Member Info for lostinspace69

Almost certainly

Faron Announces Positive Phase II results in higher-risk myelodysplastic syndrome

Faron Pharmaceuticals Ltd | Stock Exchange Release | April 15, 2025 at 09:00:00 EEST

Inside Information: BEXMAB Phase II trial met its primary endpoint in treatment-resistant High Risk MDS (r/r HR MDS)

Key Highlights

Topline read-out from the Phase II BEXMAB trial confirms earlier positive findings in both frontline and relapsed/refractory higher-risk myelodysplastic syndrome (HR MDS) patients

The combination of bexmarilimab and azacitidine remains very well tolerated

Full data has been submitted to the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

Faron is planning for a Phase III trial, pending U.S Food and Drug Administration (FDA) End of Phase II meeting Feedback

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announced positive topline results of the BEXMAB trial, which shows a high overall response rate (ORR) among both frontline as well as relapsed/refractory (r/r) HR MDS patients treated with a combination of bexmarilimab and azacitidine.

According to this first fully enrolled Phase II analysis, the treatment continues to be well tolerated without any dose-limiting toxicity in r/r HR MDS patients with no other currently effective treatment options. A high objective response rate of 63% was observed in this initial data cut. The median overall survival remains at the same level as previously reported. Among treatment naïve (frontline phase 1) HR MDS patients, an ORR of 76% was observed. Many patients are still early in their treatment, which means responses may deepen over time and results are subject to minor changes as data matures. The full data has been submitted to the 2025 ASCO Annual Meeting.

“This is one of the strongest data set ever seen in an all-comer population of treatment resistant HR MDS”, says Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. “There is a significant unmet need in the treatment of HR MDS, as drug development in HR MDS and macrophage re-programming has proven to be extremely challenging, with a lot of previous failures. What really makes bexmarilimab stand out in this field is its good safety profile combined with very high efficacy especially in last line HR MDS. This gives us conviction that bexmarilimab is the long-awaited drug to overcome treatment resistance”.

Not long to wait now folks.

- Faron is on track to report frontline and HMA-failed (r/r) MDS top-line efficacy results in April 2025

Will the results of phase II be published this month?

I disagree that it was only ever a matter of time. The truth is, without Shaun Day , we most likely would have lost most or all of our investment. Big shout out to Shaun Day. He is absolute class and a true gentleman.

Or not

The AIM market has become a basket case. Wait until we cross list on ASX, then an orderly market will be in place and the share price will begin to reflect true value.

For those feeling nervous, does any of this sound familiar??

Prometheus Biosciences

Running out of money - few months of runway

Diagnostics business spun out

Investors struggle with mixed business model companies

CEO flew on air miles - running low on money

Raised £20m

Eventually sold for $10.8B to Merck

Keep the faith

Shocking website

Top BREAST surgeon, which suggests they are already treating patients with breast cancer, right?!

Cash runway until end of Q1 25. Phase 2 full readout expected end of Q1 25. It is the plan to partner on full phase 2 readout for phase 3. So, there is a relatively small amount (20m max?) of funding required, which shouldn't be difficult to find via some kind of private placement. The clinical results are excellent and consistent and the regulators are aligned. For big pharma, this is a platform technology across oncology and autoimmune diseases. All looks good to me. I expect to hear they have bridged any gap on finance in short order.

10x from here me thinks

Thanks for all the info shared. Any thoughts on when we might get back to the all time high? 13bn shares would mean market cap circa £5bn at 37p. Clearly there is huge upside here, but over what timeframe do we think it'll be testing those all time highs. I would think realistically 2027-2028?

Remarkable and consistent results. Surely big pharma will partner this before end of year.

Any idea when the next trial update is due?

I think the danger is AI not PE. Surely, the combination of AI software and smart meters will render this piece of kit useless within 2yrs? Feels a bit like VCR before the advent of streaming. I don't deny the problem it's trying to fix, just not sure it's the fix (long term).

No revenue numbers attached because there is no revenue. It’s a free download with no payment gateway

I doubt it’ll fall below £1. Fully funded, phase 2, debt free, commercialisation phase about to commence. I bought back in yesterday at 1.09. My guess is it’ll be a lot higher by end of year. Exciting time to be in this one

I think this return to 20p+ in short order

Placing incoming maybe 🤔