Stefan Bernstein explains how the EU/Greenland critical raw materials partnership benefits GreenRoc. Watch the full video here.
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FRDA is one of Reata's lead disease targets, and the following abstract published 15th October 2019, gives a detailed summary of Phase 2/3 trial results which appear far from convincing imho, and another reason why they ( or any other Major player ) might be very interested in developing SFX-01's potential side by side for FRDA and many other disease targets. Gla ;-)
Orphan Drugs In Development For The Treatment Of Friedreich’s Ataxia: Focus On Omaveloxolone
MOXIe (RTA 408)
The MOXIe trial (NCT02255435, Reata Pharmaceuticals Inc) was conducted to assess the safety and efficacy of Omav in patients with FRDA between 2015 and 2017.15 The trial was a multicenter, double blind, randomized, placebo-controlled Phase 2/3 clinical trial in FRDA patients.
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Other Nrf2 Activators
Other members of the class of Nrf2 activators, such as sulforaphane (SFN) and dimethyl fumarate (DMF), have also been studied for potential positive effects on FRDA.14 SFN is a naturally occurring Nrf2 activator noted for its anti-inflammatory mechanisms and ability to quickly cross the blood-brain-barrier. DMF, another Nrf2 activator that efficiently crosses the blood-brain-barrier, is an approved treatment for Multiple Sclerosis. In a recent 2017 in-vitro study, the molecules were evaluated for their potential neuroprotective effects on frataxin-silenced neurons. Both DMF and SFN exhibited significant upregulation of Nrf2 and its associated target genes. This was evidenced by tremendous increases in Nrf2 mRNA levels and Nrf2-regulated phase 2 enzymes. Both SFN and DMF effectively reverse oxidative stress buildup and function to protect the neurons from the neurodegenerative phenotype in frataxin deficient cells.21
Nrf2 activators mechanism of action make them a viable option in the treatment of many diseases associated with oxidative stress in addition to FRDA, including several neurodegenerative diseases. Neurodegenerative diseases such as Alzheimer’s disease (AD), Parkinson’s Disease (PD), Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS) have all been linked to abnormalities in the Nrf2 pathway.22
https://www.dovepress.com/orphan-drugs-in-development-for-the-treatment-of-friedreichs-ataxia-fo-peer-reviewed-fulltext-article-DNND
University Dundee Discovery Research Paper with Evgen and Reata listed dated 2019.
Therapeutic Targeting of the NRF2 and Keap 1 Partnership in Chronic Diseases.
https://discovery.dundee.ac.uk/files/28898360/Cuadrado_et_al_NRDD
Well, they've now got the cash in the bank to make any strategic investments to expand their development and commercial capabilities.....watch this space...;-)
June 24 (Reuters) - Reata Pharmaceuticals Inc:
* REATA PHARMACEUTICALS - ANNOUNCED RECEIPT OF $350 MILLION RELATED TO CLOSING OF PREVIOUSLY ANNOUNCED STRATEGIC INVESTMENT
Reata have also got strong links with University of Rochester New York, where SFX-01 is currently under evaluation for Chronic Kidney Disease since February, and with an update possible at anytime, perhaps they have a close eye on proceedings. ;-)
or would Reata be very interested in SFX-01....???? ;-)
"It positions us to make strategic investments to further expand our development and commercial capabilities in preparation for the potential approval and launch of our drugs,” said Manmeet S. Soni, Chief Operating Officer and Chief Financial Officer at Reata.
Transaction Summary
The strategic investment by Blackstone Life Sciences includes $300 million in return for royalty payments on worldwide net sales of bardoxolone by Reata and its licensees, other than Kyowa Kirin Co., Ltd. The financing also includes a $50 million investment in 340,793 shares of Reata’s Class A common stock at $146.72 per share. Reata will receive the $350 million investment at closing, which is expected to occur on or before June 24, 2020.
“This $350 million financing further strengthens Reata’s balance sheet, and extends Reata’s cash runway through the end of 2023. It positions us to make strategic investments to further expand our development and commercial capabilities in preparation for the potential approval and launch of our drugs,” said Manmeet S. Soni, Chief Operating Officer and Chief Financial Officer at Reata.
One would have thought that Blackstone or similar, would be very interested in a strategic investment partnership with Evgen, given SFX-01's similar properties and potential to Reata's NRF2 pathway pipeline. Gla ;-)
Reata Pharmaceuticals, Inc. and Blackstone Life Sciences Announce $350 Million Strategic Investment
June 11 Source: Reata Pharmaceuticals, Inc.
FINANCING WILL ADVANCE BARDOXOLONE AS THE FIRST POTENTIAL THERAPY FOR ALPORT SYNDROME, AS WELL AS CONTINUE DEVELOPMENT FOR OTHER RARE AND SERIOUS FORMS OF CHRONIC KIDNEY DISEASE
NEW YORK and PLANO, Texas, June 11, 2020 (GLOBE NEWSWIRE) -- Blackstone (NYSE: BX) and Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata”), a clinical-stage biopharmaceutical company, today announced that funds managed by Blackstone Life Sciences (“BXLS”) will lead a $350 million royalty and equity investment in Reata to fund the development and potential commercialization of bardoxolone methyl (“bardoxolone”), an investigational once-daily oral therapy being studied for chronic kidney disease (“CKD”) in Alport syndrome, autosomal dominant polycystic kidney disease (“ADPKD”), and other associated potential future indications. These are severe, life-threatening diseases with few or no effective therapies approved by the U.S. Food and Drug Administration (“FDA”).
Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences, said, “This investment aligns with Blackstone Life Sciences’ mission to help advance promising new medicines to patients with high unmet needs. If approved, bardoxolone has the potential to provide for the first time a therapy that improves the quality of life for tens of thousands of patients around the world suffering from Alport syndrome.”
“Bardoxolone has been a primary focus of our company’s research and development efforts to date,” said Warren Huff, Reata’s Chief Executive Officer and President. “We are extremely pleased that Blackstone Life Sciences has recognized the potential of bardoxolone, and the potential of Reata more generally. We are proud to enter into this strategic investment agreement with Blackstone Life Sciences.”
“Bringing the first potential therapy to Alport syndrome patients, a devastating genetic condition with no approved treatments, is very motivating,” said Paris Panayiotopoulos, Blackstone Life Sciences Senior Managing Director. “With this investment, we will support Reata in further developing bardoxolone for CKD in Alport syndrome, autosomal dominant polycystic kidney disease and multiple other chronic kidney diseases.”
Reata Pharmaceuticals, Inc. - $5 Billion Market Cap
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone methyl and omaveloxolone, target the important transcription factor Nrf2 that promotes restoration of mitochondrial function, reduction of oxidative stress, and inhibition of pro-inflammatory signaling. Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.
Evgen - £13 Million Mark Cap
"We move forward with the confidence that the value of SFX-01 as a potential drug that is active against the two key pathways of Nrf2 and STAT3 will become increasingly clear. These pathways are of significance in a range of diseases including cancer, autism and those where oxidative stress is a factor. We therefore believe that the fundamentals are in place to underpin sustainable share price growth and deliver the undoubted potential of SFX-01. On behalf of myself and the Board, I would like to thank our shareholders for their continued support and we look forward to updating the market with positive news in the coming year."
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Oxidative Medicine and Cellular Longevity - 2019
Activators and Inhibitors of NRF2: A Review of Their Potential for Clinical Development
Bardoxolone-methyl
RTA-408 (omaveloxolone)
Sulforaphane
https://www.hindawi.com/journals/omcl/2019/9372182/tab1/
Reata was mentioned in the Final Results, and the comaparrison in value is staggering and highlights Evgen's undoubted upside potential, and perhaps Reata could ve very interested in SFX-01....Gla ;-)
15/6/20
Barry Clare, Executive Chairman of Evgen Pharma, said: "We move forward with the confidence that the value of SFX-01 as a potential drug that is active against the two key pathways of Nrf2 and STAT3 will become increasingly clear. These pathways are of significance in a range of diseases including cancer, autism and those where oxidative stress is a factor. We therefore believe that the fundamentals are in place to underpin sustainable share price growth and deliver the undoubted potential of SFX-01. On behalf of myself and the Board, I would like to thank our shareholders for their continued support and we look forward to updating the market with positive news in the coming year."
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There remains a strong rationale for clinically testing SFX-01 in any condition that is mechanistically linked to Nrf2, as evidenced by the recent positive developments at Reata (NASDAQ: RETA). Reata is developing Nrf2 activators based on triterpenoids and with positive top-line results in pivotal trials in Friedriech's Ataxia and Alport Syndrome has a current market capitalisation of circa US$5bn. This illustrates that the fundamentals of Nrf2 activation as a therapeutic strategy are sound and SFX-01 is a potent and well tolerated Nrf2 activator; on this basis we advance with confidence in SFX-01.
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Evgen has exclusive rights to the only technology (Sulforadex(R)) proven to synthesise this very unstable molecule in a stabilised composition that will satisfy regulatory and medicinal needs for a pharmaceutical and that can be used as a therapeutic.