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You are correct Stu . I guess I was generalising .
What I should have said was they were funded through to the important FDA meetings ( happening in Q3 ) and their decisions.
These type of companies will always only be a few quarters from running out of funds , and £5 million isn't a big raise for Faron . If push comes to shove they could have probably raised twice as much I reckon .
In my opinion ,they really believe that this Bexmab data will open the door to some kind of commercial conditional approval - possibly by Q4 ( hence the emphasis on manufacturing too ).
That will tie in with some kind of partnership deal one would hope - and from then on , funding will be a lot less painful .
The finishing line always seems to be just one quarter away , but the fact that Timo is still onboard and adding large amounts is reassuring , given that he has a huge stake and a vested interest in not letting them stall at the last hurdle due to lack of funding .
Another 1000 for me too .
There has been so much good news coming through - just look at the BOD , the US connections being built , the LLS support , the new trial sites . Fast track applications . The team they have . The Bexmab study results so far - FDA meetings next month . Fully funded now through this year .
For any new investor - what a great entry point given how much risk has been removed .
Also no accelerated book build - all done beforehand .
They didn't have to go chasing it - and I'd rather have a small dilution than any more debt deals ( like IPF - which possibly was partially responsible for them to have to make a placing to keep to their rules of funding in place )
Markku has 5% - he doesn't want his share going south either in the long term .
Well if it gets us hopefully to the point where Bexmab will have enough data to present to FDA for potential conditional approval - then it will be worth it .
Timo adds again - he wouldn't be chucking more in unless he could see the reason .
But yes it does make you wonder when they will ever make some kind of proper deal .
Its a positive move in as much as they remain funded - and certainly building up to something .
I suppose I will add a bit today too if we drop to placing price .
Update to clinical site yesterday - 2 US sites added -
United States, California
City of Hope National Medical Center
[Recruiting]
Duarte, California, United States, 91010
Contact:Contact: Rochelle Hernandez 626-218-0247 rochernandez@coh.org
Contact:Contact: Diana Oganesyan '626-218-0247 dioganesyan@coh.org
Contact:Principal Investigator: Anthony Stein, MD
United States, Texas
University of Texas, MD Anderson Cancer Center
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Shenell Alexander 713-745-8290 SAAlexander@mdanderson.org
Contact:Contact: Joie Alvarez 713-792-7321 jalvarez1@mdanderson.org
Contact:Principal Investigator: Naval Daver, MD
WE know about Nval Daver MD , but now we have Anthony Stein MD at City of Hope Cancer Center in California .
He looks to be a top man in his field ( Leukemia research)
Anthony S. Stein, M.D., a member of the City of Hope team since 1985. Dr. Stein is a professor and physician in the Department of Hematology & Hematopoietic Cell Transplantation and associate director of the Gehr Family Center for Leukemia Research within the Hematologic Malignancies Research Institute.
Educated in South Africa, Dr. Stein received his medical degree from the University of Cape Town. He completed his residency at Montefiore Medical Center in Pittsburgh before joining City of Hope as a fellow in hematology/oncology.
Dr. Stein is principal investigator in multiple clinical trials examining the newest drugs for battling acute myeloid leukemia and acute lymphoid leukemia and hematopoietic stem cell transplantation.
City of Hope - also a top notch set up -
City of Hope is one of only 53 National Cancer Institute-designated comprehensive cancer centers in the U.S. The NCI designation recognizes excellence in treatment, research and expertise to address the many facets of the disease. We’re also a founding member of the National Comprehensive Cancer Network (NCCN), reflecting our national leadership in advancing research and treatment. NCCN member institutions are recognized for their world-renowned experts and for treating complex, rare and aggressive forms of cancer.
Exciting times - we are now firmly set up and recruiting in 2 of the most prestigious sites in the US for Leukemia and cancer studies - with two high ranking principal investigators , along with full backing and investment from the LLS.
Panel discussing Bexs latest data from the Bexmab trial - 20th June
https://www.vjhemonc.com/feature/post-asco-eha-2023-aml-highlights/
Panel is chaired by Naval Daver ( our man in the US with high hopes for Bex )- with Farons Mika Kontro on the panel .
Should be seen by all the right people in this sector .
New patent just posted up
https://patents.justia.com/patent/20230167173
Lots of detail on how Bex in combi with Interleukin inhibitor - can have beneficial effects against a host of illness ( including sepsis , virus and cancer )
Must admit I'm not sure how this affects current strategy with Bex - but it looks like another big step in locking in the IP of Bex and laying out in detail what further value it has .
Read as much as I could - and it seems to contain some pretty bold statements !
Breaththough status details ( possibly out of date now - but gives you the basics)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3745545/
One requirement is that the Company must be able to manufacture the drug at commercial scale - which Faron has in place .
It would lead to -
Conditional or full approval
Expedited development
Rolling submission
Review shortened
Faron are in my opinion fairly confident it will get approval - just how soon depends on the FDA .
Fantastic update . Won't be long until Faron apply for Breathrough Status for Bex in AML treatment .
Only reason they hadn't already was small number of patients . I think MLF said they needed 12 .
So not far off that .
The science pages have also been rewrittten on the Faron website now (at last ).
All 3 drugs have new summaries.
https://www.faron.com/bexmarilimab
https://www.faron.com/traumakine
https://www.faron.com/haematokine
EHA 2023 tomorrow , with Faron presenting a Bexmab abstract
https://library.ehaweb.org/eha/2023/eha2023-congress/386371/mika.kontro.a.phase.i.ii.study.to.assess.safety.tolerability.and.preliminary.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Ac_id%3D386371
This I believe is from data up to Feb , so they don't have the latest April additions .
Would be nice if they dropped another update asap - been 7 weeks since last one nearly .
Summary/Conclusion:
The initial data show that BEX treatment is well-tolerated without additional toxicity to standard treatment.
Preliminary efficacy shows 3 responses out of 5 patients in the first dose cohort. The study is ongoing
All focus is on gaining ' expedited market access for Bex ' via Bexmab with LLS assistance .
In my opinion , that is what they are busy doing . Once that happens ( via FDA meeting to evaluate the Bexmab data )
, then the ball will firmly be rolling .
AS noted - no RNS's in April . Matins data is being finalised . Bexmab data being studied . New sites being prepared . Finance guy laying the foundations for future moves .
The quiet before the storm ?
It's building up to something soon I'm pretty sure .
The pipeline page on their website may be a clue .
As well as the new wording around the Bexmab trial goals , the new labeling of the other 2 drugs into a ' Cancer Supportive care ' category is a new shift . We haven't heard much there at all - yet there is a trial planned to start at the Fred Hutch cancer center .
Talking of AI , looks like Faron are using it themselves .
https://www.aiforia.com/blog/spatial-biology-cancer-research?utm_content=249976186&utm_medium=social&utm_source=twitter&hss_channel=tw-4349146708
The automated scoring of Clever-1 positive cells sped up the pathological scoring of our tissue samples, which we are routinely staining as part of our ongoing clinical trials. Pathologists at a contract research organization currently do this work, and the availability of pathologists is often a limiting factor in obtaining timely results. This research project will help us identify patients who can benefit from our experimental cancer treatment, so we foresee promise in Aiforia as our companion in diagnostic development.
Compared to many on Aim we are holding pretty well .
But yes , we need , and should get something soon .
It's almost ironic that every time we get to an important moment for the company , the US finances seem to be in turmoil .
Lets hope that our new CFO and board members are helping get things moving.
It may be a month or so , or we may get news tomorrow .
I'll go for either a Bexmab patient data update , or some kind of Fast Track/ Orphan approval
Probably be something totally different like Traumakine/Haematokine ( both of which should still bring us significant value at some point )