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A very promising RNS today.

Bit by bit analysis below.

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'We have generated additional safety and efficacy data, building on the positive data from both the monotherapy and KEYTRUDA combination studies last year.' - 4d CSO

Data from a larger trial cohort, ready to take to the FDA for Breakthrough approval.

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To back this up, what I think is a nod to the FDA:

'This will support 4D pharma's continued productive engagement with regulatory authorities to develop the clinical strategy to bring this novel therapeutic to patients suffering from a range of cancers.'

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For the MRx0518/Keytruda combination:

'24 additional patients across five active US sites have now been treated in Part B of this ongoing study.'

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'The safety review following the first Part B cohort of 10 renal cell carcinoma (RCC) patients has been completed indicating no dose limiting toxicities.'

Fantastic. Further proof of the fantastic safety profile and affirmation of LBPS generally.

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'Target tumor reductions in Part B patients have been observed as patients reach the first scheduled restaging timepoint (nine weeks). These include the first signals of anti-tumor activity for the combination in bladder cancer'(!)

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This is key for two reasons:

A) Showing that the MRx0518 + Keytruda combination is meeting expectations in a larger trial cohort
B) Showing potential applicability of MRx0518 in more cancers, like the $240m bladder cancer market

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'Three Part A patients with RCC and NSCLC that were previously reported to have experienced clinical benefit continue on the study. Two of these patients have now been treated for over 18 months and have had further target tumor reductions or extended DC'

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I cannot explain how important this is.

Two patients with malignant, late stage cancer for whom immune checkpoint inhibitors (ICIs) previously had limited effect seeing their disease either controlled or improving using MRx0518 and an ICI?

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This shows the potential of MRx0518 in late-stage cancer patients, and we have not even explored its potential in early-stage cancer patients.

4d could be in a position to capture a multi £bn sized chunk of the global cancer market.

Unprecedented.

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New tumour cohorts open to recruitment - again positive. Based on precedent I am cautiously optimistic of MRx0518 + Keytruda delivering approval-worthy safety and efficacy data in larger trials, and thus having a great chance of FDA Breakthrough approval.

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More trials started for MRx0518 with Radiation in Pancreatic Cancer and MRx0518 in Neoadjuvant Setting Monotherapy - more data is always good and can inform, as 4d say, the construction and makeup of further trials.

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'The previously reported 17 patients in the completed Part A of this Phase I study (for MRx0518 in Neoadjuvant Setting Monotherapy) continue in the follow up phase for survival outcomes.'

Again, very good news and positive for all involved.

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NASDAQ listing expected to become effective in 'early 2021' - I am taking this to mean likely Q1 until further notice. From the wording may also mean early Q2 IMO.

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Overall, a great RNS.

Trials are being expanded and safety and efficacy data is being replicated for patients for whom nothing had worked before.

MRx0518 is the single biggest non-platform prospect for 4d Pharma right now.

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The fact that data is being expanded to new cancers just increases 4d's addressable market with MRx0518.

MRx0518 could, as early as within the next year, make 4d Pharma a company worth over £1 billion. For more info see thread: https://twitter.com/BlogShrey/status/1347305913754001410