Member Info for Moneymunch

Shorting exercise done, share transfer accumulation must be almost done....news imminent and maybe Finncap are ready to let this go...at long last...the current market cap is the bargain of the century given potential and prospects...Fill ya Boots and enjoy the ride...:-)

No doubt Spreadex in cahoots with Finncap....all the cards are near enough shuffled...Get ready for the re-rate!!! Gla :-)

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Compassionate use and accelerated development of any Covid-19 drug in patient trials that shows positive indications could be highly likely given the dire predictions of what's ahead. :-(

SAGE experts predict entire UK will be locked down by DECEMBER as they warn second wave will be deadlier than first with 500 deaths a day within weeks.

https://www.google.com/amp/s/www.dailymail.co.uk/news/article-8887775/amp/SAGE-experts-warn-second-wave-deadlier-first.html

Lol....I've been here since 7p and have accumulated a sizeable chunk for the inevitable significant re-rate that is imminent....and any positive indications from the imminent Covid-19 patient trials will see Evgen's market cap rise from this current bargain £15m to several £100m and more...keep bashing King Canute, you haven't got a clue...ha ha ha :-)

Lol....you desperate numptie....just checked your posts here and the following post is the last time you mentioned the sp....ha ha ha ha ha....:-)

Kingalf

Posted in: EVG

Posts: 57

Price: 12.60

No Opinion

RE: Trial 08 Oct 2020 12:15

I could be wrong, but it looks like a breakout to the upside on the chart. Reinforced if it closes above 12.25 today.

Ps kingalf the Clueless ...;-)

No he wasn't, Company House confirmed 28/10/20 that his appointment was terminated 30/4/20, he was looked after by Evgen as he was allowed to accelerate his 4m plus share options the following month.

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Accused of misinformation by the one who thinks he knows it all, for suggesting that SFX-01's randomized, double-blind, placebo-controlled Phase 2/3 Covid-19 patient trials could report early...ha ha ha...well here's an example of exactly what could happen if a therapeutic benefit is observed early during the trial...you couldn't a more similar example to SFX-01 and the imminent Covid-19 patient trials...Gla :-)

Covid-19 pneumonia drug candidate being prepared rapidly RedHill Biopharma collaborates with European and Canadian suppliers to ramp up production of opaganib for potential emergency use.

By Abigail Klein Leichman  OCTOBER 28, 2020, 11:10 AM

RedHill Biopharma of Tel Aviv is collaborating with two pharmaceutical manufacturers in Europe and Canada to ramp up manufacturing of its drug candidate opaganib (Yeliva) or severe Covid-19 pneumonia.

The orally administered drug, which has anti-inflammatory and antiviral capabilities, could then meet potential demand for emergency use as the pandemic continues worldwide.

Under a compassionate use program, Covid-19 patients treated with opaganib in an Israeli hospital were discharged without requiring intubation and mechanical ventilation, whereas one-third of the matched case-control group required intubation and mechanical ventilation.

“Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes Covid-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue,” RedHill reports.

Opaganib is currently in global randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 and US Phase 2 studies in hospitalized patients with severe Covid-19 pneumonia requiring supplemental oxygen.

The US Phase 2 study is approaching completion of enrollment in eight sites, with initial results expected before the end of this year. The Phase 2/3 study is enrolling up to 270 patients across 15 study sites in six countries by year’s end.

RedHill is in discussions with US government agencies regarding rapid advancement of opaganib manufacturing toward potential emergency use applications.

Opaganib also has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications. It has FDA orphan drug status for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

ps Judging by Finncap's Finncap's Life Sciences report that indicates Cell and Gene therapy is driving the next wave of innovation in pharma.....then SFX-01 suggests plenty of reasons why BIG pharma would maybe like a slice of Evgen. 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."

Review

Nrf2: Redox and Metabolic Regulator of Stem Cell State and Function

Nuclear factor erythroid 2-related factor 2 (Nrf2) is ubiquitously expressed in most eukaryotic cells and functions to induce a broad range of cellular defenses against exogenous and endogenous stresses, including oxidants, xenobiotics, and excessive nutrient/metabolite supply.

Because the production and fate of stem cells are often modulated by cellular redox and metabolic homeostasis,important roles of Nrf2 have emerged in the regulation of stem cell quiescence, survival, self-renewal, proliferation, senescence, and differentiation. In a rapidly advancing field, this review summarizes Nrf2 signaling in the context of stem cell state and function and provides a rationale for Nrf2 as a therapeutic target in stem cell-based regenerative medicine.

htTps://www.cell.com/trends/molecular-medicine/pdf/S1471-4914(19)30246-1.pdf

..........................

Highlighted STAT3 as a potential drug target for cancer therapy

Abstract

Signal transducer and activator of transcription 3 (STAT3) is a cytoplasmic transcription factor that regulates cell proliferation, differentiation, apoptosis, angiogenesis, inflammation and immune responses. Aberrant STAT3 activation triggers tumor progression through oncogenic gene expression in numerous human cancers, leading to promote tumor malignancy. On the contrary, STAT3 activation in immune cells cause elevation of immunosuppressive factors. Accumulating evidence suggests that the tumor microenvironment closely interacts with the STAT3 signaling pathway. So, targeting STAT3 may improve tumor progression, and anti-cancer immune response. In this review, we summarized the role of STAT3 in cancer and the tumor micro environment, and present inhibitors of STAT3 signaling cascades.

Keywords: Cancer stem cells, Cancer therapy, Immune suppression, STAT3, Tumor micro environment

htTp://www.bmbreports.org/journal/view.html?uid=1389&vmd=Full&

Some of the key reasons why the report considers the C> sector to be an attractive one for investment are:

· Pharma’s next ‘wave’ of innovation. C>s can be potentially curative treatment options as they usually target the underlying cause of disease. In the long term, these therapies could become the backbone of treatment regimens, and solutions to various unmet needs.

· Deals. Big Pharma had to play catch-up with monoclonal antibody technology and seems determined not to make the same mistake with C>, as reflected in the high deal activity and high deal values seen within this space.

· Sector maturation. Advances in the sector mean that the C> sector is beginning to mature beyond the R&D stage and into commercialisation, with some products already approved, and with a very large future pipeline of therapies.

· Revenue. Therapies in this space can command high prices, allowing for high revenue generation, even from rare diseases and limited patient populations.

Despite its vital role in the future of medicine, C> also comes with challenges. The report highlights that the manufacture of C>s is difficult given they are, by definition, personalised for the patient. This means they cannot be batch produced for distribution to multiple patients as more traditional medicines can. For example, Zolgensma, which treats those with motor neurone disease, is priced at $2.1 (£1.6) million per therapy, making it the most expensive drug treatment ever.

The report also notes how the payment process for C> requires a reworking of reimbursement systems not used to outlaying so much money up front for a treatment with long-term benefits/curative potential versus continuous, and lower payments for ongoing medicine treatment.

The technologies the report shines a spotlight include CAR-T therapy, stem cell therapy, CRISPR, RNA therapies, among various others.

Arshad Ahad, Research Analyst, Life Sciences, at finnCap, commented: “Few technologies in the life sciences sector hold as much promise as Cell and Gene Therapy, with its ability to provide long-term benefits and curative potential. These technologies have been seen as the future of medicine for many years, and now we are closer than ever to that future becoming a reality. If Cell and Gene therapy does become the backbone of treatment regimes in the future, similar to the rise of monoclonal antibodies, then the companies involved are developing expertise in a critical part of the life sciences industry, which should confer a significant competitive advantage as the sector matures further. Now is therefore a good time to invest in the ‘future’.”

SFX-01's activation of the two key pathways of STAT3 and NRF2 asscoiated with multiple diseases and potential treatment, certainly fit the criteria of the therapies currently in the spotlight. Gla ;-)

26-Aug-2020

FINNCAP’S LIFE SCIENCES REPORT INDICATES CELL AND GENE THERAPY SECTOR IS DRIVING THE NEXT WAVE OF INNOVATION IN PHARMA

Breakthrough in delivery for cell and gene therapy products has led to a wave of M&A activity as big pharma aims not to miss out on the ‘future of medicine’

AIM healthcare index at the centre of innovation, has risen 6% YTD compared with the AIM all share, which has declined 7%

‘finnLife 50’ index has also risen 6% in 2020 led by gains in Synairgen (+2,930%), Avacta (+654%), Omega Diagnostics (+322%) and Tiziana Life Sciences (+283%)

London 25 August 2020 – Healthcare companies employing and developing cell and gene therapy (C>) are driving the next wave of innovation in the pharmaceutical industry, leading to increased M&A activity as big pharma aims not to miss out on the ‘future of medicine’. The AIM healthcare index has been at the centre of this innovation, rising 6% YTD compared with the AIM all share, which has declined 7%.

These are the findings of finnCap’s new quarterly Life Sciences sector report, ‘Rude Health’.

Rather than just treating a disease and its symptoms, C> can target the underlying cause of a disease, with long-term benefits and curative potential. C> is now being realised on an applicable level, with many products already approved and the FDA expects to approve 10-20 products a year by 2025.

The financials of the sector are reflective of this rapid progress. In 2018, the market value of C> was $536 million - $1.07 billion; but by 2026 it is set to have a valuation of up to$35.4 billion. Given the high proportion of start-ups in the sector, M&A activity is on the rise, as evidenced by the $3 billion Astellas spent in January 2020 to acquire Audentes Therapeutics, specialists in genetics medicines.

In 2014/2015, M&A activity in the sector was $5 billion; by 2018/2019 it had surged 880% to $49 billion. Much of this is driven by big pharma firms not wanting to fall behind their smaller, more versatile competition, as they did with monoclonal antibody technology. Consequently, they have engaged with M&A to speed up and enhance their own R&D efforts.

The report notes that innovators in C> will be well placed to take part in the land grab that will follow as a result of continued advancements in the sector, and highlights now as a good time for investors and pharmaceutical companies to become involved as the sector is rapidly maturing past its high potential research and development stage – with an established pipeline of therapies already being developed.

Some of the key reasons why the report considers the C> sector to be an attractive one for investment are:

With Finncap obviously pulling all the strings, and firm evidence of some massive share transfers since mid May, along with the sudden departure of the ex CEO, I wonder if Finncap could have a client who have plans to accumulate discreetly a significant percentage of Evgen's stock....Gla :-)

Finncap!!!

7th August 2020

Our work in Public M&A Advisory at finnCap

finnCap are delighted to have been involved in six announced situations during 2020 – on the sellside: acting as financial advisers to Castleton on its recommended takeover by MRI, to HML Holdings on its ongoing recommended offer by Harwood Capital; on the buyside: as financial advisers to the Fortune 500 company Motorola Solutions, Inc. on its takeover of the AIM-listed IndigoVision and to PETRA Group on its ongoing recommended offer for HWSI Realisation Fund. We are supporting Best of the Best as Rule 3 adviser as it explores its options. We have acted for Frenkel Topping in response to an approach by Harwood Capital and have significant experience in working with PLC boards behind the scenes to help them in planning their bid defences from actual or feared approaches. We continue to act for companies in response to unwanted shareholder activism, and for shareholders wishing to bear influence on public companies. Since the start of 2018, we have advised on 21 announced public takeover situations, for both our retained corporate clients and for those outside it who recognise a need for our expertise, involving parties based at home or across the globe, on a sole basis or collaborating with other advisers.

We are proud to be a leader in the field and to have been trusted to advise on so many interesting and rewarding situations. We expect the coming months to be busy and look forward to continuing to help our clients to acquire, defend or otherwise achieve their strategic objectives.

https://www.finncap.com/news-events/is-there-a-renewed-appetite-for-m-a-amongst-plcs

and another trade for 1.6m....priced as a buy!!!??? ;-)

A recent example of early reporting from a Covid-19 patient trial. Gla ;-)

Although the study is still ongoing, an independent data and safety monitoring board overseeing the trial reviewed the data and shared their preliminary analysis with NIAID. Due to the public health implications, NIAID made these primary results public, and they were published on May 22, 2020, in the New England Journal of Medicine.

https://www.nih.gov/news-events/nih-research-matters/early-results-show-benefit-remdesivir-covid-19

The end date for SFX-01's Covid-19 patient trials comes from Prof Chalmers research website, and so as well as early reporting being very likely form the Phase 2 stage of the trial, then given the nature of the Respiratory infections, Pneumonia, ARDS etc then it's highly plausible that a much earlier conclusion for Phase 3 stage could be reached....the investigators will know very quickly from data compared and computed from those administered SFX-01 and those on the placebo, given the 15 day treatment and 29 day evaluation, if SFX-01 is having a positive effect...or not.....all eyes on Evgen soon enough....this is going to go BIG time imho....Gla Holders . ;-)

A randomized controlled trial of SFX-01 to improve clinical outcomes in COVID-19 patients (STAR-COVID)

Chalmers, J. & Dinkova-Kostova, A.

LifeArc

1/10/20 ? 30/09/21

Project: Research

https://discovery.dundee.ac.uk/en/persons/james-chalmers

GSTM1 Deletion Exaggerates Kidney Injury in Experimental Mouse Models and Confers the Protective Effect of Cruciferous Vegetables in Mice and Humans

November 2019 Journal of the American Society of Nephrology

Abstract

Background: GSTM1 encodes glutathione S-transferase µ-1 (GSTM1), which belongs to a superfamily of phase 2 antioxidant enzymes. The highly prevalent GSTM1 deletion variant is associated with kidney disease progression in human cohorts: the African American Study of Kidney Disease and Hypertension and the Atherosclerosis Risk in Communities (ARIC) Study. Methods: We generated a Gstm1 knockout mouse line to study its role in a CKD model (involving subtotal nephrectomy) and a hypertension model (induced by angiotensin II). We examined the effect of intake of cruciferous vegetables and GSTM1 genotypes on kidney disease in mice as well as in human ARIC study participants. We also examined the importance of superoxide in the mediating pathways and of hematopoietic GSTM1 on renal inflammation. Results: Gstm1 knockout mice displayed increased oxidative stress, kidney injury, and inflammation in both models. The central mechanism for kidney injury is likely mediated by oxidative stress, because treatment with Tempol, an superoxide dismutase mimetic, rescued kidney injury in knockout mice without lowering BP. Bone marrow crosstransplantation revealed that Gstm1 deletion in the parenchyma, and not in bone marrow-derived cells, drives renal inflammation. Furthermore, supplementation with cruciferous broccoli powder rich in the precursor to antioxidant-activating sulforaphane significantly ameliorated kidney injury in Gstm1 knockout, but not wild-type mice. Similarly, among humans (ARIC study participants), high consumption of cruciferous vegetables was associated with fewer kidney failure events compared with low consumption, but this association was observed primarily in participants homozygous for the GSTM1 deletion variant. Conclusions: Our data support a role for the GSTM1 enzyme in the modulation of oxidative stress, inflammation, and protective metabolites in CKD.

13/2/20

University of Rochester Collaboration

Evgen Pharma (Evgen) and The University of Rochester School of Medicine and Dentistry have entered into a Memorandum of Understanding to advance SFX-01 towards a clinical trial in chronic kidney disease (CKD).

Thu Le, Professor of Medicine, and Chief of the Division of Nephrology at the University of Rochester Medical Center said: "We are pleased that Evgen will support our plans to undertake a clinical trial on SFX-01 in patients with CKD. Increased oxidative stress is a major molecular underpinning of CKD progression and our research suggests that patients with the GSTM1 null allele may particularly benefit from sulforaphane treatment via SFX-01 dosing."

Dr Stephen Franklin, CEO of Evgen Pharma, commented:

"We are delighted to be supporting the work of such a respected team and prestigious university. We very much hope the proposed trial will generate data demonstrating that SFX-01 could potentially improve the lives of patients suffering from CKD."

The following, published Septmber 2020 is the latest research from University of Rochester , New York on Gstm1 and its roll in Chronic Kidney Disease....SFX-01 is under evaluation for patient clinical trials following compelling research published November 2019 on the clinical positive effects of Sulforphane, and so more potential material news in the pipeline. Gla ;-)

Abstract P046: Variable Effect Of Gstm1 Knockout In Mice

Yves T Wang
, Keith Nehrke
, Paul S Brookes
, Thu H Le

Originally published9 Sep 2020

hTtps://doi.org/10.1161/hyp.76.suppl_1.P046Hypertension. 2020;76:AP046

Abstract

Glutathione S-transferase µ-1 (GSTM1) is an enzyme that has a role in the detoxification of electrophiles, including xenobiotics and products of oxidative stress. In humans, the GSTM1(0) null allele deletion variant is highly prevalent and is associated with both an increase in oxidative stress and an increased risk/severity of a variety of diseases, including cancers, chronic kidney disease, hypertension, and coronary artery disease.Recently, we generated a Gstm1 knockout (Gstm1-/-) mouse line on a 129S6 background. Using these animals, we demonstrated that the loss of GSTM1 resulted in increased oxidative stress and greater kidney injury with either subtotal nephrectomy-induced chronic kidney disease or angiotensin II-induced hypertension, in accordance with clinical data.Following myocardial infarction, reperfusion of the heart results in additional tissue damage that is also mediated by acute oxidative stress. Here, we used an ex vivo Langendorff-perfused heart model of acute cardiac ischemia-reperfusion injury (IRI). Contrary to the expectation that hearts from Gstm1-/- mice would be more susceptible to IRI, we found that the loss of the antioxidant enzyme GSTM1 was protective in males compared to age-matched wild-type controls. In contrast, the Gstm1-/-genotype was deleterious in female hearts as expected.To explore the hypothesis that the loss of GSTM1 causes compensatory upregulation of other GSTs and that this effect varies based on both tissue and sex, we examined mRNA expression of a, ?, ?, µ, and p classes of Gst genes via qPCR and corresponding protein expression via HPLC and western blot. We found significant differences between male vs. female and heart vs. kidney in several GSTs both in their expression in wild-type mice and in the change in expression between wild-type and Gstm1-/- mice. These results suggest that the severity of cardiac IRI may depend on the adaptive response mediated by genes encoding GST enzymes.

It would appear those from the secret squirrel club are desperate to try and undermine EVG's prospects, and a further appearance from the halfwit kingelf in another feeble and futile attempt to hold back the tide...ho ho ho ho, and it's laughable not to expect an early update from the Covid-19 patient trials if phase 2 stage proves to be positive. Gl to all holders...Evgen is firmly in the spotlight and investor focus. ;-)

......

Finncap 15/6/20..Research note only focussed on SFX-01's breast cancer potential.....pre phase 2/3 Covid-19 patient trials....and Jim Mellon's £250k plus the ex CEO £80k and so even more cash in the bank on Finncap's forecast..... Gla ;-)

Forecasts and valuation.

We have increased operating expenses in FY 2021 to
reflect the delayed phasing of pre-clinical costs and completion of CMC package.

We introduce FY 2022 forecasts, with the cash runway extending into Q3 CY 2021.

We maintain our target price of 25p, which is based on an rNPV for SFX-01 in mBC only. This excludes any value attributable to other indications, such as in autism or NASH,which will be pursued through non-dilutive financing sources, or the potential value of SFX-01 as a sulforaphane delivery platform.

Https://researchlibrary.finncap.com/File/View?file=c0021c92-9b4c-4987-82d5-825e28dc7824

Here's an example phase 2 and phase 3 combined. Gla :')

Phase 2 and 3 Combination Designs to Accelerate Drug Development

For late-stage clinical development, we propose combining phase 2 and 3 trials via a two-stage adaptive design. In the first stage, short-term safety and efficacy are examined, after which low doses that lack efficacy and high doses that cause safety concerns are eliminated from further evaluation. The trial continues to the second stage with doses that are not eliminated. For the second stage, the required sample size is adjusted to maintain power. All patients, including those enrolled in the first stage, are evaluated using a clinical endpoint requiring a longer follow-up. For the second stage, trend statistics are adaptively chosen based on the estimated dose-response curve in the clinical endpoint of the first-stage patients. At the end of the trial, pairwise statistics for the first stage and adaptive trend statistics for the second stage of the clinical endpoint are combined to establish dose-response and to identify the lowest effective dose. A notable feature is that the adaptation rule governing dose selection, sample size calculation, and derivation of test statistics for the second stage need not be specified in advance to maintain the validity of the trial. The phase 2/3 combination design is effective in achieving robust statistical power and is also efficient, because the number of patients and time needed are substantially reduced.

SFX-01's Phase 2 and Phase 3 combined Covid-9 patient trials.....Top Line Results expected Septmenber 2021, although it's reasonable to speculate that early reporting would be highly likely given that the trial is combined Phase 2 and Phase 3, as well as the urgency in finding an effective treament for Covid-19 and also the fact that clinical trial data on ongoing Covid-19 trials are very often shared with other world health organisations......a very exciting time for those invested in Evgen regardless, with more material news expected from the rest of their multiple disease pipeline. Gla Holders....Full market appreciation and investor interest on its way, with so much potential transformational UPside from this lowly £18m market cap....an absolute bargain....On and UP!!! ;-)

......................

A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or confirmed SARS-CoV-2 infection

*for the avoidance of doubt, this trial permits inclusion of patients presenting with acute respiratory infections whether or not the test for SARS-CoV-2 is positive. Patients can be randomised to the study while awaiting the results of the test for SARS-CoV-2.

TIMEPOINTS of EVALUATION

E.5.1.1 Timepoint(s) of evaluation of this end point: Day 15 (where day 1 is the first day of treatment)

E.5.2 Secondary end point(s): Clinical Severity;

Time to an improvement of one category from admission using 7-point ordinal scale.

Daily whilst hospitalised

Participant clinical status on 7-point ordinal scale. Days 3, 5, 8, 11, 15 and 29.

Participant change from baseline on 7-point ordinal scale. Day 15.

Proportion of participants showing improvement on 7-point ordinal scale. Day 15.

Mean change in the 7-point ordinal scale. Baseline to days 3, 5, 8, 11, 15 and 29

NEWS;

Time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first

Change from baseline Days 8, 15, 29

Oxygenation;

Oxygen free days 0-29 days

Incidence and duration of new oxygen use during the trial 0-29 days

Mechanical Ventilation:

Ventilator free days 0-29 days

Incidence and duration of new mechanical ventilation use during the trial 0-29 days.

Duration of hospitalisation; date of admission and discharge

15day and 28day mortality; date of death

Cumulative incidence of serious Adverse events (SAEs) 0-29 days

Discontinuation or temporary suspension of treatment 0-29 days