Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURE™ and VPURE+™ products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company is in the process of implementing a titanium dioxide pigment plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business support a low carbon future.
Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Sales and realized prices were down. Production volumes (preannounced) fell 31% q-t-q due to maintenance and rain. Realized vanadium prices fell 12% with Largo prices falling below benchmark prices due to a drop in ferrovanadium prices and timing factors associated with contract deliveries.
Costs were up. Operating costs continued to rise in the fourth quarter. The change in cost per unit produced was especially noteworthy as production levels dropped. Management has put a priority on controlling operating costs and expects costs in future quarters to decline. Non-operating cost remain high, although they have eased since the third quarter.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Which Way is Oil Going, and What it Could Mean for Investors in Related Sectors
Whether the sudden and severe decline in oil prices is an opportunity to invest in sectors that will benefit from cheaper fuel, a sign of further problems in the economy, or transitory, remains to be seen. It may depend on two overriding factors – and there are strong arguments supporting each. Below we look at the different scenarios and the sectors that are impacted.
Background
Energy futures and oil-related stocks like Chevron (CVX) and Exxon (XOM) gapped down at the open two days this week as concern about the overall health of the financial sector as two banks were closed and a major rating agency downgraded the banking sector Since Friday. U.S. oil futures remained below $70 per barrel midweek, as prices of WTI have now dipped 13% to levels not seen since December 2021.
These downward price moves are a reaction to thinking that demand will wane in a slowing U.S. economy. Also that it may take longer for the Chinese economy to rise to expected levels. Although far less impactful, approval of the Willow oil drilling project by the White House demonstrates a reversal of the ‘no more drilling’ policy by this administration.
A report by the International Energy Agency (IEA) this morning suggests the price decline may be temporary. The IEA anticipates that the oil markets will switch from a supply overhang in the first half of 2023 to a deficit later in the year. This is expected as OPEC continues its plan to cut production, and that the increased air traffic, along with an economic rebound in China will push global oil demand to a record high, according to the IEA.
Image: President Joe Biden meets with staff in the Oval Office, Monday, January 23, 2023, to discuss the Willow oil project. (Official White House Photo by Cameron Smith)
Oil remains one of the most crucial commodities to the modern world. Its price has a significant impact on various industries and investment sectors. Below are the sectors that stand to benefit if the recent decline in prices remains intact or declines further:
Transportation Industry is a significant beneficiary of lower oil prices. The reason of course is because fuel costs are a significant expense for airlines, trucking, and shipping companies. When the cost of fuel follows the decline, the transportation industry enjoys a reduction in operating costs. This can result in wider margins on tickets sold for air travel, lower shipping costs for businesses including retailers, and lower prices for cruise lines.
The Chemical Industry is another sector that benefits from declining oil prices. Many chemicals are derived from crude oil, and a decrease in oil prices means a decrease in the cost of raw materials. This, in turn, can lead to lower prices for chemical products such as fertilizers, plastics, and other materials.
The Consumer Goods Industry is also a significant beneficiary of declining oil prices. This is because many consumer goods are made from oil-based materials such as plastics, rubber, and synthetic fabrics. When oil prices decline, the cost of these materials decreases, resulting in lower production costs and, ultimately, lower prices for consumers.
The Renewable Energy Industry is not directly related to oil prices, a decline in oil prices can benefit this sector indirectly. Renewable energy sources such as wind and solar power are becoming increasingly competitive with traditional fossil fuels, and a decrease in the price of oil can make it more challenging for the fossil fuel industry to compete. This can result in increased investment in renewable energy and a shift toward cleaner, more sustainable sources of energy.
Emerging Markets, particularly those that are oil-importing countries, can benefit significantly from declining oil prices. These countries rely heavily on imported oil, and a decrease in oil prices can result in significant cost savings for these countries. This can lead to increased economic growth, as businesses have more money to invest in other areas and consumers have more disposable income to spend.
Take Away
Oil has dropped considerably this year. This is in part because economic activity is expected to become lower, and problems in the banking sector. This may not last through the year as indicated by the IEA. Others believe this is the start of further declines. Should oil prices not track higher, stock market investors could look at the transportation, chemical, and consumer goods industries, as well as the renewable energy sector and emerging markets. As with any economic change, it is essential to carefully analyze the potential effects on different industries and sectors to make informed investment decisions.
As March Madness Looms, Growth in Legalized Sports Betting May Pose a Threat to College Athletes
March Madness began on March 14, 2023, it’s a sure bet that millions of Americans will be making wagers on the annual college basketball tournament.
The American Gaming Association estimates that in 2022, 45 million people – or more than 17% of American adults – planned to wager US$3.1 billion on the NCAA tournament. That makes it one of the nation’s most popular sports betting events, alongside contests such as the Kentucky Derby and the Super Bowl. By at least one estimate, March Madness is the most popular betting target of all.
While people have been betting on March Madness for years, one difference now is that betting on college sports is legal in many states. This is largely due to a 2018 Supreme Court ruling that cleared the way for each state to decide whether to permit people to gamble on sporting events. Prior to the ruling, legal sports betting was only allowed in Nevada.
Since the ruling, sports betting has grown dramatically. Currently, 36 states allow some form of legalized sports betting. And now, Georgia, Maine and Kentucky are proposing legislation to make sports betting legal.
About two weeks after sports betting became legal in Ohio on Jan. 1, 2023, someone, disappointed by an unexpected loss of the University of Dayton men’s basketball team to Virginia Commonwealth University, made threats and left disparaging messages against Dayton athletes and the coaching staff.
The Ohio case is by no means isolated. In 2019, a Babson College student who was a “prolific sports gambler” was sentenced to 18 months in prison for sending death threats to at least 45 professional and collegiate athletes in 2017.
Faculty members of Miami University’s Institute for Responsible Gaming, Lottery, and Sports are concerned that the increasing prevalence of sports betting could potentially lead to more such incidents, putting more athletes in danger of threats from disgruntled gamblers who blame them for their gambling losses.
The anticipated growth in sports gambling is quite sizable. Analysts estimate the market in the U.S. may reach over US$167 billion by 2029.
Gambling Makes Inroads into Colleges
Concerns over college athletes being targeted by upset gamblers are not new. Players and sports organizations have expressed worry that expanded gambling could lead to harassment and compromise their safety. Such concerns led the nation’s major sports organizations – MLB, NBA, NFL, NHL and NCAA – to sue New Jersey in 2012 over a plan to initiate legal sports betting in that state. They argued that sports betting would make the public think that games were being thrown. Ultimately, the Supreme Court ruled that it was up to states to decide if they wanted to permit legal gambling.
Sports betting has also made inroads into America’s college campuses. Some universities, such as Louisiana State University and Michigan State University, have signed multimillion-dollar deals with casinos or gaming companies to promote gambling on campus.
Athletic conferences are also cashing in on the data related to these games and events. For instance, the Mid-Atlantic Conference signed a lucrative five-year deal in 2022 to provide real-time statistical event data to gambling companies, which then leverage the data to create real-time wager opportunities during sporting events.
As sports betting comes to colleges and universities, it means the schools will inevitably have to deal with some of the negative aspects of gambling. This potentially includes more than just gambling addiction. It could also involve the potential for student-athletes and coaches to become targets of threats, intimidation or bribes to influence the outcome of events.
The risk for addiction on campus is real. According to the National Council on Problem Gambling, over 2 million adults in the U.S. have a “serious” gambling problem, and another 4 million to 6 million may have mild to moderate problems. One report estimates that 6% of college students have a serious gambling problem.
What Can be Done?
Two faculty fellows at Miami University’s Institute for Responsible Gaming, Lottery, and Sport – former Ohio State Senator William Coley and Sharon Custer – recommend that regulators and policymakers work with colleges and universities to reduce the potential harm from the growth in legal gaming. Specifically, they recommend that each state regulatory authority:
Develop plans to coordinate between different governmental agencies to ensure that individuals found guilty of violations are sanctioned in other jurisdictions.
Dedicate some of the revenue from gaming to develop educational materials and support services for athletes and those around them.
Create anonymous tip lines to report threats, intimidation or influence, and fund an independent entity to respond to these reports.
Assess and protect athlete privacy. For instance, schools might decline to publish contact information for student-athletes and coaches in public directories.
Train athletes and those around them on basic privacy management. For instance, schools might advise athletes to not post on public social media outlets, especially if the post gives away their physical location.
The NCAA or athletic conferences could lead the development of resources, policies and sanctions that serve to educate, protect and support student-athletes and others around them who work at the schools for which they play. This will require significant investment to be comprehensive and effective.
This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Jason W. Osborne,Professor of Statistics, Institute for Responsible Gaming, Lottery, and Sport, Miami University.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Tonix Reported FY2022 and Gave Clinical Milestone Updates. Tonix reported a loss of $34.1 million or ($0.56) per share for 4Q22 and $116.9 million or $(3.27) per share for FY2022. The company reaffirmed its guidance for a 2Q23 announcement of interim analysis for TNX102 SL in the Phase 3 RESILIANT trial testing in fibromyalgia. The full analysis is expected in 4Q23, one of several clinical milestones expected in 2023. Tonix had $120.2 million in cash on December 31.
Interim Analysis Expected For Phase 3 in Fibromyalgia. The RESILIANT Phase 3 trial is a double-blind, placebo-controlled study for fibromyalgia. It reached the 50% patient milestone in December 2022, with the interim analysis results expected in 2Q23. If successful, the RESILIANT trial could lead to an NDA filing for product approval.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Major New Award. On Friday, the Department of Defense announced the Dragados/Hawaiian Dredging/Orion JV was awarded a $2.84 billion firm-fixed-price task order for the construction of a concrete dry dock at Pearl Harbor Naval Shipyard. The Orion in the JV is Orion Group Holdings. This is a significant win for the Company, in our view.
Contract Details. Work will be performed in Hawaii and is expected to be completed by September 2027. This contract is part of the Shipyard Infrastructure Optimization Program (SIOP). The contract is incrementally funded with $463 million being allocated at the time of award. Subsequent contractual increments will be funded yearly from fiscal 2024 through fiscal 2026 in the amounts of: $1.267 billion; $613 million; and $496.9 million. The contract also contains three unexercised options, which if exercised, would increase cumulative contract value to $3.4 billion.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Newrange is focused on district-scale exploration for precious metals in the prolific Red Lake District of northwestern Ontario. The past-producing high-grade Argosy Gold Mine is open to depth, while the adjacent North Birch Project offers additional blue-sky potential. Focused on developing shareholder value through exploration and development of key projects, the Company is committed to building sustainable value for all stakeholders. Further information can be found on our website at www.newrangegold.com .
Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Creating a new Americas-focused silver-gold exploration company. Newrange Gold Corp. recently executed a letter of intent with Mithril Resources Limited (ASX: MTH) to acquire 100% of Mithril in a reverse takeover (RTO). The transaction will be completed via a Scheme of Arrangement in Australia and the resulting company will be named Pinnacle Silver & Gold Corp. and will be listed on the TSX Venture exchange. Mithril will be delisted from the ASX exchange.
Flagship project. The Copalquin gold-silver project is in Durango State, Mexico and covers an entire mining district of 70 square kilometers containing several dozen historic gold and silver mines and workings. The district is within the Sierra Madre Gold-Silver Trend which extends north-south along the western side of Mexico and hosts many world-class gold and silver deposits. At the El Refugio target area, there is a historic maiden JORC-compliant mineral resource estimate highlighting indicated resources of 121,000 ounces of gold and 2,538,000 ounces of silver and inferred resources of 252,000 ounces of gold and 8,414,000 ounces of silver.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
FOMC Now Contending With Banks and Sticky Inflation
The Federal Reserve is facing a rather sticky problem. Despite its best efforts over the past year, inflation is stubbornly refusing to head south with any urgency to a target of 2%.
Rather, the inflation report released on March 14, 2023, shows consumer prices rose 0.4% in February, meaning the year-over-year increase is now at 6% – which is only a little lower than in January.
So, what do you do if you are a member of the rate-setting Federal Open Market Committee meeting March 21-22 to set the U.S. economy’s interest rates?
The inclination based on the Consumer Price Index data alone may be to go for broke and aggressively raise rates in a bid to tame the inflationary beast. But while the inflation report may be the last major data release before the rate-setting meeting, it is far from being the only information that central bankers will be chewing over.
Don’t let yourself be misled. Understand issues with help from experts
And economic news from elsewhere – along with jitters from a market already rather spooked by two recent bank failures – may steady the Fed’s hand. In short, monetary policymakers may opt to go with what the market has already seemingly factored in: an increase of 0.25-0.5 percentage point.
Here’s why.
While it is true that inflation is proving remarkably stubborn – and a robust March job report may have put further pressure on the Fed – digging into the latest CPI data shows some signs that inflation is beginning to wane.
Energy prices fell 0.6% in February, after increasing 0.2% the month before. This is a good indication that fuel prices are not out of control despite the twin pressures of extreme weather in the U.S. and the ongoing war in Ukraine. Food prices in February continued to climb, by 0.4% – but here, again, there were glimmers of good news in that meat, fish and egg prices had softened.
Although the latest consumer price report isn’t entirely what the Fed would have wanted to read – it does underline just how difficult the battle against inflation is – there doesn’t appear to be enough in it to warrant an aggressive hike in rates. Certainly it might be seen as risky to move to a benchmark higher than what the market has already factored in. So, I think a quarter point increase is the most likely scenario when Fed rate-setters meet later this month – but certainly no more than a half point hike at most.
This is especially true given that there are signs that the U.S. economy is softening. The latest Bureau of Labor Statistics’ Job Openings and Labor Turnover survey indicates that fewer businesses are looking as aggressively for labor as they once were. In addition, there have been some major rounds of layoffs in the tech sector. Housing has also slowed amid rising mortgage rates and falling prices. And then there was the collapse of Silicon Valley Bank and Signature Bank – caused in part by the Fed’s repeated hikes in its base rate.
This all points to “caution” being the watchword when it comes to the next interest rate decision. The market has priced in a moderate increase in the Fed’s benchmark rate; anything too aggressive has the potential to come as a shock and send stock markets tumbling.
This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Christopher Decker,Professor of Economics, University of Nebraska Omaha.
Will Adam Aron CEO of AMC Win the Long Awaited Battle?
Management of AMC Entertainment Holdings ($AMC) is holding the long-awaited special meeting at noon Eastern time, Tuesday, March 14. At this meeting, shareholders will vote the peculiar $APE shares that were paid out as a dividend to shareholders. The dividend shares that were announced with the message “Today we Pounce” from the CEO Adam Aron created quite a stir – they seemed to have been designed to root out fraudulent shares and challenge any naked shorts of the AMC common shares.
The shareholders’ opportunity is a decision of whether or not to increase the firm’s stock authorization and convert AMC Preferred Equity Units (ticker: APE) into AMC common shares ($AMC). It will also vote on a 10-for-1 reverse stock split that would only take place if the APE measure passes.
AMC management won an endorsement from the proxy firm Institutional Shareholder Services (ISS) for the reverse stock split and preferred stock conversion. Institutional Shareholder Services is a market intelligence and influence proxy voting firm, its endorsement increases the odds of management having their wish.
If approved, it would represent an important career win for AMC’s Aron, who has become a superhero of sorts to the meme stock investors that helped the firm through the pandemic. He has shown himself to be able to stay one step ahead of those that would profit if AMC stock falters. Some stockholders supporting the measure take this as a fight between weak and strong and good and evil where prevailing is the only option.
In 2020 AMC Theatres lost $4.6 billion in sales due to Covid-related lockdowns and low attendance. Some powerful investors had shorted shares, many small investors grouped together and purchased the stock in droves, this created unexpected problems for the institutional short sellers that had large trades betting against AMC’s survival.
These investors caused the stock price to increase which allowed AMC to raise cash and survive and thrive.
The APE units, which represent one hundredth of a preferred share, have the same voting power of common shares.
Not all AMC shareholders are as supportive. Some are suing the company, arguing the APE sales decimated the voting power of common shareholders who might oppose increasing the firm’s share authorization.
Aron said during the fourth-quarter earnings call that if the vote falls short, the company could be forced to sell more APE shares at lower prices than a combined AMC share. On the same call he credited selling stock with helping the firm survive the lockdowns.
“We wouldn’t be blocked from raising capital, but we’d be raising capital on much less attractive terms,” Aron said. “It would cost more dilution to the stock that is entirely 100% preventable if a majority of our shareholders vote yes.”
R.Greenleaf Paves Way for Direct Commerce Relationship with Customers, Provides Seamless, Time-Saving Shopping Experience
DENVER, March 13, 2023 /PRNewswire/ – Schwazze, (NEO: SHWZ) (OTCQX: SHWZ) (“Schwazze” or the “Company”), announces the launch of a new ecommerce shop site for R.Greenleaf, its New-Mexico based retail banner with 17 locations throughout the state. This new shopping experience, available at http://rgreenleaf.com, allows customers to ‘skip the line and order online’ by ordering ahead to reserve product and picking up in store. Customers can create an account on the new shop site to access prior orders and receive special offers while also enrolling in R.Greenleaf’s customer loyalty program, Gratify.
“We are excited to bring the convenience of ecommerce shopping to all of our R.Greenleaf locations. Our enhanced online shopping experience allows us to deliver our brands, product assortment and dedicated service to customers in all of our neighborhoods as we continue to expand throughout the state,” said Ken Diehl, Division President – New Mexico.
R.Greenleaf, offering a wide variety of quality products serviced by top-notch, knowledgeable staff, has grown from 10 locations to now 17 since Schwazze’s acquisition nearly one year ago. All locations serve the needs of medical patients as well as recreational consumers.
Since April 2020, Schwazze has acquired, announced the planned acquisition of, or opened 44 cannabis dispensaries as well as seven cultivation facilities and two manufacturing assets in Colorado and New Mexico. In May 2021, Schwazze announced its BioSciences division and in August 2021 it commenced home delivery services in Colorado.
About Schwazze
Schwazze (NEO: SHWZ) (OTCQX: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.
Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.
Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements are not guarantees of future events or 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. Consequently, actual events and 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) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses, including the acquisition described in this press release, and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, and (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws. 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 Company’s 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 website 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 except as required by law.
TORONTO, ON / ACCESSWIRE / March 13, 2023 / Eskay Mining Corp. (“Eskay” or the “Company”) (TSX-V:ESK)(OTCQX: ESKYF)(Frankfurt:KN7)(WKN:A0YDPM) is pleased to announce the addition of Mr. Riaz Mirza, M.Sc., as Geophysical Advisor to its exploration team. Mr. Mirza brings a wealth of experience in the application of geophysics for precious- and base-metal exploration in the Golden Triangle where he has been actively engaged in numerous projects over the past decade. Eskay Mining welcomes Mr. Mirza as the newest member of its world-class team of explorers in search of “Eskay Creek V2.0.”
Riaz Mirza, founder of Simcoe Geoscience Limited, a global geophysical service provider, has significant experience exploring a variety of deposit types including volcanogenic massive sulfide (“VMS”) deposits across the Golden Triangle, British Columbia. This experience, as well as Simcoe’s reliance on “next-generation” geophysical data collection and processing, provides Eskay Mining with an entirely new set of tools with which to define new exploration targets for future drill testing.
Mac Balkam, CEO of Eskay Mining, commented: “Riaz and his team have been reviewing our geophysical data from our 100% controlled 602.55 sq km Consolidated Eskay project area with the goal of drawing direct comparisons to that from the original Eskay Creek precious metal-rich VMS deposit. Because VMS deposits typically occur in clusters, drawing direct comparisons of our data to that of our neighbor provides a huge step forward in our quest for discovering ‘Eskay Creek V2.0.’”
John DeDecker, VP of Exploration for Eskay Mining, commented: “Using our large geophysical database, Riaz and his team immediately identified some compelling similarities between the amplitude, texture, distribution and depth of magnetic anomalies associated with the Eskay Creek deposit and multiple areas displaying such patterns across our Consolidated Eskay project. This very distinct magnetic signature associated with the ore bodies at Eskay Creek gives us a powerful tool with which to identify new VMS targets. Combined with our BLEG, rock chip, and soil geochemical data, we now have the ability to undertake much more tightly focused exploration work in 2023.”
Riaz Mirza, Geophysical Advisor to Eskay Mining, noted: “We here at Simcoe Geoscience have already been able to use Eskay Mining’s existing data to illuminate further potential VMS targets. Key magnetic signatures observed at the Eskay Creek deposit are visible in multiple locations across the Consolidated Eskay project telling us we have excellent discovery potential. With this work, Eskay will be able to better use its 2023 exploration budget by targeting its drilling more effectively. We here at Simcoe look forward to teaming up with Eskay’s technical team to strategize our next approaches to exploration including focused mapping, sampling, drilling and perhaps other approaches across Eskay’s large land holdings. We thank Eskay Mining’s for the opportunity to work with their strong technical team as we pursue discovery of ‘Eskay Creek V2.0.’”
Data, Methodology and Interpretation by Simcoe Geoscience
A Leapfrog model of mineralization at Eskay Creek was made utilizing publicly available data from the following sources:
Drill core assay results for Eskay Creek were obtained from Assessment Report number 18958, as well as news releases available on Skeena Resources Limited’s website.
Rock chip assays for Eskay Creek were obtained from Assessment Report number 11160.
Drill collar locations reported in Skeena Resources news releases were transformed from mine grid to UTM Zone 9 NAD83.
Drill hole assay results in Au equivalent are graphically represented in the image in Figure 1.
Airborne SkyTEM and magnetic data gathered in 2021 covering the Consolidated Eskay project and peripheral areas.
New analysis of these data show that there is a distinct magnetic signature associated with the Eskay Creek deposit that is clearly evident when a tilt derivative is applied to the magnetic data. This process re-scales the data range allowing for low amplitude magnetic features to be resolved graphically. Mineralized bodies appear sharply resolved as magnetic highs surrounded by distinct magnetic lows giving a bullseye-like appearance to the deposit (Figure 1). Eskay’s geologic team interprets this distinct signature to result from deformation and metamorphism of hydrothermally altered rocks during post-mineralization tectonic events. A three-dimensional model of magnetic susceptibility shows a strong correlation between domains of high magnetic susceptibility with VMS mineralization situated along a surface defined by a magnetic susceptibility of 0.001 SI. Weaker magnetic susceptibility anomalies are associated with the 21A Zone and the 22 Zone.
Comparable magnetic anomalies are observed in several areas across Eskay Mining’s Consolidated Eskay property (Figures 2-4, and 6-9). A strong correlation is clearly evident between these anomalies and areas of known VMS mineralization (TV, Jeff, Scarlet-Tarn, Sib-Lulu, C10, and Virginia Lakes) as well as in areas where Au- and Ag-bearing sulfide rock chip samples have been collected along the Harrymel Valley, Eskay Anticline and the Scarlet-Tarn trends. In every case, VMS mineralization encountered by drilling occurs along the margins of the modeled 3D magnetic susceptibility volume as described above at Eskay Creek.
Based on observations from magnetic data, a new target named Maroon Cliffs has been identified in the far northeast part of the property (Figures 2-4). Legacy soil sampling on the west side of this anomaly shows strongly elevated Ag and Hg values (Assessment Report number 24155). Data from BLEG surveys conducted in 2020 and 2022 further support the prospectivity of Maroon Cliffs (Figure 5), with two Au BLEG anomalies immediately downstream from this newly identified magnetic anomaly. The presence of the VMS system, CBS Zone, occurring on Tudor Gold’s property to the east along strike from Maroon Cliffs adds further support for the potential of this area. This new target will be a key focus of exploration in 2023.
Although the target between Hexagon-Mercury and Jeff North has recently been identified through geologic mapping, and data from Eskay’s 2021 SkyTEM survey, its magnetic signature proves compelling (Figure 6). In addition to a bullseye-like magnetic anomaly visible when the tilt derivative is applied, this target is also associated with several shallow protrusions evident in the 3D magnetic susceptibility model. Such protrusions are distinct at Eskay Creek where they are associated with mineralization. Helipads were constructed in this area in September 2022 to allow access to this rugged area in 2023.
The TV-Jeff trend is associated with Eskay Creek-like magnetic anomalies (Figure 7), with the most prominent protrusions in the magnetic susceptibility model corresponding with areas of most intense Au and Ag mineralization. Notably, small protrusions in the magnetic susceptibility model between TV and Jeff correspond with anomalous Au and Ag values from sulfide rock chip samples and widely scattered drill holes. Eskay Mining’s technical team suspects the intensity of magnetic susceptibility anomalies may correlate with the intensity of VMS mineralization. This appears to be the case at TV which is associated with the most pronounced magnetic anomaly in the area (Figure 8). Importantly, this magnetic anomaly continues into un-drill tested areas to the south and west of TV suggesting that VMS mineralization likely extends to these regions. This TV extension will be explored in 2023.
The recently identified Scarlet-Tarn trend also appears to be associated with Eskay Creek-like magnetic anomalies (Figure 9). Extensive work in this area in 2021 and 2022 concluded that the Tarn Lake-Scarlet Knob area is underlain by the same rock units hosting the Eskay Creek deposit (e.g., the Eskay Rhyolite). High-grade Au and Ag anomalies associated with intense localized hydrothermal alteration were discovered through rock chip sampling and drilling. It was also determined that stratigraphic up is to the west meaning that the highly prospective Contact Mudstone horizon, host to the Eskay Creek deposit, is likely situated to the west of Tarn Lake. The observed trend of magnetic susceptibility anomalies extending to the west of Tarn Lake indicates this area could indeed host high-grade VMS mineralization similar to that at the Eskay Creek deposit. This area will be a primary focus of Eskay Mining’s 2023 exploration program.
Dr. Quinton Hennigh, P. Geo., a Director of the Company and its technical adviser, a qualified person as defined by National Instrument 43-101, has reviewed and approved the technical contents of this news release.
About Eskay Mining Corp:
Eskay Mining Corp (TSX-V:ESK) is a TSX Venture Exchange listed company, headquartered in Toronto, Ontario. Eskay is an exploration company focused on the exploration and development of precious and base metals along the Eskay rift in a highly prolific region of northwest British Columbia known as the “Golden Triangle,” 70km northwest of Stewart, BC. The Company currently holds mineral tenures in this area comprised of 210 claims (60255 hectares).
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements: This Press Release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made, including those factors discussed in filings made by us with the Canadian securities regulatory authorities. Should one or more of these risks and uncertainties, such as actual results of current exploration programs, the general risks associated with the mining industry, the price of gold and other metals, currency and interest rate fluctuations, increased competition and general economic and market factors, occur or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Shareholders are cautioned not to put undue reliance on such forward-looking statements.
MELVILLE, N.Y. – March 13, 2023–Comtech (NASDAQ: CMTL) recently secured multiple multi-million-dollar contracts for its ELEVATE platform to provide commercial and government customers with satellite cellular backhaul as well as telemetry data and video services over Low Earth Orbit and Geostationary Orbit constellations.
Under the contracts, Comtech will deliver up to 1,000 ELEVATE terminals this year to customers in six countries. Comtech ELEVATE is a platform designed to support multi-orbit constellations as well as the convergence of communications infrastructures.
“Comtech ELEVATE is one of the unique end-to-end technologies and services we are delivering to customers that will usher in a new era of democratized access to global connectivity,” said Ken Peterman, President and CEO, Comtech. “These contracts demonstrate the strong and growing demand for secure, adaptable, and scalable solutions that will be needed to close the digital divide and empower people across the globe with access to new technologies.”
Comtech ELEVATE provides connectivity over satellite as well as access over high capacity wireless networks. ELEVATE’s versatility can support emerging use cases that will enable the convergence of space-based applications in the United States as well as international markets.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
Interim Analysis of Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL Expected Second Quarter 2023; Topline Data Expected Fourth Quarter 2023
Potentially Pivotal Phase 2 Trials of TNX-1900 in Chronic Migraine and TNX-601 ER in Depression Scheduled for Interim Analyses in Fourth Quarter 2023
Potentially Pivotal Phase 2 Fibromyalgia-Type Long COVID Study Enrolling
Cash and Cash Equivalents Totaled Approximately $120.2 Million at December 31, 2022
CHATHAM, N.J., March 13, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided an overview of recent operational highlights.
“Our clinical activity is at a high point in the Company’s history, and we believe it is setting the stage for a year of significant accomplishments across an expanded portfolio of novel pharmaceutical candidates designed to serve major unmet medical needs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.
“We are pleased with the progress of our current Phase 3 program in fibromyalgia, and we are looking forward to the results of a planned interim analysis due next quarter, followed by topline results in the fourth quarter of this year. If successful, we believe it will be the second and final adequate and well-controlled efficacy trial required for filing a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA)”, he added. “Moreover, we believe we have satisfied all the other clinical and non-clinical requirements for an NDA.”
Dr. Lederman added, “Patients and caregivers alike report widespread dissatisfaction with the three currently approved drugs for fibromyalgia – Lyrica®, Cymbalta®, and Savella®, and generic pregabalin and duloxetine – switching back and forth between them, and too often taking off-label products, including addictive opiates. Fibromyalgia affects between six and 12 million adults in the U.S. according to the American Pain Association, and there hasn’t been a new FDA drug approval in the category in more than a dozen years.”
Dr Lederman continued, “Our recently expanded late-stage clinical programs include four potentially pivotal Phase 2 trials. Two are currently enrolling, one in Long COVID and the other in chronic migraine. The two others – one in depression and the other in cocaine intoxication – are due to start enrolling. We expect to initiate enrollment in the depression study by the end of March, followed by the cocaine intoxication study in the second quarter of this year.”
“In summary”, he concluded, “these programs, together with several others in earlier development, represent a diverse portfolio of programs with multiple opportunities for value creation in 2023 and beyond.”
Recent Highlights—Key Product Candidates*
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual tablet): small molecule for the management of fibromyalgia (FM)
The first 50% of participants were randomized on December 19, 2022, in the RESILIENT study, a double-blind, randomized, placebo-controlled, potentially pivotal confirmatory Phase 3 study of TNX-102 SL for the management of fibromyalgia. Results from a planned interim analysis are expected in the second quarter of 2023, with topline results expected in the fourth quarter of 2023. A positive topline outcome, together with results from the previous positive Phase 3 RELIEF study, would support submission of an NDA.
TNX-102 SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
Enrollment continues in the PREVAIL study, a potentially pivotal Phase 2 study of TNX-102 SL for fibromyalgia-type Long COVID.
During a February 2023 virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, the Company presented its analysis that the majority of Long COVID patients present with a constellation of symptoms called nociplastic pain that overlap with fibromyalgia, and Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) and that fibromyalgia-type Long COVID appears to be one of several chronic overlapping pain conditions (COPCs) that are related by sharing the neurological process called central sensitization.
TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and obesity-associated binge eating disorder
In February 2023, Tonix announced that enrollment began in the potentially pivotal Phase 2 PREVENTION study of TNX-1900 for the prevention of migraine headache in chronic migraineurs. The double-blind, placebo-controlled study has a target enrollment of 300 participants at approximately 25 sites across the U.S. Results from a planned interim analysis after the first 50% of enrolled patients have completed the study are expected in the fourth quarter of 2023.
In January 2023, data from clinical and nonclinical studies were presented at the 16th Annual Headache Cooperative of the Pacific (HCOP) Winter Conference by collaborator Professor David Yeomans. The oral presentation titled, “Primary vs Secondary Sex Hormones and Migraine,” includes research sponsored by and licensed by Tonix. Preliminary results from a positron emission tomography (PET) study in humans showed that intranasal application of a radioisotope of magnesium-potentiated oxytocin is delivered to the trigeminal ganglia which have known roles in migraine headaches. In addition, preliminary results of data collected from isolated human trigeminal ganglia neurons in vitro show co-expression of oxytocin receptors and calcitonin gene-related peptide (CGRP), which are believed to represent the first observation of oxytocin receptors in human trigeminal ganglia. Furthermore, the presentation highlights data which suggest a sex difference in oxytocin potency.
Tonix announced data from an in vitro study describing the impact of oxytocin on isolated human sensory neurons, presented by collaborator Professor David Yeomans at Neuroscience 2022, the annual meeting of the Society for Neuroscience. The poster, titled “In Vitro Impact of Oxytocin on Human Sensory Neurons,” is the first to show that oxytocin receptors are present on human sensory neurons and that inflammation drives expression of oxytocin receptors on these neurons. The results of this study are consistent with data from animal models and provide support for the use of oxytocin for the treatment of pain.
An investigator-initiated Phase 2 study of TNX-1900 in obesity-associated binge eating disorder is expected to start enrolling in the second quarter of 2023 directed by principal investigator Professor Elizabeth Lawson at the Massachusetts General Hospital, a teaching hospital of Harvard Medical School.
TNX-601 ER (tianeptine hemioxalate extended-release tablets): a once-daily orally-administered small molecule for the treatment of major depressive disorder (MDD), Posttraumatic Stress Disorder (PTSD), and neurocognitive dysfunction associated with corticosteroid use.
Enrollment is expected to initiate in the first quarter of 2023 in the potentially pivotal Phase 2 ‘UPLIFT’ Study for the treatment of MDD. Results from planned interim analysis after the first 50% of enrolled patients have completed the study are expected fourth quarter 2023.
TNX-601 ER represents a novel approach to treating depression in the U.S., since the active ingredient tianeptine induces a neuroprotective and resilient phenotype in both neurons and microglia under conditions of stress. In contrast, antidepressants that are marketed in the U.S. act by modulating neurotransmitter levels or receptor binding in the synapse. The Phase 2 UPLIFT study is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken orally once-daily for 6 weeks to treat MDD. It is a parallel design study with two arms, a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 300 participants will be randomized in a 1:1 ratio into the two arms across approximately 30 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of depression and a duration for the current major depressive episode (MDE) of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression of Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS).
Tonix expects to initiate a new, potentially pivotal, Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the second quarter of 2023, pending agreement with the FDA on trial design.
As previously mentioned, in 2022, Tonix received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300.
TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)
TNX-2900 has been granted Orphan Drug designation from the FDA for the treatment of PWS.
As previously mentioned, in 2022, Tonix delivered a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome” at the World Orphan Drug Congress USA.
Immunology Pipeline
TNX-1500 (anti-CD40L monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.
A First-in-Human Phase 1 study is expected to start in the second quarter of 2023 of TNX-1500 for prophylaxis of organ rejection in adult patients receiving a kidney transplant.
In February 2023, Tonix announced a research agreement with the University of Maryland, Baltimore, to study and assess the role of TNX-1500 in the prevention of heart xenograft rejection. The genetically engineered pig donors will be provided by the Revivicor Division of United Therapeutics Corporation. Preclinical xenotransplantation studies are expected to support an IND application.
Tonix announced a research agreement with Boston Children’s Hospital to study TNX-1500 for the prevention of graft-versus-host diseases (GvHD) after hematopoietic stem cell transplantation (HCT) in animals. HCT from unrelated donors is a component of the treatment protocol for several hematologic malignancies, but GvHD complicates treatment and limits the success of engraftment after HCT.
Infectious Disease Pipeline
TNX-801 (live horsepox virus vaccine for percutaneous administration): vaccine to protect against smallpox and mpox designed as a single-administration vaccine to elicit T cell immunity
A Phase 1 study in is expected to start in the second half of 2023.
Tonix presented a development update from the Company’s TNX-801 vaccine program in an oral presentation at the World Vaccine and Immunotherapy Congress on December 1, 2022. The oral presentation titled, “Live Virus Smallpox and Monkeypox Vaccine,” describes the history of live virus vaccines and rationale for the development of the Company’s Recombinant Pox Virus (RPV) platform, including TNX-801 to protect against mpox and smallpox. Non-human primates vaccinated with TNX-801 were fully protected with sterilizing immunity from a lethal challenge with intra-tracheal monkeypox.
A publication describing the activity of TNX-801 to protect non-human primates against a lethal challenge with intra-tracheal monkeypox was published in the peer-reviewed journal, Viruses (Noyce RS, et al. “Single Dose of Recombinant Chimeric Horsepox Virus (TNX-801) Vaccination Protects Macaques from Lethal Monkeypox Challenge.” Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234.)
*All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.
Recent Highlights—Corporate and Other
In February 2023, Tonix announced the appointment of R. Newcomb Stillwell to its Board of Directors, effective March 15, 2023. Mr. Stillwell is a retired partner at Ropes & Gray LLP, an international law firm, where he devoted approximately 38 years.
In February 2023, Tonix announced that it has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection. The licensed monoclonal antibodies were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020.
In February 2023, Tonix announced the acquisition of a preclinical portfolio of next-generation antiviral technology assets from Healion Bio, Inc. (Healion). Healion’s drug portfolio includes a class of broad-spectrum small molecule oral antiviral drug candidates including TNX-3900, formerly known as HB-121, which are cathepsin protease inhibitors, some of which have activity in vitro against SARS-CoV-2.
On January 26, 2023, data from Tonix’s research collaboration with The University of Alberta were presented by Tom Hobman, Ph.D., Professor of Cell Biology, University of Alberta, during a presentation at the 2nd Wnt/β-catenin Targeted Drug Development Conference. The oral presentation titled, “Targeting the Wnt/β-catenin pathway as a broad-spectrum antiviral strategy,” includes research sponsored by Tonix Pharmaceuticals focused on the development and testing of Wnt/β-catenin signaling pathway inhibitors as broad-spectrum antivirals against SARS-CoV-2 and other emerging viruses.
In January 2023, Tonix announced the publication of a paper entitled, “Development of a rapid image-based high-content imaging screening assay to evaluate therapeutic antibodies against the monkeypox virus,” in the journal Antiviral Research. The publication describes the development and optimization of two high-content image-based assays that were employed to screen for potential therapeutic antibodies against the monkeypox virus using surrogate poxviruses such as vaccinia virus. The article highlights Tonix’s TNX-3400 platform, which includes antibodies to potentially prevent or treat mpox and smallpox. These data represent the first wave of research and development conducted at the Company’s Infectious Disease R&D Center (RDC) in Frederick, Md. (Kota KP, et al., “Development of a rapid image-based high-content imaging screening assay to evaluate therapeutic antibodies against the monkeypox virus.” Antiviral Res. 2023 Feb;210:105513. doi: 10.1016/j.antiviral.2022.105513. Epub 2022 Dec 30. PMID: 36592670; PMCID: PMC9803393.)
In January 2023, Tonix announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its new Executive Vice President, Medical.
Tonix announced data from its fully human anti-SARS-CoV-2 monoclonal antibody platform in an oral presentation at the World Antiviral Congress 2022. The presentation titled, “Platform for Generating Fully Human anti-SARS-CoV-2 Spike Therapeutic Monoclonal Antibodies” highlights the need for a broad array of monoclonal antibodies which can be scaled up quickly and potentially combined with other monoclonal antibodies to treat or prevent COVID-19. The platform is part of a broader research collaboration and option agreement with scientists at Columbia University designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine.
In December 2022, Tonix announced that it has obtained an exclusive license from Curia Global, Inc., a leading contract research, development and manufacturing organization, for the development of three humanized murine monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection, the cause of COVID-19. Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes. SARS-CoV-2 has mutated to evade the existing FDA Emergency Use Authorization (EUA)-approved therapeutic monoclonal antibodies.
Recent Highlights—Financial
As of December 31, 2022, Tonix had $120.2 million of cash and cash equivalents, compared to $178.7 million as of December 31, 2021. Net proceeds from financing activities were approximately $87.8 million for full year 2022, compared to $212.5 million for the full year 2021.
Since January 1, 2023, the Company repurchased 15,700,269 shares of common stock under a $12.5 million share purchase program at prices ranging from $0.44 to $1.38 for a gross aggregate cost of approximately $12.5 million.
In January 2023, the Board of Directors approved a new $12.5 million share repurchase program. Since January 1, 2023, the Company repurchased 1,000,000 shares of common stock under this share repurchase program at $1.14 for a gross aggregate cost of $1.1 million.
Cash used in operations was approximately $98.1 million for the full year 2022, compared to $75.6 million for the full year 2021. The increase in cash outlays was primarily due to an increase in research and development (R&D) and general and administrative (G&A) activities, described below.
Cash used by investing activities for the years ended December 31, 2022, and 2021 was approximately $48.1 million and $35.3 million, respectively, related to the purchase of property and equipment.
Fourth Quarter 2022 Financial Results
R&D expenses for the fourth quarter 2022 were $24.7 million, compared to $22.3 million for the same period in 2021. The increase is predominately due to increased employee-related, facility and laboratory expenses. We expect R&D expenses to increase during 2023 as we move our clinical development programs forward and invests in our development pipeline.
G&A expenses for the fourth quarter 2022 were $8.1 million, compared to $7.3 million for the same period in 2021. The increase is primarily due to increased employee-related and financial reporting expenses.
Net loss available to common stockholders was $34.1 million, or $0.56 per share, basic and diluted, for the fourth quarter 2022, compared to net loss of $29.6 million, or $2.08 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for the fourth quarter 2022 was 61,379,692 compared to 14,230,897 shares for the same period in 2021.
Full Year 2022 Financial Results
R&D expenses for the full year 2022 were $81.9 million, compared to $68.8 million for the same period in 2021. The increase is predominately due to increased employee-related, facility and laboratory expenses. We expect R&D expenses to increase during 2023 as we move our clinical development programs forward and invest in our development pipeline.
G&A expenses for the full year 2022 were $30.2 million, compared to $23.5 million for the same period in 2021. The increase is primarily due to increased employee-related and financial reporting expenses.
Net loss available to common stockholders was $116.9 million, or $3.27 per share, basic and diluted, for the full year 2022, compared to net loss of $92.3 million, or $8.10 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for full year 2022 was 35,739,057 compared to 11,387,308 shares for the same period in 2021.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is being studied in a potential pivotal Phase 2 study that initiated enrollment in the first quarter of 2023 and for which interim data is expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and mpox, TNX-801; a next-generation vaccine to prevent COVID-19, TNX-1850; a platform to make fully human and murine monoclonal antibodies to treat COVID-19, TNX-3600 and TNX-4100, respectively; and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800; and a class of broad-spectrum small molecule oral antivirals, TNX-3900. TNX-801, Tonix’s vaccine in development to prevent smallpox and mpox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in the second half of 2023.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic and social and economic unrest; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report as filed with the Securities and Exchange Commission (the “SEC”) and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Company to Host Investor Conference Call for 2022 Q4 and Full-Year Financial Results on March 29, 2023
TORONTO–(BUSINESS WIRE)– Sierra Metals Inc. (TSX: SMT) (“Sierra Metals” or the “Company”) announced today that the Company, Banco de Credito del Peru and Banco Santander S.A. (together, the “Lenders”) are engaged in advanced discussions on terms to refinance $18,750,000 of the $25,000,000 principal debt repayment obligations that are due in 2023 under the Company’s senior secured credit facility. All figures in this news release are stated in U.S. dollars.
The parties intend to formalize the refinancing contract prior to the due date of the second quarterly principal installment on June 8, 2023, subject to, among other things, the completion of due diligence.
The Lenders have agreed to provide a bridge loan of $6,250,000 to refinance the first quarter 2023 amortization payment, due on March 8, 2023, while the refinancing contract for the balance of the 2023 payments is being finalized.
2022 Financial Results
Sierra Metals also announced a revised date of March 28, 2023 for the expected filing of its financial and operating results for the year ended December 31, 2022. The Company’s senior management team will host a conference call on Wednesday, March 29, 2023, at 11:00 AM EDT to discuss the results. The call may be accessed as follows.
The webcast, along with presentation slides, will be archived for 180 days on www.sierrametals.com.
Via phone:
For those who prefer to listen by phone, dial-in instructions are below. To ensure your participation, please call approximately five minutes prior to the scheduled start time of the call.
Canada dial-in number (Toll Free): 1 833 950 0062 Canada dial-in number (Local): 1 226 828 7575 US dial-in number (Toll Free): 1 844 200 6205 US dial-in number (Local): 1 646 904 5544 All other locations: +1 929 526 1599
Access code: 077974
Press *1 to ask a question, *2 to withdraw your question, or *0 for operator assistance.
About Sierra Metals
Sierra Metals is a diversified Canadian mining company with Green Metal exposure including copper production and base metal production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru, and Bolivar and Cusi Mines in Mexico. The Company is focused on increasing production volume and growing mineral resources. The Company also has large land packages at all three mines with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential. For further information regarding Sierra Metals, please visit www.sierrametals.com.
This press release contains forward-looking information within the meaning of Canadian and United States securities legislation. Forward-looking information relates to future events or the anticipated performance of Sierra and reflect management’s expectations or beliefs regarding such future events and anticipated performance based on an assumed set of economic conditions and courses of action. In certain cases, statements that contain forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, or “will be taken”, “occur” or “be achieved” or the negative of these words or comparable terminology. Forward-looking statements include those relating to formalizing the refinancing contract and the timeline related thereto and the timing of senior management’s conference call to discuss the Company’s financial and operating results for the year ended December 31, 2022. By its very nature forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual performance of Sierra to be materially different from any anticipated performance expressed or implied by such forward-looking information.
Forward-looking information is subject to a variety of risks and uncertainties, which could cause actual events or results to differ from those reflected in the forward-looking information, including, without limitation, the risks described under the heading “Risk Factors” in the Company’s annual information form dated March 16, 2022 for its fiscal year ended December 31, 2021 and other risks identified in the Company’s filings with Canadian securities regulators and the SEC, which filings are available at www.sedar.com and www.sec.gov, respectively.
The risk factors referred to above are not an exhaustive list of the factors that may affect any of the Company’s forward-looking information. Forward-looking information includes statements about the future and is inherently uncertain, and the Company’s actual achievements or other future events or conditions may differ materially from those reflected in the forward-looking information due to a variety of risks, uncertainties and other factors. The Company’s statements containing forward-looking information are based on the beliefs, expectations, and opinions of management on the date the statements are made, and the Company does not assume any obligation to update such forward-looking information if circumstances or management’s beliefs, expectations or opinions should change, other than as required by applicable law. For the reasons set forth above, one should not place undue reliance on forward-looking information.
Investor Relations Sierra Metals Inc. Tel: +1 (416) 366-7777 Email: info@sierrametals.com
