Member Info for Heikkinen

Verneri: How long have you developed Bex?
Markku: Faron started developing this during 2010-2011 and MATINS started during December 2018. I would like to say that we have progressed with this development quite quickly.

06:25 How does he see the Bexmarilimab licensing situation, how far it is worth going alone and at what point would the inclusion of a deep pocket partner speed up market entry?
The current situation is that we are in the middle of the most critical sharevalue increase because our MATINS trial is producing such critical research data that it wouldn’t be wise to partner up/do a licensing deal with anybody just yet. We would prefer to wait a while longer. For example, we are presenting our results in ESMO which is the forum that opens doors and greatly increases the interest in us because all the chiefs of all of the big pharmas are there. Not everybody get’s a chance for a pitch in ESMO. We will continue the development work and more and more will be knocking behind our door. We have very strong believe in our products and that’s why we don’t want to hesitate with this.
Verneri: You are talking about increasing sharevalue with the new information...?
Markku: You are right. When we can investigate safety and efficiency of the drug we can reduce the risk. When we reduce the risk the expected value of our success will increase. This is the value increase that is happening in this equation.

08:10 Partner diagnostics is becoming more common in the industry
If you can prove that the patient has a problem in some mechanics that can be cured with your drug then you need some diagnostic treatment. For example, in prostate cancer we have a PSA-marker that can be identified from our blood circulation. For Clever-1 we have created a diagnostic system with which we can identify from the sample’s that these result(s) have been caused by Clever-1 treatment. Regulators nowadays require more and more this kind of partner diagnostics that should be included to the overall treatment plan.
Verneri: So it’s becoming an industry norm?
Markku: Yes it is.

09:15 There may be a trend in cancer treatments that there are more combination treatments, are more studies on different treatment combinations expected?
Human body’s immunological system is very diverse and we know that different foreign objects can cause different counter-actions from our immune system. With cancer patients we don’t necessarily know which part of our immune system has become inactive. Cancer hides away in these. Harnessing the full power of our immune system could require multiple treatment combinations. Cancer is very Clever (pun-intended) to slip trough the cracks of these treatments. With treatment combinations we could minimize the possibility of cancer slipping away.

00:13 Welcome to Markku's first challenge with inderesTV, can you tell us a little about yourself first?
My background: I was in Stanford for 3 years. After that I came back to Finland to a medical research productisation environment. My first biotechnology firm (employer) was Biotie (IPO year 2000) and Faron was founded during year 2007. In a nutshell I have moved from research to productization. My whole family has a doctorate in medicine.

01:00 How does drug development twist an iron wire?
Drug regulators are interested in two things: safety and efficiency of the drug. You must showcase this with recruited patients which you treat with your drug. You try to optimize the dosing etc with your patients and in some point you try to impress the regulators that your drug is efficient. Drug development process can take 1 -10 years, although COVID-19 vaccines were developed in approx. 11 months. Regulators are nowadays more flexible when it comes to the needs-based drug development.
Verneri: So I would guess that Faron is not for short term invertors?
Markku: Definitely not.

02:25 Faro's drug development by twisting the iron wire: what, where and at what stage the development is.
In general, we would like to utilise human body’s own immune system to take care of diseases. We live under significant disease threat all the time – COVID-19 is an example of this. Due to this threat human body has learned to fight against diseases during it’s evolution. When our immune system fails, we would like to active/recover the immune system. Our immune system does not detect cancer and due to this cancer can spread throughout our body. Why doesn’t our immune system take care of cancer? For this we are developing Bex.
In some cases, there are diseases that can harm us because human body’s own protection molecules aren’t enough. Traumakine is for these instances. For example, with diabetes human body needs outside help with handling the insuline.
The third one is Haematokine. It can re-produce the bone cores stem cells. We hope that we can give first doses of Haematokine to the patients during the next year.

04:20 In light of the current research findings, what is Faro's perception of bexmarilimab (Clevegen) TAM, or total addressable Market?
This depends heavily on the cancer type because in some cases 60-80% of patient population are those who we can’t cure. This equals to a very significant amount of people. What kind of market share would/could Bex conquer is very hard to predict. Anyhow, we are giving new tools in the form of activating human body’s own immune system for the patients who we can’t currently cure. We believe that the market potential for this immunological treatment is enormous but I don’t dare to evaluate any tangible figures for it. For example, new immunological treatments (that have emerged in less than few years) are predicted to sell approx. 25B this year and during year the 2025 50B.

Hello.

I’m not concerned about this fact. Benecol was retail food product (butter) so it was significantly easier to copycat than Faron’s products. If I remember correctly some US company came up with their own Benecol product which was released to the wholesale montha before FDA approved Benecol (FDAs approval process took over one year).

I wouldn’t mind to be hired for Faron’s PR department and have my share of their employees’ incentive plan etc.

This has been mentioned when talking about Faron’s collaboration/projects with US Defence Department.

’ in January 2021, [Faron] received $6.1 million from the US Department of Defense (DOD) as part of the Coronavirus Aid, Relief, and Economic Security (CARES)’