement Program, Cedars-Sinai Orthopaedic Center, said, “OA knee pain presents a host of challenges for patients and clinicians alike, and there has been very little innovation in this area in recent years. Zilretta is a groundbreaking new therapy, providing clinically meaningful pain relief with a safety profile that is similar to saline.”
Sometimes called degenerative joint disease or “wear and tear” arthritis, OA is a progressive and incurable condition and the most common form of arthritis. Its effects may range from intermittent discomfort to the loss of function and severe chronic pain associated with irreversible structural damage.
“As OA progresses, many patients experience intractable joint pain, which can ultimately lead to the need for a total joint replacement,” said John Richmond, M.D., Medical Director for Network Development, New England Baptist Hospital. “As a result, healthcare providers are eager for new, non-opioid therapies that may help patients manage their OA pain for extended periods of time. Zilretta gives us an important new non-surgical intervention.”
Zilretta’s label also includes the results from a double-blind, randomized, parallel-group trial, which examined blood glucose concentrations in patients with type 2 diabetes.
Steven Russell, M.D., Ph.D., Assistant Professor of Medicine, Massachusetts General Hospital Diabetes Research Center, commented, “Our trial demonstrated that Zilretta may avoid the disruptive blood glucose spikes that can be seen with corticosteroid use in patients coping with both knee OA and type 2 diabetes. As a practicing diabetologist, I believe the availability of Zilretta will make intra-articular injection of glucocorticoid an attractive option for these patients.”
The pain from OA of the knee can have a profound impact on the people it afflicts, often resulting in a cascade of consequences, which patient advocates warn is only expected to grow.
According to Seth Ginsberg, President and Co-Founder of CreakyJoints®, a national patient advocacy organization for people with all forms of arthritis, “Despite common misperceptions, OA is not a disease that is limited to the elderly. In fact, the average age of knee OA diagnosis has decreased while the number of people diagnosed with OA of the knee has been steadily rising. That’s why our community advocates for and welcomes new therapeutic options for people to consider in consultation with their doctor.”
Flexion expects Zilretta will be available in the U.S. by the end of October. For more information, visit www.Zilretta.com or call 1-844-FLEXION.
Conference Call Details
Flexion’s management will host a conference call Monday, October 9, 2017, at 8:00 a.m. ET. The dial-in number for the conference call is 855-770-0022 for domestic participants and 908-982-4677 for international participants, with Conference ID # 92539488. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website, and a replay will be available online after the call.
About Zilretta
Zilretta is the first and only FDA-approved extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. Zilretta employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks.
Indication and Important Safety Information
Indication: ZILRETTATM (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.
Limitations of Use: ZILRETTA is not intended for repeat administration.*
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions
- Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal or subcutaneous routes. Serious events have been reported with epidural and intrathecal administration of corticosteroids and none are approved for this use. ZILRETTA should not be considered safe for epidural or intrathecal administration.
- Hypersensitivity Reactions: Rare instances of anaphylaxis, including serious cases, have occurred in patients with hypersensitivity to corticosteroids.
- Joint Infection and Damage: A marked increase in pain accompanied by local swelling, restriction of joint motion, fever and malaise are suggestive of septic arthritis. Examine joint fluid to exclude a septic process. If diagnosis is confirmed, institute appropriate antimicrobial therapy. Avoid injecting corticosteroids into a previously infected or unstable joint. Intra-articular administration may result in damage to joint tissues.
- Increased Risk of Infections: Infection with any pathogen in any location of the body may be associated with corticosteroid use. Corticosteroids may increase the susceptibility to new infection and decrease resistance and the ability to localize infection.
- Alterations in Endocrine Function: Corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression, with potential for adrenal insufficiency after withdrawal of treatment, which may persist for months. In situations of stress during that period, institute corticosteroid replacement therapy.
- Cardiovascular and Renal Effects: Corticosteroids can cause blood pressure elevation, salt and water retention and increased potassium excretion. Monitor patients with congestive heart failure, hypertension and renal insufficiency for edema, weight gain and electrolyte imbalance. Dietary salt restriction and potassium supplementation may be needed.
- Increased Intraocular Pressure: Corticosteroid use may be associated with increased intraocular pressure. Monitor patients with elevated intraocular pressure for potential treatment adjustment.
- Gastrointestinal Perforation: Corticosteroid administration may increase risk of gastrointestinal perforation in patients with certain GI disorders and fresh intestinal anastomoses. Avoid corticosteroids in these patients.
- Alterations in Bone Density: Corticosteroids decrease bone formation and increase bone resorption. Special consideration should be given to patients with or at increased risk of osteoporosis prior to treatment.
- Behavior and Mood Disturbances: Corticosteroids may cause adverse psychiatric reactions. Prior to treatment, special consideration should be given to patients with previous or current emotional instability or psychiatric illness. Advise patients to immediately report any behavior or mood disturbances.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough and contusions.
Please see the full Prescribing Information at www.ZILRETTAlabel.com.
* The efficacy and safety of repeat administration of ZILRETTA have not been evaluated.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.
About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA, a type of degenerative arthritis. The company’s core values are focus, ingenuity, tenacity, transparency and fun. Flexion was named one of the Boston Business Journal’s 2017 Best Places to Work.
Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; timing for the expected commercial availability of Zilretta; our plans to commercialize Zilretta and its market potential; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of launching a new pharmaceutical product in the United States; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; the risk that we may not be able to successfully hire, train and maintain an effective sales force to commercialize Zilretta; the risk that Zilretta may not be successfully commercialized, including as a result of limitations in Zilretta’s label and package insert information; risks regarding our ability to obtain adequate reimbursement from payors for Zilretta; risks related to the manufacture and distribution of Zilretta, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
Corporate Contact:
Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com
$MTEM to Present at the 2017 BIO Investor Forum
AUSTIN, Texas, Oct. 06, 2017 — Molecular Templates, Inc., (Nasdaq:MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, today announced that Eric E. Poma, Ph.D., Chief Executive and Chief Scientific Officer, will provide a corporate overview at the 2017 BIO Investor Forum, being held October 17-18 in San Francisco, California.
BIO Investor Forum
Date: Tuesday, October 17
Time: 10:30am Pacific Time
Location: Westin St. Francis, San Francisco, Elizabethan C Ballroom
Webcast: http://www.veracast.com/webcasts/bio/investorforum2017/25111335172.cfm
About Molecular Templates
Molecular Templates is focused on the discovery, development and commercialization of next-generation immunotoxins called Engineered Toxin Bodies (ETBs) for the treatment of cancers and other serious diseases. For additional information, please visit Molecular Templates’ website at www.mtem.com.
Investor Contact:
Andrew McDonald, Ph.D.
andrew@lifesciadvisors.com
646-597-6987
$STLHF NetworkNewsWire Publication Discussing the Imminent Surge in Lithium Demand
NEW YORK, NY–(Oct 6, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring Standard Lithium Ltd. (TSX VENTURE: SLL) (FRANKFURT: S5L) (OTCQX: STLHF), a client of NNW that is building one of the largest portfolios of high quality, domestic U.S. lithium brine assets.
The publication, titled, “The Global Scramble for Lithium,” highlights companies that are ready to exploit the forecasted surge in the lithium market.
To view the full publication, visit: https://www.networknewswire.com/global-scramble-lithium/
“Standard Lithium Ltd. (TSXV: SLL) (FRA: S5L) (OTCQX: STLHF) is in the thick of the hunt for new lithium sources. The company is intensely focused on further exploration and the immediate development of its Bristol Dry Lake, Brine Project located in the Mojave region of California. With the signing of its mineral lease agreement with National Chloride Corporation of America — a Permitted Brine Producer — for the exploration of lithium, Standard Lithium’s Bristol Lake project now encompasses approximately 25,000 acres of placer mineral claims and private property. The company’s geophysics team recently concluded a comprehensive gravity survey over the entire basin, and initial interpretation of the data indicates that the basin is deep and expansive. Historical drilling and sampling to total depths of approximately 500 feet has produced brine samples with lithium values over 100 mg/L for the entire drilled interval.
“The strategic relationship with National Chloride, allows Standard Lithium immediate access to conduct exploration brine sampling and extraction, evaporation and processing activities, and enable a fast-tracked project development schedule. The project is in a friendly, clean energy development jurisdiction with proven near surface brines which provide for efficient geophysical exploration drilling programs. The company anticipates selective lithium recovery through a combination of membrane, chemical precipitation and solvent extraction. With a market cap of only $62 million, successful strategy execution could easily propel Standard Lithium to new heights as a significant low cost domestic producer of battery grade lithium materials.”
About Standard Lithium
Standard’s value creation strategy encompasses acquiring a diverse and highly prospective portfolio of large-scale domestic brine resources, led by an innovative and results-oriented management team with a strong focus on technical skills. The company is currently focused on the immediate exploration and development of the Bristol Dry Lake Lithium Project located in the Mojave region of San Bernardino County, California; the location has significant infrastructure in-place, with easy road and rail access, abundant electricity and water sources, and is already permitted for extensive brine extraction and processing activities. The company is also commencing resource evaluation on its 33,000 acres of lithium brine leases located in the Smackover Formation.
For more information, visit the company’s website at www.StandardLithium.com.
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
For more information please visit https://www.NetworkNewsWire.com
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
NNW Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact
$ATHX to Present at 2017 Cell & Gene Meeting on the Mesa
CLEVELAND, Oct. 05, 2017 — Athersys, Inc. (NASDAQ:ATHX) announced today that Robert W. Mays, Ph.D., Vice President, Regenerative Medicine and Head of Neuroscience Programs, will present at the annual Partnering Forum as part of the Cell & Gene Meeting on the Mesa to be held October 4-6 in La Jolla, California.
Dr. Mays will provide a brief overview of the Company’s neuroscience programs, focusing on the Phase 3 clinical program for ischemic stroke, which previously received special Protocol Assessment (SPA) and Fast Track designations from the U.S. Food and Drug Administration (FDA), and recently obtained a Final Scientific Advice positive opinion from the European Medicines Agency.
The Company is also pleased to announce that it has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, recently established under the 21st Century Cures Legislation. The RMAT designation may be obtained for eligible cell therapy and other regenerative medicine and advanced therapies when the FDA agrees that preliminary clinical evidence indicates that the therapy has demonstrated the potential to address unmet medical needs for a serious or life threatening disease or condition. The designation enables sponsors to discuss with the FDA multidisciplinary strategic development plans, including expediting manufacturing development plans for commercialization to support priority review and accelerated approval.
The following are specific details regarding Athersys’ presentation at the conference:
Event: | 2017 Cell & Gene Meeting on the Mesa – Partnering Forum | |
Date: | October 5, 2017 | |
Time: | 4:30 – 4:45 pm Pacific Time | |
Location: | La Jolla Ballroom 1 at the Estancia La Jolla Hotel & Spa, 9700 North Torrey Pines Road, La Jolla, CA 92037 |
This conference is the largest partnering meeting organized specifically for the cell and gene therapy sector, providing the opportunity for participants to establish key relationships and accelerate business development. Organized by ARM and the Sanford Stem Cell Clinical Center at UC San Diego, the Cell & Gene Meeting on the Mesa is a three-day conference featuring three distinct parts, the program’s two-day Partnering Forum, a Public Forum lecture and a full-day Scientific Symposium. The event’s Partnering Forum on October 4-5, features more than 70 dedicated company presentations in addition to 90 panelists and featured speakers.
A live video webcast of all company presentations will be available at: http://www.meetingonthemesa.com/webcast/ and will also be published on ARM’s website shortly after the event. Please visit www.meetingonthemesa.com for full information including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Parsons at lparsons@alliancerm.org and interested media should contact Lyndsey Scull at lscull@alliancerm.org.
About Athersys
Athersys is an international biotechnology company engaged in the development of therapeutic products designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the neurological, cardiovascular, and inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.
ATHX-G
Contact:
William (B.J.) Lehmann
President and Chief Operating Officer
Tel: (216) 431-9900
bjlehmann@athersys.com
Karen Hunady
Corporate Communications
Tel: (216) 431-9900
khunady@athersys.com
David Schull
Russo Partners, LLC
Tel: (212) 845-4271 or (858) 717-2310
David.schull@russopartnersllc.com
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