Month: April 2021

Energy Fuels (UUUU)(EFR:CA) – Energy Fuels and Hyperion Sign MOU for the Supply of Monazite to Produce Rare Earth Products

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Energy Fuels and Hyperion Sign MOU for the Supply of Monazite to Produce Rare Earth Products

 

A Further Step in the Development of a Fully Integrated U.S. Rare Earth Element Supply Chain

  • Energy Fuels and Hyperion have signed a memorandum of understanding to evaluate the potential supply of monazite sands from the Titan Project in Tennessee to Energy Fuels’ White Mesa Mill in Utah for the production of rare earth products.

  • Monazite is a very valuable rare earth-bearing mineral, planned to be produced at the Titan Project as a component of its heavy mineral sand concentrate product.

  • The MOU highlights the potential importance of Hyperion’s Titan Project, as Energy Fuels advances its initiatives to establish a fully integrated, low-cost U.S rare earth element supply chain.

  • Energy Fuels and Hyperion will also evaluate a potential arrangement to collaborate in the development of an integrated U.S. rare earth supply chain.

LAKEWOOD, Colo., April 21, 2021 /CNW/ – Energy Fuels Inc. (“Energy Fuels”) (NYSE: UUUU) (TSX: EFR) and Hyperion Metals Limited (“Hyperion”) (ASX: HYM) are pleased to announce the execution of a non-binding memorandum of understanding (“MOU“) for the supply of natural monazite sands (“Monazite“) from Hyperion’s Titan Project in Tennessee (the “Titan Project“). Energy Fuels plans to produce mixed rare earth element (“REE“) products from processing the Monazite at its White Mesa Mill in Utah.

The parties have also agreed to evaluate a potential teaming, joint venture, equity investment or other arrangement under which Hyperion would collaborate with Energy Fuels, and potentially other parties, in advancing Energy Fuels’ current initiative to establish a fully integrated, “mine to market” U.S. rare earth supply chain for the electric vehicle and renewable energy sectors, as well as other specialty uses.

The collaboration between Energy Fuels and Hyperion will initially focus on the potential commercial supply of Monazite from Hyperion’s Titan Project to Energy Fuels’ White Mesa Mill. Under the MOU, the parties have agreed to negotiate a definitive sales agreement for this supply of Monazite. In addition, subject to Hyperion supplying Energy Fuels with a sufficient quantity of Monazite from the Titan Project within a reasonable period of time, Hyperion and Energy Fuels will evaluate entering into a joint venture or other similar arrangement whereby Hyperion would participate with Energy Fuels, and potentially other parties, in the continuing development and operation of an integrated, low-cost and sustainable independent U.S. rare earth supply chain, under which Monazite would be supplied from The Chemours Company (NYSE: CC) (“Chemours“) U.S. projects, the Titan Project, and potentially other U.S and international mines, with the Monazite to be processed and separated into value-added rare earth products at Energy Fuels’ White Mesa Mill. This could potentially also result in the development of rare earth metal production capabilities.

Hyperion’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. The Titan Project is in an area which saw significant historic exploration from 1960 – 1990 by DuPont, BHP and others, strategically located in the southeast of the U.S., close to significant manufacturing capacity, providing what Hyperion believes to be a significant logistical advantage over current U.S. supplies of imported titanium feedstock.

Hyperion is nearing completion of a three-phase drilling and bulk sampling test work program at the Titan Project. Results to date have successfully confirmed the high grade and significant thickness of mineralization over approximately a 3.6 km strike length. Assays from the drill programs to date have returned thick zones of high-grade Total Heavy Mineral (“THM“) near surface, with highlights including:

  • 47.2m @ 3.69% THM including 10.7m @ 8.09% THM and 10.7m @ 5.47% THM
  • 36.6m @ 3.37% THM including 12.2m @ 7.65% THM
  • 35.1m @ 3.04% THM including 10.7m @ 8.16% THM
  • 41.1m @ 2.14% THM including 9.1m @ 5.55 THM
  • 33.5m @ 2.21% THM including 12.2m @ 5.64% THM

Hyperion’s bulk sampling test work for flow-sheet development is nearing completion, and is evaluating the production of a number of mineral products, including:

  • Titanium minerals – used to produce titanium metal and for the production of paint and pigments;
  • Monazite – used for the production of rare earth products;
  • Zircon – used for the ceramic and foundry markets; and
  • High quality silica – used in float glass, solar panel glass and pharmaceutical grade glass.

A 70-hole Phase 3 drill program is nearing completion, and together with the bulk sample program will form the basis for Hyperion’s initial mineral resource estimate expected to be delivered in Q2 2021. For more information about the Titan Project go to:  www.hyperionmetals.us

Energy Fuels and Neo Performance Materials Inc. (TSX: NEO) (“Neo“) recently announced the joint launch of a U.S.-European REE supply chain involving Energy Fuels, Neo and Chemours. Under this emerging initiative, Energy Fuels is currently purchasing 2,500 tons of Monazite per year from the Chemours Company’s Georgia (USA) heavy mineral sand operations. Energy Fuels is currently processing this Monazite at its White Mesa Mill in Utah into a clean, mixed REE carbonate, as well as recovering the contained uranium. Energy Fuels is selling this intermediate REE product to Neo’s REE separations facility in Sillamae, Estonia for the production of commercial value-added REE products, supplying U.S. and European markets.

In addition to producing mixed REE carbonate, Energy Fuels is also evaluating the potential to develop U.S. separation, metals, alloys, and other downstream REE capabilities at the White Mesa Mill, or nearby, thereby fully integrating a U.S. rare earth supply chain in the coming years. Energy Fuels is seeking to increase its supply of Monazite feed to approximately 15,000 tons per year (or greater) for this initiative. Subject to completion of permitting, development and commencement of operations, the Titan Project is expected to be a potential future source of Monazite to supplement Chemours’ supply of Monazite to Energy Fuels.

The MOU highlights the importance of Hyperion’s Titan Project as a potentially important source of high value American rare earth minerals, expected to play an integral role in rebuilding sustainable, robust and resilient transportation, energy and defense sectors, and the desire of Energy Fuels to build diversified and significant Monazite feedstocks from various sources.

Energy Fuels’ President and Chief Executive Officer, Mr. Mark Chalmers, said: “Energy Fuels, along with Chemours and Neo, are creating a new U.S.-Europe rare earth supply chain. For this initiative to achieve its full potential, we are actively seeking new, ethically-produced sources of Monazite, with sources from the U.S. being our first priority. Therefore, we are excited to work with Hyperion to secure additional sources of Monazite for processing at the White Mesa Mill. Through their association with Piedmont Lithium’s project in North Carolina, members of the Hyperion team have demonstrated to us that they have the know-how and resources to bring U.S. critical mineral projects into production. We look forward to working with the Hyperion team and potentially seeing our relationship grow through their participation in a fully-integrated, low cost U.S. rare earth supply chain in the future. We are particularly excited about the prospect of sourcing U.S. mined Monazite, which together with our current supplies from Chemours’ Georgia operations and the unique capabilities of the White Mesa Mill, demonstrates to us that a world-competitive and world-scale, fully integrated U.S. rare earth supply chain is becoming a reality.”

Hyperion’s Managing Director, Mr. Anastasios Arima, said: “We are excited to progress the potential supply to Energy Fuels of American Monazite for its rare earths supply chain right here in the USA, bringing back sustainable American industry and skilled jobs for generations. The import dependence of the U.S. for key critical minerals, including rare earths and titanium, presents a huge threat to the security of key domestic industries, including defense, space, aerospace, renewables and electric vehicles. Our collaboration with Energy Fuels highlights the importance of Hyperion’s Titan Project in the U.S. as a leader in American sourced critical minerals through its plans to produce zero carbon titanium metals, delivering a clean energy future through the supply of rare earth elements for electric vehicles and the renewable power sectors.”

This announcement has been authorized for release by Hyperion’s Managing Director.

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 in the process of ramping-up to commercial production of REE carbonate in 2021. Its corporate offices are in Lakewood, Colorado near Denver, and all of 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 in-situ recovery (“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 REE carbonate and uranium from Monazite. 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 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.

About Hyperion: Hyperion Metals’ mission is to be the leading developer of zero carbon, sustainable, critical material supply chains for advanced American industries including space, aerospace, electric vehicles and 3D printing. The Company holds a 100% interest in the Titan Project, covering nearly 4,000 acres of prospective titanium, rare earth minerals, high grade silica sand and zircon mineral sands properties in Tennessee, USA, as well as an option to secure the exclusive license to produce low carbon titanium metal using the breakthrough HAMR technology, invented by Dr. Z. Zak Fang and his team at the University of Utah with government funding from ARPA-E. The primary trading market for Hyperion’s common shares is the Australian Stock Exchange under the trading symbol “HYM.” Hyperion’s website is www.hyperionmetals.us.

Cautionary Statements Regarding Forward Looking Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws in the United States, Canada, and Australia. Forward-looking information may relate to future events or future performance of Energy Fuels or Hyperion. All statements in this release, other than statements of historical facts, with respect to Energy Fuels’ or Hyperion’s objectives and goals, as well as statements with respect to their beliefs, plans, objectives, expectations, anticipations, estimates, and intentions, are forward-looking information. Specific forward-looking statements in this discussion include, but are not limited to, the following: any expectation that the Titan Project will be permitted and developed into a commercial producing mine; any expectation that the Titan Project will provide a significant logistical advantage over current U.S. supplies of imported titanium feedstock; any expectation that future exploration or bulk sample results at the Titan Project will meet expectations; any expectation that a JORC Code report will be prepared for the Titan Project and that it will confirm current exploration or bulk sampling results or otherwise meet expectations; any expectation that the Titan Project will contain Monazite in a commercial form or that the Titan Project will be capable of producing satisfactory amounts of Monazite per year; any estimation of the mine life of the Titan Project or when it may commence production of Monazite, if at all; any expectation that the White Mesa Mill will be successful in producing REE carbonate on a commercial basis; any expectation that Neo will be successful in separating the White Mesa Mill’s REE carbonate on a commercial basis; any expectation that Energy Fuels will be successful in increasing its supplies of Monazite, developing U.S. separation, metals or metal/alloy capabilities at the White Mesa Mill or nearby, or otherwise fully integrating a low cost U.S REE supply chain in the future; any expectation with respect to the quantities of Monazite to be acquired by Energy Fuels; any expectation with regard to the cost of producing and separating REE carbonate; and any expectation that Energy Fuels and Hyperion will be successful in completing definitive agreements and hence proceeding with their collaborative efforts . Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates” or “believes”, or variations of, or the negatives of, such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved. This information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: permitting and developing the Titan Project; exploration results not meeting expectations on the Titan Project; commodity prices; the Titan Project never going into production; legal challenges and injunctions; processing difficulties and upsets; available supplies of Monazite; the ability of the White Mesa Mill to produce REE carbonate to meet commercial specifications on a commercial scale at acceptable costs; the ability of Neo to separate REE carbonate to meet commercial specifications on a commercial scale at acceptable costs; market factors, including future demand for REEs; and the ability of Energy Fuels and Hyperion to finalize definitive agreements. Forward-looking statements contained herein are made as of the date of this news release, and Energy Fuels and Hyperion disclaim, 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. Energy Fuels and Hyperion assume no obligation to update the information in this communication, except as otherwise required by law.

Competent Persons Statement

The information in this announcement that relates to the Titan Project Exploration Results is extracted from Hyperion’s ASX Announcements dated 10 March 2021 and 7 January 2021 (“Original ASX Announcements”) which are available to view at Hyperion’s website at www.hyperionmetals.us. Hyperion confirms that a) it is not aware of any new information or data that materially affects the information included in the Original ASX Announcements; b) all material assumptions included in the Original ASX Announcements continue to apply and have not materially changed; and c) the form and context in which the relevant Competent Persons’ findings are presented in this report have not been materially changed from the Original ASX Announcements.

SOURCE Energy Fuels Inc.

For further information: Energy Fuels Inc., Curtis Moore – VP – Marketing & Corporate Development, (303) 974-2140 or Toll free: (888) 864-2125, investorinfo@energyfuels.com, www.energyfuels.com; Hyperion Metals Limited, Anastasios (Taso) Arima – Managing Director, +1 347 899 1522, info@hyperionmetals.us, www.hyperionmetals.us; Hyperion Metals Limited, Dominic Allen – Corporate Development, +61 468 544 888, info@hyperionmetals.us, www.hyperionmetals.us

Earth Day Stocks to Review

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Earth Friendly Stocks for Earth Day (and beyond)

 

The first Earth Day, back in 1970, was the idea of Senator Gaylord Nelson as a way to force environmental issues into the national discussion. At the time, there was no EPA, no Clean Air Act, no Clean Water Act, and no smog or efficiency standards – the average car averaged 11.9 mpg on leaded gasoline.

Since that first Earth Day on April 22, 1970, each that has followed has been an occasion to celebrate past successes and recognize how much more can be done. From the perspective of an inhabitant of this planet, the progress benefits us now and preserves sustainability for the future; from purely an investor’s standpoint, cleaner environmental initiatives lead to the kind of change in spending that provides opportunity. The year 2021 is ushering in these opportunities with a number of objectives that will force transition in many businesses. High on the list in the U.S. is the re-signing of the Paris Agreement earlier this year. Additionally, President Biden has pledged that the country will work to slash America’s greenhouse gas emissions at least in half by 2030, with longer-term efforts to achieve a 100% clean energy economy and reach net-zero emissions no later than 2050. The U.S. president is hosting a virtual summit of 40 world leaders to discuss climate initiatives this week. During the summit, Biden is expected to ask for new commitments from the world’s biggest carbon emitters.

Earlier this year, Biden had proposed an infrastructure initiative, in which he expects to spend $2 trillion over eight years for infrastructure projects to curb the country’s greenhouse gas emissions. Portions of this corporate tax-funded spending will be used for clean-energy measures, including electric vehicle funding, research, and development, the addition of charging stations and retrofitting buildings and residences.

 

Five Earth-Friendly Stocks to Read Up On

An even greener red, white, and blue will make winners out of companies that were barely getting noticed a few of years ago. Environmental regulation and changing business attitudes focusing more on ESG will impact sectors such as manufacturing, fuel generation, metals and mining, utilities, and others. Below are five Earth-friendly stocks that could be worth checking in on.

 

GEVO Inc. (GEVO) is a renewable chemicals and biofuels company that develops and brings to market alternatives to petroleum-based products based on isobutanol produced from renewable feedstocks.

The “low carbon” fuel company has developed a breakthrough process that converts a high-octane fuel called isobutanol into clean, renewable diesel. The green diesel can also be made from fusel oils, a mixture of several alcohols produced as a by-product of fermentation.

 

Capstone
Turbine Corp. (CPST,
CS:CA) is a leading global producer of highly efficient, low emission, microturbine energy systems. Their microturbines serve multiple vertical markets throughout the world; they include natural resources, energy efficiency, renewable energy, critical power supply, transportation, and microgrids.

 

Comstock
Mining Inc. (LODE)  is an emerging leader in the sustainable extraction, valorization, and production of innovation-based, clean, renewable natural resources. Their focus is on high-value, cash-generating, strategic materials that are essential to meeting the rapidly increasing global demand for clean energy, carbon neutrality, and natural products.

 

Energy
Fuels (UUUU,
EFR:CA) is a leading U.S.-based uranium mining company supplying U308 to major utilities operating in the nuclear realm. The company also produces vanadium from certain projects as called for by market demand. Energy fuels expects to begin commercial production of rare earth element (REE) carbonate in 2021.

 

enCore
Energy (ENCUF,
TSX:V) is a uranium explorer and developer focused on growing its portfolio of ISR (in situ recovery) and conventional assets in the U.S. The experienced team of uranium experts have advanced large domestic growth
projects and successful sale of those projects.

 

Take-Away

As we recognize our 51st Earth Day it’s good to remember that at that time there was very little regard for the impact of industry on the planet. While some countries now have a better record than others, and more service-related industries are naturally more green, the strides we’ve made over five decades have yielded measurable results. As the global push toward a “greener” environment accelerates, there will be winners; whether an investor considers themselves to be an “impact investor” or an investor that is following trends, Earth-friendly investments offer tremendous potential.

 

Suggested Videos:

 

enCore Energy C-Suite Interview

Capstone Turbine Virtual Road Show Replay



Comstock Mining Virtual Road Show Replay

Energy Fuels C-Suite Interview

 

 

 

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Release – CanAlaska Uranium (CVVUF)(CVV:CA) – Completes Initial Drilling at Waterbury

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CanAlaska Completes Initial Drilling at Waterbury

 

First holes contain encouraging fault structures and alteration

Thick graphitic basement package intersected

Vancouver, Canada, April 21, 2021 – CanAlaska Uranium Ltd. (TSX-V: CVV; Frankfurt: DH7N) (“CanAlaska” or the “Company”) has curtailed winter drilling on its 100%-owned Waterbury uranium project. Late permitting and warming weather conditions hampered activities. Only half of the planned winter program was completed. Three drill holes, were completed on the South claim, and none on the East. The focus was to test targets near previously drilled holes which showed significant alteration, uranium values and untested geophysical targets on both the East and South Waterbury claims.

The target on the Waterbury South claim is close to the interpreted location of the regional Rabbit Lake – Collins Bay fault system, host to the Rabbit Lake, Collins Bay and Eagle Point uranium orebodies (Figure 1).

One hole targeted the unconformity one kilometre northeast of drill hole SOD-253 where a resistivity anomaly from a survey completed by CanAlaska highlighted a distinct unconformity breach style anomaly above the basement conductor (Figure 2).  The drillhole located a thick graphitic sequence in the basement and graphitic faults associated with anomalous alteration overprint. The ideal unconformity target related to these structures and alteration remains untested at this stage.

A further two holes tested the unconformity for 150 metres southeast of failed Cameco drill hole SOD-253 and found the basement structures that were the focus of that program.  The historic drillhole been abandoned above the unconformity in a faulted and altered section of Athabasca sandstone. CanAlaska’s new drillholes passed though the sandstone and intersected a thick sequence of graphitic rocks in the basement.  Notably the basement has a zone of strong faulting, and wide sections of very intense alteration consisting of clay, secondary hematization, and dravite, which together are prime signatures of fluid flow associated with uranium mineralizing events in the Athabasca region.

Core samples were collected and sent to the Saskatchewan Research Council (SRC) for geochemical analysis. Samples for clay analysis are currently being processed.

President Peter Dasler commented: “the drill team has confirmed the geophysical interpretation of strongly altered basement and sandstone with underlying reactive graphitic sediments. These are a very encouraging features for us to focus our next drill program at Waterbury South.  It is unfortunate that timing and weather did not allow further holes this season, however we have significantly upgraded the current target at Waterbury south, and look forward to getting another chance for discovery.”

About CanAlaska Uranium

 CanAlaska Uranium Ltd. (TSX-V: CVV;Frankfurt: DH7N) holds interests in approximately 214,000 hectares (530,000 acres), in Canada’s Athabasca Basin and Wollaston area – the “Saudi Arabia of Uranium.”  CanAlaska’s strategic holdings have attracted major international mining companies. CanAlaska is currently working with Cameco and Denison at two of the Company’s properties in the Eastern Athabasca Basin. CanAlaska is a project generator positioned for discovery success in the world’s richest uranium district. The Company also holds properties prospective for nickel, copper, gold and diamonds.

For further information visit www.canalaska.com.

The qualified technical person for this news release is Dr Karl Schimann, P. Geo, CanAlaska director and VP Exploration.

On behalf of the Board of Directors

“Peter Dasler”
Peter Dasler, M.Sc., P.Geo.
President & CEO
CanAlaska Uranium Ltd.

Contacts:

Peter Dasler, President
Tel: +1.604.688.3211 x 138
Email: info@canalaska.com

Cory Belyk, COO
Tel: +1.604.688.3211 x 138
Email: cbelyk@canalaska.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking information

All statements included in this press release that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements. These forward-looking statements involve numerous assumptions made by the Company based on its experience, perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. In addition, these statements involve substantial known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will prove inaccurate, certain of which are beyond the Company’s control. Readers should not place undue reliance on forward-looking statements. Except as required by law, the Company does not intend to revise or update these forward-looking statements after the date hereof or revise them to reflect the occurrence of future unanticipated events.

Gevo (GEVO) – To Report First Quarter 2021 Financial Results on May 13 2021

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Gevo to Report First Quarter 2021 Financial Results on May 13, 2021

 

ENGLEWOOD, Colorado – April 21, 2021 – Gevo, Inc. (NASDAQ: GEVO) announced today that it will host a conference call on Thursday, May 13, 2021 at 4:30 p.m. EDT (2:30 p.m. MDT) to report its financial results for the first quarter ended March 31, 2021 and provide an update on recent corporate highlights.

To participate in the conference call, please dial 1 (833) 729-4776 (inside the U.S.) or 1 (830) 213-7701 (outside the U.S.) and reference the access code 6295166# or through the event weblink:
https://edge.media-server.com/mmc/p/ocbho96s

A replay of the call and webcast will be available two hours after the conference call ends on May 13, 2021. To access the replay, please dial 1 (855) 859-2056 (inside the U.S.) or 1 (404) 537-3406 (outside the U.S.) and reference the access code 6295166#. The archived webcast will be available in the Investor Relations section of Gevo’s website at 
www.gevo.com.

About Gevo

Gevo’s mission is to transform renewable energy and carbon into energy-dense liquid hydrocarbons. These liquid hydrocarbons can be used for drop-in transportation fuels such as gasoline, jet fuel and diesel fuel, that when burned have potential to yield net-zero greenhouse gas emissions when measured across the full life cycle of the products. Gevo uses low-carbon renewable resource-based carbohydrates as raw materials, and is in an advanced state of developing renewable electricity and renewable natural gas for use in production processes, resulting in low-carbon fuels with substantially reduced carbon intensity (the level of greenhouse gas emissions compared to standard petroleum fossil-based fuels across their life cycle). Gevo’s products perform as well or better than traditional fossil-based fuels in infrastructure and engines, but with substantially reduced greenhouse gas emissions. In addition to addressing the problems of fuels, Gevo’s technology also enables certain plastics, such as polyester, to be made with more sustainable ingredients. Gevo’s ability to penetrate the growing low-carbon fuels market depends on the price of oil and the value of abating carbon emissions that would otherwise increase greenhouse gas emissions. Gevo believes that its proven, patented technology enabling the use of a variety of low-carbon sustainable feedstocks to produce price-competitive low-carbon products such as gasoline components, jet fuel and diesel fuel yields the potential to generate project and corporate returns that justify the build-out of a multi-billion-dollar business.

Gevo believes that the Argonne National Laboratory GREET model is the best available standard of scientific-based measurement for life cycle inventory or LCI.

Learn more at Gevo’s website: www.gevo.com

 

Investor and Media Contact
+1 720-647-9605
IR@gevo.com

Release – Energy Fuels (UUUU)(EFR:CA) – Energy Fuels and Hyperion Sign MOU for the Supply of Monazite to Produce Rare Earth Products

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Energy Fuels and Hyperion Sign MOU for the Supply of Monazite to Produce Rare Earth Products

 

A Further Step in the Development of a Fully Integrated U.S. Rare Earth Element Supply Chain

  • Energy Fuels and Hyperion have signed a memorandum of understanding to evaluate the potential supply of monazite sands from the Titan Project in Tennessee to Energy Fuels’ White Mesa Mill in Utah for the production of rare earth products.

  • Monazite is a very valuable rare earth-bearing mineral, planned to be produced at the Titan Project as a component of its heavy mineral sand concentrate product.

  • The MOU highlights the potential importance of Hyperion’s Titan Project, as Energy Fuels advances its initiatives to establish a fully integrated, low-cost U.S rare earth element supply chain.

  • Energy Fuels and Hyperion will also evaluate a potential arrangement to collaborate in the development of an integrated U.S. rare earth supply chain.

LAKEWOOD, Colo., April 21, 2021 /CNW/ – Energy Fuels Inc. (“Energy Fuels”) (NYSE: UUUU) (TSX: EFR) and Hyperion Metals Limited (“Hyperion”) (ASX: HYM) are pleased to announce the execution of a non-binding memorandum of understanding (“MOU“) for the supply of natural monazite sands (“Monazite“) from Hyperion’s Titan Project in Tennessee (the “Titan Project“). Energy Fuels plans to produce mixed rare earth element (“REE“) products from processing the Monazite at its White Mesa Mill in Utah.

The parties have also agreed to evaluate a potential teaming, joint venture, equity investment or other arrangement under which Hyperion would collaborate with Energy Fuels, and potentially other parties, in advancing Energy Fuels’ current initiative to establish a fully integrated, “mine to market” U.S. rare earth supply chain for the electric vehicle and renewable energy sectors, as well as other specialty uses.

The collaboration between Energy Fuels and Hyperion will initially focus on the potential commercial supply of Monazite from Hyperion’s Titan Project to Energy Fuels’ White Mesa Mill. Under the MOU, the parties have agreed to negotiate a definitive sales agreement for this supply of Monazite. In addition, subject to Hyperion supplying Energy Fuels with a sufficient quantity of Monazite from the Titan Project within a reasonable period of time, Hyperion and Energy Fuels will evaluate entering into a joint venture or other similar arrangement whereby Hyperion would participate with Energy Fuels, and potentially other parties, in the continuing development and operation of an integrated, low-cost and sustainable independent U.S. rare earth supply chain, under which Monazite would be supplied from The Chemours Company (NYSE: CC) (“Chemours“) U.S. projects, the Titan Project, and potentially other U.S and international mines, with the Monazite to be processed and separated into value-added rare earth products at Energy Fuels’ White Mesa Mill. This could potentially also result in the development of rare earth metal production capabilities.

Hyperion’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. The Titan Project is in an area which saw significant historic exploration from 1960 – 1990 by DuPont, BHP and others, strategically located in the southeast of the U.S., close to significant manufacturing capacity, providing what Hyperion believes to be a significant logistical advantage over current U.S. supplies of imported titanium feedstock.

Hyperion is nearing completion of a three-phase drilling and bulk sampling test work program at the Titan Project. Results to date have successfully confirmed the high grade and significant thickness of mineralization over approximately a 3.6 km strike length. Assays from the drill programs to date have returned thick zones of high-grade Total Heavy Mineral (“THM“) near surface, with highlights including:

  • 47.2m @ 3.69% THM including 10.7m @ 8.09% THM and 10.7m @ 5.47% THM
  • 36.6m @ 3.37% THM including 12.2m @ 7.65% THM
  • 35.1m @ 3.04% THM including 10.7m @ 8.16% THM
  • 41.1m @ 2.14% THM including 9.1m @ 5.55 THM
  • 33.5m @ 2.21% THM including 12.2m @ 5.64% THM

Hyperion’s bulk sampling test work for flow-sheet development is nearing completion, and is evaluating the production of a number of mineral products, including:

  • Titanium minerals – used to produce titanium metal and for the production of paint and pigments;
  • Monazite – used for the production of rare earth products;
  • Zircon – used for the ceramic and foundry markets; and
  • High quality silica – used in float glass, solar panel glass and pharmaceutical grade glass.

A 70-hole Phase 3 drill program is nearing completion, and together with the bulk sample program will form the basis for Hyperion’s initial mineral resource estimate expected to be delivered in Q2 2021. For more information about the Titan Project go to:  www.hyperionmetals.us

Energy Fuels and Neo Performance Materials Inc. (TSX: NEO) (“Neo“) recently announced the joint launch of a U.S.-European REE supply chain involving Energy Fuels, Neo and Chemours. Under this emerging initiative, Energy Fuels is currently purchasing 2,500 tons of Monazite per year from the Chemours Company’s Georgia (USA) heavy mineral sand operations. Energy Fuels is currently processing this Monazite at its White Mesa Mill in Utah into a clean, mixed REE carbonate, as well as recovering the contained uranium. Energy Fuels is selling this intermediate REE product to Neo’s REE separations facility in Sillamae, Estonia for the production of commercial value-added REE products, supplying U.S. and European markets.

In addition to producing mixed REE carbonate, Energy Fuels is also evaluating the potential to develop U.S. separation, metals, alloys, and other downstream REE capabilities at the White Mesa Mill, or nearby, thereby fully integrating a U.S. rare earth supply chain in the coming years. Energy Fuels is seeking to increase its supply of Monazite feed to approximately 15,000 tons per year (or greater) for this initiative. Subject to completion of permitting, development and commencement of operations, the Titan Project is expected to be a potential future source of Monazite to supplement Chemours’ supply of Monazite to Energy Fuels.

The MOU highlights the importance of Hyperion’s Titan Project as a potentially important source of high value American rare earth minerals, expected to play an integral role in rebuilding sustainable, robust and resilient transportation, energy and defense sectors, and the desire of Energy Fuels to build diversified and significant Monazite feedstocks from various sources.

Energy Fuels’ President and Chief Executive Officer, Mr. Mark Chalmers, said: “Energy Fuels, along with Chemours and Neo, are creating a new U.S.-Europe rare earth supply chain. For this initiative to achieve its full potential, we are actively seeking new, ethically-produced sources of Monazite, with sources from the U.S. being our first priority. Therefore, we are excited to work with Hyperion to secure additional sources of Monazite for processing at the White Mesa Mill. Through their association with Piedmont Lithium’s project in North Carolina, members of the Hyperion team have demonstrated to us that they have the know-how and resources to bring U.S. critical mineral projects into production. We look forward to working with the Hyperion team and potentially seeing our relationship grow through their participation in a fully-integrated, low cost U.S. rare earth supply chain in the future. We are particularly excited about the prospect of sourcing U.S. mined Monazite, which together with our current supplies from Chemours’ Georgia operations and the unique capabilities of the White Mesa Mill, demonstrates to us that a world-competitive and world-scale, fully integrated U.S. rare earth supply chain is becoming a reality.”

Hyperion’s Managing Director, Mr. Anastasios Arima, said: “We are excited to progress the potential supply to Energy Fuels of American Monazite for its rare earths supply chain right here in the USA, bringing back sustainable American industry and skilled jobs for generations. The import dependence of the U.S. for key critical minerals, including rare earths and titanium, presents a huge threat to the security of key domestic industries, including defense, space, aerospace, renewables and electric vehicles. Our collaboration with Energy Fuels highlights the importance of Hyperion’s Titan Project in the U.S. as a leader in American sourced critical minerals through its plans to produce zero carbon titanium metals, delivering a clean energy future through the supply of rare earth elements for electric vehicles and the renewable power sectors.”

This announcement has been authorized for release by Hyperion’s Managing Director.

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 in the process of ramping-up to commercial production of REE carbonate in 2021. Its corporate offices are in Lakewood, Colorado near Denver, and all of 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 in-situ recovery (“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 REE carbonate and uranium from Monazite. 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 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.

About Hyperion: Hyperion Metals’ mission is to be the leading developer of zero carbon, sustainable, critical material supply chains for advanced American industries including space, aerospace, electric vehicles and 3D printing. The Company holds a 100% interest in the Titan Project, covering nearly 4,000 acres of prospective titanium, rare earth minerals, high grade silica sand and zircon mineral sands properties in Tennessee, USA, as well as an option to secure the exclusive license to produce low carbon titanium metal using the breakthrough HAMR technology, invented by Dr. Z. Zak Fang and his team at the University of Utah with government funding from ARPA-E. The primary trading market for Hyperion’s common shares is the Australian Stock Exchange under the trading symbol “HYM.” Hyperion’s website is www.hyperionmetals.us.

Cautionary Statements Regarding Forward Looking Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws in the United States, Canada, and Australia. Forward-looking information may relate to future events or future performance of Energy Fuels or Hyperion. All statements in this release, other than statements of historical facts, with respect to Energy Fuels’ or Hyperion’s objectives and goals, as well as statements with respect to their beliefs, plans, objectives, expectations, anticipations, estimates, and intentions, are forward-looking information. Specific forward-looking statements in this discussion include, but are not limited to, the following: any expectation that the Titan Project will be permitted and developed into a commercial producing mine; any expectation that the Titan Project will provide a significant logistical advantage over current U.S. supplies of imported titanium feedstock; any expectation that future exploration or bulk sample results at the Titan Project will meet expectations; any expectation that a JORC Code report will be prepared for the Titan Project and that it will confirm current exploration or bulk sampling results or otherwise meet expectations; any expectation that the Titan Project will contain Monazite in a commercial form or that the Titan Project will be capable of producing satisfactory amounts of Monazite per year; any estimation of the mine life of the Titan Project or when it may commence production of Monazite, if at all; any expectation that the White Mesa Mill will be successful in producing REE carbonate on a commercial basis; any expectation that Neo will be successful in separating the White Mesa Mill’s REE carbonate on a commercial basis; any expectation that Energy Fuels will be successful in increasing its supplies of Monazite, developing U.S. separation, metals or metal/alloy capabilities at the White Mesa Mill or nearby, or otherwise fully integrating a low cost U.S REE supply chain in the future; any expectation with respect to the quantities of Monazite to be acquired by Energy Fuels; any expectation with regard to the cost of producing and separating REE carbonate; and any expectation that Energy Fuels and Hyperion will be successful in completing definitive agreements and hence proceeding with their collaborative efforts . Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates” or “believes”, or variations of, or the negatives of, such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved. This information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: permitting and developing the Titan Project; exploration results not meeting expectations on the Titan Project; commodity prices; the Titan Project never going into production; legal challenges and injunctions; processing difficulties and upsets; available supplies of Monazite; the ability of the White Mesa Mill to produce REE carbonate to meet commercial specifications on a commercial scale at acceptable costs; the ability of Neo to separate REE carbonate to meet commercial specifications on a commercial scale at acceptable costs; market factors, including future demand for REEs; and the ability of Energy Fuels and Hyperion to finalize definitive agreements. Forward-looking statements contained herein are made as of the date of this news release, and Energy Fuels and Hyperion disclaim, 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. Energy Fuels and Hyperion assume no obligation to update the information in this communication, except as otherwise required by law.

Competent Persons Statement

The information in this announcement that relates to the Titan Project Exploration Results is extracted from Hyperion’s ASX Announcements dated 10 March 2021 and 7 January 2021 (“Original ASX Announcements”) which are available to view at Hyperion’s website at www.hyperionmetals.us. Hyperion confirms that a) it is not aware of any new information or data that materially affects the information included in the Original ASX Announcements; b) all material assumptions included in the Original ASX Announcements continue to apply and have not materially changed; and c) the form and context in which the relevant Competent Persons’ findings are presented in this report have not been materially changed from the Original ASX Announcements.

SOURCE Energy Fuels Inc.

For further information: Energy Fuels Inc., Curtis Moore – VP – Marketing & Corporate Development, (303) 974-2140 or Toll free: (888) 864-2125, investorinfo@energyfuels.com, www.energyfuels.com; Hyperion Metals Limited, Anastasios (Taso) Arima – Managing Director, +1 347 899 1522, info@hyperionmetals.us, www.hyperionmetals.us; Hyperion Metals Limited, Dominic Allen – Corporate Development, +61 468 544 888, info@hyperionmetals.us, www.hyperionmetals.us

Lineage Cell Therapeutics (LCTX) – Announces Worldwide License Agreement With Immunomic Therapeutics

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Lineage Announces Worldwide License Agreement With Immunomic Therapeutics For An Allogeneic Cell-Based Cancer Immunotherapy Based On Its Vac Platform

 

  • Lineage to Receive $2 Million Upfront and up to $67 Million in Development and Commercial Milestones Plus Royalties
  • Partnership Leverages the VAC Allogeneic Cancer Immunotherapy Vaccine Platform and Immunomic’s Proprietary Tumor Associated Antigen to Generate a Novel Oncology Product Candidate
  • Immunomic Will be Responsible for Future Clinical Development and Commercialization Costs

CARLSBAD, Calif.–(BUSINESS WIRE)–Apr. 20, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced a worldwide license and development collaboration agreement with 

Immunomic Therapeutics, Inc.
, (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms. The collaboration will generate a novel product candidate derived from Lineage’s VAC allogeneic cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to upfront payments totaling 
$2 million anticipated in the first year and up to 
$67 million in development and commercial milestones across multiple indications and territories. Lineage also will be eligible to receive royalties up to 10% on net sales of future products.

“The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer,” stated  Brian Culley, Lineage CEO. “This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC.”

“We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM,” commented Dr.  William Hearl, CEO of ITI. “Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs.”

About Glioblastoma multiforme (GBM)

Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain “de novo” or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.

About VAC2

VAC2 is an allogeneic, or non-patient specific “off-the-shelf,” cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by 
Cancer Research UK.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its investigational proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including targeting viral antigens, cancer antigens, neoantigens and producing antigen-derived antibodies as biologics. In 2020, an investment of over 
$77M by 
HLB Co., LTD, a global pharmaceutical company, enabled ITI to accelerate application of its immuno-oncology platform, in particular to glioblastoma multiforme, and rapidly advance other key candidates in the pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19. The Company has built a large pipeline from UNITE with eight oncology programs, multiple animal health programs and a SARS-CoV-2 program to prevent and treat COVID-19. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading 
Immuno-oncology researchers at 
Duke University and the 
University of Florida. ITI maintains its headquarters in 
Rockville, Maryland. For more information, please visit www.immunomix.com.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to compensation to Lineage under its license agreement with ITI, the potential of the VAC platform and product candidates derived from the platform, Lineage’s plans to advance the VAC platform and expand its application, including through partnerships. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

electroCore Inc. (ECOR) – Announces Exclusive Distribution Agreement with East Agency For Qatar

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electroCore, Inc. Announces Exclusive Distribution Agreement with East Agency For Qatar

 

ROCKAWAY, NJ, 
April 20, 2021 (GLOBE NEWSWIRE) —  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with East Agency to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) to patients suffering from primary headache disorders in 
Qatar.

“East Agency is a dedicated healthcare company focusing on high-end technologies and innovations targeting the Qatari market, and the addition of such an innovative technology in electroCore’s nVNS therapy is a matter of pride for us” said Mohammed Abdul Moqeeth, Head of the 
Medical Division of East Agency. “nVNS therapy can save patients from traumatic situations with no present solutions and it is always exciting to offer solutions rather than just products. 
East Agency is determined to honor its commitment to establish gammaCore in the region.”

“We are excited to be working with 
East Agency as we bring our nVNS therapy to the 
Middle East region initially in the State of Qatar” said Iain Strickland, electroCore’s Vice President of European Operations. “East Agency is experienced in introducing innovative medical technologies within 
Qatar and we look forward to supporting them in introducing our nVNS therapy, gammaCore Sapphire, in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions, including minimum purchase commitments.

        
About East Agency

East Agency was founded in 1997 as a sister concern of 
AlAli Holdings. The company is privately owned and has diversified business activities marking its presence in almost every sector of the medical industry.

East Agency has been providing quality healthcare services to 
Qatar in government, Public and Private sectors dealing in Dental, Medical Devices, Hospital consumables, Pharma, Derma, Lab Chemicals and Diagnostic Equipment & Reagents.

For more information, visit http://medical.eastagency.com/about-us.html

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM

gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

  • gammaCore is contraindicated for patients with:
    • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
    • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
    • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
  • Safety and efficacy of gammaCore have not been evaluated in the following patients:
    • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
    • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
    • Pediatric
    • Patients (younger than 12 years)
    • Pregnant women
    • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in 
Qatar and other new markets and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.


Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Genprex (GNPX) – Genprex to Receive Inaugural License of the Year Award from University of Pittsburgh Innovation Institute

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Genprex to Receive Inaugural “License of the Year” Award from University of Pittsburgh Innovation Institute in Recognition of Advances Made with Gene Therapy Program in Diabetes

 

Groundbreaking, potentially curative gene therapy shown to transform alpha cells in the pancreas into functional beta-like cells is potentially applicable to both Type 1 and Type 2 diabetes 

AUSTIN, Texas — (April 20, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announces today that the Company has been selected to receive the inaugural “License of the Year” award from the University of Pittsburgh Innovation Institute (UPII) in recognition of the advances made with its license from University of Pittsburgh toward progressing the development of its gene therapy for diabetes.  

In February 2020, Genprex signed an exclusive license agreement with the University of Pittsburgh for an innovative gene therapy technology developed by lead researcher, George Gittes, M.D. at the Rangos Research Center at the University of Pittsbugh Medical Center (“UPMC”) Children’s Hospital. The diabetes gene therapy candidate, GPX-002, which is being evaluated in preclinical studies, reprograms alpha cells in the pancreas into functional beta-like cells, thereby replenishing levels of insulin and providing the potential to cure the disease. The novel infusion is by means of an endoscopic procedure that delivers Pdx1 and MafA genes to the pancreas. The genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.  

“We thank the UPII for acknowledging the breakthrough work of Dr. George Gittes and his team at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, whose efforts have produced this highly innovative therapeutic approach to treating diabetes that could replace the need for insulin replacement therapy and ultimately lead to a cure of this devastating illness afflicting tens of millions of people around the world,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We are honored to receive this recognition, considering the great number of cutting-edge technologies coming out of this distinguished university and research center. We thank UPII for bestowing this honor on our gene therapy license with Dr. Gittes and the Rangos Research Center and applaud them for the groundbreaking gene therapy research being conducted at this esteemed institution.” 

The “Celebration of Innovation” awards ceremony will be held virtually on April 22, 2021 on the Pitt Innovation Institute YouTube channel at 4:30 p.m ET. 

GPX-002 has been tested in vivo in mice and nonhuman primates. In studies in non-obese diabetic mice, a model of Type 1 autoimmune diabetes, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to the researchers, the duration of restored blood glucose levels in mice could potentially translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients. According to the U.S. Center for Disease Control, 34.2 million Americans, or approximately 10.5% of the population, have diabetes.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses. 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

Investor Relations
GNPX Investor Relations
(877) 774-GNPX (4679) ext. #2
investors@genprex.com

Media Contact
Genprex Media Relations
(877) 774-GNPX (4679) ext. #3
media@genprex.com

New Waitlist for Reddit Talk – Have you Added Yourself?

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New Waitlist for Reddit Talk – Have you Added Yourself?

 

Reddit has decided to broaden its services to include audio conversations – à la Clubhouse. Today, the social media platform announced that they are in the testing phase of what is starting to be a trend in social media.

You can get in on the early tests (we are).  So if you aren’t following u/channelchek, get that done now!

https://www.reddit.com/user/channelchek/

To be on the waitlist Reddit asks you to answer a few questions; they’ll let you know when Reddit Talk will be available. Only moderators can start talks during early tests, but any Redditor on iOS and Android can listen in.  They’ll then roll out the full version from there.

 

Clubhouse is an invitation-only social media app for iOS that facilitates auditory communication through rooms that can accommodate groups of up to 5,000 people. The audio-only app hosts virtual rooms for live discussions, with opportunities for individuals to participate through speaking and listening.

 


Functionality

You’ll be able to listen and can interact with discussions by reacting with emojis. If you have something you want to contribute to the conversation, you raise a virtual hand, and a host could invite you to talk.

How’s Your Karma?

Hosts will be able to see how much karma each user who raises a hand has. So that may be something to work on. They say they plan to give the feature “the best moderation experience possible.”  And as another differentiator to the popular Clubhouse, which has people using their real identities and photos, Reddit Talk users will be able to use pseudonyms and avatars.

See you online!

 

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What is the Approval Process for Medical Devices?

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Understanding the FDA Medical Device Approval Pathways Helps Investors

 

In order to be marketed in the US, medical devices must submit an application to the FDA (Food and Drug Administration) for marketing clearance or approval.   The FDA has developed different regulatory pathways for device manufacturers, depending on the type and classification of the device, the use of the device, and the risk associated with the device. These different pathways must be understood for the approval process to be navigated correctly and expeditiously.

Defining Medical Device

First, it must be determined whether a company indeed has a medical device that it wishes to market. So, what exactly is a medical device? According to Section 201(h) of the Food, Drug, and
Cosmetic Act (FD&C), enacted in 1938, a device is:  An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  1. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  3. Intended to affect the structure or any function of the body of man or animals, and does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Excluded from the definition of “device” is software functions pursuant to section 520(o) of the FD&C where software is intended for administrative support, serving as patient records, or transferring and storing data.

Essentially, a device can be any product that is not a service or a pharmaceutical and can be as simplistic as a bedpan, as complex as an ICD (defibrillator) and everything in between, including in vitro diagnostic next-generation sequencing tests and X-Rays.  The FDA also considers certain software, mobile applications, artificial intelligence (AI), and machine learning (ML) technologies as devices.  There will be more on this later.

Pathway Selection

Determining that the product is a device is fairly straightforward, but what regulatory approval pathway should be taken?  Medical devices are categorized into three classes of risk.  Class I devices present minimal, low potential for harm, while Class II moderate risk is higher than Class I and includes devices like catheters and syringes. Class III devices represent the highest risk with the greatest potential for harm.  Typically, these Class III devices are implanted (pacemakers, defibrillators) or support and sustain life, will require investigational trials, and many times require outside panel review and post-marketing studies.

There are five FDA device marketing classification pathways addressing risk levels and currently marketed product similarities.

  1. The most strenuous, stringent, and difficult pathway is the Premarket
    Approval (PMA)     classification.  Once a PMA filing is made, the average time to approval is 243 days. As previously indicated, the FDA considers Class III devices high risk requiring a PMA classification. If it’s unclear whether the device requires a PMA, the FDA provides the ability to search its database for substantially equivalent previously approved devices. Once approved, any substantial changes to a PMA must have a PMA supplement reviewed and approved by the FDA
  2. For Class II moderate-risk devices and where most have a predicate device cleared, the FDA often requires a Premarket Notification 510(k) clearance before marketing.  Despite the 510(k) process being less onerous, it still takes an average of 177 days to receive marketing clearance. Like the PMA, if it’s unclear whether the device requires a 510(k), searching the FDA database for already marketed products with substantial equivalence will help.   Similar to a PMA supplement, a new 510(k) application must be submitted if substantial product changes affect the safety and effectiveness of the cleared device.  
    1. Most low-risk Class I devices like
      tongue depressors, and some Class II devices like hearing aids and catheter
      guide wires are exempt from a 510(k) requirement      .
  3. Novel and low to moderate risk (Class I or II) devices would follow a De Novo classification pathway.  This pathway addresses devices that do not have a valid marketed equivalent. Upon benefit/risk review, the FDA may determine a classification for future similar products.
  4. In limited use for rare disease conditions, the Humanitarian Device
    Exemption (HDE)     might be used as a pathway. Congress included a provision in the Safe Medical Devices Act of 1990 to create this pathway for treatments in small populations if the product/device will not expose a patient to significant risk of illness or injury, and the device would not be available without the HDE. A Humanitarian Use
    Device (HUD)     with an HDE intends to treat fewer than 8000 individuals annually. Importantly, there are HDE profit restrictions unless the product is labeled for pediatric patients or adult patients where pediatric applications are impossible or unsafe.
  5. Emerging from the Investigational Device (IDE) program was the Pre-Submission
    pathway. The Pre-Submission is where the applicant seeks feedback from the FDA about a planned marketing application. Keep in mind an IDE should not be confused with the clearance or approval pathways above.  IDEs are required to allow a device to be used in clinical studies to support future marketing applications.

Now that the basic pathways have been covered, do non-traditional AI and machine-learning software and mobile applications fit in as medical devices? If so, what pathways do they use?

 

 

Medical Software

In 1993, the International Medical Device Regulators Forum (IMDRF) developed definitions for Software as a Medical Device (SaMD) given the advances using healthcare technology platforms.  Among other things, the IMDRF created two definitions.

  1. software in a medical device
  2. software as a medical device (SaMD)

The second SaMD category is defined as the medical device. SaMD had to be capable of running on non-medical platforms and was not part of or embedded in a hardware medical device to make the hardware device work. If the software was embedded, then it would fall into the first category and not be considered a medical device.

The FDA piggybacked off these definitions and in September 2019 the FDA produced non-binding recommendations in its Policy for Device Software Functions and Mobile Medical Applications. In this Policy, the FDA did not expect to regulate software or mobile apps that do not meet the IMDRF or the FD&C definitions of a device. For instance, mobile apps that promote a healthy lifestyle, or meal planners, or daily activity trackers would not meet the device definition.  But if meeting the device definition, the high-, moderate- and low-risk factor classifications outlined earlier would determine the type of marketing application.

The regulatory pathway is still evolving as the FDA adapts to new AI and ML technologies. AI/ML-based SaMD capabilities come from the ability to continuously learn, where the adaptation or change to the algorithm is realized after the SaMD is distributed for use and has gained real-world experience. The FDA first produced a proposed regulatory framework for AI and ML software as a medical device in April 2019. In February 2020, the FDA announced the first marketing authorization, through the De Novo pathway, of the first AI cardiac ultrasound software built by Caption Health (private) using the principle of Predetermined Change Control Plan. This plan reflected the anticipated modifications for the SaMD. Most recently, advancing the process to utilize adaptive technologies, the FDA produced an Action Plan in January 2021 that would include the types of anticipated algorithm modifications (SaMD Pre-Specifications) and methodologies used. 

 

Suggested Channelchek Content:

ElectroCore (ECOR) C-Suite Interview

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Helius Medical Technologies (HDST) NobleCon17 Replay

NobleCon 17 Healthcare Panel Replay

 

Photo:  Medical Imaging and Therapeutics, surgical suite for minimally invasive procedures

 

Virtual Road Show Series – Wednesday April 21 @ 1:00pm EST

Join PDS Biotechnology CEO Frank Bedu-Addo, CMO Lauren Wood, and CFO Seth Van Voorhees for this exclusive corporate presentation, followed by a Q & A session moderated by Robert LeBoyer, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level.

Register Now  |  View All Upcoming Road Shows

 

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Release – Genprex (GNPX) – Genprex to Receive Inaugural License of the Year Award from University of Pittsburgh Innovation Institute

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Genprex to Receive Inaugural “License of the Year” Award from University of Pittsburgh Innovation Institute in Recognition of Advances Made with Gene Therapy Program in Diabetes

 

Groundbreaking, potentially curative gene therapy shown to transform alpha cells in the pancreas into functional beta-like cells is potentially applicable to both Type 1 and Type 2 diabetes 

AUSTIN, Texas — (April 20, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announces today that the Company has been selected to receive the inaugural “License of the Year” award from the University of Pittsburgh Innovation Institute (UPII) in recognition of the advances made with its license from University of Pittsburgh toward progressing the development of its gene therapy for diabetes.  

In February 2020, Genprex signed an exclusive license agreement with the University of Pittsburgh for an innovative gene therapy technology developed by lead researcher, George Gittes, M.D. at the Rangos Research Center at the University of Pittsbugh Medical Center (“UPMC”) Children’s Hospital. The diabetes gene therapy candidate, GPX-002, which is being evaluated in preclinical studies, reprograms alpha cells in the pancreas into functional beta-like cells, thereby replenishing levels of insulin and providing the potential to cure the disease. The novel infusion is by means of an endoscopic procedure that delivers Pdx1 and MafA genes to the pancreas. The genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.  

“We thank the UPII for acknowledging the breakthrough work of Dr. George Gittes and his team at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, whose efforts have produced this highly innovative therapeutic approach to treating diabetes that could replace the need for insulin replacement therapy and ultimately lead to a cure of this devastating illness afflicting tens of millions of people around the world,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We are honored to receive this recognition, considering the great number of cutting-edge technologies coming out of this distinguished university and research center. We thank UPII for bestowing this honor on our gene therapy license with Dr. Gittes and the Rangos Research Center and applaud them for the groundbreaking gene therapy research being conducted at this esteemed institution.” 

The “Celebration of Innovation” awards ceremony will be held virtually on April 22, 2021 on the Pitt Innovation Institute YouTube channel at 4:30 p.m ET. 

GPX-002 has been tested in vivo in mice and nonhuman primates. In studies in non-obese diabetic mice, a model of Type 1 autoimmune diabetes, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to the researchers, the duration of restored blood glucose levels in mice could potentially translate to decades in humans. If successful, this gene therapy could eliminate the need for insulin replacement therapy for diabetic patients. According to the U.S. Center for Disease Control, 34.2 million Americans, or approximately 10.5% of the population, have diabetes.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses. 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

Investor Relations
GNPX Investor Relations
(877) 774-GNPX (4679) ext. #2
investors@genprex.com

Media Contact
Genprex Media Relations
(877) 774-GNPX (4679) ext. #3
media@genprex.com

Release – electroCore Inc. (ECOR) – Announces Exclusive Distribution Agreement with East Agency For Qatar

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electroCore, Inc. Announces Exclusive Distribution Agreement with East Agency For Qatar

 

ROCKAWAY, NJ, 
April 20, 2021 (GLOBE NEWSWIRE) —  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with East Agency to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) to patients suffering from primary headache disorders in 
Qatar.

“East Agency is a dedicated healthcare company focusing on high-end technologies and innovations targeting the Qatari market, and the addition of such an innovative technology in electroCore’s nVNS therapy is a matter of pride for us” said Mohammed Abdul Moqeeth, Head of the 
Medical Division of East Agency. “nVNS therapy can save patients from traumatic situations with no present solutions and it is always exciting to offer solutions rather than just products. 
East Agency is determined to honor its commitment to establish gammaCore in the region.”

“We are excited to be working with 
East Agency as we bring our nVNS therapy to the 
Middle East region initially in the State of Qatar” said Iain Strickland, electroCore’s Vice President of European Operations. “East Agency is experienced in introducing innovative medical technologies within 
Qatar and we look forward to supporting them in introducing our nVNS therapy, gammaCore Sapphire, in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions, including minimum purchase commitments.

        
About East Agency

East Agency was founded in 1997 as a sister concern of 
AlAli Holdings. The company is privately owned and has diversified business activities marking its presence in almost every sector of the medical industry.

East Agency has been providing quality healthcare services to 
Qatar in government, Public and Private sectors dealing in Dental, Medical Devices, Hospital consumables, Pharma, Derma, Lab Chemicals and Diagnostic Equipment & Reagents.

For more information, visit http://medical.eastagency.com/about-us.html

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCoreTM

gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

  • gammaCore is contraindicated for patients with:
    • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
    • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
    • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
  • Safety and efficacy of gammaCore have not been evaluated in the following patients:
    • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
    • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
    • Pediatric
    • Patients (younger than 12 years)
    • Pregnant women
    • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in 
Qatar and other new markets and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.


Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Release – Lineage Cell Therapeutics (LCTX) – Announces Worldwide License Agreement With Immunomic Therapeutics

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Lineage Announces Worldwide License Agreement With Immunomic Therapeutics For An Allogeneic Cell-Based Cancer Immunotherapy Based On Its Vac Platform

 

  • Lineage to Receive $2 Million Upfront and up to $67 Million in Development and Commercial Milestones Plus Royalties
  • Partnership Leverages the VAC Allogeneic Cancer Immunotherapy Vaccine Platform and Immunomic’s Proprietary Tumor Associated Antigen to Generate a Novel Oncology Product Candidate
  • Immunomic Will be Responsible for Future Clinical Development and Commercialization Costs

CARLSBAD, Calif.–(BUSINESS WIRE)–Apr. 20, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, today announced a worldwide license and development collaboration agreement with 

Immunomic Therapeutics, Inc.
, (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms. The collaboration will generate a novel product candidate derived from Lineage’s VAC allogeneic cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to upfront payments totaling 
$2 million anticipated in the first year and up to 
$67 million in development and commercial milestones across multiple indications and territories. Lineage also will be eligible to receive royalties up to 10% on net sales of future products.

“The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer,” stated  Brian Culley, Lineage CEO. “This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC.”

“We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM,” commented Dr.  William Hearl, CEO of ITI. “Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs.”

About Glioblastoma multiforme (GBM)

Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain “de novo” or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.

About VAC2

VAC2 is an allogeneic, or non-patient specific “off-the-shelf,” cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by 
Cancer Research UK.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its investigational proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including targeting viral antigens, cancer antigens, neoantigens and producing antigen-derived antibodies as biologics. In 2020, an investment of over 
$77M by 
HLB Co., LTD, a global pharmaceutical company, enabled ITI to accelerate application of its immuno-oncology platform, in particular to glioblastoma multiforme, and rapidly advance other key candidates in the pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19. The Company has built a large pipeline from UNITE with eight oncology programs, multiple animal health programs and a SARS-CoV-2 program to prevent and treat COVID-19. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading 
Immuno-oncology researchers at 
Duke University and the 
University of Florida. ITI maintains its headquarters in 
Rockville, Maryland. For more information, please visit www.immunomix.com.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to compensation to Lineage under its license agreement with ITI, the potential of the VAC platform and product candidates derived from the platform, Lineage’s plans to advance the VAC platform and expand its application, including through partnerships. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.