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Merck will find out at the end of the month if they get Emergency Use Approval for Molnuparivir, their Covid drug.

Developed by Ridgeback and the Merck Exploratory Science Centre who run their 4D collaboration

Molnuparivir will be a bit of a windfall so they should be flush with cash

Raising the Oxford Finance cash also a signal as shows they are not desperate to do a deal at a cheap price.

Merck had a drug called Sinemet that was approved for Parkinsons but the patent ran out after about 5 years. They are on PPMI so definitely have an interest in Parkinsons

In good company

https://www.ppmi-info.org/about-ppmi/who-we-are/study-sponsors

It just says 4D Pharma reps on the RNS

"4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) - a novel class of drug derived from the microbiome, today announces that it has joined the Parkinson’s Progression Markers Initiative (PPMI) as an industry partner. PPMI is a landmark study sponsored by The Michael J. Fox Foundation to better understand Parkinson’s disease and accelerate the development of new treatments.

4D pharma representatives will contribute to the efforts of the PPMI by joining the Partner Scientific Advisory Board closely involved in the design and execution of the study. In addition, 4D pharma will also join a variety of PPMI Working Groups that provide a forum to discuss PPMI data and address Parkinson’s clinical trial challenges with other PPMI industry and non-profit partners."

I certainly have not written it off Scrambler. I felt a bit pessimistic about getting a deal done but my reflection today on the commercial production capacity comment has made me more optimistic that a deal is in the works.

A deeper analysis of the data showed results were much more positive than first thought and if can be replicated in more patients FDA approval could be achieved from the stool consistency and frequency improvement alone.

Posted this before

So my prediction for Blautix is a strategic collaboration with a partner who will run the trial and take care of approval and marketing whilst 4D provide the capsules for the trial and hopefully the market.
Upfront payment and profit share arrangement.

The circus came to town.

It's fine if you stick to reading my posts

The reason why the Blautix point about manufacturing capacity is because when they filed prospectus with Nasdaq they said existing capacity was possibly not sufficient for commercial manufacture.

Now they are saying that they do have capacity for commercial production of Blautix.

Because they will have done a detailed evaluation.

This is a clue to where Blautix discussions have been leading

People say that I ramp and then deramp.

No, I just say if you are going to invest do so with patience and not because someone has told you this will easily be 100p this time next week

Thanks Boonco. I just wondered, that's all especially since Brexit and the MHRAs new role.

I see they are a month ahead of the FDA in granting approval for Molnuparivir and the vaccines before that.

Thought maybe Angle could send them a nice email and get approval before teatime!

Micro RX platform with 9 drug candidates in pipeline discovered in 7 years

Blautix ready for P3 and talk of commercial manufacture in a US market conservatively estimated to be worth $2.4bn.

Partnerships in place with 2 mega pharmas in MSD and Pfizer and a mid market one Merck Kgaa

Massive opportunity for 0518 as combination therapy with other treatments including immune checkpoint inhibitors $27bn market. Next ICI collaboration likely to require upfront payment if the pharma wants to play with 0518.

Collaborations with top cancer research settings like MD Anderson and Imperial college.

Forthcoming trial for Parkinsons with a seat on the science advisory board of Michael J Fox Foundation and partnership with Parkinsons UK. Both collaborations will make patient recruitment a lot easier.

Funding in place until the end of 2022

Incredibly experienced board with heavyweights like Axel Glasmacher and Katrin Rupalla (check out their CVs)

Directors DP and AS own 10% of the company including further investments in the last placing at 110p

Vaccines collaboration with MSD with milestone payments potentially available of up to $1bn

A second generation oncology drug in pre clinical development already recognised for potential to make CAR-T therapies work in solid tumours (holy grail)

Manufacturing capacity in place for commercial production with 7 years worth of accumulated experience and expertise

With 2 partnerships in place with MSD and them owning nearly 5% surely the inevitable will be only a matter of time

As I mentioned yesterday Chris Carite of 4D is going to be at Microbiome Connect in Boston next week to discuss manufacturing and commercialization of LBPs.

4D are not only leaders in the science but in the practical and commercial side of things.

So my prediction for Blautix is a strategic collaboration with a partner who will run the trial and take care of approval and marketing whilst 4D provide the capsules for the trial and hopefully the market.
Upfront payment and profit share arrangement.

There you go. You heard it here first!

The Blautix P2 trial is still the largest completed trial in the microbiome space.

It was bigger than the Seres P3 that reported last year. Although Seres are in the process of adding more patients to that trial as FDA said they hadn't included enough to apply for approval.

Makes me wonder how big a P3 trial would actually need to be if they have already gathered a lot of patient data.

They did well to target IBS as it is a high unmet need. A lot of funding has gone into IBD so if they had opted to push Thetanix forward they would have encountered a lot of competition with other IBD candidates that are due to come on the market.

One thing that was mentioned at the Jefferies chat was that the 4D manufacturing facility has capacity to produce Blautix at a commercial scale.

Up until now it has just been used to produce capsules for the trials.

Presumably they have run some kind of analysis to determine this, which could have been necessary for any talks with potential commercial partners.

Normal practice in an out licensing deal would be for the partner to source production capacity from a specialist manufacturer and the company outlicensing the drug would have no more to do.

But here the specialist manufacturer is the company offering the drug for licensing. On the face of it this seems like something that would strengthen 4Ds hand in any negotiation.

In addition to the drug they can offer up the ability to manufacture it which for LBPs is a highly specialist area.

Despite having previously boasted of having their own production facility, Seres have had to contract additional capacity from Bacthera to get ready for commercial rollout of SER109, which is their c-difficil drug.

You are taking my comment out of it's context.

Which is that the pointless Proactive Investors puff piece interviews seem to have stopped and if you want to keep up with company comms in between RNSs you need to register for the investor chats run by brokers where the questions asked are a bit more challenging.

With getting MHRA or EMA approval?

Is that something that would come after FDA process?

I didn't say they would affect anything.

They are not geared at small retail investors. They are for building awareness among IIs.

That takes time. They don't invest because someone tipoed the stock on Twitter.

Jefferies really need to get on and deliver a broker note on 4D.

It can be a long drawn out process getting interest from IIs but you could see that their analyst Chris Howerton was looking impressed at the event last month.

You can see that 4D are focusing their PR on getting solid write ups in pharma industry publications and doing the investor conference roadshows.

Makes a change from all those old Proactive puff piece interviews.

Clearly looking to attract the right kind of investor.