Release – Energy Fuels Announces 2021 Results

 


 


Energy Fuels Announces 2021 Results, Including Net Profits, Strong Cash Position, and Market-Leading U.S. Uranium, Rare Earth and Vanadium Position

Research, News, and Market Data on Energy Fuels

 

LAKEWOOD, Colo.March 15, 2022 /CNW/ – Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) (“Energy Fuels” or the “Company”) today reported its financial results for the year ended December 31, 2021. The Company’s annual report on Form 10-K has been filed with the U.S. Securities and Exchange Commission (“SEC“) and may be viewed on the Electronic Document Gathering and Retrieval System (“EDGAR“) at www.sec.gov/edgar.shtml, on the System for Electronic Document Analysis and Retrieval (“SEDAR“) at www.sedar.com, and on the Company’s website at www.energyfuels.com. Unless noted otherwise, all dollar amounts are in U.S. dollars.

Highlights:

  • Energy Fuels reported a net income of $1.5 million for 2021.
  • At December 31, 2021, the Company had a robust balance sheet with $143.2 million of working capital, including $113.0 million of cash and marketable securities, $30.8 million of inventory, and no short term (or long term) debt. At current commodity prices, the Company’s December 31, 2021 product inventory would have a value of approximately $60.6 million.
  • During 2021, prices for all the commodities Energy Fuels produces, or has the ability to produce, rose significantly. Uranium oxide (“U3O8“) prices increased approximately 38%, neodymium-praseodymium oxide (“NdPr“) prices increased approximately 112%, and vanadium oxide (“V2O5“) prices increased approximately 62%. Prices for each of these commodities have continued to show significant strength to date in 2022. The Company continues to closely follow developments related to Russia’s invasion of Ukraine, as Russia is a major supplier of uranium and nuclear fuel to U.S. and European customers. Prices of uranium have risen sharply in recent days.
  • While the Company chose to not sell any uranium during 2021, it is now actively engaged in pursuing selective long-term uranium sales contracts.
  • The Company produced approximately 270 metric tonnes of mixed rare earth element (“REE“) carbonate (“RE Carbonate“), containing 120 metric tonnes of total rare earth oxides (“TREO“) during 2021, as it commenced ramping up its REE recovery infrastructure. Energy Fuels’ RE Carbonate is the most advanced REE material being produced in the U.S. today.
  • The Company is currently in active discussions with several sources of natural monazite sands around the world to significantly increase the supply of feed for its growing REE initiative.
  • During Q1-2022, the Company began commercially separating Lanthanum (La) and Cerium (Ce) on a small scale from its RE Carbonate, using an existing solvent extraction circuit at the Mill. This represents the first commercial level REE separation to occur in the U.S. in many years.
  • The Company is planning to install a full separation circuit at its White Mesa Mill (the “Mill“) to produce both “light” and “heavy” separated REE oxides in the coming years, subject to successful licensing, financing, and commissioning, and continued strong market conditions. The Company has hired Carester SAS (“Carester“), a global leader in producing separated REE oxides, to support these REE separation initiatives.
  • On December 15, 2021, the Company announced a strategic venture with Nanoscale Powders LLC (“NSP“) for the development of a novel technology that would potentially produce REE metals. The technology has the potential to reduce the costs of production, energy consumption, and greenhouse gas emissions versus existing technologies.
  • In 2021, the Company sold small quantities of its existing V2O5 inventory to capitalize on recent market strength. The Company expects to continue to sell vanadium as prices increase and is evaluating the potential to resume vanadium recovery at the Mill, where its tailings pond solutions contain an estimated additional 1.0 to 3.0 million recoverable pounds of V2O5.
  • In July 2021, the Company announced the execution of a Strategic Alliance Agreement with RadTran, LLC to evaluate the potential recovery of thorium and radium from the Company’s existing RE Carbonate and uranium process streams for use in the production of medical isotopes for emerging targeted alpha therapy (“TAT“) cancer therapeutics. This initiative complements the Company’s existing uranium and RE Carbonate businesses, as it investigates the potential recovery of isotopes in existing process streams at the Mill for medical purposes.
  • In September 2021, the Company announced its establishment of the San Juan County Clean Energy Foundation (the “Foundation“), a fund specifically designed to contribute to the communities surrounding the Mill in southeastern Utah by providing funding to support local economic development and local priorities.
  • In October 2021, the Company completed the sale of certain, permitted non-core conventional uranium assets to Consolidated Uranium Inc. (“CUR”), including the Daneros mine, the Tony M mine, and the Rim mine. The Company reported a gain on the value of this transaction of $35.7 million, resulting in a significant improvement in the Company’s results of operations and net income for 2021.
  • On January 25, 2022, the Board appointed Dr. Ivy Estabrooke as a Director of Energy Fuels, bringing to the Company experience in commercial-stage biotech, research and development program leadership, and technology solutions for national security and public health challenges.

Mark S. Chalmers, Energy Fuels’ President and CEO, stated:

“In 2021, we believe Energy Fuels further strengthened its position as America’s leading multi-commodity, critical mineral company, as we made excellent progress on our uranium, REEs, vanadium and medical isotope initiatives. We are deploying our ‘one-of-a-kind’ licenses, facilities, and expertise to responsibly recover the critical elements needed for carbon-free nuclear energy, electric vehicle powertrains, wind generation, advanced electronics, grid-scale batteries, other clean energy and advanced technologies, and potentially cancer therapeutics.

“We are particularly proud of our accomplishments in REEs. We announced our entry into the REE business less than two years ago, and today we are ramping up our production of commercial quantities of RE Carbonate, which is a more advanced REE material than any other U.S. company is producing, as we are chemically recovering the REEs in a high-purity material that is ready for REE separation. We are also moving toward licensing and installing the infrastructure needed to produce separated REE oxides on a full commercial scale in the coming years. The proven processing technology for producing separated REE oxides is solvent extraction, or ‘SX,’ and our White Mesa Mill has over 40 years of experience producing uranium and vanadium using SX. With the support of Carester, a leading global consultant in the production of separated REE products, we believe it is a logical ‘next step’ for Energy Fuels to produce separated REE oxides on a full commercial scale at the Mill. We have already successfully performed La, Ce, and NdPr separations at pilot scale in the Mill’s lab over the past several months, and we recently began ramping up our commercial separation of La and Ce from our RE Carbonate on a small scale using an existing SX circuit at the Mill. Our primary REE focuses in 2022 will be building our supply of monazite ore, designing and licensing a new full commercial scale REE separation circuit at the Mill, and advancing our innovative REE metal initiative with NSP.

“With the recent events in Ukraine, security of supply in the U.S. for uranium is crucial. Energy Fuels continues to be the leading low-cost U.S. uranium producer with more production facilities and capacity than any other U.S. company, and we stand ready to be a reliable, large-scale supplier to U.S. nuclear utilities. We are seeing an increase in utility interest for long-term contracts. We are pursuing uranium sales contracts with pricing and terms that return acceptable project margins and maintain exposure to further uranium market upside.

“Vanadium prices are rising, as well. In 2019, we built a significant inventory of vanadium to sell into the abrupt upside price volatility that vanadium markets often experience, most recently in late 2018. The next upward cycle may have begun, as prices have risen sharply in the first months of 2022, and we are selling some of our inventory. As we sell, we will evaluate the potential to resume production from the Mill’s pond solutions or our conventional deposits to replace our sold inventory. We estimate our pond solutions alone contain another 1.0 to 3.0 million pounds of recoverable V2O5 and would be first and lowest cost to market.

“A few words on our medical isotope initiative. This is another area where we are able to deploy our unique facilities, licenses, and expertise to potentially help create a domestic supply chain for emerging cancer therapies. Recovering radioisotopes for use in cancer treatments from our existing process streams, thereby recycling valuable material that would otherwise be lost to direct disposal, would, if successful, be a great way to maximally use all of our feeds. And we would be accomplishing this in a way that is environmentally beneficial and highly congruent with Energy Fuels’ recycling and sustainability goals.

“We are also very pleased to announce that, on January 25, 2022 Dr. Ivy Estabrooke was appointed to the Board of Energy Fuels. Dr. Estabrooke brings to the Company an impressive background that is highly pertinent, not only to our new REE and TAT cancer therapeutics initiatives, but also to our core uranium business, which is of the utmost importance to national security at this time.”

Webcast at 1:00 pm EDT on March 17, 2022:

Energy Fuels will be hosting a video webcast on March 17, 2022 at 1:00 pm EDT (11:00 am MDT) to discuss its FY-2021 financial results, the outlook for 2022, uranium, rare earths, vanadium, and medical isotopes. To join the webcast and access the presentation and viewer-controlled webcast slides, please click on the link below:

Webcast Link

If you would like to participate in the webcast and ask questions, please dial in to 1-888-664-6392 (toll free in the U.S. and Canada).

A link to a recorded version of the proceedings will be available on the Company’s website shortly after the webcast by calling 1-888-390-0541 (toll free in the U.S. and Canada) and by entering the code 179864#. The recording will be available until March 31, 2022.

Selected Summary Financial Information:





$000’s, except per share data

Year ended
December 31, 2021

Year ended
December 31, 2020

Year ended
December 31, 2019

Total revenues

$

3,184

$

1,658

$

5,865

Gross profit (loss)

1,370

14

(12,433)

Operating profit (loss)

(35,425)

(24,627)

(40,581)

Net income (loss) attributable to the company

1,541

(27,776)

(37,978)

Basic and diluted net income (loss) per common share

0.01

(0.23)

(0.40)

 




$000’s

As at December 31,
2021

As at December 31,
2020

Financial Position:



Working capital

$

143,190

$

40,158

Property, plant and equipment, net

21,983

23,621

Mineral properties, net

83,539

83,539

Total assets

315,446

183,236

Total long-term liabilities

13,805

13,376

Financial Discussion:

At December 31, 2021, the Company had $143.2 million of working capital, including $113.0 million of cash and marketable securities and $30.8 million of inventory, including approximately 691,000 pounds of uranium and 1,650,000 pounds of vanadium, both in the form of immediately marketable product. The spot price of U3O8 at March 11, 2022 was $58.50 per pound, according to TradeTech (up from $42.00 per pound at December 31, 2021. The current mid-point spot price of V2O5 at March 11, 2022 was $12.25 per pound after remaining relatively flat near the 2021 year-end, according to FastMarkets. Based on today’s spot prices, the Company’s December 31, 2021 uranium and vanadium inventories would have a current market value of $40.4 million and $20.2 million, respectively, totaling approximately $60.6 million. On October 27, 2021, the Company completed the sale of certain non-core conventional assets to CUR. In addition to receiving $2 million cash at closing, the Company now holds 19.1% of the outstanding shares of CUR as of December 31, 2021, for a total value to the Company of $32.2 million as at December 31, 2021.

During the year ended December 31, 2021, the Company realized net income of $1.5 million, compared to a net loss of $27.9 for the year ended December 31, 2020. The net income in 2021 was primarily due to the sale of non-core conventional uranium assets to CUR. The Company spent $10.75 million for development of the Company’s properties, primarily due to the development and ramping up of the RE Carbonate production program at the Mill. The Company also incurred underutilized capacity production costs applicable to rare earth concentrates during the year of $0.53 million. The underutilized capacity production costs are due to low throughput rates as the Mill ramps-up to commercial-scale production at full capacity. To date, the Mill has focused on producing commercially salable RE Carbonate at low throughput rates and has been very pleased with the resulting product it is shipping for separation. The Mill expects to increase its throughput rates as its supplies of monazite sands increase. The Company is in advanced discussions with several additional sources of monazite sands that, if successfully secured, we expect to result in sufficient throughput to reduce underutilized capacity production costs and allow the Company to realize its expected margins on a continuous basis.

Rare Earth Achievements in 2021 and To Date in 2022:

On March 1, 2021, the Company and Neo Performance Materials Limited (“Neo“) announced a new rare earth production initiative spanning European and North American critical material supply chains. Under an agreement in principle signed on March 1, 2021 and finalized into a definitive agreement in July 2022, Energy Fuels will process natural monazite sands, currently being mined in the state of Georgia by The Chemours Company, into an RE Carbonate at the Mill and ship a portion of the produced RE Carbonate to Neo’s rare earth separations facility in Sillamäe, Estonia (“Silmet“). Silmet will then process the RE Carbonate into separated rare earth materials for use in rare earth permanent magnets and other rare earth-based advanced materials.

On July 7, 2021, the Company announced that the first container (approximately 20 tonnes of product) of an expected 15 containers of mixed RE Carbonate had been successfully produced by Energy Fuels at the Mill and was en route to Silmet. This commercial-scale production of RE Carbonate by Energy Fuels from a U.S. mined rare earth resource positions Energy Fuels as the only company in North America that currently produces a monazite-derived, enhanced rare earth material. The physical delivery of this product also represents the launch of a new, environmentally responsible rare earth supply chain that allows for source validation and tracking from mining through to final end-use applications for manufacturers in North AmericaEuropeJapan, and other nations.

The Company also announced on March 1, 2021 that, in addition to supplying RE Carbonate to Neo, Energy Fuels is evaluating the potential to develop U.S. separation capabilities at the Mill, or nearby, as it works to increase its monazite sand supplies, thereby fully integrating a U.S. rare earth supply chain in the coming years, in addition to supplying RE Carbonate to European markets. On April 27, 2021, the Company announced it had engaged Carester to prepare a scoping study for the development of a solvent extraction REE separation circuit at the Mill utilizing the Mill’s existing equipment and infrastructure to the extent applicable, to create a continuous, integrated and optimized rare earth production sequence. Based in Lyon, France, Carester is one of the world’s leading global consultants on rare earth supply chains, with expertise in designing, constructing, operating and optimizing REE production facilities globally. Carester’s scoping work included an evaluation of the Mill’s current monazite leaching process, preparation of an REE separation flow sheet, capital and operating expense estimates, incorporation of new technologies where applicable, and recommendations on equipment vendors. The Company is planning to install a full separation circuit at its White Mesa Mill to produce both “light” and “heavy” separated REE oxides in the coming years, subject to successful licensing, financing, and commissioning, and continued strong market conditions. The Company has hired Carester to perform a second scoping study to support these REE separation initiatives.

During Q1-2022, the Company began commercially separating La and Ce from its RE Carbonate on a small scale using an existing solvent extraction circuit at the Mill. This represents the first commercial level REE separation to occur in the U.S. in many years. The Company has been performing laboratory-scale REE separations for the last several months on a 24/7 basis, successfully executing the La, Ce, and NdPr separations at high-purities and with excellent recoveries.

On December 15, 2021, the Company announced the execution of an MOU with NSP for the development of a novel technology for the potential production of REE metals, subject to the finalization of definitive agreements. We believe this technology, which was initially developed by NSP, and will be advanced by the Company and NSP working together, has the potential to revolutionize the rare earth metal making industry by reducing costs of production, reducing energy consumption, and significantly reducing greenhouse gas emissions. Producing REE metals and alloys is a key step in a fully integrated REE supply chain, after production of separated REE oxides and before the manufacture of neodymium iron boron (“NdFeB“) magnets used in electric vehicles, wind generation and other clean energy and advanced technologies.

In addition, during 2022, the Company announced the execution of a non-binding memorandum of understanding (“MOU“) for the supply of natural monazite sands from IperionX Limited’s (“IperionX’s“, formerly known as Hyperion Metals Limited) Titan Project in Tennessee, if and when the project is developed and mined. IperionX’s Titan Project covers a large area of heavy mineral sands properties in Tennessee prospective for titanium, zircon, monazite and other valuable minerals such as high-grade silica sand and other refractory minerals.

In 2021, the Company also announced that the U.S. Department of Energy (“DOE“) Office of Fossil Energy and National Energy Technology Laboratory had exercised its option to award Energy Fuels, working with a team from Penn State University, an additional $1.75 million to complete a feasibility study on the production of REE products from natural coal-based resources, as well as from other materials such as REE-containing ores like the natural monazite sands the Company is currently processing at the Mill. This award follows the DOE providing Energy Fuels a $150,000 contract in 2020 for the successful completion of a conceptual design for the same initiative, resulting in a total award to Energy Fuels of $1.9 million.

Update on Medical Isotope Initiative:

On July 28, 2021, the Company announced the execution of a Strategic Alliance Agreement with RadTran, LLC, a technology development company focused on closing critical gaps in the procurement of medical isotopes for emerging TAT cancer therapeutics and other applications. Under this strategic alliance, the Company is evaluating the feasibility of recovering Th-232, and Ra-226 from its existing RE Carbonate and uranium process streams at the Mill and, together with RadTran, is evaluating the feasibility of recovering Ra-228 from the Th-232, Th-228 from the Ra-228 and concentrating Ra-226 at the Mill using RadTran technologies. Recovered Ra-228, Th-228 and Ra-226 would then be sold to pharmaceutical companies and others to produce Pb-212, Ac-225, Bi-213, Ra-224 and Ra-223, which are the leading medically attractive TAT isotopes for the treatment of cancer. Existing supplies of these isotopes for TAT applications are in short supply, and methods of production are costly and currently cannot be scaled to meet the demand created as new drugs are developed and approved. This is a major roadblock in the research and development of new TAT drugs as pharmaceutical companies wait for scalable and affordable production technologies to become available. Under this initiative, the Company has the potential to recover valuable isotopes from its existing process streams, therefore recycling back into the market material that would otherwise be lost to disposal for use in treating cancer.

Establishment of San Juan County Clean Energy Foundation:

On September 16, 2021, the Company announced its establishment of the San Juan County Clean Energy Foundation, a fund specifically designed to contribute to the communities surrounding the Mill in Southeastern, Utah. The Company made an initial deposit of $1 million into the Foundation and anticipates providing ongoing annual funding equal to 1% of the Mill’s future revenues, providing funding to support local economic development and local priorities. The Foundation will focus on supporting education, the environment, health/wellness, and local economic development in the City of BlandingSan Juan County, the White Mesa Ute Community, the Navajo Nation and other area communities.

Sale of Non-Core Assets to Consolidated Uranium Inc.:

On October 27, 2021, CUR and the Company jointly announced the closing of a transaction whereby CUR acquired a portfolio of Energy Fuels’ non-core conventional uranium projects located in Utah and Colorado, including the Daneros mine, the Tony M mine (formerly a part of the Henry Mountains Project), the Rim mine, the Sage Plain project, and several DOE leases located in Colorado, in consideration for a 19.9% share ownership interest in CUR (as of the 2021 year-end, 19.1%) and other consideration. The Company reported a gain on the value of this transaction of $35.7 million, resulting in a significant improvement in the Company’s results of operations and net income for 2021.

Proposed U.S. Uranium Reserve:

On December 27, 2020, Congress passed the COVID-Relief and Omnibus Spending Bill, which includes $75 million for the proposed establishment of a strategic U.S. Uranium Reserve (the “U.S. Uranium Reserve“) and was signed into law by the president then serving. This key funding opens the door for the U.S. government to purchase domestically produced uranium to guard against potential commercial and national security risks presented by the country’s near-total reliance on foreign imports of uranium. Russia’s recent invasion of Ukraine has raised concerns about the United States’ reliance on imports of Russian uranium and enrichment services, which could provide further impetus for the U.S. government to bring this program into effect.

The Company stands ready to benefit from this program through future production from its mines and facilities and potentially sales out of its existing uranium inventories. However, because the U.S. Uranium Reserve has yet to be established at this time, the details of implementation of activities pursuant to the new law have not yet been defined. As a result, there can be no certainty as to the outcome of the U.S. Uranium Reserve, including the process for and details of its development, and any resulting support for the Company’s ongoing and planned activities or for any further evaluations of the Working Group.

Appointment of New Director:

On January 25, 2022, the Board appointed Dr. Ivy Estabrooke as a Director of Energy Fuels, bringing to the Company experience in commercial-stage biotech, research and development program leadership, and technology solutions for national security and public health challenges. Dr. Estabrooke is currently the Vice President of Operations and Corporate Affairs at IDbyDNA Inc., a venture backed commercial stage biotech company. She has led innovative research and development programs in both the public and private sectors delivering technology solutions for national security and public health challenges. Prior roles include as a technical program manager for the U.S. Department of the Navy, the executive director of the State of Utah’s technology-based economic development agency, and science advisor to the Governor of Utah. She earned her doctorate in neuroscience at Georgetown University in 2005, received a master’s degree in national resource strategy from the National Defense University in 2013, and a bachelor’s degree in biological sciences from Smith College in 1998. Dr. Estabrooke is also an engaged member in her local community, serving on the board of the Girl Scouts of Utah and as a member of the Utah District Export Council.

Operations Update and Outlook for 2022:

Overview

The Company continues to believe that uranium supply and demand fundamentals point to higher sustained uranium prices in the future. In addition, Russia’s recent invasion of Ukraine and the recent entry into the uranium market by financial entities purchasing uranium on the spot market to hold for the long-term has the potential to result in higher sustained spot and term prices and, perhaps, induce utilities to enter into more long-term contracts with non-Russian producers like Energy Fuels to ensure security of supply and more certain pricing. However, the Company has not yet entered into sufficient long-term supply agreements to justify commencing uranium production at the Company’s mines and in-situ recovery (“ISR“) facilities. As a result, the Company expects to maintain uranium recovery at reduced levels until such time when sustained increased market strength is observed, additional suitable term sales contracts can be procured, or the U.S. government buys uranium from the Company following the establishment of the proposed U.S. Uranium Reserve. The Company also holds significant uranium inventories and is evaluating selling all or a portion of these inventories on the spot market in response to future upside price volatility or for delivery into contracts.

The Company will also continue to seek new sources of revenue, including through its emerging REE business, as well as new sources of other uranium-bearing materials not derived from conventional material and sourced by third parties (“Alternate Feed Materials“) and new fee processing opportunities at the White Mesa Mill that can be processed under existing market conditions (i.e., without reliance on current uranium sales prices). The Company is also seeking new sources of natural monazite sands for its emerging REE business, is evaluating the potential to recover radioisotopes for use in the development of TAT medical isotopes for the treatment of cancer, and continues its support of U.S. governmental activities to assist the U.S. uranium mining industry, including the proposed establishment of the U.S. Uranium Reserve.

Extraction and Recovery Activities Overview

During the year ended December 31, 2021, the Company did not package any significant quantities of its final uranium product, U3O8, at any of its facilitiesAt the Mill, the Company focused on ramping up its mixed RE Carbonate production and produced approximately 120 tonnes of mixed RE Carbonate during 2021. The Company recovered small quantities of uranium at the Mill during 2021, but such uranium was retained in-circuit and was not packaged in 2021. The Company also continued to maintain its Nichols Ranch and Alta Mesa ISR facilities on standby.

During 2022, the Company plans to recover 100,000 to 120,000 pounds of uranium at the Mill. The Company does not plan to extract and/or recover any amounts of uranium of any significance from its Nichols Ranch Project in 2022, which was placed on standby in the second quarter of 2020 due to the depletion of its seven constructed wellfields. In addition, the Company expects to keep the Alta Mesa Project and its conventional mining properties on standby during 2022.

During 2022, the Company expects to recover approximately 650 to 1,000 tonnes of mixed RE Carbonate containing approximately 300 to 450 tonnes of TREO at the Mill, subject to the receipt of sufficient quantities of natural monazite ore. No vanadium production is currently planned during 2022, though the Company is currently evaluating potential vanadium production in light of recent market improvements in vanadium pricing.

ISR Activities

The Company expects to produce insignificant quantities of U3O8 in the year ending December 31, 2022 from Nichols Ranch. Until such time when market conditions improve sufficiently, suitable term sales contracts can be procured, or the proposed U.S. Uranium Reserve is established, the Company expects to maintain the Nichols Ranch Project on standby and defer development of further wellfields and header houses. The Company expects to continue to keep the Alta Mesa Project on standby until such time that market conditions improve sufficiently, suitable term sales contracts can be procured, or the proposed U.S. Uranium Reserve is established.

Conventional Activities

Conventional Extraction and Recovery Activities

During the year ended December 31, 2021, the Mill did not package any material quantities of U3O8, focusing instead on developing its REE recovery business. During the year ended December 31, 2021, the Mill produced approximately 270 tonnes of RE Carbonate, containing approximately 120 tonnes of TREO. The Mill recovered small quantities of uranium in 2021, which were retained in circuit. During 2022, the Company expects to recover 100,000 to 120,000 pounds of uranium at the Mill. The Company expects to recover approximately 650 to 1,000 tonnes of mixed RE Carbonate containing approximately 300 to 450 tonnes of TREO at the Mill, subject to the receipt of sufficient quantities of natural monazite ore. The Company is in advanced discussions with several sources of natural monazite sands, including the Company’s existing supplier, to secure additional supplies of monazite sands, which if successful, would be expected to allow the Company to increase RE Carbonate production. In addition to its 691,000 pounds of finished uranium inventories currently located at a North American conversion facility and at the Mill, the Company has approximately 355,000 pounds of U3O8 contained in stockpiled Alternate Feed Material and mineralized material inventory at the Mill that can be recovered relatively quickly in the future, as general market conditions may warrant (totaling about 1,046,000 pounds of U3O8 of total uranium inventory).

In addition, there remains an estimated 1.0 to 3.0 million pounds of solubilized recoverable V2O5 inventory remaining in tailings solutions awaiting future recovery, as market conditions may warrant.

Conventional Standby, Permitting and Evaluation Activities

During the year ended December 31, 2021, standby and environmental compliance activities continued at the Company’s fully permitted and substantially developed Pinyon Plain Project.

The Company is selectively advancing certain permits at its other major conventional uranium projects, such as the Roca Honda Project, which is a large, high-grade conventional project in New Mexico. The Company is also continuing to maintain required permits at its conventional projects, including the Sheep Mountain Project, La Sal Complex and Whirlwind Project. In addition, the Company will continue to evaluate the Bullfrog Project. All of these projects serve as important pipeline assets for the Company’s future conventional production capabilities, as market conditions may warrant.

Uranium Sales

During the year ended December 31, 2021, the Company elected not to complete any sales of uranium; however, the Company is now actively engaged in pursuing selective long-term uranium sales contracts with suitable quantities, pricing, and other terms.

Vanadium Sales

During the year ended December 31, 2021, the Company sold 5,000 pounds of ferrovanadium (“FeV“) for an average, weighted price of $14.74 per pound. The Company expects to sell the remaining finished vanadium product when justified into the metallurgical industry, as well as other markets that demand a higher purity product, including the aerospace, chemical, and potentially the vanadium battery industries.

Rare Earth Sales

The Company commenced its ramp-up to commercial production of a mixed RE Carbonate in March 2021 and has shipped all of its RE Carbonate produced to-date to Silmet, where it is currently being fed into their separation process. All RE Carbonate produced at the Mill in 2022 is expected to be sold to Neo for separation at Silmet. Until such time as the Company expects to permit and construct its own separation circuits at the Mill, production in future years is expected to be sold to Neo for separation at Silmet and, potentially, to other REE separation facilities outside the U.S. To the extent not sold, the Company expects to stockpile mixed RE Carbonate at the Mill for future separation and other downstream REE processing at the Mill or elsewhere.

As the Company continues to ramp up its mixed RE Carbonate production and additional funds are spent on process enhancements, improving recoveries, product quality and other optimization, profits from this initiative are expected to be minimal until such time when monazite throughput rates are increased and optimized. However, even at the current throughput rates, the Company is recovering most of its direct costs of this growing initiative, with the other costs associated with ramping up production, process enhancements and evaluating future separation capabilities at the Mill being expensed as development expenditures. Throughout this process, the Company is gaining important knowledge, experience and technical information, all of which will be valuable for current and future mixed RE Carbonate production and expected future production of separated REE oxides and other advanced REE materials at the Mill.

About Energy Fuels: Energy Fuels is a leading U.S.-based uranium mining company, supplying U3O8 to major nuclear utilities. The Company also produces vanadium from certain of its projects, as market conditions warrant, and is ramping up to full commercial-scale production of RE Carbonate. Its corporate offices are in Lakewood, Colorado near Denver, and all its assets and employees are in the United States. Energy Fuels holds three of America’s key uranium production centers: the White Mesa Mill in Utah, the Nichols Ranch ISR Project in Wyoming, and the Alta Mesa ISR Project in Texas. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today, has a licensed capacity of over 8 million pounds of U3O8 per year, and has the ability to produce vanadium when market conditions warrant, as well as RE Carbonate from various uranium-bearing ores. The Nichols Ranch ISR Project is currently on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Alta Mesa ISR Project is also currently on standby. In addition to the above production facilities, Energy Fuels also has one of the largest S-K 1300 and NI 43-101 compliant uranium resource portfolios in the U.S. and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.

Cautionary Note Regarding Forward-Looking Statements: This news release contains certain “Forward Looking Information” and “Forward Looking Statements” within the meaning of applicable United States and Canadian securities legislation, which may include, but are not limited to, statements with respect to: production and sales forecasts; costs of production; any expectation that the Company will continue to be ready to supply uranium into the proposed U.S. Uranium Reserve once it is established; scalability, and the Company’s ability and readiness to re-start, expand or deploy any of its existing projects or capacity to respond to any improvements in uranium market conditions or in response to the proposed U.S. Uranium Reserve; any expectation regarding any remaining dissolved vanadium in the Mill’s tailings facility solutions or the ability of the Company to recover any such vanadium at acceptable costs or at all; the ability of the Company to secure any new sources of Alternate Feed Materials or other processing opportunities at the Mill; expected timelines for the permitting and development of projects; the Company’s expectations as to longer term fundamentals in the market and price projections; any expectation that the Company will maintain its position as a leading uranium company in the United States; any expectation that the proposed U.S. Uranium Reserve will be implemented and if implemented the manner in which it will be implemented and the timing of implementation; any expectation with respect to timelines to production; any expectation that the Mill will be successful in producing RE Carbonate on a full-scale commercial basis; any expectation that Neo will be successful in separating the Mill’s RE Carbonate on a commercial basis; any expectation that Energy Fuels will be successful in developing U.S. separation, or other value-added U.S. REE production capabilities at the Mill, or otherwise; any expectation that the Company and Neo will be successful in jointly developing a fully integrated U.S.-European REE supply chain; any expectation that the Company will be successful in building a low-cost, fully integrated U.S. rare earth supply chain; any expectation with respect to the future demand for REEs; any expectation with respect to the quantities of monazite sands to be acquired by Energy Fuels, the quantities of RE Carbonate to be produced by the Mill or the quantities of contained TREO in the Mill’s RE Carbonate; any expectation that additional supplies of monazite sands will result in sufficient throughput at the Mill to reduce underutilized capacity production costs and allow the Company to realize its expected margins on a continuous basis; any expectation that the Company’s strategic venture with NSP to develop technology for the production of REE metals will be successful or that the technology has the potential to reduce the costs of production, energy consumption, or greenhouse gas emissions versus existing technologies; any expectation that IperionX’s Titan Project in Tennessee will be developed and mined, or that the Company will receive any monazite sands from the project; any expectation that the Company’s evaluation of thorium and radium recovery at the Mill will be successful; any expectation that the potential recovery of medical isotopes from any thorium and radium recovered at the Mill will be feasible; any expectation that any thorium, radium and other isotopes can be recovered at the Mill and sold on a commercial basis; any expectation as to the value to the Company of its ownership interest in CUR resulting from its sale of certain non-core assets in 2021; any expectation that the Company will be successful in completing one or more contracts for the sale of uranium to U.S. utilities; and any expectation that the Company will generate net income in future periods. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as “plans,” “expects,” “does not expect,” “is expected,” “is likely,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates,” “does not anticipate,” or “believes,” or variations of such words and phrases, or state that certain actions, events or results “may,” “could,” “would,” “might” or “will be taken,” “occur,” “be achieved” or “have the potential to.” All statements, other than statements of historical fact, herein are considered to be forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements express or implied by the forward-looking statements. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: commodity prices and price fluctuations; processing and mining difficulties, upsets and delays; permitting and licensing requirements and delays; changes to regulatory requirements; legal challenges; the availability of sources of Alternate Feed Materials and other feed sources for the Mill; competition from other producers; public opinion; government and political actions; the appropriations for the proposed U.S. Uranium Reserve not being allocated to that program and the U.S. Uranium Reserve not being implemented; the manner in which the proposed U.S. Uranium Reserve, if established, will be implemented; the Company not being successful in selling any uranium into the proposed U.S. Uranium Reserve at acceptable quantities or prices, or at all; available supplies of monazite sands; the ability of the Mill to produce RE Carbonate to meet commercial specifications on a commercial scale at acceptable costs; the ability of Neo to separate the RE Carbonate produced by the Mill to meet commercial specifications on a commercial scale at acceptable costs; market factors, including future demand for REEs; the ability of the Mill to be able to separate thorium and radium at reasonable costs or at all; the ability of the Company and RadTran to be able to recover other isotopes from thorium and radium recovered at the Mill at reasonable costs or at all; market prices and demand for medical isotopes; and the other factors described under the caption “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K, which is available for review on EDGAR at www.sec.gov/edgar.shtml, on SEDAR at www.sedar.com, and on the Company’s website at www.energyfuels.com. Forward-looking statements contained herein are made as of the date of this news release, and the Company disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. The Company assumes no obligation to update the information in this communication, except as otherwise required by law.

SOURCE Energy Fuels Inc.

Release – Department of Defense Selects Vectrus for Development of 5G Smart Warehouse



Department of Defense Selects Vectrus for Development of 5G Smart Warehouse

Research, News, and Market Data on Vectrus

 

COLORADO SPRINGS, Colo.March 16, 2022 /PRNewswire/ — Vectrus, Inc. (NYSE: VEC) has been selected by the Department of Defense to complete the final phases of application development for a 5G Smart Warehouse at Naval Base Coronado (NBC). The NBC 5G Smart Warehouse Assessment Team conducted a down select during Phase 1, comparing application solutions from three companies including Vectrus. This effort is part of the DoD’s $600 million 5G experimentation and testing initiative, originally awarded in 2020. Vectrus successfully demonstrated a Converged Environment solution, addressing NAVSUP operational challenges through the implementation of advanced technology applications.

Vectrus’ solutions focused on increasing efficiency, reducing costs, improving readiness and cybersecurity, and strengthening national security. The NBC 5G Smart Warehouse Assessment Team participated in live demonstrations of technologies at the 5G Converged Environment Smart Warehouse – Vectrus’ 5G smart technology testbed – just outside of Richmond, Virginia.

The smart warehouse is a realization of Vectrus’ Converged Environment concept, bringing together the support services, including base operations support, supply chain and logistics, IT and network operations, engineering and digital integration, and security, in one synchronized environment.

“The smart warehouse will serve as a test bed for refining, validating and operationalizing 5G-enabled technologies,” said Corinne Minton-Package, Senior Vice President of Systems and Technology at Vectrus. “This high-tech warehouse will more efficiently facilitate the transshipment between shore facilities and naval units. Our work at Naval Base Coronado will bring next generation efficiencies to naval logistics operations.”

About Vectrus

Vectrus, a defense technology company, has provided mission critical support for the toughest operational challenges our customers have faced for more than 70 years. We leverage emerging technologies, unmatched technical expertise, exceptional talent, and deep domain knowledge to deliver innovative solutions for military and government customers worldwide. Whether it’s base operations supportconverged environment solutionssupply chain and logisticsIT mission supportengineering and digital integrationsecurity, or maintenance, repair, and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on FacebookTwitter, and LinkedIn.

Media Contact:

Mike Smith, CFA
719-637-5773
michael.smith@vectrus.com

SOURCE Vectrus, Inc.

Department of Defense Selects Vectrus for Development of 5G Smart Warehouse



Department of Defense Selects Vectrus for Development of 5G Smart Warehouse

Research, News, and Market Data on Vectrus

 

COLORADO SPRINGS, Colo.March 16, 2022 /PRNewswire/ — Vectrus, Inc. (NYSE: VEC) has been selected by the Department of Defense to complete the final phases of application development for a 5G Smart Warehouse at Naval Base Coronado (NBC). The NBC 5G Smart Warehouse Assessment Team conducted a down select during Phase 1, comparing application solutions from three companies including Vectrus. This effort is part of the DoD’s $600 million 5G experimentation and testing initiative, originally awarded in 2020. Vectrus successfully demonstrated a Converged Environment solution, addressing NAVSUP operational challenges through the implementation of advanced technology applications.

Vectrus’ solutions focused on increasing efficiency, reducing costs, improving readiness and cybersecurity, and strengthening national security. The NBC 5G Smart Warehouse Assessment Team participated in live demonstrations of technologies at the 5G Converged Environment Smart Warehouse – Vectrus’ 5G smart technology testbed – just outside of Richmond, Virginia.

The smart warehouse is a realization of Vectrus’ Converged Environment concept, bringing together the support services, including base operations support, supply chain and logistics, IT and network operations, engineering and digital integration, and security, in one synchronized environment.

“The smart warehouse will serve as a test bed for refining, validating and operationalizing 5G-enabled technologies,” said Corinne Minton-Package, Senior Vice President of Systems and Technology at Vectrus. “This high-tech warehouse will more efficiently facilitate the transshipment between shore facilities and naval units. Our work at Naval Base Coronado will bring next generation efficiencies to naval logistics operations.”

About Vectrus

Vectrus, a defense technology company, has provided mission critical support for the toughest operational challenges our customers have faced for more than 70 years. We leverage emerging technologies, unmatched technical expertise, exceptional talent, and deep domain knowledge to deliver innovative solutions for military and government customers worldwide. Whether it’s base operations supportconverged environment solutionssupply chain and logisticsIT mission supportengineering and digital integrationsecurity, or maintenance, repair, and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on FacebookTwitter, and LinkedIn.

Media Contact:

Mike Smith, CFA
719-637-5773
michael.smith@vectrus.com

SOURCE Vectrus, Inc.

Generating Synthetic Data to Speed AI




When it Comes to AI, Can We Ditch the Datasets?

 

Adam Zewe | MIT
News Office

 

Huge amounts of data are needed to train machine-learning models to perform image classification tasks, such as identifying damage in satellite photos following a natural disaster. However, these data are not always easy to come by. Datasets may cost millions of dollars to generate, if usable data exist in the first place, and even the best datasets often contain biases that negatively impact a model’s performance.

To circumvent some of the problems presented by datasets, MIT researchers developed a method for training a machine learning model that, rather than using a dataset, uses a special type of machine-learning model to generate extremely realistic synthetic data that can train another model for downstream vision tasks.

Their results show that a contrastive representation learning model trained using only these synthetic data is able to learn visual representations that rival or even outperform those learned from real data.

This special machine-learning model, known as a generative model, requires far less memory to store or share than a dataset. Using synthetic data also has the potential to sidestep some concerns around privacy and usage rights that limit how some real data can be distributed. A generative model could also be edited to remove certain attributes, like race or gender, which could address some biases that exist in traditional datasets.

“We knew that this method should eventually work; we just needed to wait for these generative models to get better and better. But we were especially pleased when we showed that this method sometimes does even better than the real thing,” says Ali Jahanian, a research scientist in the Computer Science and Artificial Intelligence Laboratory (CSAIL) and lead author of the paper.

Jahanian wrote the paper with CSAIL grad students Xavier Puig and Yonglong Tian, and senior author Phillip Isola, an assistant professor in the Department of Electrical Engineering and Computer Science. The research will be presented at the International Conference on Learning Representations.

 

Generating Synthetic Data

Once a generative model has been trained on real data, it can generate synthetic data that are so realistic they are nearly indistinguishable from the real thing. The training process involves showing the generative model millions of images that contain objects in a particular class (like cars or cats), and then it learns what a car or cat looks like so it can generate similar objects.

Essentially by flipping a switch, researchers can use a pre-trained generative model to output a steady stream of unique, realistic images that are based on those in the model’s training dataset, Jahanian says.

But generative models are even more useful because they learn how to transform the underlying data on which they are trained, he says. If the model is trained on images of cars, it can “imagine” how a car would look in different situations — situations it did not see during training — and then output images that show the car in unique poses, colors, or sizes.

Having multiple views of the same image is important for a technique called contrastive learning, where a machine-learning model is shown many unlabeled images to learn which pairs are similar or different.

The researchers connected a pretrained generative model to a contrastive learning model in a way that allowed the two models to work together automatically. The contrastive learner could tell the generative model to produce different views of an object, and then learn to identify that object from multiple angles, Jahanian explains.

“This was like connecting two building blocks. Because the generative model can give us different views of the same thing, it can help the contrastive method to learn better representations,” he says.

 

Even Better Than the Real Thing

The researchers compared their method to several other image classification models that were trained using real data and found that their method performed as well, and sometimes better, than the other models.

One advantage of using a generative model is that it can, in theory, create an infinite number of samples. So, the researchers also studied how the number of samples influenced the model’s performance. They found that, in some instances, generating larger numbers of unique samples led to additional improvements.

“The cool thing about these generative models is that someone else trained them for you. You can find them in online repositories, so everyone can use them. And you don’t need to intervene in the model to get good representations,” Jahanian says.

But he cautions that there are some limitations to using generative models. In some cases, these models can reveal source data, which can pose privacy risks, and they could amplify biases in the datasets they are trained on if they aren’t properly audited.

He and his collaborators plan to address those limitations in future work. Another area they want to explore is using this technique to generate corner cases that could improve machine learning models. Corner cases often can’t be learned from real data. For instance, if researchers are training a computer vision model for a self-driving car, real data wouldn’t contain examples of a dog and his owner running down a highway, so the model would never learn what to do in this situation. Generating that corner case data synthetically could improve the performance of machine learning models in some high-stakes situations.

The researchers also want to continue improving generative models so they can compose images that are even more sophisticated, he says.

 

This research was supported, in part, by the MIT-IBM
Watson AI Lab, the United States Air Force Research Laboratory, and the United
States Air Force Artificial Intelligence Accelerator.

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Doubling Down on Stocks Advancing



Image: Trafigura (Flickr)


Why JP Morgan’s Guru has Maintained a Positive Stance on Stocks

 

A month back, JP Morgan released a research note indicating the bull market in stocks is “far from over” despite investors’ increasing concerns about a hawkish Federal Reserve. Since then, Russia has invaded Ukraine, interest rates have risen, and the major indices have fallen another 3.00-5.50%. Yesterday (March 15), JP Morgan’s “quant guru,” Marko Kolanovic doubled down on the positive stance with the notion that the S&P 500’s year-to-date decline of 12% represents an opportunity that investors with a medium-term time horizon should take advantage of.

Priced for Negativity

With interest rates already having begun their climb, a spike in producer prices, and a full-blown war between two large European countries, the stock market has reacted to hit after hit of news and events to feel negative over. Despite this, JPMorgan’s, Kolanovic, said Monday the S&P 500’s year-to-date decline of 12% represents an opportunity that investors with a medium-term time horizon should take advantage of. The confidence is largely attributed to the idea that despite the disruptions, he doesn’t expect the US economy to enter a recession. He highlighted that consumers and corporations currently have healthy balance sheets.

 

 

“We think that outright recession should not be a base case given continued favorable financing conditions, very strong labor markets, an unleveraged consumer, strong corporate cash flows, strong bank balance sheets, a turn for the better in the China policy outlook, and the COVID-19 impact should be fading further,” Kolanovic said. This is “quant speak” for recession shouldn’t be the expectation since rates are still low, people are not heavily in debt, they have jobs, banks will continue to lend, and the China situation along with the pandemic drag is fading.

Of course, there are still risks that were pointed out. While Russia is not a large trading partner with the US, it is a substantial producer of commodities that can slow US economic growth as prices for raw materials rise globally. Despite all of this, the expectations he believes are largely built into prices, none of these are a surprise, they have already had their impact. “A lot of risk is already priced in, sentiment is depressed and investor positioning is low, so we would add to risk with a medium-term horizon,” Kolanovic said.

 

Monetary Policy Impact

Kolanovic points out that prior periods of Fed rate hikes have proven to be bullish for the broader stock market. “Equities tended to firm up 3-4 months after the first hike, and make fresh all-time highs within 6-12 months,” he said.

Take-Away

Is the worst close to over? JP Morgan seems to think so. While the Global Head of Macro Quantitative and Derivatives Research at the bank thinks the broader market may treat investors well, he also cautions that this view is intended for medium-term investors. This means the turnaround may not occur for a while.

The risk to this position is that more or new negativity occurs. There is hardly a limit on events that could frighten the market. On the flip side, there is risk in not being invested when prices are down, the rates being paid for being in cash, even after a Fed rate hike are below current inflation.

 

Suggested Reading



New Economic Variables Confound Fed’s Future Path



Investors Have Added Money to the Markets a Record 71.4% After Dips





Carl Icahn Selling into Warren Buffet’s Buying, Can they Both be Right?



What it Means When the Federal Reserve Bank Tightens Monetary Policy

 

Sources

https://www.linkedin.com/in/marko-kolanovic-a335b6/

https://markets.businessinsider.com/news/stocks/stock-market-outlook-bull-market-far-from-over-dovish-fed-2022-2

https://markets.businessinsider.com/news/stocks/stock-market-outlook-economy-will-avoid-recession-jpmorgan-kolanovic-inflation-2022-3

 

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ACCO Brands Announces Deborah A. O’Connor as Chief Financial Officer



ACCO Brands Announces Deborah A. O’Connor as Chief Financial Officer

Research, News, and Market Data on ACCO Brands

 

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that Deborah A. O’Connor has been named as Executive Vice President and Chief Financial Officer, effective April 4, 2022.

“Deb is an experienced Chief Financial Officer with a track record of delivering value with deep operational, industry, mergers and acquisitions, international and public company accounting experience. We’re excited to have her join ACCO Brands and help lead our transformation to a faster growing brand-, consumer- and technology-centric company,” said Boris Elisman, ACCO Brands Chairman and Chief Executive Officer.

Ms. O’Connor was President and Chief Financial Officer of True Value Company, a wholesaler and distributor of home improvement and hardware products, from 2020 to 2021, having previously served as its Senior Vice President and Chief Financial Officer from 2015 to 2020. Prior to joining True Value Company, she served in various executive capacities at Office Max/Office Depot, an office supply distributor and retailer, including Senior Vice President of Integration at Office Depot, Interim Chief Financial Officer at OfficeMax, and Senior Vice President and Chief Accounting Officer at OfficeMax. Prior to OfficeMax, Ms. O’Connor served in senior financial roles at ServiceMaster.

Ms. O’Connor will succeed Neal Fenwick whose upcoming retirement was announced by the Company on February 15, 2022. In connection with Ms. O’Connor’s appointment as Executive Vice President and Chief Financial Officer, Mr. Fenwick will step down as Chief Financial Officer and serve as an executive advisor to ensure a smooth transition until he retires in August 2022.

“Neal’s contributions to ACCO Brands over his long career are numerous and profound. He has been instrumental in establishing the financial foundation which has allowed ACCO Brands to invest, grow, acquire, transform and thrive. Neal has been a leader, partner and mentor to many in the company, and a wise counselor and friend to me. We thank him for his service and congratulate him on starting a new chapter in his life,” concluded Elisman.

About ACCO Brands Corporation

ACCO Brands Corporation (NYSE: ACCO) is one of the world’s largest designers, marketers and manufacturers of branded academic, consumer and business products. Our widely recognized brands include Artline®, AT-A-GLANCE®, Barrilito®, Derwent®, Esselte®, Five Star®, Foroni®, GBC®, Hilroy®, Kensington®, Leitz®, Mead®, PowerA™, Quartet®, Rapid®, Rexel®, Swingline®, Tilibra®, Wilson Jones® and many others. Our products are sold in more than 100 countries around the world. More information about ACCO Brands, the Home of Great Brands Built by Great People, can be found at www.accobrands.com.

Christine Hanneman
Investor Relations
(847) 796-4320

Julie McEwan
Media Relations
(937) 974-8162

Source: ACCO Brands Corporation

PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers



PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers

Research, News, and Market Data on PDS Biotech

 

NCI achieves the enrollment objective of thirty patients in the checkpoint inhibitor refractory arm of the study

FLORHAM PARK, N.J., March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, today announced that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune®+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers. Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

“We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective.” 

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms.

Our Versamune®-based molecularly targeted products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers. 

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital

PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd.


PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

Research, News, and Market Data on PsyBio

 

PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa

OXFORD, Ohio and COCONUT CREEK, Fla.March 15, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has entered into a definitive agreement (the “Agreement“) to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. (“Everest“), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the “Acquisition“). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.

PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio’s abilities which encompass fully translational capabilities in its current scientific laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.

“Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The next step is for PsyBio to collaborate with Everest’s current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions.”

Upon completion of the Acquisition, PsyBio will acquire Everest’s active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.

“The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes.”

The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the “SVS“), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange (“TSXV“).

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

Tighter But Still Easy Money



Image Credit: Federal Reserve (Flickr)


New Economic Variables Confound Fed’s Future Path

 

Federal Reserve Chairman Jay Powell tends to tell the markets exactly what to expect from the Fed. Last week he said he’d propose raising interest rates by 25bp (up from 0.00-0.25) after the March 15-16 FOMC meeting. This would be the first increase since 2018. Earlier this year, Powell set expectations for the possibility of raising rates by twice as much; he also suggested the Fed might need to eventually raise borrowing costs to a level designed to deliberately slow economic growth. This was the chairman’s thinking before the war broke out in Europe. The uncertainty of its impact on growth here in the US is the main reason to be cautious now. What are the variables?

 

Uncertain Impact

While the Fed Chairman is just one of 12 voting members, past FOMC meeting minutes show that the vote on monetary policy change, after debate and deliberations, most often goes along with the Fed Chairman’s judgment. Prior to the war-related global economic upheaval, the big risk was inflation caused by a number of variables, including tight labor markets, supply chain problems, raw material shortages, etc. A 0.50% hike could have added enough pressure on the economic brake pedal to temper some of these price pressures while letting other problems such as shortages work their way out of the system.

The market was pricing itself for 0.50% prior to the invasion of Ukraine, now a 50bp hike would surprise and disrupt the markets. While market levels are not part of the Fed’s mandate, a severe downturn in stock and bond markets could pummel spending and economic growth. So, the Fed is cognizant of market reaction. And with recent uncertainty, likely to err on the side of doing too little.

 

Decision and Outlook

If not for the international upheaval of unknown length and consequences, a half percentage hike would have been the most likely action after this meeting. But after Powell’s more recent comments, the decision on what to say after the rate announcement is likely the bigger decision at the meeting. In 2022 we are accustomed to an extremely overt Fed, anything but clarity and confidently setting expectations will leave markets uneasy.

The last time inflation was running in 8% territory (decades ago), the Fed did not signal its intentions, nor did it announce a change. Its actions backe then were just another variable in the market that participants needed to analyze and speculate on. If it eased or tightened was not certain until the FOMC meeting minutes were published three weeks after the next FOMC meeting. And the rate changes were most often between meetings. The need to guide expectations and fear of catching the market off-guard was not a part of any decision. Secrecy and being covert was its own powerful tool.

Today all involved want to be told what to expect, and when. Currently, the markets (stock, commodity, real estate, currency, and bond) are pricing themselves for the 0.25% expectation newly set by the Fed Chair. But speculation is running high on the guidance statement that follows the two-day meeting. The interest-rate path that is signaled will indicate the US central bank’s best evaluation of the most likely economic outlook. And the updated outlook in the face of stiff economic sanctions with trading partners, which could slow the US economy and at the same time add to some root causes of inflation, is highly anticipated. The markets want to know what the Fed sees and what it views as its path.

 

Take-Away

The Fed Announcement will be the most important in nearly two years. Three months ago, almost all Fed voting members indicated they felt a need for between two and four rate rises this year. This has changed, we’ll learn by how much soon.

The market has expectations that the Fed will raise rates 25bp and the market reaction at this point, if that is the level, will be minimal. Perhaps relieved. However, the announcement following at 2 pm, Wednesday (March 16) is likely to show that Fed officials are on guard for either weakness related to changed global circumstances or strength based on recent US economic numbers.  This is what is most anticipated.

What is certain about the statement afterward is the Fed will sound confident in its assessment; uncertainty would roil markets further.

 

Suggested Reading



The Detrimental Impact of Fed policy on Savers



Money Supply is Like Caffeine for Stocks





Deflation Not Inflation is Risk Says Cathie Wood



The Limits of Government Economic Tinkering (June 2020)

 

Sources

https://www.federalreserve.gov/monetarypolicy/fomccalendars.htm

https://www.wsj.com/articles/fed-wrestles-with-the-challenge-of-how-quickly-to-raise-interest-rates-11647336602?mod=hp_lead_pos2

 

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Metaverse Vacations are Latest Use of this Technology



Image: Genoa Roofs, Shocking Wonder (Flickr)


Publisher Embraces Technology that Allows Travel Experiences Regardless of Global Restrictions

 

Vacation travelers have been kept home the past few years, and from the looks of things, if a world tour was on their bucket list, they are likely to remain frustrated. However, technology has an answer to this frustration, and a 22-year-old company has worked with its partner to develop a solution. The company is a subscription-based travel company that sees the opportunity to embrace technology, as they did with the internet back when founded – and in a way that allows them to broaden customer base and serve current users better.

Travelzoo (TZOO) is a US based company that has published “real-world” travel and entertainment packages since 1998. Since then, management has successfully grown and navigated through a changing world. The most recent addition to their travel deals is metaverse based, this puts them at the forefront of metaverse-travel access.

The announcement by the company yesterday (March 14) that they have created a metaverse division and plan to launch Travelzoo META in a few weeks adds an entirely new and exciting dimension to its business. Travelzoo
META
is a paid subscription-based service that provides members with exclusive access to metaverse travel and unique metaverse vacation experiences.

 

 

About the Meta Division

Travelzoo has been building a team of Metaverse travel experience scouts in collaboration with a business partner. Similar to its other travel services, TZOO doesn’t plan to produce or organize the experiences, they will be the conduit that allows subscribers access to unique travel experiences.

“We believe that Metaverse spaces and its future destinations provide completely new and different experiences that consumers want to see,” said Holger Bartel, Global CEO of Travelzoo. “The Metaverse is disruptive and abundant with lucrative opportunities for innovative companies that are willing to be the first movers.”

The build-out of the new business is expected to be funded from annual membership fees to be paid by Travelzoo META members.

About Travelzoo

Travelzoo boasts 30 million members throughout Asia Pacific, Europe, and North America, as well as millions of website users. It has provided for decades what it considers the best travel, entertainment, and local deals available from various companies that advertise through Travelzoo’s service. Most of the company’s revenue is derived from North America.

One of the four research analysts that publishes reports on TZOO is Mike
Kupinski,
Director of Research – Senior Research Analyst, Media & Entertainment at Noble Capital Markets. Mr. Kupinski’s most
recent report
on Travelzoo was published on March 4, 2022. The report titled Why
Investors Should Not Look In The Rearview Mirror
 includes a price target and earnings numbers, along with the analyst’s current rating.

The new META division is in addition to the ongoing real-world travel and entertainment deals the company publishes. 

Travelzoo plans to host an investor conference call at the end of April to provide an update.

Take-Away

As new technology becomes available, successful companies pivot, adapt, and find creative ways to recognize where they can add more value. While businesses are looking for ways to enhance their own businesses with new technology, the late April conference call planned by Travelzoo is on my to-do list. 

Paul Hoffman

Managing Editor, Channelchek

 

Suggested Reading



Why the Metaverse Matters



What Does this Blockchain Crypto-Asset Stuff Have to do With the Metaverse?





Why Web3 is a True Collaboration Between Young and Old



Workcations Add a New class of Traveller (Aug 2020)

 

Sources

https://www.prnewswire.com/news-releases/travelzoo-creates-metaverse-division-301501692.html

https://channelchek.vercel.app/companies/TZOO/research-report/3364

 

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Release – PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma Pty Ltd


PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

Research, News, and Market Data on PsyBio

 

PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa

OXFORD, Ohio and COCONUT CREEK, Fla.March 15, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has entered into a definitive agreement (the “Agreement“) to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. (“Everest“), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the “Acquisition“). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.

PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio’s abilities which encompass fully translational capabilities in its current scientific laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.

“Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The next step is for PsyBio to collaborate with Everest’s current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions.”

Upon completion of the Acquisition, PsyBio will acquire Everest’s active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.

“The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes.”

The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the “SVS“), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange (“TSXV“).

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

Release – PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination



PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers

Research, News, and Market Data on PDS Biotech

 

NCI achieves the enrollment objective of thirty patients in the checkpoint inhibitor refractory arm of the study

FLORHAM PARK, N.J., March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, today announced that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune®+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers. Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

“We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective.” 

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms.

Our Versamune®-based molecularly targeted products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers. 

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital

Filament Health (FLHLF) Scheduled to Present at NobleCon18 Investor Conference


Filament Health CEO Ben Lightburn provides a preview of their upcoming presentation at NobleCon18

NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events

Free Registration Available – More Info


Research, News, and Advanced Market Data on FLHLF


About Filament Health

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.