Member Info for itsallamess

Let's see a nice price rise going into the meeting tomorrow and them saying something that will sustain a further price rise

Also I think we can submit question?

Faron feels a bit more confident today.. we may well see a.rise into next Wednesday half year financials.

No doubt we will get some.details on future developments.. normally there would be an interview after an RNS like we just had..

I reckon they are holding back for some really good news very soon..

Timo is on the board now, doubt he will push for a massive dilution!

​4. Potential Challenges and Considerations

​Financing Requirements: While Faron has recently conducted capital raises to extend its financial runway and prepare for the next stage of development, the cost of a global Phase 3 trial is substantial. This makes a partnership, where a larger company with greater financial resources can share the burden, a necessity. The company's financial status will be a key consideration for any potential partner.

​Choosing the Right Partner: Faron has been transparent about its desire to choose the best partner, one that will maximize the drug's value for both patients and shareholders. This careful approach, while prudent, can take time.

​Competition: The drug development landscape is highly competitive. While Faron's data appears promising, potential partners will be evaluating other compounds in the same therapeutic space.

​In summary, Faron's strong clinical data, clear regulatory path, and a focused business development strategy make it highly likely to secure a partnership to finance Phase 3 trials for bexmarilimab. The company has taken the necessary steps to make itself an attractive prospect, and its recent public statements suggest that discussions are well underway.

I asked google gemini AI the following:

How likely will faron pharmaceuticals get a get a partner to finance phase 3 trials?

Faron Pharmaceuticals' likelihood of securing a partner to finance its Phase 3 trials, particularly for its lead drug bexmarilimab, appears to be relatively high, and the company is actively pursuing this path. Several factors support this optimistic outlook:

1. Strong Clinical Data and Regulatory Progress for Bexmarilimab

* Positive Phase 1/2 Data: Faron has reported very encouraging data from its BEXMAB trial in high-risk myelodysplastic syndromes (HR-MDS). The company has stated that the drug has shown a high response rate, significantly exceeding what is typically seen with standard treatments. This kind of robust, early-phase data is the single most important factor for attracting a large pharmaceutical partner.

* Favorable FDA Feedback: A major milestone was Faron's recent positive and "highly productive dialogue" with the U.S. Food and Drug Administration (FDA). The FDA has provided a clear, actionable path for the clinical development of bexmarilimab, recommending a registrational Phase 2/3 study. This de-risks the program significantly, as it provides a clear regulatory strategy for potential accelerated approval.

* Orphan Drug Designation: Bexmarilimab has been granted Orphan Drug Designation by the FDA for MDS, which provides incentives and a clearer path to market, making it more attractive to potential partners.

2. Strategic Focus on Partnership

* Active Partnering Discussions: Faron has been very open about its intention to find a partner to finance and commercialize bexmarilimab. The company has stated that it has been in dialogue with several potential partners and is carefully evaluating the terms to ensure the best outcome for the company and its shareholders.

* Reinforced Business Development Team: Faron has strategically strengthened its leadership team with the appointment of a Chief Business Officer, Ralph Hughes, who has extensive experience in commercial due diligence and business development at large pharmaceutical companies like Pfizer. This indicates a serious and focused effort to secure a deal.

3. Addressing Unmet Medical Need

* High-Risk MDS: The disease Faron is targeting, high-risk MDS, is an area with a profound unmet medical need. Current treatments are often not effective, and the prognosis for patients is poor. A drug that can offer a significant improvement in outcomes is highly valuable to both patients and the pharmaceutical industry.

4. Potential Challenges and Considerations

* Financing Requirements: While Faron has recently conducted capital raises to extend its financial runway and prepare for the next stage of development, the cost of a global Phase 3 trial is substantial. This makes a partnership, where a larger company with greater financial resources can share the burden, a necessity. The company's financial status will be a key consideration for any poten

Anyone know how much cash faron has?

Https://www.linkedin.com/mwlite/feed/posts/juho-jalkanen-md-phd-2176a83_faron-pharmaceuticals-fda-minutes-activity-7363675298132905984-erSV?utm_source=share&utm_medium=member_android&rcm=ACoAAAGqaz4BXKfrVRvYM3TqkStqcjyeyLusq1g

After three major Phase 3 strike outs from Gilead, Novartis and Abbvie, and nothing new for the treatment of HR MDS for 20 years (except Servier's IDH inhibitor), next up to the plate is Faron for a registrational trial in HR MDS. A true David vs. Goliath story of a small biotech tackling one the most notorious cancers known to man. Why will Faron be successful even after all the giants have failed?

- Faron's bexmarilimab comes with un-precedented last line safety and efficacy.

- Faron's bexmarilimab is the first drug to actually tackle the core biology of HR MDS, which makes it such a difficult disease to defeat in the first place.

- Faron's bexmarilimab is a result of 30 years of deep understanding of immune cells and cancer biology. No AI, no HTS, no shortcuts, only hard work.

- Learning from previous trials, Faron will be the first company to use a stepwise adaptive trial approach in HR MDS to secure the final win. It's been done before, but not in HR MDS.

- Because we believe we can truly bring something game changing to the field and we won't rest until it's done.

Primary endpoints: complete response rate and life expectancy

Guidelines were also obtained from the criteria used in the study. In the interim, complete responses (CR and CReq) according to the IWG2023 criteria are used as the primary endpoint. These are strong responses that correlate best with life expectancy and can therefore be used when assessing a possible early marketing authorization application. In our understanding, Faron originally proposed the use of so-called cCR responses (composite complete remission) as the primary endpoint. According to the FDA guidelines, cCR can be used as a secondary endpoint, i.e. to support the primary efficacy data. In our opinion, the criteria used or the exact types of responses are not of great importance to Faron or to the practical implementation of the study. In the later phase of the study, overall survival (OS) is, in our opinion, the most important variable determining the final marketing authorization. Final results in this regard will only be available at the end of the study.

We await further information in connection with the H1 report.

Faron's H1 report will be released on Wednesday, August 27, when the company is expected to hold a webcast. We expect the company to provide more details about the meeting held, and in particular the detailed implementation and schedule of the planned future research. We will review our forecasts and views in more detail in connection with the H1 update

Https://www.inderes.fi/analyst-comments/faronin-ratkaisevan-tutkimuksen-suuntalinjat-alkavat-tarkentua

Analyst comment

The directions of Faron's crucial research are beginning to become clearer

– Antti Siltanen Analyst

19.08.2025 at 08.05

Faron Pharmaceuticals

Faron announced on Monday that it had held a consultation with the US Food and Drug Administration. This is a typical End-of-Phase II Meeting with the authority. Compared to the FDA's guidance received a year ago, the upcoming pivotal study for marketing authorization will focus on first-line MDS, with second-line (r/r MDS) taking a back seat. Another change from the previous one relates to the dosing phase that will be implemented first in the upcoming study, which is likely to increase the total duration and number of patients in the study somewhat compared to the previous outlook. We will review our view and forecasts no later than the H1 report to be published next Wednesday.

FDA feedback modified the design of the upcoming pivotal study in some respects

According to the release, the FDA advised Faron to conduct a pivotal phase study in high-risk MDS patients in the first-line setting. This means patients who are receiving treatment for their disease for the first time. The change from the previous one is that a potential accelerated approval can be applied for in the first-line setting, if the results are favorable, but not, based on this study, in the second-line r/r MDS setting, in our understanding. Previously, an r/r MDS application was on the roadmap as a possibility before the first-line application, according to comments made by the FDA last summer. The planned number of patients was not commented on in the release, which is an interesting clarification question with a view to the upcoming H1 report.

Phase II/III study first determines appropriate dosage

Another new aspect was the information about the dose-response phase that opens the study. This means that the best-performing dose (1 vs. 3 mg/kg) is first determined, after which the study is seamlessly continued with the best-performing dose. This was somewhat of a surprise to us, as a suitable dosage was already sought in an earlier study phase. In practice, a new dosage study may extend the study completion schedule and increase the number of patients needed somewhat compared to the previous outlook.

Primary endpoints: complete response rate and life expectancy

Guidelines were also obtained from the criteria used in the study. In the interim, complete responses (CR and CReq) according to the IWG2023 criteria are used as the primary endpoint. These are strong responses that correlate best with life expectancy and can therefore be used when assessing a possible early marketing authorization application. In our understanding, Faron originally proposed the use of so-called cCR responses (composite complete remission) as the primary endpoint. According to the FDA guidelines, cCR can be used as a secon

Normally after a RNS like yesterday, there would have been a proactive interview... or at least some aditional comments from someone in the faron team..

Why the silence? Could they be in talks to sign a deal? Or are.they preparing a fund raise for phase 3?

Western, it often takes a couple of days after news to move

I would have thought today's news would have done something major to the shareprice!

Maybe the news is neutral until a funding result for phase 3 is announced..

Well I like the idea of a partner but I also like the idea of self funding.. but which one is better... well theres only one way to find out.. fight... (harry hill 😂)

Https://www.placera.se/externa-analyser/faron-pharmaceuticals-faron-pharmaceuticals-advancing-into-a-registrational-study-20250818

If they were to g onit alone and want to raise funds, us listing would seem they way to go..

However, any new shares will dilute Timo.. and all.of us!

Higher reward if go it alone!

Forget about anything said by Faron before.. where we stand today, who thinks Faron will try phase 3 themselves considering the accelated route they are on?

Https://www.proactiveinvestors.co.uk/companies/news/1076839/faron-wins-fda-support-to-advance-bexmarilimab-into-pivotal-trial-1076839.html

"endorsed a direct route towards accelerated approval using Complete Response (CR) + CR equivalent (CReq) per International Working Group (IWG) 2023 criteria as a co-primary endpoint with Overall Survival (OS)"

​Here are the key changes and what they mean:

​Rationale for the Update:

The previous criteria (from 2006) had limitations. They didn't always accurately capture the benefits of new therapies, and their ambiguity could lead to inconsistent reporting of clinical trial results. The IWG 2023 criteria were developed by a panel of experts to be more practical, precise, and reflective of patient-centered outcomes.

​Changes to Response Categories:

​New "Less-than-Complete" Response Categories: The new criteria introduce provisional response categories like "complete remission (CR) with partial hematologic recovery" and "CR with limited count recovery." These new categories allow for a more nuanced assessment of treatment efficacy, recognizing that patients may see significant clinical benefit even if they don't achieve a full "complete remission."

​Elimination of "Marrow Complete Remission":

The old category of "marrow CR" was found to be less clinically meaningful and has been eliminated.

​Revised Hemoglobin Threshold: The hemoglobin threshold for achieving complete remission was lowered from ≥11 g/dL to ≥10 g/dL.

​Emphasis on Patient-Reported Outcomes (PROs):

The new guidelines also emphasize the importance of collecting and reporting on patient-reported outcomes, ensuring that clinical benefits are measured from the patient's perspective, not just through laboratory values.

​Impact on Clinical Practice and Research:

​Improved Accuracy: The new criteria are designed to provide a better correlation between treatment response and long-term outcomes, such as overall survival.

​Standardization:

They aim to standardize the way clinical trials report results, making it easier to compare the effectiveness of different drugs and therapies.

​Enhanced Assessment of New Drugs:

The updated criteria are particularly important for the evaluation of novel therapies with new mechanisms of action, allowing for a more accurate assessment of their clinical benefit.

​In essence, IWG 2023 represents a major step forward in how the medical community assesses and reports on the treatment of HR-MDS, with a focus on improving patient care and advancing clinical research.

Let that sink in

"we are now only one study away from getting bexmarilimab approved for the benefit of HR MDS patients"

Would love aRNS in the morning, even if its just a date for the next FDA meeting

When's FDA meeting?

When they give their approval and recommendations for next steps.. this is when a partnered will step on board..