Month: April 2021

Capstone Green Energy (CGRN) – Capstone Turbine Transforms Into Capstone Green Energy Corporation (Nasdaq: CGRN)

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Capstone Turbine Corporation Celebrates Earth Day 2021 With Its Transformation Into Capstone Green Energy Corporation (Nasdaq: CGRN); Adding New Business Lines, Product Offerings And Network Partners

 

Capstone CEO, Darren Jamison Provides a Virtual New Company Overview

VAN NUYS, CA / ACCESSWIRE / April 22, 2021 / Capstone Turbine Corporation (www.capstoneturbine.com) (NASDAQ:CPST) (“Capstone” or the “Company”), the world’s leading manufacturer of clean technology microturbine energy systems, announced today that effective immediately it will become Capstone Green Energy Corporation (www.CapstoneGreenEnergy.com) (NASDAQ:CGRN), a global partner in carbon reduction and on-site resilient green energy solutions. Capstone Green Energy will be adding new business lines, product offerings, network partners, and services as part of the transition.

“This Earth Day, Capstone is celebrating our most tangible achievements in having shipped more than 10,000 units worldwide. Among other things, we estimate we helped customers reduce carbon emissions by approximately 397,000 tons annually in FY21 and saved them over $217 million in annual energy costs over the same time period,” said Capstone Green Energy Chief Executive Officer, Darren Jamison. “The Company is also using this day to announce a more intense focus on accelerating the market adoption of our unique, clean energy technologies and those of our network partners.”

“Our name is changing to reflect our evolution as a Company and the developments we are planning. While we have a new name, Capstone’s mission and goals for the future remain resolute, and that is to be a highly trusted partner providing energy conversion systems, microgrid solutions, energy as a service, and strategic energy management. Capstone Green Energy will help customers build and maintain smart energy infrastructure and engage with them as a long-term service provider and partner for their critical carbon saving initiatives,” added Jamison.

With this new name, Capstone demonstrates its intent to remain focused on clean energy technologies, while expanding its carbon reduction solutions portfolio to include new clean energy conversion technologies and battery storage offerings, as well as developing hydrogen-based products and bolstering its Energy as a Service (EaaS) business.

Virtual Company Overview

Capstone Green Energy Chief Executive Officer, Darren Jamison, will discuss the new developments in a virtual press release, which can be accessed here:

CGRN Virtual Press Release

New Capstone Green Energy

As a trusted energy solutions partner, Capstone places the power, literally and strategically, back into the hands of customers, by offering custom solutions that are designed to improve energy costs, reduce carbon footprints and provide energy resiliency. We will execute our strategy through four business lines.

  1. Energy as a Service (EaaS)
  2. Energy Conversion Products
  3. Energy Storage Products
  4. Hydrogen Solutions

EaaS is a growth area for Capstone Green Energy driven by its industry-leading Factory Protection Plan (FPP) service program and its ultra-low emission microturbine rental fleet, which currently stands at 10.6 megawatts (MW). At the same time, the Company’s Distributor Support System (DSS) subscription program generates increased marketing, branding, customer acquisition, documentation, and training of its worldwide Capstone distribution partners across 83 countries.

Leveraging its existing, reliable microturbine products, Capstone Green Energy is also proud to announce today that it is currently expanding its energy conversion and storage products with Baker Hughes 5 MW, 12 MW, and 16 MW industrial gas turbines. Capstone selected Baker Hughes as a network partner because of their similar focus on low emissions, long service intervals, low lifecycle costs, and hydrogen development program.

Capstone Green Energy is also introducing this quarter a new hybrid energy solutions product designed to meet a broad range of customized peak shaving and remote energy applications. Specifically, the Company will begin assembling modular hybrid energy stations and Lithium-Ion battery energy storage systems (BESS). These will be sold either individually or combined as part of a custom microturbine-battery storage solution.

Lastly, Capstone Green Energy will continue to expand and develop its Hydrogen Solutions business line. The Company recently demonstrated that it can safely run on a 10% hydrogen – 90% natural gas mix and is currently testing a 70% hydrogen – 30% natural gas configuration through its Research & Development partnership with Argonne National Laboratory. These are promising milestones on the development roadmap to 100% hydrogen solutions.

Changing Energy Landscape

Since the very first microturbine unit shipped more than 20 years ago from Capstone’s headquarters in Southern California, the clean energy landscape has shifted dramatically and includes a substantial increase in clean energy technologies and investments. This is being pushed even further by the rise in public awareness of climate issues and consumer preference.

According to Bloomberg, “In 2020, global investment in the low-carbon energy transition totaled $501.3 billion, up from $458.6 billion in 2019 and just $235.4 billion in 2010.” Investments in clean energy are driving markets and consumer decision-making now, as opposed to being viewed as promising technologies of the future.

“At Capstone Green Energy, we invite customers to partner with us in smart energy solutions to help lower their carbon footprint, increase cost efficiencies, and add resiliency to their business. This is also a reflection of how our customers’ customers view their businesses, and they are increasingly demanding green and sustainable products and services,” concluded Mr. Jamison.

This consumer choice is aptly demonstrated in a Nielsen study showing that “73% of consumers said they would likely change behavior to reduce their impact on the environment and sustainable and ethical business practices is the second-highest reason most consumers return to a brand, second only to product quality.”

Company History

In 1999, Capstone shipped its first commercial microturbine units and just a short time later announced to the world its clean energy focus in its Initial Public Offering that the Capstone MicroTurbine is a compact, environmentally friendly generator of electricity and heat. Our goal then was the same as it is now: Provide highly efficient, low-emission, cost-effective energy solutions in order to deliver on the promise of a sustainable clean energy future.

About Capstone Green Energy

Capstone Green Energy (www.CapstoneGreenEnergy.com) (NASDAQ: CGRN) is a leading provider of customized microgrid solutions and on-site energy technology systems focused on helping customers around the globe meet their environmental, energy savings, and resiliency goals. Capstone Green Energy focuses on four key business lines. Through its Energy as a Service (EaaS) business, it offers rental solutions utilizing its microturbine energy systems and battery storage systems, comprehensive Factory Protection Plan (FPP) service contracts that guarantee life-cycle costs, as well as aftermarket parts. Energy Conversion Products are driven by the Company’s industry-leading, highly efficient, low-emission, resilient microturbine energy systems offering scalable solutions in addition to a broad range of customer-tailored solutions, including hybrid energy systems and larger frame industrial turbines. The Energy Storage Products business line designs and installs microgrid storage systems creating customized solutions using a combination of battery technologies and monitoring software. Through Hydrogen Energy Solutions, Capstone Green Energy offers customers a variety of hydrogen products, including the Company’s microturbine energy systems.

For customers with limited capital or short-term needs, Capstone offers rental systems; for more information, contact: rentals@CGRNenergy.com. To date, Capstone has shipped over 10,000 units to 83 countries and in FY21, and estimates it saved customers over $217 million in annual energy costs and approximately 397,000 tons of carbon. Total savings over the last three years are estimated at 1,115,100 tons of carbon and $698 million in annual energy savings.

For more information about the Company, please visit: www.CapstoneGreenEnergy.com. Follow Capstone Green Energy on Twitter , LinkedIn, Instagram, Facebook, and YouTube.

Cautionary Note Regarding Forward-Looking Statements

This release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding expectations for green initiatives and execution on the Company’s growth strategy and other statements regarding the Company’s expectations, beliefs, plans, intentions, and strategies. The Company has tried to identify these forward-looking statements by using words such as “expect,” “anticipate,” “believe,” “could,” “should,” “estimate,” “intend,” “may,” “will,” “plan,” “goal” and similar terms and phrases, but such words, terms and phrases are not the exclusive means of identifying such statements. Actual results, performance and achievements could differ materially from those expressed in, or implied by, these forward-looking statements due to a variety of risks, uncertainties and other factors, including, but not limited to, the following: the ongoing effects of the COVID-19 pandemic; the availability of credit and compliance with the agreements governing the Company’s indebtedness; the Company’s ability to develop new products and enhance existing products; product quality issues, including the adequacy of reserves therefor and warranty cost exposure; intense competition; financial performance of the oil and natural gas industry and other general business, industry and economic conditions; the Company’s ability to adequately protect its intellectual property rights; and the impact of pending or threatened litigation. For a detailed discussion of factors that could affect the Company’s future operating results, please see the Company’s filings with the Securities and Exchange Commission, including the disclosures under “Risk Factors” in those filings. Except as expressly required by the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.

CONTACT: Capstone Green Energy
Investor and investment media inquiries:
818-407-3628
ir@CGRNenergy.com

SOURCE: Capstone Green Energy Corporation

FAT Brands Inc. (FAT) – Upsized $144 Million Securitization Provides Multiple Benefits

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Thursday, April 22, 2021

FAT Brands Inc. (FAT)
Upsized $144 Million Securitization Provides Multiple Benefits

FAT Brands Inc is a multi-brand restaurant franchising company. It develops, markets, and acquires predominantly fast casual restaurant concepts. The company provides turkey burgers, chicken Sandwiches, chicken tenders, burgers, ribs, wrap sandwiches, and others. Its brand portfolio comprises Fatburger, Buffalo’s Cafe and Express, and Ponderosa and Bonanza. The company’s overall footprint covers nearly 32 countries. Fatburger generates maximum revenue for the company.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Whole Business Securitization. After the market closed Tuesday, FAT Brands announced the completion of a $144.5 million offering of fixed rate asset-backed notes, structured as a whole business securitization. This is the Company’s third successful securitization over the past twelve months, with the amount raised rising from the initial $40 million raise in March 2020.

    More Ammunition.  The upsized deal provides FAT Brands with additional capital to continue its strategy of acquiring high growth potential restaurant concepts to its existing stable of nine restaurant brands. At the end of the fourth quarter, the Company had $80 million of existing Notes and a $5 million sellers note outstanding. If all of these were refinanced, that would leave some $60 million of …



This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Ocugen (OCGN) – Positive Results Of The Second Interim Analysis Of Phase 3 Study Of COVAXIN

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Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech, Shares Second Interim Results demonstrating 100% Protection against Severe Disease including Hospitalization

 

  • Primary efficacy in the second interim analysis demonstrates COVAXIN to be 78% effective after the second dose in preventing COVID-19 in those without prior infection

  • Demonstrates 70% efficacy against asymptomatic COVID-19 infections; indicates potential to significantly reduce virus transmission

  • COVAXIN has been administered to several million people in India and is playing a critical role in combating the pandemic

MALVERN, Pa., April 21, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, shared positive results of the second interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease alone of 100%.

“We continue to be excited by the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market. Based on a traditional vaccine platform that has a long-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“The safety and efficacy demonstrated by COVAXIN is remarkable because of the prevalence of several variants of the coronavirus circulating at the time of the trial. This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children,” said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.

Second Interim Phase 3 Results as Reported by Bharat Biotech

Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age in India, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The trial will be continuing to its pre-planned conclusion.

The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8?C.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

About Bharat Biotech

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

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

Ayala Pharmaceuticals (AYLA) – Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Agent WVT078

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Ayala Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma

 

REHOVOT, Israel and WILMINGTON, Del., April 21, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced the dosing of the first patient in the ongoing Phase 1 clinical trial evaluating its potent investigational gamma secretase inhibitor (GSI), AL102, in combination with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).

AL102 is an oral small molecule that inhibits gamma secretase. Inhibition of gamma secretase prevents the cleavage and shedding of BCMA, which are ubiquitously expressed on MM cells. Preclinical data have demonstrated that treatment with AL102 increases expression of membrane-bound BCMA on the surface of MM cells and could enhance activity of WVT078.

“The dosing of the first patient in this Phase 1 trial marks an important milestone in our collaboration with Novartis. We view this trial, not only as a significant opportunity to explore the clinical viability of enhancing BCMA-targeting agents with GSIs such as AL102, but also as an important step forward in bringing a novel treatment option to patients with MM,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Despite numerous advances in the treatment landscape for MM, the disease remains incurable. BCMA is ubiquitously expressed on myeloma cells. Increasing BCMA expression on target cells and reducing the shedding in circulation is believed to potentially enhance therapies and increase responses. We look forward to further evaluating this potential as we bring this program into the clinic.”

The Phase 1, open-label, multicenter trial of AL102 in combination with Novartis’ WVT078 is currently enrolling patients with relapsed and/or refractory multiple myeloma who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent. The first-in-human dose escalation trial is designed to assess the safety, tolerability and recommended dose regimen(s) of WVT078 alone and in combination with AL102. In addition, the trial will assess preliminary anti-MM response and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with AL102.

Under the terms of the option and license agreement established in December 2018, Novartis is responsible for the conduct and expenses of any trials of AL102 in combination with their BCMA-targeting agents, as well as potential commercialization, in multiple myeloma. Ayala retains worldwide license rights to AL102 in all other indications.

About AL102
AL102 is a potent, selective and oral gamma secretase inhibitor (GSI). AL102 is currently being developed for the treatment of desmoid tumors, as well as in combination with Novartis’ BCMA-targeting agents for the treatment of multiple myeloma (MM).

About WVT078
WVT078 is a bispecific antibody that engages both BCMA and CD3, resulting in the recruitment of cytotoxic T cells that target BCMA-positive MM cells.

About Multiple Myeloma
Multiple myeloma is a rare and aggressive blood cancer that accounts for approximately one percent of all cancers. In the U.S., there are nearly 90,000 people living with, or in remission from, multiple myeloma. Approximately, 26,850 Americans are diagnosed with multiple myeloma each year and 11,240 patient deaths are reported on an annual basis.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trial for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
Julie.seidel@sternir.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

QuickChek – April 21, 2021

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

Energy Fuels announced the execution of a non-binding memorandum of understanding for the supply of natural monazite sands from Hyperion’s Titan Project in Tennessee

Research, News & Market Data on Energy Fuels

Watch recent presentation from NobleCon17



CanAlaska Completes Initial Drilling at Waterbury

CanAlaska Uranium announced that it has curtailed winter drilling on its 100%-owned Waterbury uranium project

News & Market Data on CanAlaska Uranium



Ocugen Shares Positive Results of the Second Interim Analysis of Phase 3 Study of COVAXIN

Ocugen announced that its co-development partner, Bharat Biotech, shared positive results of the second interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate

Research, News & Market Data on Ocugen

Watch recent presentation from NobleCon17



ISG Adds Real-Time Data Feeds To Its Vendor Compliance And Risk Management Platform

Information Services Group announced that it is adding real-time data feeds to its market-leading ISG GovernX® vendor compliance and risk management platform

Research, News & Market Data on ISG

Watch recent presentation from NobleCon17



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

Gevo, Inc. announced that it will host a conference call on Thursday, May 13, 2021 at 4:30 p.m. EDT to report its financial results for the first quarter ended March 31, 2021

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Ayala Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of AL102

Ayala Pharmaceuticals announced the dosing of the first patient in the ongoing Phase 1 clinical trial evaluating its potent investigational gamma secretase inhibitor (GSI), AL102, in combination with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078

Research, News & Market Data on Ayala Pharmaceuticals

Watch recent presentation with Ayala CEO Roni Mamluk, PhD



Kratos Awarded Approximately $30 Million to Support Space-Related National Security Efforts

Kratos Defense & Security announced that it had received more than $30 million to support space-related U.S. national security efforts

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Kratos Defense and Security Solutions (KTOS) – Awarded Approximately $30 Million to Support Space-Related National Security Efforts

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Kratos Awarded Approximately $30 Million to Support Space-Related National Security Efforts

 

SAN DIEGO, 
April 21, 2021 (GLOBE NEWSWIRE) — 
Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a leading National Security Solutions provider, announced today that it had received more than 
$30 million to support space-related 
U.S. national security efforts. The follow-on awards are to previous contracts, implementing advanced technologies to provide better system performance.  

“Kratos enables technological approaches and modernization that were not possible even a few years ago, but can now support this program for many years to come with the inherent flexibility to upgrade and evolve at the speed of relevance,” commented Senior Vice President  Frank Backes. “Kratos’ broad space portfolio is focused on technology-leading products and services that realize the 
DoD’s vision of data being an asset. These advanced capabilities are scalable, flexible and resilient; allowing real-time data to flow from multiple domains in support of national defense.”

Phil Carrai, President of Kratos’ Space, Training and Cybersecurity Division, said, “Space is undergoing a renaissance. Advancements in ground systems and satellite technologies are joining to form space networks that support multi-domain missions and broader data requirements. Kratos is leading the digital transformation on the ground side by introducing into space networks proven technologies from other network-centric industries. Not only does this enhance performance and affordability for the 
DoD, it opens doors for the defense industry to better integrate with and capitalize on commercial space enterprises as well.”

Due to competitive, customer-related and other considerations, no additional information will be provided.

About Kratos Defense & Security Solutions

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms and systems for United States National Security related customers, allies and commercial enterprises. Kratos is changing the way breakthrough technology for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research and streamlined development processes. At Kratos, affordability is a technology and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training, combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “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 the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended 
December 27, 2020, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the 
SEC by Kratos.

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Information Services Group (III) – Adding Real-Time Data Feeds To Its Vendor Compliance And Risk Management Platform

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ISG GovernX® Adds Real-Time Data Feeds for Complete Risk Management Solution

 

Newest version of ISG GovernX platform integrates external market data with provider performance metrics and intelligent workflows to quickly address third-party risks

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, said today it is adding real-time data feeds to its market-leading ISG GovernX® vendor compliance and risk management platform, to help clients monitor and respond to risk events as they happen.

GovernX is the industry’s only governance solution that integrates contract information, strategic relationship management and real-time risk monitoring and alerts to pro-actively mitigate business risk. Users can now add a variety of external data feeds to the platform for an unparalleled view of all potential risks, both within their specific supplier ecosystem and from the broader marketplace. Intelligent workflows identify and categorize each risk, alert the appropriate functions, and trigger automated responses, including targeted risk assessments to the suppliers involved.

The new third-party risk management capabilities come as provider ecosystems continue to grow more complex, introducing more risk to the enterprise, and threats against supply-chain integrity become more diverse. In addition to monitoring the operational performance and financial viability of their suppliers, enterprises need to address a range of other internal and external risks, from data security and regulatory issues, to adverse environmental, health and geopolitical events, to social responsibility, diversity and inclusion considerations.

“As companies prioritize digital transformation and increase their reliance on third-party vendors to achieve their goals, it’s no longer enough to simply monitor the supplier landscape and conduct periodic, point-in-time risk assessments,” said Lois Coatney, partner and president, ISG GovernX. “The newest version of our platform proactively monitors a company’s entire landscape and sends real-time alerts on potential threats to the right people, with a clear path for action and resolution.”

Beyond these new risk management capabilities, the ISG GovernX platform allows clients to manage their full portfolio of contracts, ensuring the right controls are in place through the entire contract lifecycle. The platform also manages each supplier’s performance and compliance to obligations, ensuring an accurate and up-to-date profile of each relationship.

“Internal and external intelligence is crucial to a well-managed business, but CIOs and CSOs lose sleep over the many red flags that are missed in the deluge of data that is generated every day,” Coatney said. “Sending information to the right team with a clear record of accountability and follow-through not only helps mitigate risk, it proves to regulators and other stakeholders that a company has evaluated and acted on information in a timely way.

“Combined with our internal supplier performance monitoring, ISG GovernX clients now have a complete inside-out and outside-in view of each supplier’s operational performance, how it is meeting its contractual obligations, and how risks in the supplier’s business and in the broader marketplace can impact overall service and supply chain integrity,” she said.

In 2020, ISG GovernX saw a 90 percent increase in enterprise subscriptions, as clients embrace a more effective way to automate and manage their ever-growing portfolio of software and services contracts and understand potential risks to their supply chain, which have been amplified by the COVID-19 pandemic.

ISG GovernX enables organizations to control costs by managing consumption, validating invoices, optimizing demand, reviewing all new requests against the spending portfolio and controlling value leakage. More than $46 billion of supplier contracts are now managed on GovernX, and there are more than 12,000 active users on the platform.

To learn more about the enhanced risk management capabilities of GovernX, visit this webpage. For an overview of the broader GovernX platform, click here.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Source: Information Services Group, Inc.

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

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.

Release – Ocugen (OCGN) – Positive Results Of The Second Interim Analysis Of Phase 3 Study Of COVAXIN

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Ocugen’s COVID-19 Vaccine Co-Development Partner, Bharat Biotech, Shares Second Interim Results demonstrating 100% Protection against Severe Disease including Hospitalization

 

  • Primary efficacy in the second interim analysis demonstrates COVAXIN to be 78% effective after the second dose in preventing COVID-19 in those without prior infection

  • Demonstrates 70% efficacy against asymptomatic COVID-19 infections; indicates potential to significantly reduce virus transmission

  • COVAXIN has been administered to several million people in India and is playing a critical role in combating the pandemic

MALVERN, Pa., April 21, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, shared positive results of the second interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease alone of 100%.

“We continue to be excited by the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market. Based on a traditional vaccine platform that has a long-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“The safety and efficacy demonstrated by COVAXIN is remarkable because of the prevalence of several variants of the coronavirus circulating at the time of the trial. This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children,” said Dr. Bruce Forrest, member of the vaccine scientific advisory board of Ocugen.

Second Interim Phase 3 Results as Reported by Bharat Biotech

Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age in India, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The trial will be continuing to its pre-planned conclusion.

The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8?C.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

About Bharat Biotech

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data that is the subject of this release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

Release – Ayala Pharmaceuticals (AYLA) – Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Agent WVT078

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Ayala Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma

 

REHOVOT, Israel and WILMINGTON, Del., April 21, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced the dosing of the first patient in the ongoing Phase 1 clinical trial evaluating its potent investigational gamma secretase inhibitor (GSI), AL102, in combination with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).

AL102 is an oral small molecule that inhibits gamma secretase. Inhibition of gamma secretase prevents the cleavage and shedding of BCMA, which are ubiquitously expressed on MM cells. Preclinical data have demonstrated that treatment with AL102 increases expression of membrane-bound BCMA on the surface of MM cells and could enhance activity of WVT078.

“The dosing of the first patient in this Phase 1 trial marks an important milestone in our collaboration with Novartis. We view this trial, not only as a significant opportunity to explore the clinical viability of enhancing BCMA-targeting agents with GSIs such as AL102, but also as an important step forward in bringing a novel treatment option to patients with MM,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Despite numerous advances in the treatment landscape for MM, the disease remains incurable. BCMA is ubiquitously expressed on myeloma cells. Increasing BCMA expression on target cells and reducing the shedding in circulation is believed to potentially enhance therapies and increase responses. We look forward to further evaluating this potential as we bring this program into the clinic.”

The Phase 1, open-label, multicenter trial of AL102 in combination with Novartis’ WVT078 is currently enrolling patients with relapsed and/or refractory multiple myeloma who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent. The first-in-human dose escalation trial is designed to assess the safety, tolerability and recommended dose regimen(s) of WVT078 alone and in combination with AL102. In addition, the trial will assess preliminary anti-MM response and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with AL102.

Under the terms of the option and license agreement established in December 2018, Novartis is responsible for the conduct and expenses of any trials of AL102 in combination with their BCMA-targeting agents, as well as potential commercialization, in multiple myeloma. Ayala retains worldwide license rights to AL102 in all other indications.

About AL102
AL102 is a potent, selective and oral gamma secretase inhibitor (GSI). AL102 is currently being developed for the treatment of desmoid tumors, as well as in combination with Novartis’ BCMA-targeting agents for the treatment of multiple myeloma (MM).

About WVT078
WVT078 is a bispecific antibody that engages both BCMA and CD3, resulting in the recruitment of cytotoxic T cells that target BCMA-positive MM cells.

About Multiple Myeloma
Multiple myeloma is a rare and aggressive blood cancer that accounts for approximately one percent of all cancers. In the U.S., there are nearly 90,000 people living with, or in remission from, multiple myeloma. Approximately, 26,850 Americans are diagnosed with multiple myeloma each year and 11,240 patient deaths are reported on an annual basis.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trial for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
Julie.seidel@sternir.com

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com