Thread by @AimHardy

#DDDD💊

Why I believe @4dpharmaplc are on the cusp of a multi hundred million pound licencing deal for IBD and IBS?

https://twitter.com/AimHardy/status/1286223652451647489?s=20

#DDDD💊

Great Video 'Our Approach' highlighting @4dpharmaplc world leading innovative concept

Harnessing the bodies own Microbiome (Gut Bacteria) to solve genetic imbalances and malfunctions commonly referred to as diseases

4dpharmaplc.com/en/newsroom/vi…

#DDDD💊

Are you excited yet?

#DDDD💊

Highlighted in this video is the autopsy findings of #COVID19 patients who have died

If is evident Cytokine storm and inflammation, which leads to Pneumonia and ARDS is a significant contributing factor to mortality (death)

#DDDD💊

@4dpharmaplc

MRx0004- Pre Clinical Indications shows it controls the Immune Response

To have the sufficient capabilities to deal with the issue but prevent over inflammation which can lead to ARDS and Pneumonia

#DDDD💊

Further comparative data highlighting the control and reduction of inflammatory cells

Untreated vs MRx0004

#DDDD💊

Further Data showing MRx0004 significantly reduces Lung Infiltration and Inflammation
Allowing the lungs to remain porous for gaseous exchange, eradicating the need for ventilation?

🚨Potentially significant treatment to prevent ARDS + Death in Patients with #COVID19🚨

#DDDD💊

I have now discussed the positive effects of inflammation reduction but what about actually killing the virus?

#DDDD💊

COVID19 paitents are seen to have depleted levels of CD4 and CD8

cell.com/immunity/pdf/S…

#DDDD💊

MRx0004 has been shown to slightly elevate the circulating levels of CD4 and CD8 in the lungs

#DDDD💊

“All disease begins in the gut”

Amazing research in the relation between the Microbiome+health

Not everyone will change their diet!

Therefore @4dpharmaplc is exquisitely poised to assist in the therapeutic ailment of modern day illness+disease

#DDDD💊

Further Data from the Merck KEYTRUDER ®️ Collaboration In Oncology (Cancer) Treatment is showing to be very encouraging!

Clinical benefit increasing
25% ➡️ 33-42%

Why is this early data massively encouraging?

#DDDD💊

The patients @4dpharmaplc have recruited are patients with no therapeutic options available meaning there is a DESPERATE need for a treatment

Remember my previous tweet when analysing the data this combination is shown to yield even higher clinical benefit %’s

#DDDD💊

Thread🧵

Here are my thoughts on the clinical validation results of KEYTRUDA with MRx0518 and how this early data is showing revolutionary results for therapeutic treatment

This very well may be the start of a multi billion industry 🚀📈💥

https://twitter.com/AimHardy/status/1298515350275981318?s=20

#DDDD💊

🤯WOW🤯

Further substantial data released from Italy🇮🇹 signifying the role of Live Bio-therapeutics on Regulation of the Immune Response and improving patients outcomes

BODES WELL AS THIS IS RELATED TO #COVID19😉💥🔥

prnewswire.com/news-releases/…

Credit- @Licensed2trade👍

#DDDD 💊

I will now go into further favourable data which suggests MRx0004 is perfect for the fight against COVID19

#DDDD💊

MRx0004 has shown in studies it boosts and maintains Tregs- control the immune response to self and foreign particles (antigens)

importantly Th1- T cell that promotes cell-mediated immune responses and is required for host defence against intracellular viral pathogens

#DDDD💊

MRx0004 increased FoxP3+ T A MASTER REGULATOR ensuring the body maintains an optimal balance of immune cells, to prevent lung damage while killing viral pathogens🤯💥

#DDDD💊

The aforementioned just disclosed in conjunction with my early analysis of MRx0004 signifies all the relevant biomarkers for the successful treatment of #COVID19 💥

MRx0004 potentially may yield PHENOMENAL results (which are expected towards the end of the year)📈🔥

#DDDD💊

Now taking a look into MRx Platform for CNS diseases such as Parkinson's Disease

Here is a video highlighting

🚨'Parkinson's occurs due to the death DOPAMINE producing neurons'🚨

#DDDD💊

Both MRx0005 and MRx0029 have stimulating properties which
-Reduces neurological inflammation💥
-Protect Dopaminergic Neurons💥
-Increases Dopamine💥

Dopamine is the neurological pathway which allows movement

#DDDD💊

MRx0004 #COVID Trial🦠

Although it is not a pleasant statistic to report on

Hospital admissions are exponentially rising and will continue to rise into winter

This will accelerate Trial recruitment (90) with potentially a read out by Jan IMO
england.nhs.uk/statistics/wp-…

#DDDD💊

MRx0005/MRx0029 Targeting Parkinson’s disease

🤯🚨🤯🚨🤯🚨🤯

1/2 Causes of Parkinson’s Disease (Body First) originates in the intestines with the Microbiome 😳

technologynetworks.com/neuroscience/n…

Credit- @coxypete79

#DDDD💊

6 Cohorts for their Phase 2 Treatment IN DIFFERENT SOLID TUMOURS

SIMILAR EFFICACY SEEN when compared to @4dpharmaplc Treatment!!

$5.7bn DEAL?!?!?

https://twitter.com/LRamseu/status/1312391912956010498?s=20

#DDDD💊

My thoughts and opinions on Blautix results for IBS

https://twitter.com/AimHardy/status/1313802382732603398

#DDDD💊

Thread on the potential early revenue generation from US markets alone of MRx0518 which potentially may gain approval as early as next year

🚨$3.52 Billion per annum🚨

https://twitter.com/AimHardy/status/1319541051221250048?s=20

#DDDD💊

My thoughts on the earlier than anticipated NASDAQ Listing🇺🇸🔥 and how this will propel @4dpharmaplc to a MULTI BILLION 💰 Valuation

📈📈📈📈

https://twitter.com/AimHardy/status/1319179022899810304?s=20

#DDDD💊

@4dpharmaplc CEO Q&A revealing some
🚨very interesting🚨 aspects of 4D and why they are the World Leader in a new a evolving therapeutic division... 🌍💊

🔥🦠Live Bio Therapeutics🦠🔥

https://twitter.com/AimHardy/status/1319297760030453760?s=20

#DDDD💊

SUPER PHARMA's are still on the lookout for efficacious drugs to treat #COVID19 and are prepared to pay HUNDRED'S OF MILLIONS IN UPFRONT PAYMENTS💥

Similarly 4D's compound MRx0004 is currently in Phase 2 #COVID19 Trials with results expected Q1

https://twitter.com/AimHardy/status/1319314612110659585?s=20

#DDDD 💊

COVID Daily Hospital Admissions continue to rise

997 Admissions in a 24 hour Period (21st Oct)

Surely Clinical Enrollment for MRx0004 is expected to be accelerating with 90 Patients to enrol

https://twitter.com/AimHardy/status/1308850423902670857

#DDDD 💊

MRx0004 specifically dampens the immune response...💥

Dangerously ill coronavirus patients are making
🚨"startling recoveries" 🚨
in spite of being at "death's door" after being given
🔥drugs that dial down the immune system🔥
experts have said
telegraph.co.uk/news/2020/10/2

#DDDD💊

NASDAQ listing expected Mid January 🇺🇸

COVID Phase 2 Trial Results I expect shortly after (February)🦠

Can you imagine what US investors will do if MRx0004 follows suit with the aforementioned and is proven to significantly help #COVID Hospitalised Patients 📈

https://twitter.com/AimHardy/status/1319883086113476608

#DDDD💊

Blautix- What has sparked my eye?👁

The company have stated they are conducting further investigational work regarding their Phase 2 Trial

Specifically Bio Markers for “Sub Groups” and will announce results Q4, refining further/digging deeper than a specific cohort

#DDDD 💊

I believe 4D may have stumbled on an entirely different way of looking at/diagnosing the mechanism of disease with this study🚨

Each arm of Blautix in IBS C/D/M ALL generated very similar efficacy 23.4% to 25%

This efficacy across the board is far to similar to ignore

#DDDD💊

I believe there is a potential to categories specific IBS, primarily by using bio markers

I believe the further investigational work will show strong signals Blautix will cure specific Microbiome deficiencies leading to a Pivotal Phase 3 which will show v high efficacy

#DDDD 💊

Overview

10% of the Global Population is expected to have IBS

Blautix has shown to be 25% effective across the board for improving peoples outcomes for IBS

🚨That indicates the potential market for Blautix is effectively 2.5% of the global population🚨

#DDDD💊

Blautix is safe with No SAE

This leads me to believe even with 25% efficacy

🚨This could become the first line of Therapy routinely prescribed by GP’s👨🏼‍⚕️around the globe (potentially OTC Treatment)🚨

With an initial 6-8 week prescription to see if benefits are seen

#DDDD💊

11th Nov I hope you are ready

Why would you host a presentation with an associate professor from
🌍THE BEST CANCER HOSPITAL IN THE WORLD🌍
discussing your drug in
Pancreatic (Gastrointestinal) Cancer
💥🔥UNLESS YOU HAD SOME NEW GROUND BREAKING NEWS TO PUBLISH...🔥💥

#DDDD💊

MRx0518 is already showing great signs of Efficacy in Lung and Kidney Cancer...

Are we now going to receive news on a further application to treat Pancreatic Cancer?🔥📈

#DDDD💊

Thread

Update of MRx0518 at SITC and the subtle and early indications presented for the long term growth and validation of the MRx Platform®️

https://twitter.com/AimHardy/status/1326539660638605313?s=20

#DDDD $LBPS 💊

Thread

How MRx0518 has the potential to penetrate multiple indications of Cancer due to its efficacy and excellent safety profile 🔥

https://twitter.com/AimHardy/status/1327381385267585026

#DDDD 💊

@GSK🔥
'WE think that modulation of the Lung Microbiome + the immune response to the Lung Microbiome will help us to modify diseases in a way that ISN'T CURRENTLY POSSIBLE with existing therapies...
🤯leading us more toward CURE of the disease'🤯
gsk.com/en-gb/behind-t…

#DDDD 💊

BLAUTIX

💥COMPARABLE💥
to
🔥FDA APPROVED🔥
IBS Drugs

Could Blautix become the the initial first line of treatment offered 🌎Globally🌎 for IBS across all indications?

#DDDD 💊

BLAUTIX

Now directors have laid it out very clearly

YOU CAN SEE WHY Blautix IS GAINING SUBSTANTIAL INTEREST FROM MAJOR INTERNATIONAL COMPANIES IN THE SPACE

You only need to look at the deals which are being signed in the area
🚨(BUT NOT IN THIS INDICATION)🚨

#DDDD 💊

A recent accelerated approval for an ADC produced by @GSK for Multiple Myeloma had an Overall Response Rate of 31% and has significant side effects

Currently MRx0518 has shown a similar ORR of 25% with an excellent safety profile ⏰

gsk.com/en-gb/media/pr…

#DDDD 💊

Tocilizumab the “anti inflammatory drug” to receive approval for treatment of COVID19

bbc.co.uk/news/health-55…

“an encouraging result which SUGGESTS that OTHER MORE TARGETED ANTI-INFLAMMATORY DRUGS may help”

MRx0004 a LBP that SPECIFICALLY targets Lung Inflammation🔥

#DDDD 💊

4D are now 5 months into their P2 trial for MRx0518 x KEYTRUDA and have recently requested an FDA meeting for accelerated approval which is now planned for Q1 2021...

#DDDD 💊

With so little patient enrolment to date (Likely less than 100) why are 4D going for approval so early into trials?

Is the growing body of evidence showing large statistical significance/benefit for these desperately in need Stage 4 Cancer Patients?🤷‍♂️

#DDDD 💊

4D have shown some remarkable results already with 70%+ tumour shrinkage in a patient with Stage 4 cancer

You have to remember these patients are terminally ill after having exhausted multiple different treatments which all have failed

#DDDD 💊

Another encouraging update

MRx0518 shows most promise in Lung Cancer (NSCLC) and more efficacy as a monotherapy ALONE than an already approved drug which is actually approved for FIRST LINE OF THERAPY💥🤯

#DDDD 💊

Developing on why MRx0518 may be ground breaking for Lung Cancer 🫁

Observe this patient NSCLC

They had a STAGGERING 7 lines of therapy with no meaningful benefit before 4D's trial
Now they have seen a continued steady shrinkage of the Tumour 💥

Data- 8 months ago

#DDDD $LBPS 💊

This Stage 4 Terminally ill patient that had exhausted ALL other treatments STILL remains on treatment 18 MONTHS LATER using MRx0518💥🤯

STILL continuing Progression Free Survival and Tumour Shrinkage

This is HUGE

Now lets look at ORR...

#DDDD $LBPS 💊

Objective Response Rate is currently at 33%
However taking into account the ground breaking results just discussed, the current data is skewed due to patient withdrawal due to factors unrelated to MRx0518

ORR is likely to improve much further in NSCLC from here📈

#DDDD 💊

As shown on the graph the 2 other NSCLC participants withdrew before the first assessment at 9 weeks (This is the point you will BEGIN to see meaningful benefit)

The patients also did not discontinue due to drug related side effects

#DDDD $LBPS 💊

Therefore to date the ONLY patient within the NSCLC cohort which continued treatment up to the first meaningful assessment point shows VERY SIGNIFICANT clinical benefit

Adjusted ORR for NSCLC (Lung Cancer) is a HUGE
💥100%💥
🔥Continuing to show PFS 18 Months+ 🔥

#DDDD $LBPS 💊

Thread
Identifying similarities found between MRx0518 and Iova's TIL Therapy
A NASDAQ listed company developing similar very safe and efficacious drug pathways
The only difference $IOVA valued 3700%🤯(YES 37 TIMES) higher than 4D Currently

https://twitter.com/AimHardy/status/1333888698602168322?s=20

#DDDD 💊

Commentary on $GLSI and likelihood of multiple near term value inflection point for 4D Pharma Q1 2021

https://twitter.com/AimHardy/status/1336766100391026689?s=20

#DDDD 💊

Incredible safety profile🔥

NO Moderate Side Effects atall (All mild)

All while yielding clinical benefit in terminally ill patients which have exhausted all other treatment methods

A effective treatment that shows the possibility to be stacked with many other combos

#DDDD $LBPS 💊

Information on how the Microbiome can enhance immune activation increasing efficacy of drugs.. in particular VACCINES 🔥

4D Pharma has a joint development agreement with @Merck valued @ $1bn+ specifically targeting vaccine innovation 💥

#DDDD $LBPS 💊

This one specific study highlighting the potential of
Live Bio Therapeutics (Microbiome)🧫
To reactivate the immune system in
-Elderly
-Antibiotic Resistant Patients

Improving efficacy of vaccinations to sufficiently generate Anti Bodies

#DDDD $LBPS 💊

There is now a large growing body of evidence in many arms of Therapeutics showing the vast potential of the Microbiome

Signalling this new arm of Therapeutics plays an important role in modulating and optimising the immune response in combatting disease

#DDDD $LBPS 💊

24min30sec
Discussing how Live BioTherapeutics can re engage an immune response to increase the efficacy of Immune Checkpoint Inhibitors (In this instance PD-1/PD-L1)

MRx0518 follows this functionality

#DDDD $LBPS 💊

A good overview for the potential
Revenue➡️$1bn
Profit➡️$140m
Value attributed➡️$2.8bn

🚨For ONLY IBS-M🚨

As Blautix is well tolerated I believe this therapy may also penetrate IBS-C and IBS-D

I believe Blautix is worth $5bn if approved

https://twitter.com/BlogShrey/status/1343825524049784833?s=20

#DDDD 💊

Thread on share price appreciation concerns with dual listing in the US 🇺🇸

'Arbitrage'

https://twitter.com/AimHardy/status/1344253738006016000?s=20

#DDDD $LBPS 💊

The land grab for Intellectual Property has been critical
1000 patents already secured✅
1000 patents under review🔎

Will we expect to see a number of partnerships announced over the following years?

Collaborating to bring multiple LBP therapies to patients?

#DDDD $LBPS 💊

MicroRx Platform providing Breakthrough discoveries💥🦠

'Built a library that includes Novel Organisms that had previously never been isolated'

#DDDD $LBPS 💊

Dr. Steven Gundry (a 35 year heart surgeon) on the importance of the Microbiome for Health 🔥

8min30sec

Live Bio Therapeutics will play a role in restoring optimal health🔥

#DDDD $LBPS 💊

💥“99% of the Genetic Material that exist in you and me is non human”💥

🔥🔥 You can see why Seres $MCRB is part of @CathieDWood @ARKInvest GENOMIC ETF 🔥🔥

#DDDD $LBPS 💊

Zymeworks' Zanidatamab achieves FDA breakthrough therapy designation for Biliary Duct Cancer with

DCR of 66%
based on
ONLY 15 patients

Zanidatamab will receive an accelerated approval pathway to commercialise the drug

Why is this relevant to 4D?

#DDDD $LBPS 💊

Using the same criteria applied for Zanidatamab

MRx0518 achieved a broad

DCR= 55-71%
based on
12 Patients

Although this was achieved through 2 indications (Kidney and Lung)

Phase 2 enrolment is recruiting 30 patients in each cohort

https://twitter.com/AimHardy/status/1270669228501319680?s=20

#DDDD $LBPS 💊

MRx0518 has now been in Phase 2 Open Label Patient Expansion Trials for 6+ months

In November the CSO stated they are planning to meet FDA in Q1 2021

This leads me to believe that they believe they will have enough data by Q1 to request FDA Breakthrough Therapy

#DDDD $LBPS 💊

...designation

The fact this trial is open label (they are able to see the data generated from patients)

This validates my thesis that they are continuing to see HIGHLY SIGNIFICANT results prompting them to request a FDA meeting fully knowing the data they...

#DDDD $LBPS 💊

... are generating.

The fact that they are working on patients that have exhausted all available lines of therapy means if they are repeating the results we have first seen it is HIGHLY LIKELY they will receive Breakthrough therapy designation

Speeding up...

#DDDD $LBPS 💊

...the process to get this Live Bio therapeutic to market to help patients in desperate need of a solution, resulting in penetrating MULTI BILLION $ indications for each type of cancer

#DDDD $LBPS 💊

The market has yet woke up to this potentially near term REVOLOUTIONARY milestone but if it is approved this marks a A REVOLOUTIONARY LANDMARK

Connecting the Microbiome (Live Bio therapeutics) to significantly influencing and preventing cancer progression🔥

#DDDD $LBPS 💊

I truly believe this will be the moment the market truly wakes up to the potential of the Micro biome in disease

A whole new class of Medicine is emerging

The valuations which are to follow are potentially mind blowing🤯

#DDDD $LBPS 💊

Many many companies catapult and begin a tremendous multi year bull run into the multi billion 💰 MCap valuations once this land mark of Breakthrough Therapy Designation is achieved especially in Oncology designations

Now a NASDAQ listing is in sight well

📈📈

#DDDD $LBPS 💊

Immunology of the Lung... specifically in Asthma
(the $28bn Market)

Have a think of how

MRx0004 has been shown to work in preclinical models and tell me if 4D have a drug which SPECIFICALLY targets this issue 🤷🏼‍♂️

#DDDD $LBPS 💊

“Eosinophils play CENTRAL roles in ALMOST all Allergic Diseases”

MRx0004 squashing this key driver in Lung Inflammation

I wonder what 4D’s Asthma Clinical trial results will show in 2021...

#DDDD $LBPS 💊

4D are initially attempting to penetrate the Severe indication ($5.66bn)

Of which 20% are inadequately controlled

Meaning there is a $1.13bn segment of sever asthmatics that are crying out for a therapeutic to control their disease

Could MRx0004 be the answer❓

#DDDD $LBPS 💊

🤯🔥An ANTI CANCER DRUG with NO SIDE EFFECTS 🔥🤯

#DDDD $LBPS 💊

Here is a great video highlighting the micro biome composition influences vaccine efficacy

#DDDD $LBPS 💊

4D today updated on the progress of the vaccine collaboration with @Merck

Screening hundreds of LBP's as seen below (Vastly diverse MoA)
to select for the very specific desired immunomodulatory characteristics needed

This really begins to sink in...

#DDDD $LBPS 💊

We are now beginning to understand just how important the microbiome is for health 🦠

4D have created a World Leading proprietary platform 'MicroRx' based on 2 decades of research on mining the Microbiome recovering the Genomic immunomodulatory data of these LBPs

#DDDD $LBPS 💊

This vast database MicroRx will be used to exquisitely select the most optimal powerful organisms for the desired need.... tailored to treat and potentially cure diseases and restoration of health ⚕️

#DDDD $LBPS 💊

With already 1000 patents and another 1000 patents under review, 4D own vast IP relating to many of these important LBPs, that I believe will likely be proven in the future to be best in class therapeutics (Like MRx0518, MRx0004, MRx0029 are beginning to show)

#DDDD $LBPS 💊

“The Intestinal Surface
(Where most of the Microbiome reside)
hosts the largest population of Immune Cells”

#DDD $LBPS 💊

Are mucosal oral vaccines a GAME CHANGER? 🔥
4D intended use

Benefits
-administration
-distribution
-manufacturing (supply chains)
-higher consistent quality
-harnesses highest immune response
-expands scope of vaccines
-favourable immunity

#DDDD $LBPS 💊

Strong indication that the Gut Microbiota plays a role in Central Nervous System Diseases

Can Live Bio therapeutics such as MRx0029 and MRx0006 play a vital role in restoring optimal function in Parkinson's and Autism 🧠

#DDDD $LBPS 💊

A thread on some key information regarding preclinical work in Central Nervous System Diseases

https://twitter.com/aimhardy/status/1348045738173988873

#DDDD $LBPS 💊

Cathie Wood one of the best forward looking innovative investors of our generation

believes (13mins) the Biden Administrations KEY FOCUS is the

🔥Accelerated Approval of Breakthrough Therapies...🔥

🚨ESPECIALLY in Cancer🚨

MRx0518📈📈

#DDDD $LBPS 💊

One of the main issues with ImmunoTherapy in Oncology is the majority of patients are old and their immune systems are failing

(Pretty much the reason why Tumours have been able to start growing in the first place)

#DDDD $LBPS 💊

This means that ImmunoTherapies like
-Check Point Inhibitors
-T Cell Therapies
-Costimulatory Molecules

Fail due to the patients immune system failing to generate a significant response when prompted by the Therapy

#DDDD $LBPS 💊

This video clearly highlights how the the Microbiome plays a PIVOTAL role in the regulation of immune response to a foreign subject, highlighting the Microbiome can activate an immune response

#DDDD $LBPS 💊

🔥A VERY STRONG VALIDATING PAPER EMPHASISES THAT🔥

due to the recent revolution in genetic sequencing we have found out

🚨THE MICROBIOTA PLAYS A SIGNIFICANT ROLE IN IMMUNE REGULATION/ ACTIVATION🚨

Switching the immune system back ✅ON✅

ncbi.nlm.nih.gov/pmc/articles/P…

#DDDD $LBPS 💊

Couple this with the astonishing results we have seen so far in terminal cancer patients...

Has MRx0518 been the missing piece to ImmunoTherapy?

MRx0518 may be the actual future foundation which Cancer therapies are built upon

Priming the immune System🚨

https://twitter.com/aimhardy/status/1330278341744746497