A glance at some of the day's highlights from the Proactive Investors US and Canada newswires
Aequus Pharmaceuticals Inc () () is getting ready to file for regulatory approval in Canada for the Evolve line of dry eye products, it said Monday. The news comes as the Vancouver-based firm said its UK partner Medicom Healthcare received the final certificate for the Canadian Medical Device Single Audit Program necessary to complete the regulatory submission for Health Canada approval. Aequus said it expects to file for Canadian regulatory approval for the first three dry eye products in the Evolve line within the next 10 days.
() () released topline results from its Phase 3 TRILOGY 2 trial of lead drug CaPre that saw over 30% reduction in triglyceride levels in participants. The Quebec-based biopharmaceutical company reported a 30.4% average reduction in triglyceride levels among all patients receiving CaPre, as compared to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks as compared to 27.5% in TRILOGY 1. However, the company said unadjusted, placebo corrected triglyceride reduction of 12.4% achieved a “p” value of 0.19 – which was not statistically significant – meaning the TRILOGY 2 study did not meet its primary endpoint. As a result, Acasti said it will not file a New Drug Application with the US Food and Drug Administration for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.
Internet of Things Inc () (OTCMKTS:INOTF), a software and solutions provider in the artificial intelligence and industrial IoT markets, has changed its name to Predictiv AI Inc. The share consolidation trimmed the company’s outstanding shares at a ratio of up to 5.5:1 pre- to post-consolidation shares. Post-consolidation, there are now 61,345,803 shares issued and outstanding. The shares will trade on a post-consolidated basis under its new name and ticker symbol "PAI" on the TSX Venture Exchange at the opening of trading on September 1. The company changed its name to reflect its broader commitment and expertise in accelerating artificial intelligence (AI) innovation as it advances AI and machine learning solutions.
Ltd () () announced Monday that its Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-to-moderate COVID-19 received approval from the independent Institutional Review Board at Advarra, a premier IRB services company in North America. “With the IRB approval of the Phase 3 study protocol for COVID-19, we can recruit US clinical sites efficiently, allowing us to move forward with providing Bucillamine to patients under our Investigational New Drug (IND) application that was approved by the FDA last month,” said Revive CEO Michael Frank in a statement. An IRB operates under US Food and Drug Administration regulations and is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects.
Inc () (CSE:HUGE.CN) (FRA:0K9A) announced on Monday that it has submitted an Investigational New Drug Application (IND) application to the US Food and Drug Administration (FDA) for the use of its lead candidate FSD-201, or anti-inflammatory ultra-micronized-palmitoylethanolamide (PEA), to treat coronavirus (COVID-19) patients. The company said that “severe COVID-19” is characterized by an “over-exuberant inflammatory response” that may lead to a cytokine storm and ultimately death. is developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients. The trial will be a randomized, controlled, double-blind, US multicenter study at 25 to 30 sites, to assess the effectiveness and safety of FSD-201 dosed at 600 mg or 1,200 mg twice-daily, together with standard of care (SOC), versus SOC alone in hospitalized patients with documented COVID-19.
NexTech AR Solutions Corp. () () (FSE:N29) revealed that its recently launched augmented reality solution for video ‘ScreenAR’ has generated over $100,000 in sales in its first month and is gaining great momentum. The firm, an emerging leader in augmented reality for eCommerce, AR learning applications, AR-enhanced video conferencing and virtual events, said ‘ScreenAR’ has been seamlessly integrated into the InfernoAR platform and uses the company's ARitize technology. In a statement, Evan Gappelberg, NexTech AR chief executive officer noted: “Due to the insatiable demand of InfernoAR, the surging demand for our AR products and continued growth in our AR eCommerce we are on target to have a record-breaking Q3.”
Corp () ended a busy second quarter with just over US$6.3 million in cash and saw the company make its debut on the TSX Venture Exchange. CEO Kyle Floyd deemed the quarter “tremendously successful” for the newly-listed royalty company as it acquired 27 royalties as part of a reverse takeover transaction and has added an additional five since its listing. A big move for the Toronto-based company was its acquisition of a proprietary royalty database from Mineral Royalties Online Pty Ltd, which includes over 7,000 global royalties, providing Vox with a first-mover advantage to execute non-brokered royalty deals.
Todos Medical Ltd (), a diagnostics company, announced Monday that it has entered into a sales agreement with a Wisconsin-based laboratory to supply it with the necessary coronavirus (COVID-19) polymerase chain reaction (PCR) testing equipment and supplies. Under the $23.76 million, initial eight-month contract, Todos said it will supply automated extraction machines, liquid handlers and PCR machines. The company also has been granted a priority right to supply the lab with up to 100,000 COVID PCR tests per day in the event the laboratory sees significant additional testing demand. Todos said its customer has inked an agreement with the state of Wisconsin to supply COVID-19 PCR tests.
Todos Medical also announced that it will be presenting at the LD 500 investor conference on Thursday, September 3 at 4.00pm EST. Gerald Commissiong, President & CEO of Todos, will be presenting to a live virtual audience. For the real-time presentation register here: https://ld500.ldmicro.com/. In addition, a replay will be available on Todos’ website: https://www.webcaster4.com/Webcast/Page/2019/36834
Inc () (OTCMKTS:EXROF) CEO Sue Ozdemir told investors the company has been able to add three new "high quality" partnerships as she reported financial and business results for the second quarter. In a statement accompanying the Vancouver-based technology company’s latest numbers, Ozdemir said: "We are excited that Exro has been able to add three new high-quality partnerships over the last four months with Ltd (TSX:CSX), Zero Motorcycles and SEA Electric Private Limited." Exro has developed a new class of control technology for electric motors powertrains using artificial intelligence. The company’s patented motor control technology Coil Driver expands the capabilities of electric motors and powertrains in terms of output and efficiency.
\The Flowr Corporation () (OTCMKTS:FLWPF) has closed a third tranche under its agreement with Terrace Global Inc (CVE:TRCE) to fund its outdoor medical cannabis site in Portugal. The facility in Aljustrel is jointly operated with Terrace Global, a Canadian company focused on the development and acquisition of international cannabis assets. Under the third tranche, Flowr will receive C$350,000 as part of the equity line and profit share agreement with Terrace, which will fund the operations and certain expenditures at Aljustrel in exchange for common shares and warrants in Flowr. Terrace Global is expected to fund at least C$3 million under the agreement.
Naturally Splendid Enterprises Ltd () () posted its unaudited financial results for the six months ended June 30 on Friday, noting that the coronavirus (COVID-19) pandemic slowed production and sales. The company also said its manufacturing facility in Pitt Meadows, British Columbia, which focuses on developing and manufacturing plant-based nutritional bars and bites, recently passed its annual Safe Quality Food Level 2 (SQF2) annual audit. Such certification allows the company to focus on higher-margin product opportunities. Naturally Splendid recorded sales of C$1,025,636 during the first six months of 2020, compared to C$1,723,541 for the six months ended June 30, 2019.
() said that, following the closing of its private placement announced on August 27, 2020, the group has entered into an additional definitive securities purchase agreement with multiple institutional health care focused funds to raise aggregate gross proceeds of approximately $5.0 million through another private placement of its common stock and pre-funded warrants. TRACON said it will sell approximately 3.0 million shares of common stock, or in lieu of common stock, pre-funded warrants to purchase common stock at a purchase price of approximately $1.67 each. The pre-funded warrants will have a per share exercise price of $0.01 and will expire seven years from the date of issuance. The company said it intends to use the net proceeds from the private placement to conduct the ENVASARC pivotal study of envafolimab in sarcoma and for working capital and general corporate purposes.
Company Ltd. () (OTCQX NSRXF) announced that it has appointed experienced banking executive, Susan Kudzman to its board of directors. Kudzman, a specialist in risk management and an actuary, has recently retired as executive vice-president, chief risk officer and corporate affairs at . She previously held the position of executive vice-president and chief risk officer at Caisse de dépôt et placement du Québec.
() (FSE:1WZ1) (), a global natural health products and eCommerce technology company, said it has engaged Electrik Dojo for native advertising and digital marketing services to increase brand awareness for the company. Certain services to be provided by Electrik Dojo are anticipated to include investor relations activities under the policies of the CSE and applicable securities laws. The company will continue to look at strategic consultants to expand awareness of the Company and its activities. The company will compensate Electrik Dojo for a two-month period at a total rate of US$300,000.
(OTCQB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, has announced that Nader Pourhassan, its president and chief executive officer, Scott Kelly, its chairman, chief medical officer and head of Business Development, and Jacob Lalezari, its senior science advisor, will host an investment community conference call on Wednesday, September 2, 2020, at 1.00pm PT / 4.00pm ET, to provide a comprehensive update on the most anticipated timelines for multiple regulatory and clinical initiatives, including coronavirus (COVID-19) potential approval timelines in US and UK. The conference call dial-In numbers are: 877-407-8291 U.S. / 201-689-8345 International. A live audio webcast may also be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. The webcast can also be accessed via the following link: https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/40466/indexl.html. A replay of the conference call will be available until October 2, 2020. To access the replay, interested parties may dial 877-660-6853 (U.S.) / 201-612-7415 (International) and enter conference identification number 13709272.
. () () has announced that the company will be presenting at the following two conferences. LD Micro 500 – Virtual Event September 1, 2020, at 12:20pm (Eastern Time): ld500.ldmicro.com. The TSX Venture 50 Capital Conference for the second year in a row, with the 50 winners selected based on market capitalization growth, share price appreciation and trading volume for the 2019 calendar year - September 3 - 5, 2020, at Delta Grand Okanagan Resort: capitalevent.ca/tsx-venture-50-capital-conference
. () (OTCPINK:MYIDF), the global leader in consumer-controlled identity, announced that it will be presenting at the LD 500 investor conference on Thursday, September 3, 2020, at 9.00amPST / 12.00pm EST. Neil Sweeney (CEO of .) will be presenting to a live virtual audience. Killi is a consumer privacy ecosystem that aims to put people back in control of their data. Available on iOS, Android, and the web, Killi is available internationally. With Killi, consumers can opt-in and link specific pieces of personal information from various financial and social accounts that they would like to put under their control or share with companies and be compensated directly in the form of cash for its use. Investors can register here: https://ld-micro-conference.events.issuerdirect.com/
(), the operator of financial markets for over 10,000 US and global securities, announced that Item 9 Labs Corp. (OTCQX:INLB), a vertically integrated cannabis operator that produces premium products, has qualified to trade on the OTCQX Best Market and has today upgraded from the OTCQB market. Graduating to the OTCQX Market marks an important milestone for companies, enabling them to demonstrate their qualifications and build visibility among US investors. To qualify for OTCQX, companies must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with applicable securities laws. "On the heels of qualifying for the OTCQB Market just a few short weeks ago, upgrading to the OTCQX is yet another significant milestone for Item 9 Labs," said Item 9 Labs CEO Andrew Bowden. "We've made considerable movement over the past year to strengthen our shareholder base and financial position to support long-term growth initiatives. This is a prime example of these efforts and our commitment to facilitating access to investors through transparent and consistent reporting."
