BioPorto A/S (CPH:BIOPOR) announced Monday that it will provide additional patient information in support of its US application for regulatory clearance of its NGAL test for pediatric risk assessment of acute kidney injury (AKI). In a statement, the Danish company said that, following substantive dialog with the FDA and detailed data analysis, it has decided to supplement its 510(k) application for pediatric use of the NGAL Test to detect AKI. The company said it will provide additional data in order to fully respond to the most recent review shared by the agency. The company noted that the “valuable study” from which BioPorto drew its original dataset was published in the premier clinical journal, The New England Journal of Medicine. The data showed that the NGAL biomarker can be successfully deployed to assess risk of pediatric acute kidney injury (AKI) in the critical care setting. However, the FDA disagreed with the clinical community, expressing concern over risk of clinician bias in the data.
Great Panther Mining Limited (NYSEAMERICAN:GPL) (TSE:GPR) reported Monday that a worker lost his life in an accident at the processing plant of the company’s Coricancha mine in Peru. "We are extremely saddened by this tragic accident and extend our deepest condolences to the family, friends and colleagues of our co-worker, an experienced plant operator who worked at the Coricancha mine complex for almost seven years,” said Jeffrey Mason, interim CEO. The area where the accident occurred is barricaded and closed off as an investigation into the cause is underway. "Safety is a core value at Great Panther and we will continue to strive to prevent such accidents from occurring,” Mason said. “This includes completing an investigation of this accident and taking remedial action. Great Panther is continuing an in-depth review of its comprehensive safety policies, programs, and training across all operations."
Capstone Turbine Corporation (NASDAQ:CPST) has received an order for its first-ever flare gas project from Colombian oil giant Ecopetrol SA (NYSE:EC). Ecopetrol, one of the world’s largest oil producers, has multiple hydrocarbon extraction fields throughout Colombia, and in order to replace one of its reciprocating engine generators in the Rio Ceibas oil field, the company turned to Capstone. The company’s C1000 Signature Series will provide electrical power for site operations with associated gas from the oil extraction process that would have otherwise been flared into the atmosphere.
Parallax Health Sciences Inc (OTCMKTS:PRLX) posted third-quarter results before the bell Monday that revealed substantial revenue gains year over year and a narrowing operating loss. The healthcare company posted revenue of $25,855, well ahead of its 2018 third-quarter revenue of $990. Its operating loss shrunk to $5.1 million, $0.02 per diluted share, from $5.1 million, $0.03 per diluted share. The company saw a net loss of $2.4 million, $0.01 per diluted share, compared to a $25 million net profit, $0.12 per diluted share, a year earlier. The reason for the disparity, the company said, is due primarily to significant gains from the disposal of a subsidiary, and related extinguished debt, recognized during the 2018 fiscal year.
American Battery Metals Corporation (OTCMKTS:ABML) announced Monday it had participated in the recent 2019 Benchmark Minerals Intelligence Minerals Week, where the topic of battery recycling prompted discussions. Minerals Week is the premier lithium-ion battery and electric vehicle supply chain event focused on the key battery raw materials of lithium, cobalt, nickel and graphite. The event, hosted and run by the team at Benchmark Minerals Intelligence, featured participants and global experts in the battery metals and renewables markets. In a statement, the company said battery recycling was heavily discussed as a short-term necessity in terms of e-waste, but also as a long-term solution to supply shortages. Minerals Week 2019 included participants and speakers from the US Department of State, SQM (NYSE:SQM), Lithium Americas (NYSE:LAC), Piedmont Lithium Ltd (ASX:PLL), Jervois Mining Ltd (ASX:JRV) (CVE:JRV), Rio Tinto plc (LON:RIO), Pilbara Minerals Ltd (ASX:PLS), Pulead Technology, Standard Lithium, Tesla Inc (NASDAQ:TSLA), General Motors Company (NYSE:GM), and many more.
Armenia gold mine developer Lydian International Ltd (TSX:LYD) reported positive legal news Monday as it continues to try and advance its giant Amulsar project. The country's administrative court has now rejected an application, which called for the Minister of Environment to revoke the Environmental Impact Assessment (EIA) of the Amulsar project approved in April 2016. "Lydian’s EIA is compliant with Armenian and International standards and was prepared based on International best practices," said Lydian's interim CEO and president Edward Sellers, who described the latest development as "good news". "We are thankful that the Armenian Judiciary has confirmed the validity of the EIA. This application is yet another example of the continuing attempts to interfere with Lydian’s legal right to develop and operate the Amulsar Project."
EuroLife Brands Inc (CSE:EURO) (OTCMKTS:CANVF), the cannabis focused company, told investors it had now migrated all of its cannabis and hemp related business to Europe away from North America. In the last six weeks, the group has struck relationships with three important partners to bring new products to the European marketplace, namely, with The Yield Growth Corp, Champignon Brands Inc, and AgraFlora Organics International Ltd, the firm noted. "We are of the belief that the cannabis, hemp, and associated tertiary health and wellness product markets in Europe are still relatively untapped vis-à-vis North American opportunities. As such, we will continue to focus our business development resources in Europe as we aim to broaden our reach into this important marketplace," said Shawn Moniz, chief executive at EuroLife.
Seelos Therapeutics Inc (NASDAQ:SEEL) stock soared Monday after its SLS-002 intranasal ketamine depression drug aimed at patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at risk of committing suicide, was granted fast track designation. The FDA granted the status for the development of the drug for the treatment of Acute Suicidal Ideation and Behavior in patients with MDD. Investors responded well, sending shares in the New York company 10.2% higher to $0.95. “We will be working diligently in collaboration with the FDA to finalize the protocol for the proof of concept study and future clinical development,” CEO Raj Mehra said. The FDA's fast track program is designed to speed up the development and review of new medicines for the treatment of serious conditions where there is an unmet need.
Jerome Jabbour, CEO of Matinas BioPharma Holdings Inc (NYSEAMER:MTNB) will share his thoughts on the clinical-stage biopharmaceutical company’s outlook as well as host meetings with investors at the upcoming Piper Jaffray Healthcare conference. The event is set to take place at 10:30am on December 3 at the Lotte New York Palace Hotel in New York. Matinas’s lead drug candidate is MAT9001, which treats cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA (both essential polyunsaturated fatty acids), that is under development for the treatment of hypertriglyceridemia – or higher levels of triglycerides. Trigylcerides are a type of fat in human blood, and having too many can lead to heart disease or acute pancreatitis.
Hillcrest Petroleum Ltd (CVE:HRH) (OTCMKTS:HLRTF) said the TSX venture exchange had granted the company an extension to November 30 this year to close an earlier announced unit financing. On September 9, the oil group revealed it was set to bring in up to C$600,000 from a placing at C$0.03 a unit. It said it would issue up to 20 million units following a discretionary waiver by the TSX venture exchange of the C$0.05 minimum price requirement.
Mongolia-focused explorer Kincora Copper Ltd (CVE:KCC) said the TSX Venture Exchange had accepted for filing documentation on a letter agreement dated October 28 this year between the firm and an arm's-length party, whereby Kincora may acquire up to an 80% stake in Temuulen-Orshikh LLC, a private company that owns 100% of the Badrakh copper-gold porphyry project, in southern Gobi, Mongolia. Under the terms, Kincora will earn up to 80% of the project by providing financing of up to US$6.25 million over 5.5 years.
Valens Groworks Corp (CVE:VGW) told shareholders that the TSX Venture has accepted filing for documentation related to a share purchase agreement on November 7. The purchase agreement saw Toronto-based Valens acquiring all of the issued and outstanding shares of Southern Cliff Brands Inc, which does business as Pommies Cider Co. Valens will pay C$3.5 million and issue nearly 863,000 shares to the vendor, with 258,880 shares to be held in escrow. The extraction company will place C$500,000 and just over 345,000 shares in escrow pending achievement of earnout milestones, it said in a statement.
Nabis Holdings Inc (CSE:NAB) (OTCMKTS:NABIF) announced the appointment of Yoni Ashurov to its board of directors. Ashurov, founder and CEO of MWR Life, joined the board on November 15, filling the vacancy created by the departure of Liran Kandinov who resigned to focus on other business and personal obligations. Nabis said Ashurov is an expert in designing and building scalable business infrastructures to market a diverse line of products and services, resulting in extensive long-term growth and profitability for his companies and stakeholders. “Yoni brings a fresh business acumen to the board. His impressive qualifications including global international real estate sales and development, energy efficiency technology and financial services will lend a unique perspective to Nabis. We look forward to his diverse background and passion about success,” CEO Shay Shnet Shnet said.
Kincora Copper Ltd (CVE:KCC) updated on first phase exploration work this season, in which nine holes have tested five targets at its Bronze Fox and East Tsagaan Suvarga (East TS) projects. Last week, the group also announced an earn-in deal worth up to over US$6 million for the Badrakh copper gold project, where the first of a proposed two-hole program has just kicked off. "Field activities have been under budget, safely and successfully executed, systematically advancing the company's wholly owned 828.3 sq km district scale portfolio, focused on first phase target testing drilling at Bronze Fox and East Tsagaan Suvarga," said senior vice-president of exploration Peter Leaman.
Fireweed Zinc Ltd (CVE:FWZ) revealed a boost to its flagship Macmillan Pass property in Yukon, with the receipt of an upgraded land use permit. The new Class 4 permit replaces the previous Class 3 and allows for a larger work program with up to a 150-person camp and larger and more extensive exploration programs, the firm said. It also sets out environmental, wildlife, infrastructure, reclamation and First Nations heritage requirements for ongoing work. and covers Fireweed's main deposits at the Tom, Jason and End Zones.
Nabis Holdings Inc (CSE:NAB) (OTCMKTS:NABIF) is betting on Michigan’s cannabis potential with two new investments in the Great Lakes state. The Vancouver-based company said that it had completed its investments in two properties in Emmett Township and Kawkawlin that already have municipal approvals for provisioning centres. Nabis now has seven investments in the northeastern US state.
Discovery Metals (CVE: DSV) (OTCMKTS: DSVMF) joined the OTCQX Market Monday. Discovery Metals is a Canadian exploration firm headquartered in Toronto, Canada, which is focused on historic precious metal districts in Mexico. Its flagship property is the 100%-owned 37,000 hectare Cordero silver project in Chihuahua State, Mexico. "We are pleased to join the OTCQX Market. Our current and future investors will benefit from a stronger and more efficient platform to trade within the U.S. that also provides us with significant additional market exposure," said Taj Singh, the president and CEO of Discovery.
GlobeX Data Ltd (CSE:SWIS) CEO Alain Ghiai chatted about the software company’s plans in a recent episode of the CSE’s podcast #HashtagFinance. In a discussion with host Phillip Shum, Ghiai voiced his views on how Vancouver-based GlobeX is working to outperform rivals like Dropbox, Gmail and WhatsApp when it comes to cybersecurity and privacy. He was also keen to discuss how data has managed to vault past oil and gas to become what is arguably the most sought-after asset in the world. To tune into the CSE podcast, click here. GlobeX develops software and cybersecurity programs that protect data.
eWellness Healthcare Corporation (OTCMKST:EWLL), the pioneer in physical therapy telehealth treatments, announced that its PHIZO.com digital treatment platform is gaining traction with customers of third-party insurance administrators. The company also said the platform, which targets the musculoskeletal-treatment market, is now generating fourth-quarter revenues. The PHZIO platform allows employees and physical therapists to cut the cord from the old-school brick and mortar clinical experience to an immediate in-home physical therapy experience.
CytoDyn Inc (OTCMKTS:CYDY) revealed that leronlimab data had been accepted for presentation at the three-day conference on retroviruses and opportunistic infections (CROI), starting on March 8 at the Hynes convention center, in Boston. The Vancouver, Washington-based late-stage biotechnology company said an abstract from the PRESTIGIO Registry Study Group showing that leronlimab was effective in inhibiting multi-drug resistant HIV-1 isolates from heavily treatment-experienced (HTE) patients was accepted for presentation at the CROI conference. The authors concluded that, in HTE patients with multi-drug resistance to HIV-1, all CCR5 tropic strains were fully susceptible to leronlimab. “This completely independent research study on clinical isolates from patients with documented 4-class drug resistances demonstrates that leronlimab may play a key role in patients with very limited therapeutic options,” said CytoDyn CEO Nader Pourhassan.
American Resources Corporation (NASDAQ:AREC) CEO Mark Jensen said that the company was “extremely excited” about the future of the metallurgical coal company as the demand for infrastructure increases around the world. "We are extremely excited about how our platform is set up to perform in 2020 and beyond,” Jensen told shareholders in a release Monday. “Overall, the market for our products remains very promising as the world's need for carbon, steel and infrastructure continues to be healthy, and our platform remains in a unique position of bringing a robust pipeline of growth to the market and to our investors."