Member Info for sadoldgit

Please enlighten us what this 'something' is KS

Sareum will not release any news that will give rise to speculation. They made a big mistake on that when they made a statement many moons ago.

If and when news is released with regards to CTA authorisation it will also provide details of funding.

Star786.
Pleased you found the Sar link referring to. Thanks very much for the memory jog.
Yes. I will admit I were wrong on that and offer apologies to those involved in this discussion.
Regards

Regards

There is a lot going on in the background Potnak further propelled by the period of silence by Sar.
Basically , there are only 2 viable options

Raise funds via investor
On licence/ co partnership.

Raising via investor I believe would have happened by now. I believe since the CTA was originally submitted there may very well be an impending on license (late stage informal discussions) If this is the case then there will definitely be a change of sponsor. If co partnership then funds would need to be made available by co partner.

Now firstly a formal contract would have to be signed.
Once the contract is signed and hence agreed by both parties then the new sponsors details will be required as is one of the conditions of authorisation of the CTA. Unless of course Co partnership but funds would be required from the co partner.
I see nothing else that can cause the current delay.
I have posted before of approx timescale of 2 to 3 months for finalising of contract. Tim will not release any info until agreements completed and signed. He made that mistake in 2012 with the ' transformational deal' that never materialised.
Science is important yes, after all that is what a company is buying. The other side of the coin is marketing and deal negotiation which to an extent at this current time is at least equally if not far more important.

My 100% belief is that if we required funds via an investment bank, we would have received by now.

'Our approach is to discover and develop programmes to late preclinical or early clinical stages before licensing or partnering'

I may be wrong, but see no other cause for current delay

Regards

Nobody is disputing thast we attracted HNWI whilst in the pennies. So for what purpose do you state this as a fact?

This notion as you described set out in official SAR documents
Please then post official SAR documentation which your argument relies on. If they are Sareums words then please post them here to give an accurate and factual account as opposed to an interpretation.

Regards

Share consolidation was done as we had over 3 billion shares issued.

There was no notion that reducing the shares by a factor of 50 to increase the price would make the share more attractive.

At present Sareum will be looking at means to securing funding. If they are not then 1801 will not be going into clinical trials.
A possibility may well be that a company could well be looking to on license,. if this is the case then this would dramatically change the CTA. Details of the sponsor are required at early application stage. This change of sponsorship would need to be approved by the licensing body. This will be time consuming, no ifs and no buts.

'The sponsor has specific legal responsibilities under the Clinical Trials Regulations. Before initiating a trial, the sponsor should define, establish and allocate all trial-related duties and functions. The NHS R&D Forum Sponsorship Principles document provides a comprehensive summary of requirements, including various models of sponsorship and guidance on the allocation of responsibilities, duties or functions.

Note carefully
the term sponsor is defined in the Clinical Trial Regulations as: the person who takes responsibility for the initiation, management, and financing (or arranging the financing) of that trial.

Note also very carefully especially as 'before initiating a trial.'
'The sponsor has specific legal responsibilities under the Clinical Trials Regulations. Before initiating a trial, the sponsor should define, establish and allocate all trial-related duties and functions.'

A sponsor is the organisation which funds a project. If an on license is being sought then Sareum are no longer the sponsor.

Sareum have not fundamentally got it wrong. Please provide factual information to support your argument as opposed to an opinion.
The only people that know what is going on behind the doors are Tim et al.

A big market in breast cancer.

The global breast cancer therapeutics market size was USD 21.58 billion in 2019 and is projected to reach USD 55.27 billion by 2027,

Again here estimated figures , 2021 of 1.54 billion dollars by 2030 projected 19.92 billion dollars.

All in all well over a 100 billion dollar projected market for NSCLC, Breast cancer and Ovarian cancer.

Not easy money by any means, but should 737 continue development and live up to expectations and beliefs then commercialisation of such a product will prove very lucrative.

GSK have their foot in the door. With 737 as a competitor merely clearing the hurdle may not prove to be enough for GSK combo therapy.

There are so many variables with Sareum at the moment. i do feel that CHK1 returning home may have complicated things just a tad.

Regards

http://www.sareum.com/development/chk1-kinase/

interesting to note here that it refers to former
'SRA737 has now completed two Phase 1/2 clinical trials in genetically selected patients with advanced cancers, conducted by former licence partner, Sierra Oncology:'

it has just crossed my mind that as 737 will be returned does this have any influence with regards to funding.Great results in NSCLC.'CPF acquired worldwide commercial rights to the programme in 2013 as part of a co-development agreement with Sareum. SRA737 was licensed by CPF to Sierra in September 2016. Sierra progressed SRA737 through Phase 1/2 clinical development and, at the 2019 ASCO Annual meeting, reported positive preliminary efficacy and safety data from two clinical trials evaluating SRA737 as a monotherapy and in combination with chemotherapy. In addition, preclinical data have been reported that indicate triple drug combinations involving SRA737 may show great promise against hard-to-treat cancers. Sierra has not progressed the asset beyond the Phase 1/2 clinical trial.Sierra was acquired by GSK in July 2022.Dr Tim Mitchell, CEO of Sareum, commented:"We continue to believe that SRA737 has great potential in several oncology applications, and Sareum now has the opportunity to be involved in planning its future development, supported by the positive clinical studies previously undertaken by Sierra.Should Sareum source sufficient funds for 1801 phase 1a and 1 b clinical, then how would they fund SRA737?More to the point do they intend to develop via partnership or further on license? The major holder CPF will be looking at options for 737.On license will involve up front payment. Sareum will then by definition not be involved in future development. Co development would still require considerable finance.The main questions are How much financial requirement are Sareum looking for?Who will provide the funding?SRA737 commercialisation is worth considerable amount, current projection for NSCLC aloneThe global non small cell lung cancer (NSCLC) therapeutics market size was valued at USD 16,011.7 Million in 2018 and is projected to reach USD 43,713.1 Million by the end of 2026, exhibiting a CAGR of 13.4% in the forecast period (2019-2026).I cant see Sareum letting this one slip. Regards

Spot on with Tyk2 and Jak1 C79

Many new ideas on drugs as the early Jak's were found to have safety issues. It is not that the Jaks cant work but the precise levels of pathway inhibition that matters.

Tyk2 on its own will not cut the mustard in IBD. Requires some help from Jak1 and the minimal amount of Jak2 and Jak 3 via selectivity as Tyk2 can be specific but jak1 2 and 3 are selective.

Regards and looks very exciting for our 1801.

Data from preclinical.
Why was it not picked up prior to starting trials?
Could have saved themselves a lot of money.
Tyk2 Jak1 all the way for psoriasis.

Half a million in milestone payment not make much difference.
With SRA737 lack of development caysed by lack of funding. GSK as we now know have their own combo.
Much potential still exists with 737. Overcoming cancer resistance to CHK1 well documented and researched. Forget CHK1 for the moment.

Significant funding is required for phase 1 a and also at some stage funding to take 1802 in my estimate to phase 2 trials.

Big question is how far at this present time are Sareum looking ahead to fund?

cut it short. Do they look for circa 8 million or 50 million?
My belief as per Tims interviews we are looking at taking on licensing up front payment to fund 1802 to completion of stage 2 clinical trial.

But dear old Sareum need to commit. They will avoid to the best of their ability heavy dilution at a low SP I feel.

The longer it goes on indicates progression of a 3rd party. This satisfies the point that CTA will want the financial commitment of the sponsor. If raised by PH via dilution Sareum are the sponsor. No problem or delay should ensue.
3rd party involves change of sponsorship and until settled/finalised will lead to delay.

Regards.

Our funding for CHK1 was made available 2 months before the ICR made their application for CTA.
I see no difference in this case.
Funds were made available and when taken or on licences we received around 300k back as unused.

i would estimate we need around 8 million for phase 1 and 1a to cover all costs. in the grand scale of things peanuts.

We will find out in due course.

Regards

It is a very complex issue. When reading through info you can find the sponsorship does have connotations. For example changing the sponsor is then under the scrutiny of serious changes of original terms on the original terms of the CTA.

I am firmly of the belief that Sareum require additional funding and have to obtain the funding as a condition of CTA approval.
No big deal itself. As they require funding for stage/phase 1b trials do they use this opportunity to raise funds for continuation of 1802?
They could if involved with a partner (1801) raise funds for phase 1 and 1a, thus leaving current balance to continue on 1802.
This is where I believe the bug bear lies.
I do not believe that the application will be approved on the good results of phase 1 dose escalation studies, to then enable funds to be raised for 1a.

Sp is getting hammered on short predicted cash runway on currently increasing cash burn up.. We are able to raise funds via PH. Why were funds not raised around time of CTA ie end of July?

It does pave the way that discussions are in place for some sort of partnership or co funding to resolve issue with CTA approval.
Until fully funded as a condition of CTA approval all i believe will remain quiet.
Sareum must have been aware of these conditions at the very latest mid August. allow arouns 12 weeks for write up od contracts following late stage negotiations.

For the life of me I can see nothing else.

Regards

Agree Seawolf, Sareum have never been up and coming with info.

With regards to Bobbler and Covid?Agile funding we would not expect this to be released as paty of CTA info. We will be into November next week, expect RNS around mid to late November are my thoughts.

Just in from work and back in for a long day tomorrow. Will have a scout round for info a little later.

Regards to all,

In opinion for what it is worth is a very good probability of co partnership. Looking at funding l would place an educated guess that had sareum chosen to take the route of share dilution this would have been known way before now.

All Sareum has abated is they need to raise funds.

Typically negotiations and drawing up contracts take approx 3 months give or take a week or 2. Those that think you just get on the phone and do a deal are wrong.

3 things we need to know is how much and from whom and for what?

Of course this news could drop at any time and there will be those of course that on a slight rise will dump and then brag about the gains. (The in and out brigade)

If it were funds via share dilution we would know by now as would have been submitted in CTA. Although cannot be ruled out 100%, a share dilution l don't see as the route being chosen. I may be wrong but it does not add up. to me at the moment.

whoops
https://www.ct-toolkit.ac.uk/routemap/funding-proposal/

Had we failed CTA
We would know by now.
At some time in the not too distant future.
Expect news of funds raised, along with initiation of clinical trial via RNS.

https://www.ct-toolkit.ac.uk/routemap/trial-supplies/

'The Sponsorship station follows the Risk Assessment station and precedes a parallel process in which the Protocol is developed and R&D Consultation takes place. Sponsorship is a legal requirement which is relevant to all trials. This station is part of the ‘trial planning phase’ group of stations.

Sponsorship is required for studies under the UK Policy Framework for Health and Social Care Research including trials that that fall within the scope of the Clinical Trial Regulations. It may take some time to secure a sponsor(s)*, so identification of the sponsor must be considered early in the planning process.

*Note: More than one entity can sponsor a clinical trial. This is referred to as joint or co-sponsorship.

For Clinical Trials of Investigational Medicinal Products (CTIMPs), the term sponsor is defined in the Clinical Trial Regulations as: the person who takes responsibility for the initiation, management, and financing (or arranging the financing) of that trial. The person(s) responsible for the sponsor’s functions must also be named on the Clinical Trial Authorisation (CTA).

The sponsor has specific legal responsibilities under the Clinical Trials Regulations. Before initiating a trial, the sponsor should define, establish and allocate all trial-related duties and functions. The NHS R&D Forum Sponsorship Principles document provides a comprehensive summary of requirements, including various models of sponsorship and guidance on the allocation of responsibilities, duties or functions.


Note carefully
the term sponsor is defined in the Clinical Trial Regulations as: the person who takes responsibility for the initiation, management, and financing (or arranging the financing) of that trial.

Note also very carefully especially as 'before initiating a trial.'
'The sponsor has specific legal responsibilities under the Clinical Trials Regulations. Before initiating a trial, the sponsor should define, establish and allocate all trial-related duties and functions.'

Trial related duties and that shall include financing by my interpretation. Indicates part of the statutory requirement by the sponser.

No big deal. Maybe lead to a big deal should all go well.

Regards

Good post Potnak and the funds were paid 2 months in advance by Sareum prior to the CTA application for CCT245737. Approval of CTA was made within 60 calender days. This is the only hurdle I can see to satisfy the argument regarding delay of CTA approval as I believe will be a condition of the application.
Interested parties or investment banking finance is the question?

Great post Salfordred.
At the end of the day it is those that have suffered or suffering cancer who should benefit. My Sister and my mother both died of cancer. I have known friends diagnosed of cancer and have died within 6 weeks. My mother diagnosed last year. Delays due to Covid and from diagnosis to death less than 3 months.

Early diagnosis should lead to rapid treatment and at least some extension of life to enable those to say goodbye to their offspring.

It is a cruel disease and I do feel at times that it is not so much about the cure but more about making money.

Very difficult nigh impossible to cure all. Latest stage of inhibitors should give those suffering more hope that are not responding to current treatment.

It was Celtic 007 saying we need hit from all angles. In a sense a vast understatement. Cancer develops resistance to treatment. Later stage treatments what we have now surpass treatments of 20 or 30 years ago. In some treatment areas of cancer this has never changed.

The same can be said for immuno therapy. At times I feel it is not about the benefit of the patient but to generate profit.

Somebody give us a one to one discussion please, of GSK with their monoclonal antibody in combo against SRA737 LDG and PD1 inhibitor, or even the recommendations of a CHK1 inhibitor with a Pl-3K o rAKT inhibitor to counteract the effects of cancer resistance to CHK1.

My honest opinion is that SRA737 delayed to make way for GSK combo. The deeper you look into it the more it becomes apparent. Those that come and go and who talks to who.

Enough negative from me and onwards and upwards from now.

We are very good in what we do carried out by a small team of dedicated people.

Attention to detail pays off.

Regards