#47 - 600% in 3 Days: the execution playbook behind Abivax’s breakthrough in IBD

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If you want medical advance,

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you need to do some bad.

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Three months after the readout,

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we are going to run out of cash.

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We will go bankrupt.

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The beauty of Obafacin Mod is that it's not an immunoblocker.

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It's basically what we call,

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it resets the immune system.

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So we win together,

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we lose together.

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The tiny little biotech can actually do better in execution of clinical trials than the giant.

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It's like a Hollywood movie.

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Three days,

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we went from maybe we'll go bankrupt.

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to one of the,

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honestly,

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one of the stars of the Nasdaq.

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Within three hours,

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we raised $750 million,

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and we had essentially more than $3 billion in demand.

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Welcome,

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everyone,

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to this new episode.

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Today,

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I have an exceptional guest.

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I am with Marc de Garidel.

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Hello,

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Marc.

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Thank you for welcoming me.

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Again.

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Thank you.

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Again,

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here,

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two years after,

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you came already here two years ago.

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You just started a new position as the CEO of Abivax.

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And long story short,

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this was a biotech in difficulties at this time.

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And you started to raise 350 million to start a phase three.

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You had positive results.

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and then you just...

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This summer raised 750 million,

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which makes the story quite exceptional.

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And yes,

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I'm very happy to have you here today again to have the details of the story.

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It's a masterpiece,

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I think,

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in terms of leadership in biotech.

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I don't know.

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For the moment,

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yes.

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For the last two years,

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yes.

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The future will say that.

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I would like to start for like a chronologic thing.

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maybe with the beginning when you arrived at Abivax,

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the first days.

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Can you share a bit what you've seen?

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Sure.

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So,

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you know,

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I was actually lucky when I joined to be immediately immersed in the field of gastroenterology because,

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again,

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my background was not in gastroenterology.

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So

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I was also learning as I went on.

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But my first days were actually in the U.S.

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at one of the largest congresses called DDW,

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where I had the opportunity to meet,

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you know,

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with a number of the top carers in the world and where,

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you know,

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I could share a bit,

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you know,

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thinking around what Abivax was going to go.

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But it was a very good foundation because I could understand more what essentially physicians wanted with the drug.

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and how potentially to lead this phase three to success.

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So that was also the foundation for establishing the strategy of the company.

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Because if you look back,

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again,

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a couple of years ago,

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the company had been refinanced with essentially sort of a salvage program in

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September of 2022,

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where some U.S.

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investors and so forth,

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you know,

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partners,

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We refianced the company with 50 million euros.

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And then they did,

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again,

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prior to my coming,

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another crossover round for 130 million euros.

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That was basically in

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February of 2023.

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So when I came in,

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in April,

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again,

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I was lucky to have at least a bit of cash,

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but not enough to carry on the phase three.

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So DDW was very important to try to meet the KORs,

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but also meet with my team.

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a new team to figure out what would be our strategy.

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Again,

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at the time,

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there was no,

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when I ask,

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you know,

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where is the business plan,

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where,

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you know,

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what are the plans?

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You know,

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this company was really built to sell initially.

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Yes.

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And there was not really planned to go to continue and to do the phase three.

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So,

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you know,

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we had to start a bit from scratch about,

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you know,

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what,

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you know,

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indication we wanted to pursue.

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You know,

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how we would go ahead,

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how we would develop ourselves,

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especially within the U.S.

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Because,

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you know,

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70%

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of the market for

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IBD is in the U.S.

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And again,

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the CDW meeting was a foundation.

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So then what we did after we heard,

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you know,

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a lot of comments about,

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you know,

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what we could do or what we should do.

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As a team,

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we gathered together in the south of France and we established the foundation for the strategy,

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which ultimately we presented a month and a half later to the board.

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And that was actually the basis of what we would do a couple of months later for the IPO.

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Because when you do an IPO...

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You need to have a story.

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And it's not only,

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you know,

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a very short-term story.

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It needs to be also a long-term story of value creation and trying to fulfill,

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you know,

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a medical need for patients.

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On the market,

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yes.

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Okay,

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then you started with the science and then the finance and then,

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yes,

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operations,

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the teams and finding the right story.

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Okay.

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And do you remember which was the first decision you made?

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Okay,

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going to this Congress?

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And then,

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yes,

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starting a plant from scratch.

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Well,

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yeah.

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So I think,

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you know,

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part of developing a company is you need to have a long-term vision.

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Because otherwise,

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as the

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Americans say,

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if you don't have a vision,

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you may end up somewhere else.

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So what we did is we said,

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first priority is really develop this drug in ulcerative colitis,

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where phase three was beginning.

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Two,

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we wanted to develop it in a second indication,

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which is a bit more serious,

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which is called Crohn's disease.

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Then we realized that the doctors at the DDW told us you need to develop combination therapy,

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a bit like in oncology where you combine different mechanism of action in order to improve efficacy while trying to maintain safety.

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And the fourth pillar of the strategy was try to develop a new compound for a drug.

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Because in the south of France,

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in Montpellier,

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where we have a small research center,

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we have a library of about 2,000 molecules that could be also helpful,

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you know,

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to keep the adventure going beyond the

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OB-FASI mode,

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even though OB-FASI mode is turning out to be,

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you know,

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and again,

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a knock on wood because we are not finished yet with the studies,

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but turns out to be really a fantastic drug.

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So that was really,

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you know,

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the foundation for...

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for having a strategy.

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Then the question was,

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how much is this strategy going to cost and how much money do we need to raise?

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And we knew we could not get enough money in Europe for carrying the phase three and doing these other things that you described.

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So,

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you know,

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we built up,

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essentially,

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you know,

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worked with banks,

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worked on the bank syndicates.

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to try to access,

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you know,

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the Nasdaq.

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So we were actually,

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at the end of July of 23,

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we did what we call test the water meeting with U.S.

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investors.

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We got a lot of interest,

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actually,

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at the time.

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You know,

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the verbal commitment from U.S.

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investors was

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$1.2 billion,

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potentially,

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of interest,

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which was,

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you know,

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very encouraging.

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But a couple of months later,

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actually shortly after our conversation,

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in October,

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when we wanted to go public,

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then,

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as you know,

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there were the events in Gaza and,

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you know,

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in Israel.

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So the market started to fall apart.

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But nevertheless,

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we were able to raise that,

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you know,

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third week of October,

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you know,

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$240 million.

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Actually,

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that week,

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there were three companies trying to go.

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public and we were the only one that actually did it.

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But we didn't get as much as we wanted compared to what we had in July,

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but enough to carry on and to execute fully the phase three in insurrective collectives.

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You talked a lot about a lot of things.

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I just wanted to,

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it's very interesting,

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but I wanted to go back to the decision of the indication to decide not to go to To crown first,

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it was a decision,

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yes,

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related to...

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to science,

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to budget?

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Yes,

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it was mostly budget driven.

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Because we know the phase three in the colitis was going to cost over $350 million.

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So that alone,

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and this was the most advanced one.

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So it was a priority to colitis and put on a second priority Crohn's and start later phase to be in crowds.

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If I understand it well,

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you were disappointed to raise the first...

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everything is ready it was nevertheless you know the bigger i mean uh put things in perspective it was one of the 11 ipos of of 2023 so it was you know it was obviously the largest ever in the french market for for this for french company so i mean there were a lot of satisfaction if you were to raise this amount that was pretty spectacular in 23 due to make the phase three

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Yes. So from that sense,

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it was.

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It was very good.

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But nevertheless,

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if you were looking a few months back,

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again in July of 23,

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we thought we could raise 300 million.

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So it was,

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you know,

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it is good,

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but not enough to what we had hoped for.

281
00:10:04.024 --> 00:10:04.224
Yes.

282
00:10:04.365 --> 00:10:06.066
And you talk about the momentum.

283
00:10:07.687 --> 00:10:07.827
Yeah.

284
00:10:07.828 --> 00:10:09.011
The momentum.

285
00:10:09.031 --> 00:10:11.070
You cannot decide on the momentum of the company.

286
00:10:11.089 --> 00:10:11.230
Yeah.

287
00:10:11.812 --> 00:10:14.433
But I think this was obviously very foundational,

288
00:10:14.792 --> 00:10:17.534
the fact that we got to the NASDAQ.

289
00:10:18.777 --> 00:10:20.824
Then we could build up our

290
00:10:21.277 --> 00:10:23.058
US infrastructure because until then,

291
00:10:23.324 --> 00:10:26.980
we were essentially 35 employees in France.

292
00:10:26.981 --> 00:10:29.808
And we basically built up another 35 people.

293
00:10:30.164 --> 00:10:30.724
in the US.

294
00:10:30.764 --> 00:10:32.284
So we opened an office in Boston,

295
00:10:32.765 --> 00:10:34.085
in the suburbs in Waltham.

296
00:10:34.605 --> 00:10:34.886
Actually,

297
00:10:34.906 --> 00:10:35.347
as I say,

298
00:10:35.406 --> 00:10:38.769
often very close to the New England Journal of Medicine.

299
00:10:38.808 --> 00:10:41.488
So when we get hopefully positive phase three,

300
00:10:42.183 --> 00:10:45.324
we can bring back directly the printout to the New England.

301
00:10:46.933 --> 00:10:47.433
But yeah,

302
00:10:47.434 --> 00:10:48.683
we were able to recruit,

303
00:10:48.745 --> 00:10:49.027
I think,

304
00:10:49.089 --> 00:10:51.886
some very talented people,

305
00:10:52.042 --> 00:10:54.949
also some people who had been in the field of

306
00:10:55.370 --> 00:10:56.011
IBD. So,

307
00:10:56.667 --> 00:10:57.386
you know,

308
00:10:57.387 --> 00:10:57.792
we are out.

309
00:10:58.260 --> 00:11:01.503
We were able to attract some people from Arena Pharma,

310
00:11:01.864 --> 00:11:05.606
which had been sold just before to Pfizer.

311
00:11:06.149 --> 00:11:08.411
So we got a very good experience.

312
00:11:08.849 --> 00:11:11.270
Because one of the challenges in biotech,

313
00:11:11.395 --> 00:11:12.794
going from phase two to phase three,

314
00:11:12.856 --> 00:11:15.091
and certainly was true for Abivax,

315
00:11:16.060 --> 00:11:20.138
is phase three is much harder to execute than phase two,

316
00:11:20.747 --> 00:11:21.560
and for different reasons.

317
00:11:21.700 --> 00:11:22.185
Number one,

318
00:11:22.419 --> 00:11:22.981
the scale.

319
00:11:24.013 --> 00:11:24.419
Phase three,

320
00:11:24.513 --> 00:11:25.044
for example,

321
00:11:25.091 --> 00:11:25.653
for us was

322
00:11:26.106 --> 00:11:27.185
36 countries.

323
00:11:28.625 --> 00:11:29.686
600 centers,

324
00:11:32.868 --> 00:11:33.129
you know,

325
00:11:34.270 --> 00:11:36.071
two and a half year programs,

326
00:11:36.072 --> 00:11:38.215
$150 million program.

327
00:11:38.653 --> 00:11:39.856
The phase two was,

328
00:11:40.536 --> 00:11:40.817
you know,

329
00:11:41.176 --> 00:11:44.340
probably about 16 countries and

330
00:11:45.075 --> 00:11:45.919
200 patients,

331
00:11:45.965 --> 00:11:46.684
you know,

332
00:11:46.809 --> 00:11:49.278
compared to 1,275.

333
00:11:49.279 --> 00:11:49.403
So,

334
00:11:50.762 --> 00:11:52.465
and the phase three is a pivotal study.

335
00:11:53.153 --> 00:11:53.731
or if it's two,

336
00:11:54.747 --> 00:11:55.153
you can,

337
00:11:55.403 --> 00:11:55.715
you know.

338
00:11:56.612 --> 00:12:01.578
the FDA and the EMA are less regarding on how you conduct phase two.

339
00:12:02.097 --> 00:12:02.218
So,

340
00:12:02.558 --> 00:12:02.797
you know,

341
00:12:02.798 --> 00:12:04.242
the level of expectation,

342
00:12:04.781 --> 00:12:05.625
level of demands,

343
00:12:05.626 --> 00:12:09.586
the level of quality needs to rise significantly from phase two and phase three.

344
00:12:09.648 --> 00:12:09.765
So,

345
00:12:10.547 --> 00:12:11.968
and the team we had in France,

346
00:12:12.086 --> 00:12:13.093
although it was a good team,

347
00:12:13.172 --> 00:12:14.109
you know,

348
00:12:14.234 --> 00:12:17.109
was not really experienced to do a phase three program.

349
00:12:17.125 --> 00:12:17.359
Yes,

350
00:12:18.218 --> 00:12:18.797
developers,

351
00:12:18.828 --> 00:12:20.422
it was researchers.

352
00:12:20.453 --> 00:12:20.656
Well,

353
00:12:20.657 --> 00:12:21.281
it was a clinical team.

354
00:12:21.282 --> 00:12:22.031
Clinical team.

355
00:12:22.140 --> 00:12:22.562
And again,

356
00:12:22.812 --> 00:12:24.265
there was some of the research.

357
00:12:24.504 --> 00:12:25.845
people in the south of France.

358
00:12:26.046 --> 00:12:26.246
Yes,

359
00:12:26.305 --> 00:12:27.708
but clinical team for phase two.

360
00:12:28.028 --> 00:12:29.530
And then in the US,

361
00:12:29.608 --> 00:12:29.729
you...

362
00:12:29.768 --> 00:12:29.929
Yeah,

363
00:12:30.491 --> 00:12:31.272
so we build up,

364
00:12:31.671 --> 00:12:31.870
you know,

365
00:12:31.871 --> 00:12:33.796
the chief medical officer came from the US.

366
00:12:34.210 --> 00:12:39.218
We had a head of clinical operation that ultimately was in the US.

367
00:12:39.382 --> 00:12:41.975
So we really reinforced the head of statistics.

368
00:12:43.507 --> 00:12:43.616
So,

369
00:12:43.710 --> 00:12:43.944
you know,

370
00:12:43.975 --> 00:12:48.554
we really build up truly an execution machine.

371
00:12:48.569 --> 00:12:48.710
Yes,

372
00:12:48.850 --> 00:12:50.725
your phase three team was built in the US.

373
00:12:50.835 --> 00:12:51.054
Yeah,

374
00:12:51.147 --> 00:12:51.272
yeah,

375
00:12:51.632 --> 00:12:51.929
exactly.

376
00:12:52.548 --> 00:12:53.088
And for you,

377
00:12:53.128 --> 00:12:53.509
it was,

378
00:12:54.089 --> 00:12:54.268
yes,

379
00:12:54.349 --> 00:12:56.990
not a choice to try to split or to make,

380
00:12:58.010 --> 00:13:00.510
you had to focus on the U.S.

381
00:13:00.572 --> 00:13:00.830
market.

382
00:13:01.393 --> 00:13:01.549
Well,

383
00:13:01.550 --> 00:13:03.353
we have to focus on the U.S.

384
00:13:03.549 --> 00:13:03.713
again,

385
00:13:03.853 --> 00:13:08.252
partly because of the size of the market and the importance of the U.S.

386
00:13:08.291 --> 00:13:09.111
market in general.

387
00:13:09.518 --> 00:13:10.674
But the skill set,

388
00:13:11.346 --> 00:13:11.596
you know,

389
00:13:11.674 --> 00:13:13.033
there are not too many,

390
00:13:15.033 --> 00:13:15.268
you know,

391
00:13:15.455 --> 00:13:17.768
employees who have phase three IBD,

392
00:13:18.377 --> 00:13:20.939
who had the phase three IBD experience in Europe,

393
00:13:20.971 --> 00:13:21.549
unfortunately.

394
00:13:22.392 --> 00:13:23.093
It tended to be,

395
00:13:23.133 --> 00:13:24.273
you know,

396
00:13:24.873 --> 00:13:25.133
U.S.

397
00:13:25.752 --> 00:13:26.174
employees.

398
00:13:26.354 --> 00:13:26.494
Yes.

399
00:13:26.674 --> 00:13:30.553
It's related to the numbers of studies conducted from the U.S.?

400
00:13:31.357 --> 00:13:31.475
Yeah,

401
00:13:31.498 --> 00:13:36.818
I think it's also part of the fact that the big leaders in the field of IBD,

402
00:13:37.037 --> 00:13:37.592
historically,

403
00:13:38.272 --> 00:13:40.037
have been U.S.-based companies.

404
00:13:41.897 --> 00:13:42.912
Okay.

405
00:13:43.084 --> 00:13:43.740
You have Gen J,

406
00:13:43.959 --> 00:13:45.240
you have AbbVie,

407
00:13:45.303 --> 00:13:46.100
for example,

408
00:13:46.740 --> 00:13:47.240
you have Lilly,

409
00:13:47.381 --> 00:13:48.475
you have Pfizer.

410
00:13:49.701 --> 00:13:51.643
Some of the key players are already in the US,

411
00:13:51.644 --> 00:13:57.868
so you need to attract some of these talents into a smaller biotech.

412
00:13:59.110 --> 00:13:59.313
Okay.

413
00:14:00.188 --> 00:14:04.258
And then you raised this money and you had to execute this plan?

414
00:14:05.290 --> 00:14:05.633
Yes.

415
00:14:05.758 --> 00:14:08.680
And then things started to get a bit complicated.

416
00:14:09.227 --> 00:14:09.461
Again?

417
00:14:09.868 --> 00:14:11.399
Again.

418
00:14:13.149 --> 00:14:13.571
Because again,

419
00:14:13.665 --> 00:14:14.821
the execution of...

420
00:14:15.649 --> 00:14:16.040
It seems...

421
00:14:17.581 --> 00:14:18.942
an easy story from the outside.

422
00:14:20.223 --> 00:14:21.003
Yeah,

423
00:14:21.905 --> 00:14:22.686
but part of,

424
00:14:22.788 --> 00:14:23.026
again,

425
00:14:23.128 --> 00:14:27.327
part of the dilemma when you are in a biotech is you are pressed,

426
00:14:27.608 --> 00:14:27.850
you know,

427
00:14:27.874 --> 00:14:31.171
to execute fast because you run out of cash.

428
00:14:31.811 --> 00:14:32.499
In our case,

429
00:14:32.999 --> 00:14:35.718
we knew that with the $250 million we had raised,

430
00:14:36.858 --> 00:14:45.124
we would run out of cash actually essentially by the end of 2025.

431
00:14:45.125 --> 00:14:45.671
So we are only...

432
00:14:46.597 --> 00:14:47.901
two years of cash.

433
00:14:49.262 --> 00:14:50.264
So the pressure was,

434
00:14:50.967 --> 00:14:54.014
we need to finish this study as fast as possible.

435
00:14:54.553 --> 00:14:55.631
That's one side.

436
00:14:56.272 --> 00:15:00.123
But then the other one was the importance of the quality of the study.

437
00:15:00.868 --> 00:15:01.769
And please bear in mind,

438
00:15:01.789 --> 00:15:07.093
this study was the second largest ever to be conducted in the field of ulcerative colitis ever.

439
00:15:08.097 --> 00:15:08.335
Two,

440
00:15:09.214 --> 00:15:11.777
what we wanted to show is that our drug,

441
00:15:12.199 --> 00:15:12.917
Obifazimod,

442
00:15:13.441 --> 00:15:17.371
was not working potentially well in what we call naive patients,

443
00:15:17.372 --> 00:15:21.355
so patients who are put first time on an advanced therapy treatment,

444
00:15:22.011 --> 00:15:26.996
but also patients who had been exposed to multiple therapies before and were failing,

445
00:15:28.261 --> 00:15:29.261
just as a reference.

446
00:15:30.224 --> 00:15:30.845
In the U.S.,

447
00:15:30.925 --> 00:15:32.867
when you look at the U.S.

448
00:15:33.248 --> 00:15:33.729
patients,

449
00:15:34.647 --> 00:15:36.068
after three years of treatment,

450
00:15:37.111 --> 00:15:38.072
only 5%

451
00:15:38.529 --> 00:15:39.397
are on the same drug.

452
00:15:40.217 --> 00:15:49.006
So the unmet medical need is huge for having a drug that can help patients that have been already on an advanced treatment,

453
00:15:49.240 --> 00:15:50.865
but we failed quickly.

454
00:15:51.818 --> 00:15:54.053
This was a valuable position for Bethesda.

455
00:15:54.553 --> 00:15:59.490
So what we tried was not only to get these naive patients who are relatively easy to find.

456
00:16:00.012 --> 00:16:00.633
for execution,

457
00:16:01.333 --> 00:16:03.015
but also this advanced patience.

458
00:16:03.576 --> 00:16:04.238
And this is where,

459
00:16:04.239 --> 00:16:04.558
you know,

460
00:16:04.796 --> 00:16:05.738
the challenge was,

461
00:16:06.179 --> 00:16:13.105
this is where why we didn't go as fast as we thought because those patients are hard to get.

462
00:16:14.308 --> 00:16:15.027
But ultimately,

463
00:16:15.269 --> 00:16:18.675
they proved to be the winning proposition and why,

464
00:16:18.691 --> 00:16:20.285
you know,

465
00:16:20.286 --> 00:16:20.972
a few months ago,

466
00:16:21.206 --> 00:16:28.253
everyone was so impressed by the drug because we were able to essentially include the half of this sir.

467
00:16:28.740 --> 00:16:31.723
hard-to-treat or refractory population into our study.

468
00:16:32.344 --> 00:16:32.564
Oh,

469
00:16:33.826 --> 00:16:34.025
okay.

470
00:16:34.588 --> 00:16:35.287
And this is,

471
00:16:35.588 --> 00:16:35.787
yes,

472
00:16:36.209 --> 00:16:40.314
the beginning of the long-term strategy to have something really well-built for the future?

473
00:16:41.189 --> 00:16:41.330
Yeah.

474
00:16:41.369 --> 00:16:43.057
To be able to write a big story?

475
00:16:43.197 --> 00:16:44.158
Yeah,

476
00:16:44.213 --> 00:16:44.643
but I think,

477
00:16:44.658 --> 00:16:44.893
you know,

478
00:16:45.143 --> 00:16:46.814
the fundamental thing is,

479
00:16:46.955 --> 00:16:47.205
you know,

480
00:16:47.206 --> 00:16:49.564
you need to develop a good drug for patients.

481
00:16:49.580 --> 00:16:49.846
That's,

482
00:16:49.908 --> 00:16:50.158
you know,

483
00:16:50.174 --> 00:16:51.408
the foundation of everything.

484
00:16:51.409 --> 00:16:51.455
Yes,

485
00:16:51.456 --> 00:16:52.221
but it will get approved.

486
00:16:52.908 --> 00:16:53.158
Yes,

487
00:16:53.564 --> 00:16:53.846
clearly.

488
00:16:54.846 --> 00:16:54.986
But,

489
00:16:55.611 --> 00:16:55.846
you know,

490
00:16:55.847 --> 00:16:56.893
the differentiation.

491
00:16:59.061 --> 00:17:00.263
When you are in a biotech,

492
00:17:00.264 --> 00:17:01.102
actually as a CEO,

493
00:17:01.284 --> 00:17:03.888
this is one of the first questions you have to ask yourself,

494
00:17:04.446 --> 00:17:07.833
is are your drugs going to be differentiated with the rest of the pack?

495
00:17:08.528 --> 00:17:09.731
And in ulcerative colitis,

496
00:17:09.732 --> 00:17:11.794
there are many drugs that have been approved.

497
00:17:12.536 --> 00:17:14.841
But as I was mentioning just before,

498
00:17:15.591 --> 00:17:18.716
those drugs are essentially immunoblockers.

499
00:17:19.403 --> 00:17:19.934
So what they do,

500
00:17:20.028 --> 00:17:20.981
they work very well,

501
00:17:21.388 --> 00:17:22.403
very short term.

502
00:17:23.028 --> 00:17:23.513
But then,

503
00:17:24.450 --> 00:17:25.028
over time,

504
00:17:25.591 --> 00:17:26.028
either...

505
00:17:27.644 --> 00:17:28.985
patients develop resistance.

506
00:17:29.366 --> 00:17:29.485
So,

507
00:17:29.665 --> 00:17:29.907
you know,

508
00:17:29.927 --> 00:17:33.630
the human body find a way to develop the inflammation across that,

509
00:17:33.872 --> 00:17:34.110
you know,

510
00:17:34.911 --> 00:17:35.693
around that pathway.

511
00:17:36.130 --> 00:17:36.716
That was one.

512
00:17:37.153 --> 00:17:38.232
Or the side effects,

513
00:17:38.857 --> 00:17:40.739
because they block the immune system,

514
00:17:41.294 --> 00:17:41.997
they create,

515
00:17:42.161 --> 00:17:42.396
you know,

516
00:17:42.560 --> 00:17:43.700
their own set of issues,

517
00:17:43.778 --> 00:17:44.044
like,

518
00:17:44.045 --> 00:17:44.325
you know,

519
00:17:44.794 --> 00:17:47.325
patients develop opportunistic infection,

520
00:17:47.528 --> 00:17:47.810
you know,

521
00:17:47.841 --> 00:17:48.747
they have pneumonia,

522
00:17:48.841 --> 00:17:49.700
they're hospitalized,

523
00:17:50.200 --> 00:17:51.435
and sometimes they could have even,

524
00:17:51.466 --> 00:17:51.794
you know,

525
00:17:51.810 --> 00:17:52.325
malignancy.

526
00:17:52.982 --> 00:17:53.107
So...

527
00:17:53.684 --> 00:17:56.727
The beauty of Oberfasimod is that it's not an immunoblocker.

528
00:17:56.827 --> 00:17:58.370
It's basically what we call,

529
00:17:59.268 --> 00:18:01.573
it resets the immune system.

530
00:18:01.690 --> 00:18:02.612
So it's much more,

531
00:18:03.573 --> 00:18:04.917
it's more pre-artropic.

532
00:18:05.237 --> 00:18:06.940
It works on different pathways,

533
00:18:07.354 --> 00:18:08.182
predominantly two.

534
00:18:09.713 --> 00:18:17.104
But it reduces the cytokine expression by around 20 to 30 percent,

535
00:18:17.588 --> 00:18:18.792
not by 100 percent.

536
00:18:18.870 --> 00:18:22.807
And this is why we have this differentiation.

537
00:18:23.472 --> 00:18:23.592
So,

538
00:18:24.493 --> 00:18:26.936
to get back to you is,

539
00:18:27.115 --> 00:18:27.656
at the end,

540
00:18:28.496 --> 00:18:29.559
what you really want,

541
00:18:29.660 --> 00:18:38.465
you want to develop a drug that is highly differentiated and that will have this sort of nice combination between efficacy and safety.

542
00:18:38.863 --> 00:18:43.348
And you got that from the beginning and you knew it.

543
00:18:43.488 --> 00:18:45.891
could be your winning point.

544
00:18:46.071 --> 00:18:46.830
Well,

545
00:18:47.393 --> 00:18:48.311
at least in the phase two,

546
00:18:48.553 --> 00:18:51.174
we had indication that we could get there.

547
00:18:51.237 --> 00:18:52.975
But what was very unique in the phase three,

548
00:18:53.014 --> 00:18:54.475
and I'm sure we're going to talk about that,

549
00:18:55.116 --> 00:18:59.991
is our phase three got even better than phase two.

550
00:19:00.444 --> 00:19:03.787
We had greater efficacy and safety profile was actually,

551
00:19:03.866 --> 00:19:04.553
to some extent,

552
00:19:04.787 --> 00:19:05.444
slightly better,

553
00:19:05.584 --> 00:19:06.553
which is very unique.

554
00:19:07.397 --> 00:19:08.491
And then that goes,

555
00:19:08.975 --> 00:19:09.256
you know,

556
00:19:09.319 --> 00:19:12.053
about the learning of when you design study.

557
00:19:13.172 --> 00:19:14.333
When you design a phase three,

558
00:19:15.373 --> 00:19:16.555
you need to learn about,

559
00:19:16.756 --> 00:19:17.057
you know,

560
00:19:18.276 --> 00:19:19.377
what happened in the phase two.

561
00:19:19.440 --> 00:19:19.639
Yes,

562
00:19:19.998 --> 00:19:21.397
the differentiation of the phase two.

563
00:19:21.819 --> 00:19:22.217
Exactly.

564
00:19:22.701 --> 00:19:23.686
And to try to,

565
00:19:23.687 --> 00:19:24.905
you know,

566
00:19:25.303 --> 00:19:29.451
improve what didn't go as well in the phase two and try to,

567
00:19:30.405 --> 00:19:30.655
you know,

568
00:19:30.748 --> 00:19:35.467
change some of the criteria so that you have better chance of success for the phase three.

569
00:19:35.498 --> 00:19:35.701
Because,

570
00:19:35.717 --> 00:19:35.858
again,

571
00:19:35.859 --> 00:19:37.248
the phase three is a large investment.

572
00:19:37.311 --> 00:19:37.436
So,

573
00:19:37.437 --> 00:19:37.780
you know,

574
00:19:37.873 --> 00:19:38.061
again,

575
00:19:38.092 --> 00:19:39.123
350 million.

576
00:19:39.639 --> 00:19:39.905
Yes.

577
00:19:40.201 --> 00:19:40.405
Okay.

578
00:19:41.384 --> 00:19:41.905
And it's part of,

579
00:19:41.906 --> 00:19:42.425
you know,

580
00:19:42.485 --> 00:19:44.548
it's part of drug development.

581
00:19:45.167 --> 00:19:54.198
The secret sauce is how do you make sure that when you spend so much amount of money,

582
00:19:55.175 --> 00:19:57.042
you work with the experts.

583
00:19:57.879 --> 00:20:00.801
To try to optimize the outcome,

584
00:20:00.942 --> 00:20:09.311
but the differentiation of the drug so that ultimately it is seen as a medical advance and not a me too of other drugs.

585
00:20:09.413 --> 00:20:09.608
Okay.

586
00:20:10.171 --> 00:20:10.850
It's also a bet.

587
00:20:11.491 --> 00:20:12.210
You need also to...

588
00:20:13.835 --> 00:20:15.991
When you have a new mechanism of action like ours,

589
00:20:16.100 --> 00:20:16.413
indeed,

590
00:20:16.475 --> 00:20:17.444
it's a bet for sure.

591
00:20:18.131 --> 00:20:19.319
But you need to bet.

592
00:20:20.303 --> 00:20:20.460
Well,

593
00:20:20.616 --> 00:20:20.881
again,

594
00:20:21.444 --> 00:20:22.803
if you want medical advance,

595
00:20:23.397 --> 00:20:24.366
you need to do some bet.

596
00:20:24.491 --> 00:20:24.960
but part of,

597
00:20:25.006 --> 00:20:25.178
again,

598
00:20:25.647 --> 00:20:26.272
of the art.

599
00:20:26.754 --> 00:20:29.054
is to try to mitigate the risk of that bet.

600
00:20:29.455 --> 00:20:31.814
Because when you go into a new mechanism of action,

601
00:20:31.877 --> 00:20:32.275
for sure,

602
00:20:33.697 --> 00:20:34.134
you don't know,

603
00:20:35.455 --> 00:20:36.455
you can be 100%

604
00:20:36.759 --> 00:20:37.400
sure that,

605
00:20:37.533 --> 00:20:37.994
for example,

606
00:20:38.017 --> 00:20:41.416
your drug is going to be as safe as others,

607
00:20:41.541 --> 00:20:45.541
because this is the first time you try this new pathway.

608
00:20:46.322 --> 00:20:47.884
But part of the art,

609
00:20:48.275 --> 00:20:50.181
and working with the KORs,

610
00:20:51.025 --> 00:20:56.134
is to design a study in such a way that you try to mitigate those risks.

611
00:20:56.863 --> 00:20:57.324
But there is,

612
00:20:57.423 --> 00:20:57.644
again,

613
00:20:57.724 --> 00:20:58.724
no guarantee.

614
00:20:58.744 --> 00:21:02.009
This is part of what is wonderful in this industry,

615
00:21:02.670 --> 00:21:04.130
is you take risks.

616
00:21:04.529 --> 00:21:05.310
Sometimes it works,

617
00:21:05.349 --> 00:21:06.170
sometimes it doesn't.

618
00:21:06.849 --> 00:21:08.271
But when it works,

619
00:21:08.591 --> 00:21:09.154
in general,

620
00:21:09.271 --> 00:21:21.209
it's because you thought through what could go wrong and you try to design the study in such a way that chances of going wrong are less than maybe...

621
00:21:21.740 --> 00:21:23.974
Can you explain a bit how you worked?

622
00:21:24.005 --> 00:21:24.834
I don't know if you can,

623
00:21:24.865 --> 00:21:25.037
but...

624
00:21:25.750 --> 00:21:31.911
How you worked on this to transform the phase two story into a better phase three story then?

625
00:21:32.611 --> 00:21:32.732
No,

626
00:21:32.751 --> 00:21:33.153
I mean,

627
00:21:33.314 --> 00:21:34.130
the part of,

628
00:21:34.575 --> 00:21:37.232
you know,

629
00:21:37.357 --> 00:21:40.177
the recipe is to listen well to the KOLs.

630
00:21:40.178 --> 00:21:41.778
You know,

631
00:21:42.419 --> 00:21:43.091
and for example,

632
00:21:43.341 --> 00:21:43.935
in our case,

633
00:21:43.982 --> 00:21:53.419
I think what was very good in the design of the phase three is the fact that those patients tend to receive.

634
00:21:53.538 --> 00:21:57.202
concomitant corticosteroid treatments.

635
00:21:58.003 --> 00:22:00.206
So what we did is,

636
00:22:01.366 --> 00:22:02.846
from the phase 2 to the phase 3,

637
00:22:03.612 --> 00:22:11.393
we decided to reduce the use of corticosteroids from 20 mg per day to 15.

638
00:22:11.550 --> 00:22:12.471
So that was one.

639
00:22:14.143 --> 00:22:14.284
Well,

640
00:22:14.300 --> 00:22:14.925
to reduce,

641
00:22:16.565 --> 00:22:22.909
to allow the drug efficacy to speak more by itself.

642
00:22:23.747 --> 00:22:28.970
rather than using drugs that are efficacious,

643
00:22:29.474 --> 00:22:32.537
but long-term corticosteroids are not good for you.

644
00:22:32.615 --> 00:22:33.052
So these are,

645
00:22:33.053 --> 00:22:33.615
you know,

646
00:22:33.677 --> 00:22:38.599
the example of how you can,

647
00:22:39.084 --> 00:22:39.365
you know,

648
00:22:39.826 --> 00:22:41.701
you learn from your phase two,

649
00:22:42.419 --> 00:22:45.544
and then you adapt it for your phase three.

650
00:22:45.545 --> 00:22:46.623
So that was an example.

651
00:22:47.076 --> 00:22:47.576
Another one,

652
00:22:47.951 --> 00:22:48.294
there were,

653
00:22:48.295 --> 00:22:48.669
you know,

654
00:22:49.185 --> 00:22:51.294
immunomodulators that were in the phase 2B,

655
00:22:52.138 --> 00:22:52.279
which

656
00:22:52.562 --> 00:22:53.303
could be used,

657
00:22:54.143 --> 00:22:55.265
like the thioperines,

658
00:22:55.745 --> 00:22:59.948
and we removed them in a phase three.

659
00:23:00.311 --> 00:23:01.429
And what we saw in the phase three,

660
00:23:01.991 --> 00:23:10.866
one of the reasons why people were so excited about our phase three is that when the results came out in July,

661
00:23:10.913 --> 00:23:11.444
late July,

662
00:23:12.944 --> 00:23:17.054
our placebo response was the lowest ever in a phase three program.

663
00:23:17.725 --> 00:23:20.522
So a tiny little biotech like Abivax.

664
00:23:21.358 --> 00:23:27.844
was able to execute a study better than anybody in history of ulcerative colitis.

665
00:23:28.446 --> 00:23:28.567
So,

666
00:23:28.844 --> 00:23:31.251
you know,

667
00:23:31.252 --> 00:23:32.227
it's an interesting lesson,

668
00:23:32.930 --> 00:23:36.071
which goes also from the learning of the phase two,

669
00:23:36.493 --> 00:23:37.399
but also the focus.

670
00:23:37.618 --> 00:23:40.883
I think that was one of my bigger mantra,

671
00:23:41.493 --> 00:23:41.758
you know,

672
00:23:42.305 --> 00:23:44.165
what I've learned over the years.

673
00:23:44.618 --> 00:23:45.196
Just like we want.

674
00:23:45.743 --> 00:23:47.258
It is focus,

675
00:23:47.336 --> 00:23:47.680
focus,

676
00:23:47.790 --> 00:23:48.040
focus.

677
00:23:48.086 --> 00:23:49.899
I think you're...

678
00:23:50.466 --> 00:23:53.909
you do a much better job when you spend 100%

679
00:23:53.930 --> 00:23:56.792
of your time on something versus working on

680
00:23:57.635 --> 00:23:58.753
30% on three things.

681
00:23:59.557 --> 00:24:12.690
I think the Abivax example is a fantastic one because it shows that a tiny little biotech that came out of nowhere can actually do better in execution of clinical trials than the giant,

682
00:24:13.846 --> 00:24:14.878
which has demonstrated it.

683
00:24:14.879 --> 00:24:16.690
And that's why all the KOLs,

684
00:24:16.753 --> 00:24:17.799
when they saw this...

685
00:24:18.418 --> 00:24:22.322
This data in July,

686
00:24:22.881 --> 00:24:24.865
we're not only impressed by the drug's,

687
00:24:26.006 --> 00:24:26.248
you know,

688
00:24:27.811 --> 00:24:33.693
ability to function and to do good for patients after eight weeks of treatment,

689
00:24:34.037 --> 00:24:35.881
but also the execution of the trial was,

690
00:24:35.975 --> 00:24:36.975
you know,

691
00:24:36.976 --> 00:24:37.193
again,

692
00:24:38.881 --> 00:24:39.959
36 countries,

693
00:24:39.960 --> 00:24:41.725
1,300 patients.

694
00:24:42.568 --> 00:24:43.803
It was a massive undertaking,

695
00:24:44.709 --> 00:24:45.240
even though,

696
00:24:45.881 --> 00:24:47.553
coming back to one of your remarks before,

697
00:24:48.014 --> 00:24:49.055
It took us more time,

698
00:24:49.116 --> 00:24:52.098
took us six months more than what we thought originally.

699
00:24:52.239 --> 00:24:55.782
So we were late compared to our original

700
00:24:56.203 --> 00:24:56.844
IPO plan.

701
00:24:58.383 --> 00:24:59.469
But at the end of the day,

702
00:24:59.524 --> 00:25:02.391
what counts is ultimately the quality and the results.

703
00:25:04.128 --> 00:25:04.288
Okay,

704
00:25:04.428 --> 00:25:04.608
yes,

705
00:25:04.648 --> 00:25:08.672
you have to leverage also the time and to have a bit of time if you need.

706
00:25:09.532 --> 00:25:09.653
Yeah,

707
00:25:09.715 --> 00:25:12.317
the only thing is the clock was ticking because,

708
00:25:12.575 --> 00:25:12.840
you know,

709
00:25:13.200 --> 00:25:14.700
three months after we read out,

710
00:25:14.762 --> 00:25:17.278
we were going to run out of cash and we would go bankrupt.

711
00:25:17.520 --> 00:25:19.559
So it was a fairly binary,

712
00:25:20.903 --> 00:25:21.137
you know,

713
00:25:21.200 --> 00:25:21.840
event for us.

714
00:25:21.918 --> 00:25:22.090
Yes,

715
00:25:22.262 --> 00:25:23.668
and you knew it was,

716
00:25:23.762 --> 00:25:23.981
yes,

717
00:25:24.122 --> 00:25:24.887
you didn't have choice,

718
00:25:24.888 --> 00:25:29.309
but you knew it was a good decision also to be able to finish this way.

719
00:25:30.590 --> 00:25:30.747
Yes,

720
00:25:31.075 --> 00:25:32.090
that's what we were.

721
00:25:32.416 --> 00:25:32.536
Yeah,

722
00:25:32.576 --> 00:25:33.017
because again...

723
00:25:33.077 --> 00:25:35.078
You knew the result could be interesting?

724
00:25:35.119 --> 00:25:35.259
Ah,

725
00:25:35.359 --> 00:25:35.480
yes.

726
00:25:35.519 --> 00:25:35.718
Yes,

727
00:25:35.900 --> 00:25:36.941
yeah.

728
00:25:36.942 --> 00:25:37.062
Well,

729
00:25:37.101 --> 00:25:37.480
we had...

730
00:25:37.601 --> 00:25:38.363
It was a redoubt,

731
00:25:38.664 --> 00:25:39.121
yeah.

732
00:25:39.144 --> 00:25:39.261
Well,

733
00:25:39.285 --> 00:25:46.152
we had some anecdotal reports,

734
00:25:46.449 --> 00:25:49.316
feedback from the physicians in the various countries.

735
00:25:50.191 --> 00:25:50.738
They told us,

736
00:25:50.847 --> 00:25:51.269
you know,

737
00:25:51.347 --> 00:25:52.456
even though it was blinded,

738
00:25:53.191 --> 00:25:53.691
they said,

739
00:25:54.097 --> 00:25:54.363
you know,

740
00:25:54.800 --> 00:25:58.941
we see some patients who are very severe doing much better,

741
00:25:59.363 --> 00:25:59.628
you know,

742
00:26:00.269 --> 00:26:01.847
and that couldn't be on placebo for sure.

743
00:26:02.653 --> 00:26:02.773
So

744
00:26:03.374 --> 00:26:11.661
I think we had some confidence as to that something was going on.

745
00:26:11.966 --> 00:26:13.481
Now what you don't know is how good.

746
00:26:13.723 --> 00:26:13.903
Yes,

747
00:26:13.942 --> 00:26:14.106
yes.

748
00:26:14.145 --> 00:26:15.684
And you cannot change the plan in the middle.

749
00:26:16.184 --> 00:26:17.934
Right,

750
00:26:18.091 --> 00:26:18.450
exactly.

751
00:26:19.747 --> 00:26:21.575
And if the results had not been good,

752
00:26:21.653 --> 00:26:22.669
we would have been bankrupt.

753
00:26:24.778 --> 00:26:25.387
Three months you said.

754
00:26:25.637 --> 00:26:25.856
Yes.

755
00:26:26.762 --> 00:26:30.794
So it shows that what we do is meaningful.

756
00:26:31.325 --> 00:26:31.466
But...

757
00:26:32.132 --> 00:26:34.155
Sometimes it doesn't end too well,

758
00:26:34.795 --> 00:26:36.358
but we are lucky to be on the good side.

759
00:26:36.815 --> 00:26:36.979
Yes,

760
00:26:37.037 --> 00:26:37.197
yes,

761
00:26:37.237 --> 00:26:37.397
yes.

762
00:26:38.018 --> 00:26:39.100
And yes,

763
00:26:39.358 --> 00:26:44.807
one thing I would like to understand also is why you decided to be such ambitious for the phase three.

764
00:26:44.987 --> 00:26:45.182
Well,

765
00:26:45.744 --> 00:26:49.416
I think it goes back again to differentiation,

766
00:26:49.432 --> 00:26:50.088
to competition.

767
00:26:50.666 --> 00:26:55.760
If you develop a drug that doesn't have much value,

768
00:26:55.963 --> 00:26:59.182
why do you spend 300 million to develop a me too?

769
00:26:59.244 --> 00:26:59.494
I mean,

770
00:26:59.526 --> 00:27:00.057
in my view,

771
00:27:00.494 --> 00:27:00.838
it's not.

772
00:27:01.448 --> 00:27:03.448
It's not very attractive.

773
00:27:03.468 --> 00:27:03.868
And I think,

774
00:27:04.189 --> 00:27:04.448
you know,

775
00:27:04.529 --> 00:27:09.488
that is one of the reasons I was attracted to Abilax is I felt,

776
00:27:10.472 --> 00:27:11.831
also speaking with the carers,

777
00:27:12.448 --> 00:27:14.847
this was a very different mechanism of action.

778
00:27:14.894 --> 00:27:16.331
This was a very different approach.

779
00:27:16.355 --> 00:27:17.589
It was not an immunoblocker.

780
00:27:18.136 --> 00:27:18.605
This could make,

781
00:27:18.886 --> 00:27:19.152
you know,

782
00:27:19.777 --> 00:27:24.573
sort of a leap for treatment.

783
00:27:24.574 --> 00:27:26.761
So the excitement of,

784
00:27:27.433 --> 00:27:27.667
you know,

785
00:27:27.730 --> 00:27:28.714
every day's life,

786
00:27:29.339 --> 00:27:30.417
also for our employees.

787
00:27:31.048 --> 00:27:33.330
It's when you know you work for something which is meaningful,

788
00:27:34.031 --> 00:27:34.150
yeah,

789
00:27:34.252 --> 00:27:35.533
that can obviously fail.

790
00:27:36.072 --> 00:27:37.154
But if it's successful,

791
00:27:37.494 --> 00:27:38.314
it can be wonderful.

792
00:27:38.416 --> 00:27:40.236
And this is where at least we are now.

793
00:27:41.236 --> 00:27:41.861
In the middle,

794
00:27:41.877 --> 00:27:42.017
yeah.

795
00:27:42.158 --> 00:27:43.861
We have only eight weeks of treatment.

796
00:27:43.978 --> 00:27:47.111
Our study needs to continue to essentially a year.

797
00:27:47.658 --> 00:27:48.627
So we cannot say,

798
00:27:48.798 --> 00:27:49.080
you know,

799
00:27:49.252 --> 00:27:50.486
we cannot claim victory yet.

800
00:27:51.205 --> 00:27:52.814
But the odds that,

801
00:27:53.892 --> 00:27:54.127
you know,

802
00:27:55.564 --> 00:27:57.111
existed before,

803
00:27:57.189 --> 00:27:57.439
you know,

804
00:27:57.517 --> 00:27:58.095
six months ago,

805
00:27:58.252 --> 00:27:58.408
where,

806
00:27:58.877 --> 00:27:59.658
you know...

807
00:28:00.744 --> 00:28:03.608
skeptical as to whether this drug would work this way.

808
00:28:04.188 --> 00:28:04.528
Obviously,

809
00:28:04.709 --> 00:28:05.268
we've passed,

810
00:28:05.307 --> 00:28:05.651
obviously,

811
00:28:05.909 --> 00:28:06.670
a big hurdle.

812
00:28:07.252 --> 00:28:07.729
And it's,

813
00:28:07.850 --> 00:28:08.131
you know,

814
00:28:09.955 --> 00:28:14.518
we were in Berlin at the big congress called UEG.

815
00:28:14.877 --> 00:28:18.494
So we had two late breakers for us,

816
00:28:18.588 --> 00:28:19.557
two independent sessions.

817
00:28:19.619 --> 00:28:20.948
The first presentations,

818
00:28:21.651 --> 00:28:22.463
700 people,

819
00:28:22.526 --> 00:28:23.791
so the room was full.

820
00:28:23.948 --> 00:28:24.744
It couldn't be,

821
00:28:24.807 --> 00:28:26.354
you know,

822
00:28:26.776 --> 00:28:27.526
when you saw the...

823
00:28:27.527 --> 00:28:27.651
Yes,

824
00:28:27.652 --> 00:28:29.354
the presentations.

825
00:28:29.355 --> 00:28:29.932
We presented.

826
00:28:30.240 --> 00:28:35.007
especially the detail on how drug does on various type of patients.

827
00:28:35.870 --> 00:28:36.109
You know,

828
00:28:36.230 --> 00:28:38.073
everyone has been really impressed.

829
00:28:38.074 --> 00:28:39.960
And this is only after eight weeks of treatment.

830
00:28:39.999 --> 00:28:40.116
So,

831
00:28:41.757 --> 00:28:41.999
you know,

832
00:28:42.000 --> 00:28:45.570
the feeling of accomplishing something a bit special.

833
00:28:46.818 --> 00:29:03.190
was there so ambition goes you know you need you need i think you know you need ambition in in life if you yeah you know it's more exciting so but it's part of also the character you need to have you need to accept that also the wish level is

834
00:29:03.253 --> 00:29:15.847
high and that you can fail that's that's part of the adventure yes but um and yes you were the good person to be able to also get this uh confidence to be able to execute this.

835
00:29:16.886 --> 00:29:17.026
Well,

836
00:29:17.066 --> 00:29:19.109
I think the advantage I have had is that,

837
00:29:19.269 --> 00:29:19.508
you know,

838
00:29:19.549 --> 00:29:21.750
since I've been CEO for a number of years,

839
00:29:21.769 --> 00:29:21.973
you know,

840
00:29:21.974 --> 00:29:23.211
I've developed drugs before,

841
00:29:23.332 --> 00:29:23.754
phase three,

842
00:29:23.755 --> 00:29:24.453
I've done phase two.

843
00:29:24.473 --> 00:29:24.871
So I've seen,

844
00:29:24.973 --> 00:29:25.191
you know,

845
00:29:25.192 --> 00:29:25.512
success,

846
00:29:25.535 --> 00:29:26.293
I've seen failures.

847
00:29:27.676 --> 00:29:27.934
You know,

848
00:29:28.355 --> 00:29:30.519
you learn also a lot through your failures.

849
00:29:30.543 --> 00:29:31.059
So I think,

850
00:29:31.402 --> 00:29:31.543
yeah,

851
00:29:31.621 --> 00:29:40.043
I was probably more attentive to certain things that some other people may not look at and that contributed to this.

852
00:29:40.121 --> 00:29:40.262
But,

853
00:29:40.324 --> 00:29:40.574
you know,

854
00:29:40.590 --> 00:29:41.230
it's not that easy.

855
00:29:41.950 --> 00:29:44.151
It's not an easy adventure.

856
00:29:44.250 --> 00:29:44.430
And,

857
00:29:44.651 --> 00:29:44.872
you know,

858
00:29:44.891 --> 00:29:46.290
there are times where you are,

859
00:29:46.512 --> 00:29:46.770
you know,

860
00:29:46.833 --> 00:29:48.633
you wonder whether you're going to make it or not.

861
00:29:49.352 --> 00:29:49.895
But at the end,

862
00:29:49.896 --> 00:29:51.012
you need to be persistent.

863
00:29:51.793 --> 00:29:52.012
And,

864
00:29:52.575 --> 00:29:52.692
yeah,

865
00:29:52.693 --> 00:29:53.856
I have a meaningful mission,

866
00:29:53.895 --> 00:29:54.129
I think,

867
00:29:54.395 --> 00:29:54.809
fundamentally.

868
00:29:55.590 --> 00:29:55.715
Yes,

869
00:29:55.731 --> 00:29:59.708
but here it was making this with a really small biotech,

870
00:29:59.879 --> 00:30:02.551
like just starting to,

871
00:30:04.583 --> 00:30:04.692
yeah,

872
00:30:04.708 --> 00:30:05.020
starting.

873
00:30:05.738 --> 00:30:06.459
And it's also,

874
00:30:07.579 --> 00:30:07.739
yes,

875
00:30:07.740 --> 00:30:08.118
a risk.

876
00:30:08.178 --> 00:30:13.278
And you were able to make this because you add also the confidence,

877
00:30:13.279 --> 00:30:13.719
the skills,

878
00:30:14.758 --> 00:30:15.321
the experience.

879
00:30:15.524 --> 00:30:15.704
Yeah,

880
00:30:15.705 --> 00:30:17.102
and you get good people around you.

881
00:30:17.922 --> 00:30:18.040
Yes,

882
00:30:18.079 --> 00:30:18.219
yes,

883
00:30:18.243 --> 00:30:19.719
you knew how to execute this.

884
00:30:20.922 --> 00:30:21.102
Yes,

885
00:30:21.180 --> 00:30:22.282
large kind of thing.

886
00:30:22.719 --> 00:30:22.844
Yeah,

887
00:30:22.845 --> 00:30:25.985
and to find the people who are able to execute.

888
00:30:26.188 --> 00:30:27.141
And some of the people,

889
00:30:27.360 --> 00:30:27.610
you know,

890
00:30:27.625 --> 00:30:31.766
also I brought from Syncore were absolutely key to the success because,

891
00:30:31.782 --> 00:30:32.000
you know,

892
00:30:32.016 --> 00:30:32.485
I knew them.

893
00:30:32.516 --> 00:30:33.219
They trusted me.

894
00:30:33.391 --> 00:30:34.047
I trusted them.

895
00:30:35.431 --> 00:30:35.730
You know,

896
00:30:36.551 --> 00:30:40.293
because in all this execution mode,

897
00:30:41.070 --> 00:30:43.453
what you want is to resolve the issues,

898
00:30:43.711 --> 00:30:43.930
you know,

899
00:30:44.016 --> 00:30:44.992
as fast as they come.

900
00:30:45.633 --> 00:30:52.438
What you don't want is to have a culture of company where people hide things because they are worried that if they do mistakes.

901
00:30:53.219 --> 00:30:53.328
So,

902
00:30:54.016 --> 00:30:54.469
and I think...

903
00:30:54.470 --> 00:30:55.000
Every day counts,

904
00:30:55.001 --> 00:30:55.141
yeah.

905
00:30:55.516 --> 00:30:55.656
Yeah,

906
00:30:55.781 --> 00:30:56.516
so every day counts.

907
00:30:56.688 --> 00:31:00.234
And then you can correct because you're getting these large clinical trials,

908
00:31:00.250 --> 00:31:00.391
again,

909
00:31:00.422 --> 00:31:00.828
I'll show you.

910
00:31:02.515 --> 00:31:03.456
In our clinical trial,

911
00:31:04.317 --> 00:31:08.362
we face some issues on a daily basis.

912
00:31:08.522 --> 00:31:10.647
And how you resolve them,

913
00:31:11.225 --> 00:31:12.366
how you characterize them,

914
00:31:12.483 --> 00:31:20.116
also you have to differentiate what you think is sort of a systemic problem versus a very punctual problem.

915
00:31:20.366 --> 00:31:21.882
But if it's a systemic problem,

916
00:31:22.319 --> 00:31:28.600
you've got to address it very seriously and take the time for it because otherwise this can contribute to...

917
00:31:29.257 --> 00:31:30.538
Do you have an example like this?

918
00:31:31.458 --> 00:31:32.280
For example,

919
00:31:32.419 --> 00:31:34.942
we had an issue with our IRT system,

920
00:31:34.961 --> 00:31:35.420
so basically,

921
00:31:35.421 --> 00:31:35.604
you know,

922
00:31:35.605 --> 00:31:40.303
the system that basically delivers the investigator,

923
00:31:41.545 --> 00:31:43.608
the drug to patients.

924
00:31:44.170 --> 00:31:44.451
And,

925
00:31:45.412 --> 00:31:45.709
you know,

926
00:31:45.834 --> 00:31:46.256
we had,

927
00:31:46.576 --> 00:31:47.350
you know,

928
00:31:47.397 --> 00:31:48.069
for a little while,

929
00:31:48.070 --> 00:31:54.819
we started to discover that some of the drug were not going to the right patients.

930
00:31:54.928 --> 00:31:55.787
And we,

931
00:31:55.819 --> 00:31:56.225
thanks God,

932
00:31:56.240 --> 00:31:58.084
we picked it up very quickly after one day.

933
00:31:59.955 --> 00:32:00.095
But,

934
00:32:00.136 --> 00:32:00.376
you know,

935
00:32:00.396 --> 00:32:02.017
we had to retrieve some of the...

936
00:32:02.058 --> 00:32:02.257
Yes,

937
00:32:02.337 --> 00:32:03.818
some of the logistic.

938
00:32:03.837 --> 00:32:03.978
Yeah,

939
00:32:04.001 --> 00:32:06.161
and do some logistic correction.

940
00:32:07.025 --> 00:32:09.962
If we had not picked up that very fast...

941
00:32:10.626 --> 00:32:11.189
You can lose,

942
00:32:11.267 --> 00:32:11.407
yeah.

943
00:32:11.845 --> 00:32:12.407
This would have been,

944
00:32:12.509 --> 00:32:12.728
you know,

945
00:32:12.751 --> 00:32:14.447
potentially you could lose the patience to,

946
00:32:14.853 --> 00:32:15.134
you know,

947
00:32:15.290 --> 00:32:17.775
and the authorities would have said this is not acceptable.

948
00:32:17.776 --> 00:32:17.900
So,

949
00:32:18.353 --> 00:32:18.587
you know,

950
00:32:18.588 --> 00:32:19.681
there are examples of,

951
00:32:20.962 --> 00:32:21.197
you know,

952
00:32:23.290 --> 00:32:26.978
of things that happen in these large studies that you want to...

953
00:32:27.654 --> 00:32:29.656
And that's why you need a culture of transparency,

954
00:32:30.057 --> 00:32:30.778
a culture of,

955
00:32:30.836 --> 00:32:31.198
you know.

956
00:32:31.199 --> 00:32:32.340
Responsibility.

957
00:32:32.899 --> 00:32:33.020
Yeah,

958
00:32:33.039 --> 00:32:33.680
responsibility.

959
00:32:34.121 --> 00:32:34.481
You know,

960
00:32:34.563 --> 00:32:35.242
as I say often,

961
00:32:35.301 --> 00:32:35.961
we win together,

962
00:32:36.000 --> 00:32:36.641
we lose together.

963
00:32:36.664 --> 00:32:37.344
You know,

964
00:32:37.360 --> 00:32:37.727
it's not,

965
00:32:37.766 --> 00:32:38.524
you know,

966
00:32:38.547 --> 00:32:38.688
it's,

967
00:32:38.922 --> 00:32:39.164
you know,

968
00:32:39.367 --> 00:32:39.547
it's,

969
00:32:40.024 --> 00:32:40.227
you know,

970
00:32:40.228 --> 00:32:44.703
this feeling we're in a special adventure together.

971
00:32:45.672 --> 00:32:45.906
And,

972
00:32:46.500 --> 00:32:47.453
you know,

973
00:32:48.235 --> 00:32:49.813
we're going to do a few things wrong,

974
00:32:50.422 --> 00:32:52.844
but let's correct them quickly and let's move on.

975
00:32:52.938 --> 00:32:53.766
And that's not,

976
00:32:53.985 --> 00:32:54.516
you know.

977
00:32:54.982 --> 00:32:58.246
be aggravated at all time about the mistakes we've done.

978
00:32:59.348 --> 00:32:59.484
Yes,

979
00:32:59.508 --> 00:33:00.309
that's part of your,

980
00:33:00.469 --> 00:33:00.688
yes,

981
00:33:00.828 --> 00:33:02.731
that's definitely part of the success.

982
00:33:03.188 --> 00:33:03.406
Yeah,

983
00:33:03.547 --> 00:33:04.469
sure.

984
00:33:04.508 --> 00:33:04.649
Yes,

985
00:33:05.149 --> 00:33:06.750
and maybe the differentiation also.

986
00:33:09.274 --> 00:33:10.758
I think that's one of the difficulties,

987
00:33:10.781 --> 00:33:11.016
I think,

988
00:33:11.063 --> 00:33:11.484
for example,

989
00:33:11.516 --> 00:33:12.406
in large companies.

990
00:33:12.719 --> 00:33:12.844
Yes.

991
00:33:13.094 --> 00:33:14.281
They become so political.

992
00:33:15.266 --> 00:33:17.844
People don't want to take risks because they think that,

993
00:33:17.906 --> 00:33:18.391
you know,

994
00:33:18.406 --> 00:33:20.313
their career is going to be affected.

995
00:33:20.828 --> 00:33:21.703
So there is much less,

996
00:33:21.875 --> 00:33:22.172
I think,

997
00:33:22.203 --> 00:33:22.766
agility.

998
00:33:24.039 --> 00:33:25.199
And also,

999
00:33:25.400 --> 00:33:25.939
to some extent,

1000
00:33:25.980 --> 00:33:26.441
modesty.

1001
00:33:28.482 --> 00:33:29.002
So you need to be,

1002
00:33:29.084 --> 00:33:30.424
I think when you develop drugs,

1003
00:33:30.425 --> 00:33:34.271
you need to be very modest because this is a very difficult undertaking.

1004
00:33:34.951 --> 00:33:35.186
And,

1005
00:33:36.053 --> 00:33:36.287
you know,

1006
00:33:36.311 --> 00:33:39.561
the egos need to be lowered.

1007
00:33:41.217 --> 00:33:42.436
And I think it works much better.

1008
00:33:43.033 --> 00:33:43.633
But yes,

1009
00:33:44.834 --> 00:33:46.674
we talk about a bit of leadership,

1010
00:33:46.715 --> 00:33:47.552
but when you arrived,

1011
00:33:49.756 --> 00:33:50.595
you created this,

1012
00:33:52.537 --> 00:33:57.498
you took the person like this and you wanted to have this mood.

1013
00:33:58.295 --> 00:33:58.420
Yeah,

1014
00:33:58.498 --> 00:33:59.435
because

1015
00:33:59.920 --> 00:34:04.091
I was fundamentally convinced that this drug could be a really good drug.

1016
00:34:04.920 --> 00:34:11.920
But what was evident from the past is this company was run on a very short term.

1017
00:34:13.227 --> 00:34:14.749
on a very short-term basis.

1018
00:34:15.509 --> 00:34:15.688
And,

1019
00:34:18.292 --> 00:34:19.675
you know,

1020
00:34:20.054 --> 00:34:23.518
when you have too much of short-term horizon,

1021
00:34:23.620 --> 00:34:25.362
you're not going to make the best decisions.

1022
00:34:26.300 --> 00:34:26.683
Because again,

1023
00:34:26.979 --> 00:34:27.464
ultimately,

1024
00:34:27.542 --> 00:34:31.300
what you want to do is to develop a good drug for patients in the long term.

1025
00:34:31.831 --> 00:34:31.940
So,

1026
00:34:33.628 --> 00:34:34.972
but this is the fruit of experience,

1027
00:34:34.973 --> 00:34:35.253
you know.

1028
00:34:35.254 --> 00:34:35.315
Yes,

1029
00:34:35.316 --> 00:34:35.425
yes.

1030
00:34:36.315 --> 00:34:38.050
But what I'm seeking is,

1031
00:34:39.893 --> 00:34:41.128
you need also a good leverage.

1032
00:34:41.634 --> 00:34:44.196
Good balance between long term and short term,

1033
00:34:44.216 --> 00:34:46.176
because if you just have this choice,

1034
00:34:46.298 --> 00:34:52.341
you need also to focus on this choice and you don't have the possibility to work on another project.

1035
00:34:52.747 --> 00:34:52.864
No,

1036
00:34:53.106 --> 00:34:53.684
of course.

1037
00:34:54.583 --> 00:34:55.591
And I had the credibility,

1038
00:34:55.630 --> 00:34:56.005
for example,

1039
00:34:56.028 --> 00:34:58.317
for raising money because I had been successful before.

1040
00:34:58.692 --> 00:35:00.036
So it is clear that...

1041
00:35:00.037 --> 00:35:00.145
Yes,

1042
00:35:00.146 --> 00:35:01.005
to explain the story,

1043
00:35:01.036 --> 00:35:02.051
to explain the story.

1044
00:35:02.817 --> 00:35:04.911
To get the trust also of investors that,

1045
00:35:04.942 --> 00:35:05.317
you know,

1046
00:35:07.536 --> 00:35:08.239
I do what I say,

1047
00:35:08.240 --> 00:35:08.833
I say what I do.

1048
00:35:10.486 --> 00:35:12.248
So that contributed to it.

1049
00:35:12.369 --> 00:35:13.189
But again,

1050
00:35:13.190 --> 00:35:15.412
the role of a leader is to,

1051
00:35:15.970 --> 00:35:16.771
you know,

1052
00:35:16.772 --> 00:35:19.955
is to lift up the ambition.

1053
00:35:20.619 --> 00:35:21.134
But again,

1054
00:35:21.838 --> 00:35:23.119
and to have the ability to work,

1055
00:35:23.120 --> 00:35:23.400
you know,

1056
00:35:23.463 --> 00:35:24.439
to think about the long term,

1057
00:35:24.463 --> 00:35:29.752
but for sure also on a daily basis to address all the issues that are coming.

1058
00:35:29.753 --> 00:35:31.002
And it's sort of constant,

1059
00:35:31.252 --> 00:35:36.017
sort of going up and down from long term to short term.

1060
00:35:36.033 --> 00:35:37.939
But I think if you are too short term oriented,

1061
00:35:39.018 --> 00:35:39.859
What is long term for you?

1062
00:35:39.999 --> 00:35:43.122
Like having the drug on the market or a few years after?

1063
00:35:43.380 --> 00:35:43.521
Yeah,

1064
00:35:43.622 --> 00:35:44.185
sure.

1065
00:35:44.865 --> 00:35:46.865
Or the life of the drug?

1066
00:35:47.669 --> 00:35:48.786
Well,

1067
00:35:48.810 --> 00:35:49.146
for us,

1068
00:35:49.208 --> 00:35:50.825
it's then the life cycle.

1069
00:35:51.107 --> 00:35:52.310
Life of a product,

1070
00:35:52.333 --> 00:35:52.450
yeah.

1071
00:35:52.669 --> 00:35:52.849
Yeah.

1072
00:35:53.052 --> 00:35:53.794
You know,

1073
00:35:53.896 --> 00:35:55.060
beyond the ulcerative colitis,

1074
00:35:55.341 --> 00:35:56.779
developing the Crohn's indication,

1075
00:35:56.982 --> 00:35:58.622
looking at the combination therapy.

1076
00:35:58.732 --> 00:35:58.857
So,

1077
00:35:59.044 --> 00:35:59.200
yeah,

1078
00:35:59.654 --> 00:36:01.700
it's part of a journey.

1079
00:36:01.904 --> 00:36:02.044
Okay.

1080
00:36:02.357 --> 00:36:04.982
Can we go back to this day when you,

1081
00:36:05.700 --> 00:36:05.857
yes,

1082
00:36:05.858 --> 00:36:06.544
you had the readout.

1083
00:36:06.763 --> 00:36:06.950
Yes.

1084
00:36:06.982 --> 00:36:07.107
you

1085
00:36:07.601 --> 00:36:10.764
You discovered what it makes on the patients?

1086
00:36:10.904 --> 00:36:11.144
Yes.

1087
00:36:12.428 --> 00:36:12.568
Yeah,

1088
00:36:12.588 --> 00:36:12.826
well,

1089
00:36:12.827 --> 00:36:14.029
it was really a special day.

1090
00:36:14.068 --> 00:36:15.310
So I was in the US.

1091
00:36:15.349 --> 00:36:16.490
You know,

1092
00:36:16.491 --> 00:36:17.131
obviously I was,

1093
00:36:17.412 --> 00:36:17.709
you know,

1094
00:36:18.295 --> 00:36:22.873
my statistical team had essentially,

1095
00:36:22.896 --> 00:36:23.740
you know,

1096
00:36:25.396 --> 00:36:26.881
blinded the data the day before.

1097
00:36:27.834 --> 00:36:36.709
And I had told my head of statistics to send me a message when I could come into the office to know the result.

1098
00:36:37.381 --> 00:36:37.562
But,

1099
00:36:37.682 --> 00:36:38.002
you know,

1100
00:36:39.904 --> 00:36:41.746
it was actually a Saturday morning,

1101
00:36:42.567 --> 00:36:42.867
and

1102
00:36:43.367 --> 00:36:43.649
I said,

1103
00:36:43.650 --> 00:36:43.887
you know,

1104
00:36:44.086 --> 00:36:47.031
please text me when I need to come in.

1105
00:36:47.750 --> 00:36:49.211
And so he texted me,

1106
00:36:50.016 --> 00:36:51.672
and on the text,

1107
00:36:51.695 --> 00:36:53.344
there was actually nothing except,

1108
00:36:53.422 --> 00:36:53.656
you know,

1109
00:36:53.703 --> 00:36:54.219
sunshine.

1110
00:36:54.766 --> 00:36:54.875
So

1111
00:36:56.234 --> 00:36:58.688
I thought that's probably a good sign.

1112
00:36:58.719 --> 00:37:02.984
That means at least we made a statistical significant,

1113
00:37:03.500 --> 00:37:03.781
you know,

1114
00:37:03.875 --> 00:37:04.266
outcome.

1115
00:37:04.641 --> 00:37:05.594
But what I didn't know...

1116
00:37:06.486 --> 00:37:09.068
is how shiny would be the sun.

1117
00:37:09.689 --> 00:37:10.650
And so when I came in,

1118
00:37:10.849 --> 00:37:11.111
you know,

1119
00:37:11.528 --> 00:37:12.911
he showed me with the team,

1120
00:37:13.794 --> 00:37:14.052
you know,

1121
00:37:14.114 --> 00:37:14.935
these results.

1122
00:37:15.474 --> 00:37:15.794
And what,

1123
00:37:16.013 --> 00:37:16.333
again,

1124
00:37:16.458 --> 00:37:22.997
was amazing is our placebo-corrected effect was 16%

1125
00:37:23.185 --> 00:37:25.528
in those two studies compared to 12%

1126
00:37:26.591 --> 00:37:27.185
in the phase 2b.

1127
00:37:27.622 --> 00:37:28.388
So in other words,

1128
00:37:28.466 --> 00:37:30.044
we had a more efficacious drug,

1129
00:37:31.091 --> 00:37:31.372
you know,

1130
00:37:31.528 --> 00:37:32.794
in phase 3 than in phase 2.

1131
00:37:33.028 --> 00:37:35.497
And in the history of drug development,

1132
00:37:35.961 --> 00:37:36.863
That happens very,

1133
00:37:36.962 --> 00:37:37.723
very rarely.

1134
00:37:37.943 --> 00:37:38.064
So,

1135
00:37:38.304 --> 00:37:38.544
you know,

1136
00:37:39.125 --> 00:37:40.166
I don't have the statistics,

1137
00:37:40.224 --> 00:37:41.209
but it's extremely rare.

1138
00:37:41.627 --> 00:37:44.466
So the level of surprise was,

1139
00:37:44.490 --> 00:37:44.732
you know,

1140
00:37:44.771 --> 00:37:46.935
beyond expectation because I thought,

1141
00:37:46.974 --> 00:37:47.216
you know,

1142
00:37:47.217 --> 00:37:48.130
the best case was 12%

1143
00:37:48.373 --> 00:37:52.310
to be pretty much at the same level of the phase it has to be because that was part of,

1144
00:37:52.404 --> 00:37:52.638
you know,

1145
00:37:52.654 --> 00:37:55.248
the changes we made in the design of the phase three.

1146
00:37:55.888 --> 00:37:56.685
But we had over,

1147
00:37:56.888 --> 00:37:57.123
you know,

1148
00:37:57.498 --> 00:37:59.607
basically overpassed any expectation.

1149
00:37:59.623 --> 00:38:00.388
So it was fantastic.

1150
00:38:00.389 --> 00:38:01.466
And then on the safety side,

1151
00:38:01.826 --> 00:38:02.794
it didn't seem to have,

1152
00:38:02.810 --> 00:38:03.029
you know,

1153
00:38:04.013 --> 00:38:04.732
really material.

1154
00:38:05.430 --> 00:38:07.011
adverse events that would,

1155
00:38:08.593 --> 00:38:08.712
yeah,

1156
00:38:08.872 --> 00:38:10.035
pretty much the same as,

1157
00:38:10.452 --> 00:38:10.874
we saw,

1158
00:38:10.937 --> 00:38:11.175
you know,

1159
00:38:11.515 --> 00:38:13.296
some headaches,

1160
00:38:15.140 --> 00:38:15.398
you know,

1161
00:38:15.523 --> 00:38:16.921
early on the first week,

1162
00:38:17.343 --> 00:38:17.882
but the last,

1163
00:38:17.883 --> 00:38:18.101
you know,

1164
00:38:18.124 --> 00:38:18.820
couple of days,

1165
00:38:19.445 --> 00:38:21.546
you take Tylenol and you're all good.

1166
00:38:21.593 --> 00:38:22.390
And the rest was,

1167
00:38:22.781 --> 00:38:29.656
there was no incidence of really any major manifestation of side effects on anything.

1168
00:38:29.687 --> 00:38:29.812
So,

1169
00:38:29.890 --> 00:38:30.109
I mean,

1170
00:38:30.156 --> 00:38:34.296
there are obviously some one-off patients that develop certain conditions,

1171
00:38:34.437 --> 00:38:34.577
But

1172
00:38:35.002 --> 00:38:36.704
There were no signals of anything.

1173
00:38:36.705 --> 00:38:41.314
So it was just an absolutely incredible time.

1174
00:38:41.634 --> 00:38:42.056
And then,

1175
00:38:42.134 --> 00:38:42.794
as a result...

1176
00:38:43.578 --> 00:38:45.060
So I called my CFO,

1177
00:38:45.300 --> 00:38:46.860
I called my head of IR,

1178
00:38:46.962 --> 00:38:47.261
I said,

1179
00:38:47.720 --> 00:38:51.704
initially we had planned to take a week to review the data,

1180
00:38:52.243 --> 00:38:52.485
you know,

1181
00:38:52.486 --> 00:38:57.173
to prepare another thing and do basically the financial communication the following weekend.

1182
00:38:57.915 --> 00:38:59.915
And what we did is we accelerated everything.

1183
00:39:00.368 --> 00:39:01.790
I said we need to have a board meeting,

1184
00:39:02.118 --> 00:39:02.384
you know,

1185
00:39:03.118 --> 00:39:03.837
on Sunday night.

1186
00:39:04.181 --> 00:39:04.540
So we,

1187
00:39:04.603 --> 00:39:04.853
you know,

1188
00:39:05.071 --> 00:39:07.165
so within a day we had to put all the slides together.

1189
00:39:07.665 --> 00:39:10.181
So people were literally day and night.

1190
00:39:11.026 --> 00:39:13.208
And we did the communication on,

1191
00:39:13.448 --> 00:39:13.688
you know,

1192
00:39:13.708 --> 00:39:14.329
essentially on

1193
00:39:15.188 --> 00:39:15.790
Monday night.

1194
00:39:16.212 --> 00:39:17.270
And on Tuesday,

1195
00:39:17.290 --> 00:39:19.852
the stock was traded.

1196
00:39:20.618 --> 00:39:21.837
We actually blocked,

1197
00:39:22.720 --> 00:39:23.337
respectively,

1198
00:39:23.618 --> 00:39:23.798
for

1199
00:39:24.298 --> 00:39:25.181
45 minutes,

1200
00:39:25.321 --> 00:39:25.438
the

1201
00:39:26.181 --> 00:39:28.665
Euronext, our quotation on Euronext,

1202
00:39:28.681 --> 00:39:29.868
because it was too much demand.

1203
00:39:30.540 --> 00:39:31.806
And then when the NASDAQ opened,

1204
00:39:31.807 --> 00:39:33.212
the same thing happened for nearly,

1205
00:39:33.493 --> 00:39:34.446
I think it was a bit less,

1206
00:39:34.493 --> 00:39:34.993
30 minutes.

1207
00:39:35.696 --> 00:39:35.931
You know,

1208
00:39:35.932 --> 00:39:37.837
there was too much demand on the stock,

1209
00:39:37.838 --> 00:39:39.009
and the stock went out that day.

1210
00:39:39.594 --> 00:39:57.398
by 600 percent and 600 percent you know no stock on the nasdaq has ever done that so it was a i mean for us it was like uh you know you it's like a hollywood movie you know is it true is it you know what happens is just beyond the beyond expectation so within i would say you

1211
00:39:57.399 --> 00:40:07.382
know three days we went from maybe we'll go bankrupt if the study doesn't work to you know one of the one of the star of the nasdaq list for 24 for the year

1212
00:40:08.214 --> 00:40:10.136
So that was the situation.

1213
00:40:10.655 --> 00:40:12.417
And then on Tuesday night,

1214
00:40:13.237 --> 00:40:15.640
because since we were listed on the French market,

1215
00:40:15.659 --> 00:40:16.440
we could not raise,

1216
00:40:17.323 --> 00:40:17.605
you know,

1217
00:40:17.862 --> 00:40:21.089
what we wanted to do our follow on the same day,

1218
00:40:21.628 --> 00:40:24.362
the first day of quotation.

1219
00:40:24.815 --> 00:40:29.534
So we had to wait basically 24 hours per year regulation in the Euronext.

1220
00:40:30.440 --> 00:40:31.097
But that night,

1221
00:40:32.784 --> 00:40:33.440
so we had,

1222
00:40:33.456 --> 00:40:33.722
you know,

1223
00:40:34.003 --> 00:40:35.175
with our syndicate of banks.

1224
00:40:35.710 --> 00:40:37.791
We started a process to raise money.

1225
00:40:37.792 --> 00:40:38.213
So we said,

1226
00:40:38.252 --> 00:40:39.494
we want to raise,

1227
00:40:39.756 --> 00:40:40.814
initially we thought 200,

1228
00:40:40.834 --> 00:40:41.295
then we said,

1229
00:40:41.334 --> 00:40:41.474
well,

1230
00:40:41.537 --> 00:40:42.197
probably 400,

1231
00:40:42.216 --> 00:40:43.435
given the stock price reaction.

1232
00:40:44.201 --> 00:40:44.420
And then,

1233
00:40:44.459 --> 00:40:47.263
which was another sort of extraordinary set of events,

1234
00:40:47.920 --> 00:40:48.826
within three hours,

1235
00:40:49.701 --> 00:40:51.873
we raised 750 million,

1236
00:40:52.841 --> 00:40:56.263
and we had essentially more than 3 billion in demand.

1237
00:40:56.716 --> 00:40:57.388
So we had to,

1238
00:40:58.013 --> 00:41:02.310
my team actually spent more time that night to allocate.

1239
00:41:03.258 --> 00:41:06.441
The amount of money that the funds wanted to see,

1240
00:41:06.460 --> 00:41:07.744
we were not able to meet.

1241
00:41:08.302 --> 00:41:08.423
Well,

1242
00:41:08.443 --> 00:41:08.744
you know,

1243
00:41:08.845 --> 00:41:09.806
we had basically,

1244
00:41:09.845 --> 00:41:10.126
you know,

1245
00:41:10.185 --> 00:41:11.587
from 3.5,

1246
00:41:11.588 --> 00:41:13.165
I think it was actually 3.5,

1247
00:41:13.166 --> 00:41:14.548
ultimately to 750.

1248
00:41:15.072 --> 00:41:19.361
So we had to divide pretty much everything by four or by five,

1249
00:41:19.362 --> 00:41:19.798
you know,

1250
00:41:19.876 --> 00:41:20.501
to allocate.

1251
00:41:21.658 --> 00:41:22.189
So they spend,

1252
00:41:22.190 --> 00:41:23.017
you know,

1253
00:41:23.142 --> 00:41:23.658
my CFO,

1254
00:41:24.033 --> 00:41:25.861
my head of AR with the banks,

1255
00:41:26.533 --> 00:41:28.564
worked probably until two o'clock in the morning to...

1256
00:41:29.606 --> 00:41:36.432
allocate what could be given out of the $750 million to all these big funds.

1257
00:41:36.772 --> 00:41:37.194
Some funds,

1258
00:41:37.233 --> 00:41:37.912
just to give you an idea,

1259
00:41:37.936 --> 00:41:40.295
wanted to invest $300 million.

1260
00:41:40.296 --> 00:41:40.373
So,

1261
00:41:40.374 --> 00:41:40.600
I mean,

1262
00:41:40.639 --> 00:41:47.006
this was just a massive event for us and like a kind of a dream.

1263
00:41:47.147 --> 00:41:54.256
But the good thing is we got the money and now we can carry on and execute again the maintenance,

1264
00:41:54.334 --> 00:41:56.272
finish this essentially one-year study.

1265
00:41:58.406 --> 00:42:01.087
I would say restart the Crohn's program because Crohn's,

1266
00:42:01.148 --> 00:42:03.572
we put it a bit on the side because,

1267
00:42:03.591 --> 00:42:03.732
again,

1268
00:42:03.751 --> 00:42:05.173
we put all our money on Aptek.

1269
00:42:05.333 --> 00:42:08.232
We're focused on Aptek because we knew if Aptek doesn't,

1270
00:42:08.255 --> 00:42:08.638
doesn't,

1271
00:42:08.716 --> 00:42:08.857
the

1272
00:42:09.638 --> 00:42:10.458
3C didn't work,

1273
00:42:10.615 --> 00:42:10.982
you know,

1274
00:42:11.576 --> 00:42:12.076
we'd be dead,

1275
00:42:12.263 --> 00:42:12.443
right?

1276
00:42:13.802 --> 00:42:14.763
So now Crohn's,

1277
00:42:14.997 --> 00:42:19.763
now we are doing also preclinical experiments with combination therapy with other drugs.

1278
00:42:20.232 --> 00:42:22.654
So we'll report them early next year.

1279
00:42:23.685 --> 00:42:25.497
And also we're trying to figure out,

1280
00:42:25.513 --> 00:42:25.732
you know,

1281
00:42:25.794 --> 00:42:27.935
how to develop a next generation compound.

1282
00:42:30.020 --> 00:42:30.139
So,

1283
00:42:31.080 --> 00:42:31.901
yeah.

1284
00:42:32.041 --> 00:42:32.282
Yes,

1285
00:42:33.082 --> 00:42:33.684
crazy week.

1286
00:42:34.223 --> 00:42:35.145
It was a crazy week,

1287
00:42:35.305 --> 00:42:35.563
yes,

1288
00:42:35.704 --> 00:42:35.946
yes.

1289
00:42:36.664 --> 00:42:37.063
No sleep?

1290
00:42:37.664 --> 00:42:39.391
No sleep for a while.

1291
00:42:39.430 --> 00:42:39.829
Actually,

1292
00:42:39.830 --> 00:42:40.032
even,

1293
00:42:40.110 --> 00:42:40.368
you know,

1294
00:42:40.430 --> 00:42:41.414
the following two weeks,

1295
00:42:41.430 --> 00:42:43.094
we had a lot of demand.

1296
00:42:43.571 --> 00:42:44.414
And it's still today.

1297
00:42:44.415 --> 00:42:44.586
I mean,

1298
00:42:44.649 --> 00:42:46.196
it's just incredible,

1299
00:42:46.680 --> 00:42:47.477
the level of,

1300
00:42:47.680 --> 00:42:47.930
you know,

1301
00:42:48.430 --> 00:42:49.524
interest we have.

1302
00:42:50.493 --> 00:42:52.008
But not only from,

1303
00:42:52.149 --> 00:42:52.399
you know,

1304
00:42:52.461 --> 00:42:53.008
investors.

1305
00:42:53.602 --> 00:42:53.836
You know,

1306
00:42:53.837 --> 00:42:55.305
the day before yesterday,

1307
00:42:55.336 --> 00:42:55.821
I was with...

1308
00:42:56.830 --> 00:42:57.972
University of California,

1309
00:42:58.491 --> 00:43:02.075
and they already want to prepare the launch for

1310
00:43:02.696 --> 00:43:03.516
4 million patients.

1311
00:43:04.516 --> 00:43:05.079
Their doctors,

1312
00:43:05.321 --> 00:43:07.298
when they saw the data we presented in Berlin,

1313
00:43:08.243 --> 00:43:09.282
are so interested.

1314
00:43:09.845 --> 00:43:14.720
They say this drug could become the standard of care in obstructive colitis.

1315
00:43:14.766 --> 00:43:17.407
So a year and a half before launch,

1316
00:43:18.235 --> 00:43:22.048
they really want to work with us to prepare everything.

1317
00:43:22.095 --> 00:43:24.532
So it's obviously pretty spectacular.

1318
00:43:26.070 --> 00:43:27.432
If you need to get used to the normal,

1319
00:43:27.513 --> 00:43:28.293
that's the thing.

1320
00:43:29.516 --> 00:43:29.937
Pass to this,

1321
00:43:30.016 --> 00:43:30.195
okay.

1322
00:43:32.735 --> 00:43:33.055
I think,

1323
00:43:33.575 --> 00:43:33.796
yes,

1324
00:43:34.416 --> 00:43:35.277
talking about this week,

1325
00:43:35.357 --> 00:43:41.304
I think there is kind of also a good communication drive.

1326
00:43:42.241 --> 00:43:46.468
Why did you decide to present it so rapidly during the night?

1327
00:43:47.827 --> 00:43:49.054
Is it a matter of,

1328
00:43:49.070 --> 00:43:50.351
I don't know?

1329
00:43:50.352 --> 00:43:50.398
No,

1330
00:43:50.399 --> 00:43:51.257
it's a materiality.

1331
00:43:51.351 --> 00:43:55.991
I think the risk was that given the quality of the data,

1332
00:43:56.038 --> 00:43:56.273
you know,

1333
00:43:56.304 --> 00:43:59.804
you have obviously to make sure because we are a publicly traded company.

1334
00:44:00.539 --> 00:44:02.021
We didn't want to have any leak.

1335
00:44:02.521 --> 00:44:02.700
Okay,

1336
00:44:02.761 --> 00:44:03.200
someone to...

1337
00:44:03.681 --> 00:44:06.044
Someone that would get a bit overly excited,

1338
00:44:06.403 --> 00:44:07.407
speak to someone to say,

1339
00:44:07.786 --> 00:44:07.907
oh,

1340
00:44:07.908 --> 00:44:08.286
by the way,

1341
00:44:08.306 --> 00:44:09.251
they get great data.

1342
00:44:09.610 --> 00:44:14.329
So it was really driven by compliance.

1343
00:44:14.790 --> 00:44:14.931
Well,

1344
00:44:14.954 --> 00:44:15.493
compliance,

1345
00:44:15.657 --> 00:44:16.595
so you need to...

1346
00:44:17.001 --> 00:44:18.017
Compliance,

1347
00:44:18.018 --> 00:44:18.782
you cannot wait to...

1348
00:44:19.314 --> 00:44:19.439
No,

1349
00:44:19.517 --> 00:44:22.626
because you have two days max.

1350
00:44:23.517 --> 00:44:24.376
By the time you get...

1351
00:44:26.039 --> 00:44:27.119
very material information.

1352
00:44:27.179 --> 00:44:30.660
You have two days to communicate it to the market when you're a public company.

1353
00:44:31.359 --> 00:44:32.301
So we were kind of...

1354
00:44:32.840 --> 00:44:33.500
But the decision,

1355
00:44:34.184 --> 00:44:34.441
obviously,

1356
00:44:34.457 --> 00:44:46.887
to convoke the board was to address that point because I was afraid that my team would be so excited that they would start to speak.

1357
00:44:47.355 --> 00:44:47.965
And you knew...

1358
00:44:48.918 --> 00:44:52.762
What did you expect instead of what happened?

1359
00:44:54.115 --> 00:44:55.477
What did I expect in terms of...

1360
00:44:56.117 --> 00:44:56.297
Yes,

1361
00:44:56.316 --> 00:44:56.437
of,

1362
00:44:56.477 --> 00:44:56.818
I don't know,

1363
00:44:56.896 --> 00:44:57.658
of a reaction,

1364
00:44:58.920 --> 00:44:59.080
of,

1365
00:44:59.760 --> 00:44:59.959
yes,

1366
00:45:00.041 --> 00:45:01.463
amount or reactions.

1367
00:45:02.342 --> 00:45:02.545
Well,

1368
00:45:02.546 --> 00:45:02.701
yeah,

1369
00:45:02.740 --> 00:45:04.826
I think it surpassed our expectations because,

1370
00:45:04.842 --> 00:45:05.068
you know,

1371
00:45:05.069 --> 00:45:05.443
for example,

1372
00:45:05.444 --> 00:45:07.889
in terms of fundraising...

1373
00:45:08.350 --> 00:45:09.732
You let the market decide.

1374
00:45:10.006 --> 00:45:10.209
Yes,

1375
00:45:10.271 --> 00:45:10.443
sure.

1376
00:45:10.678 --> 00:45:12.225
But we thought we could raise,

1377
00:45:12.834 --> 00:45:13.037
again,

1378
00:45:13.115 --> 00:45:13.334
you know,

1379
00:45:13.490 --> 00:45:14.240
the week before,

1380
00:45:14.881 --> 00:45:17.162
we thought we would raise 200 million.

1381
00:45:17.865 --> 00:45:18.662
When we saw the data,

1382
00:45:20.053 --> 00:45:20.459
we looked,

1383
00:45:20.460 --> 00:45:22.365
we thought we will raise 400 million.

1384
00:45:23.171 --> 00:45:24.891
And then when actually we went,

1385
00:45:25.652 --> 00:45:27.773
it was nearly double that and we could have raised more.

1386
00:45:28.831 --> 00:45:32.913
But then there is also a question of dilution as well.

1387
00:45:33.835 --> 00:45:38.937
And the board had set basically sort of a max to raise.

1388
00:45:39.734 --> 00:45:45.218
But 750 million was obviously fantastic in the history of Nasdaq,

1389
00:45:45.937 --> 00:45:46.593
in biotech,

1390
00:45:46.594 --> 00:45:47.640
in the top 10.

1391
00:45:48.249 --> 00:45:48.499
Yes.

1392
00:45:48.843 --> 00:45:48.952
Ah,

1393
00:45:48.984 --> 00:45:49.171
yes.

1394
00:45:49.531 --> 00:45:50.218
It's in the history.

1395
00:45:50.747 --> 00:45:53.088
And everything in France is larger.

1396
00:45:53.129 --> 00:45:53.248
So,

1397
00:45:53.750 --> 00:45:54.131
you know,

1398
00:45:54.209 --> 00:45:58.092
this was just already a pretty spectacular fundraise.

1399
00:45:59.217 --> 00:45:59.358
Yes.

1400
00:45:59.412 --> 00:46:00.436
And the limitation is,

1401
00:46:01.615 --> 00:46:01.858
yes,

1402
00:46:02.217 --> 00:46:02.858
it's related to,

1403
00:46:03.139 --> 00:46:03.436
you said,

1404
00:46:03.437 --> 00:46:03.561
OK,

1405
00:46:03.600 --> 00:46:05.100
the board didn't want more.

1406
00:46:05.264 --> 00:46:06.201
It's a matter of dilution,

1407
00:46:06.279 --> 00:46:09.131
but it's also a matter of,

1408
00:46:09.318 --> 00:46:09.443
yeah,

1409
00:46:09.662 --> 00:46:10.162
can you explain?

1410
00:46:10.834 --> 00:46:10.959
Well,

1411
00:46:10.960 --> 00:46:11.850
it's a good question of,

1412
00:46:11.975 --> 00:46:12.287
you know,

1413
00:46:12.428 --> 00:46:12.553
that.

1414
00:46:12.603 --> 00:46:18.767
But we thought we needed to have until the U.S.

1415
00:46:18.849 --> 00:46:19.067
launch.

1416
00:46:19.087 --> 00:46:19.989
The banks told us,

1417
00:46:20.591 --> 00:46:22.634
you want to get finance until the U.S.

1418
00:46:22.712 --> 00:46:28.540
launch because this is the next big material event for the company.

1419
00:46:28.634 --> 00:46:32.978
So we said 750 is what we needed.

1420
00:46:33.306 --> 00:46:35.743
And that was the end of the day,

1421
00:46:35.931 --> 00:46:36.446
the conclusion.

1422
00:46:36.847 --> 00:46:37.107
Okay,

1423
00:46:37.247 --> 00:46:38.288
and then it means,

1424
00:46:39.309 --> 00:46:39.510
okay,

1425
00:46:39.770 --> 00:46:40.710
you talk about the US,

1426
00:46:40.772 --> 00:46:41.593
launch in the US,

1427
00:46:41.690 --> 00:46:43.014
and launch in Europe would be after?

1428
00:46:44.073 --> 00:46:48.936
So because the study was done in so many countries,

1429
00:46:48.975 --> 00:46:52.538
we can file in various different markets.

1430
00:46:53.022 --> 00:46:55.507
So the US would be number one,

1431
00:46:55.569 --> 00:46:57.132
then EMA would be the next one.

1432
00:46:57.585 --> 00:46:58.475
And then we plan in

1433
00:46:58.991 --> 00:46:59.803
27.

1434
00:47:00.119 --> 00:47:00.919
to go to China,

1435
00:47:01.080 --> 00:47:01.460
to go to

1436
00:47:01.920 --> 00:47:03.162
Japan, to go to Korea,

1437
00:47:03.201 --> 00:47:03.762
I mean,

1438
00:47:03.783 --> 00:47:06.143
to most of the countries,

1439
00:47:06.264 --> 00:47:08.025
Canada and Switzerland,

1440
00:47:08.604 --> 00:47:09.690
all the rest of the world,

1441
00:47:10.330 --> 00:47:11.111
gradually speaking.

1442
00:47:11.729 --> 00:47:23.463
But our view is from a corporate development standpoint is that it would be very hard for us to execute a launch everywhere.

1443
00:47:24.135 --> 00:47:25.104
We think in the U.S.

1444
00:47:25.166 --> 00:47:27.291
we need about 300 people to launch the drug.

1445
00:47:27.510 --> 00:47:28.854
That's our current estimate.

1446
00:47:30.087 --> 00:47:30.307
I mean,

1447
00:47:30.308 --> 00:47:31.808
if we have to build up,

1448
00:47:32.149 --> 00:47:33.290
you know,

1449
00:47:33.291 --> 00:47:33.930
in every country,

1450
00:47:34.550 --> 00:47:35.811
it would be a massive undertaking.

1451
00:47:36.194 --> 00:47:37.413
So the execution risk,

1452
00:47:37.956 --> 00:47:42.257
notwithstanding also the money will be required to build up infrastructure in every country,

1453
00:47:42.280 --> 00:47:43.999
you know,

1454
00:47:44.319 --> 00:47:48.303
our strategy is to try to find a partner outside of the US.

1455
00:47:48.663 --> 00:47:49.913
So one company ideally,

1456
00:47:50.553 --> 00:47:50.882
if not,

1457
00:47:50.944 --> 00:47:51.835
would have to split,

1458
00:47:52.835 --> 00:47:53.647
you know,

1459
00:47:53.725 --> 00:47:54.850
to do the product launch.

1460
00:47:56.263 --> 00:48:01.667
But the US launch is planned currently around Q3 2027.

1461
00:48:01.668 --> 00:48:02.468
In other countries,

1462
00:48:02.511 --> 00:48:02.831
probably,

1463
00:48:02.870 --> 00:48:03.128
you know,

1464
00:48:03.929 --> 00:48:05.550
in the following month.

1465
00:48:05.870 --> 00:48:06.073
Okay.

1466
00:48:06.229 --> 00:48:07.558
Then Abibax is a

1467
00:48:09.894 --> 00:48:10.354
US company?

1468
00:48:11.456 --> 00:48:11.581
No,

1469
00:48:11.597 --> 00:48:12.886
it's a French company,

1470
00:48:12.995 --> 00:48:14.808
but it is publicly listed both in

1471
00:48:15.167 --> 00:48:17.308
Euronext Paris and in the NASDAQ.

1472
00:48:17.761 --> 00:48:17.948
And,

1473
00:48:17.949 --> 00:48:20.229
you know,

1474
00:48:20.308 --> 00:48:21.229
our operations,

1475
00:48:21.433 --> 00:48:22.026
you know,

1476
00:48:22.183 --> 00:48:23.511
will move gradually.

1477
00:48:23.542 --> 00:48:24.823
who's keeping up with the season.

1478
00:48:24.847 --> 00:48:25.687
the French operation.

1479
00:48:25.788 --> 00:48:30.151
But the US is going to take a predominant weight as time goes.

1480
00:48:30.514 --> 00:48:30.733
Yes.

1481
00:48:30.971 --> 00:48:31.834
Because we need to build up,

1482
00:48:31.835 --> 00:48:32.354
for example,

1483
00:48:33.514 --> 00:48:34.873
the launch infrastructure.

1484
00:48:34.897 --> 00:48:35.975
So in the US,

1485
00:48:36.397 --> 00:48:36.858
to launch,

1486
00:48:37.842 --> 00:48:39.077
we are against 70 people.

1487
00:48:39.600 --> 00:48:40.319
By the end of the year,

1488
00:48:40.342 --> 00:48:41.467
I think it would be at least 100.

1489
00:48:42.998 --> 00:48:45.483
But we need to probably to hire 200 people.

1490
00:48:46.340 --> 00:48:47.641
by the end of 27.

1491
00:48:48.862 --> 00:48:50.745
And that will be mostly in the US.

1492
00:48:51.346 --> 00:48:51.725
Because of,

1493
00:48:51.948 --> 00:48:52.205
you know,

1494
00:48:52.206 --> 00:48:52.526
the US...

1495
00:48:52.627 --> 00:48:54.069
The quarters are in Boston now?

1496
00:48:54.127 --> 00:48:54.330
Yes,

1497
00:48:55.010 --> 00:48:55.471
in Waltham.

1498
00:48:55.510 --> 00:48:57.752
So it's on the west side of

1499
00:48:58.690 --> 00:49:00.393
Boston. We have a lot of biotechs.

1500
00:49:00.416 --> 00:49:00.713
Actually,

1501
00:49:00.714 --> 00:49:01.338
we have a new building.

1502
00:49:02.370 --> 00:49:03.620
It's only a biotech building.

1503
00:49:03.651 --> 00:49:07.135
So you have plenty of other startups around.

1504
00:49:07.588 --> 00:49:07.745
Yes,

1505
00:49:07.807 --> 00:49:07.963
yes,

1506
00:49:09.260 --> 00:49:09.401
yes.

1507
00:49:09.823 --> 00:49:10.682
And yeah,

1508
00:49:10.963 --> 00:49:13.541
the question is how you...

1509
00:49:13.791 --> 00:49:15.323
It's a normal decision?

1510
00:49:15.572 --> 00:49:16.694
obvious decision to start,

1511
00:49:16.913 --> 00:49:17.074
yes,

1512
00:49:17.133 --> 00:49:23.661
with the US to have two years in advance to drug in the US and then for clinical trials abroad.

1513
00:49:25.004 --> 00:49:26.379
The US market is 70%

1514
00:49:26.380 --> 00:49:26.622
of the,

1515
00:49:27.582 --> 00:49:27.825
you know,

1516
00:49:28.707 --> 00:49:37.481
one of the difficulties as you know in our industry is the US pricing is a multiple of

1517
00:49:38.309 --> 00:49:40.168
Europe or other geographies.

1518
00:49:40.731 --> 00:49:44.481
So what happens in the infirmary market it.

1519
00:49:46.249 --> 00:49:46.830
the ratio,

1520
00:49:47.411 --> 00:49:50.433
which tends to be 1 to 3 in general for drugs,

1521
00:49:51.374 --> 00:49:53.073
in IBD is more 1 to 6.

1522
00:49:53.300 --> 00:49:54.558
So the price in the U.S.

1523
00:49:54.581 --> 00:49:57.018
is six times higher than in Europe.

1524
00:49:57.479 --> 00:49:57.604
So,

1525
00:49:58.362 --> 00:49:58.604
you know,

1526
00:49:58.605 --> 00:49:59.643
as a biotech,

1527
00:49:59.839 --> 00:50:02.745
you have to go where it's already complicated to develop,

1528
00:50:03.042 --> 00:50:03.292
you know,

1529
00:50:03.401 --> 00:50:03.808
yourself.

1530
00:50:04.479 --> 00:50:07.495
And you need to reward investors for the work you do.

1531
00:50:07.589 --> 00:50:08.589
So you go to the U.S.

1532
00:50:08.651 --> 00:50:08.948
first.

1533
00:50:09.808 --> 00:50:09.995
Okay.

1534
00:50:10.292 --> 00:50:13.417
And in terms of how you were seen in the...

1535
00:50:14.352 --> 00:50:17.694
In the landscape of these drugs,

1536
00:50:18.417 --> 00:50:29.589
you were seen as a biotech and now you're seen as a serious biotech and from big pharma who are already existing in this?

1537
00:50:30.495 --> 00:50:35.527
I think certainly there has been a mutation of how the company has been perceived.

1538
00:50:36.136 --> 00:50:36.417
I mean,

1539
00:50:36.698 --> 00:50:37.933
for us in Berlin,

1540
00:50:37.948 --> 00:50:40.792
it was what was astonishing is again,

1541
00:50:40.839 --> 00:50:42.527
we did the two plenaries,

1542
00:50:43.355 --> 00:50:43.839
two separate

1543
00:50:43.904 --> 00:50:46.647
Plenary is the number one presentation on both.

1544
00:50:48.770 --> 00:50:50.489
So we had 700 people.

1545
00:50:51.493 --> 00:50:54.997
When our presentations from KORs were finished,

1546
00:50:55.513 --> 00:51:02.630
half of the room got emptied because it showed that actually people only showed up for our presentation given the level of interest.

1547
00:51:03.286 --> 00:51:06.302
And yet we had a booth which was,

1548
00:51:06.303 --> 00:51:06.583
you know,

1549
00:51:07.114 --> 00:51:11.786
I would say a third of this studio.

1550
00:51:11.927 --> 00:51:12.052
Yeah,

1551
00:51:12.239 --> 00:51:12.958
because uh,

1552
00:51:13.536 --> 00:51:15.618
when we were running out of cash.

1553
00:51:16.739 --> 00:51:17.922
So when we came to Berlin,

1554
00:51:19.301 --> 00:51:19.922
we didn't know.

1555
00:51:20.043 --> 00:51:22.145
So we had a very little booth.

1556
00:51:22.426 --> 00:51:23.270
Fair enough.

1557
00:51:23.325 --> 00:51:23.450
No,

1558
00:51:23.504 --> 00:51:24.848
but it was an amazing contrast.

1559
00:51:24.965 --> 00:51:26.950
So on the podiums,

1560
00:51:27.489 --> 00:51:29.645
we were seen as the story of

1561
00:51:30.145 --> 00:51:31.676
Berlin. I think that's a fact.

1562
00:51:32.270 --> 00:51:33.036
And yet,

1563
00:51:33.364 --> 00:51:38.098
we are this tiny little company with a pretty ridiculous booth.

1564
00:51:38.254 --> 00:51:38.598
But again,

1565
00:51:39.114 --> 00:51:40.067
my team was wonderful.

1566
00:51:40.864 --> 00:51:42.605
You've made the job.

1567
00:51:43.744 --> 00:51:43.904
Yeah,

1568
00:51:44.305 --> 00:51:45.705
and a lot of people came to see us.

1569
00:51:46.467 --> 00:51:46.685
Yes,

1570
00:51:46.767 --> 00:51:46.947
and

1571
00:51:48.127 --> 00:51:58.904
I'm curious also about the conversations that these big spammers can have with you because they must be curious about how you manage this.

1572
00:51:58.951 --> 00:51:59.404
Yeah,

1573
00:51:59.904 --> 00:52:01.764
they are watching us for sure.

1574
00:52:03.623 --> 00:52:04.935
They are certainly intrigued.

1575
00:52:05.748 --> 00:52:07.607
I think initially the mechanism of action.

1576
00:52:08.560 --> 00:52:10.961
caused some concern on their side.

1577
00:52:11.461 --> 00:52:14.402
Now we got this pretty brilliant data.

1578
00:52:15.063 --> 00:52:15.340
We did,

1579
00:52:15.422 --> 00:52:15.762
by the way,

1580
00:52:15.820 --> 00:52:17.399
market research in the U.S.

1581
00:52:18.039 --> 00:52:19.266
in the month that followed,

1582
00:52:19.524 --> 00:52:20.524
so basically in August.

1583
00:52:21.344 --> 00:52:27.578
And so we had about 70 physicians from academic centers,

1584
00:52:27.719 --> 00:52:31.063
all of our community gastroenterologists,

1585
00:52:31.813 --> 00:52:34.172
and they all said this drug

1586
00:52:35.324 --> 00:52:39.550
We'd actually probably garner a third of the market in the advanced population,

1587
00:52:39.589 --> 00:52:40.671
the refractory population,

1588
00:52:41.390 --> 00:52:42.933
and about 15%

1589
00:52:43.655 --> 00:52:44.335
in the first line,

1590
00:52:44.530 --> 00:52:48.038
which would make it the leading drug in the future of IBD.

1591
00:52:48.460 --> 00:52:50.843
So I think they all confirmed our intuition,

1592
00:52:51.484 --> 00:52:54.530
which the result in July,

1593
00:52:55.046 --> 00:52:57.280
that the results are really,

1594
00:52:58.280 --> 00:52:58.530
you know,

1595
00:52:59.155 --> 00:52:59.452
such.

1596
00:53:00.012 --> 00:53:01.133
that this could become,

1597
00:53:01.234 --> 00:53:01.494
you know,

1598
00:53:01.753 --> 00:53:02.916
the number one drug in IB.

1599
00:53:03.216 --> 00:53:03.355
Now,

1600
00:53:03.656 --> 00:53:03.835
again,

1601
00:53:03.857 --> 00:53:05.416
we need to wait for the maintenance data,

1602
00:53:06.220 --> 00:53:08.900
because we still have a few months to go.

1603
00:53:09.002 --> 00:53:10.502
But that is based upon this eight-week,

1604
00:53:11.783 --> 00:53:13.744
the profile of the drug is seen.

1605
00:53:13.783 --> 00:53:15.447
So I think for Big Pharma,

1606
00:53:15.611 --> 00:53:17.705
they are going to watch us,

1607
00:53:17.783 --> 00:53:17.908
and,

1608
00:53:18.970 --> 00:53:19.814
you know,

1609
00:53:20.252 --> 00:53:22.517
I have no clue what they will do ultimately.

1610
00:53:23.783 --> 00:53:24.658
But if I were them,

1611
00:53:24.720 --> 00:53:25.439
at least some of them,

1612
00:53:25.533 --> 00:53:26.564
I would be very worried,

1613
00:53:26.642 --> 00:53:26.783
yeah.

1614
00:53:27.673 --> 00:53:27.861
Yes.

1615
00:53:29.494 --> 00:53:38.878
thank you but it's I come back to the yes we we slowly yes finish I come back to the

1616
00:53:39.850 --> 00:53:42.073
Beginning when you decided to take this project,

1617
00:53:43.194 --> 00:53:47.801
you knew you had in hands a lot of differentiation like this.

1618
00:53:49.200 --> 00:53:49.380
Yes,

1619
00:53:49.381 --> 00:53:50.059
to be able to say,

1620
00:53:50.098 --> 00:53:50.317
okay,

1621
00:53:51.044 --> 00:53:52.020
I could drive something,

1622
00:53:52.059 --> 00:53:54.465
which is something really different.

1623
00:53:54.505 --> 00:53:55.505
Or what did you have in mind?

1624
00:53:55.989 --> 00:53:57.489
You cannot imagine this,

1625
00:53:57.770 --> 00:53:59.630
like to have one of the biggest drugs.

1626
00:54:01.036 --> 00:54:02.536
I go back to the idea.

1627
00:54:03.036 --> 00:54:04.989
The phase two was intriguing.

1628
00:54:05.770 --> 00:54:06.083
Okay.

1629
00:54:06.864 --> 00:54:08.458
The way they built it and the results.

1630
00:54:08.926 --> 00:54:09.083
Yeah.

1631
00:54:09.354 --> 00:54:13.979
But the results were a bit affected,

1632
00:54:14.761 --> 00:54:14.999
I think,

1633
00:54:15.061 --> 00:54:16.440
because of an execution issue.

1634
00:54:16.441 --> 00:54:21.764
And also it was during COVID where there were some questions not only on the mechanism of action,

1635
00:54:21.827 --> 00:54:23.046
but on the dose response.

1636
00:54:23.530 --> 00:54:33.319
So some physicians and some big pharma were concerned that when you don't have a clear dose response in a trial,

1637
00:54:33.882 --> 00:54:36.616
that may mean that your drug has something a bit,

1638
00:54:37.647 --> 00:54:38.444
something strange.

1639
00:54:40.135 --> 00:54:52.368
But what I was able to find out is this question of those was mostly an issue related to the execution.

1640
00:54:53.009 --> 00:54:53.907
Because we had done,

1641
00:54:54.766 --> 00:54:55.665
you know,

1642
00:54:55.993 --> 00:54:59.493
part of the sites that were involved in that phase two were in Ukraine.

1643
00:55:00.134 --> 00:55:00.868
And in particular,

1644
00:55:00.915 --> 00:55:01.930
there was one site,

1645
00:55:01.977 --> 00:55:03.696
you know,

1646
00:55:04.618 --> 00:55:04.774
again,

1647
00:55:04.805 --> 00:55:08.290
we cannot look back with precision.

1648
00:55:09.210 --> 00:55:12.554
because we didn't do a significant audit and things like this.

1649
00:55:13.056 --> 00:55:22.380
But it turns out that one site really skewed the data in such a way that this dose response was sort of inversed.

1650
00:55:23.122 --> 00:55:23.544
But again,

1651
00:55:24.903 --> 00:55:33.810
so that was one of the noise in the phase two that you had to put a bit on the side to say.

1652
00:55:34.654 --> 00:55:39.181
what is truly the drug versus the execution of the trial.

1653
00:55:39.958 --> 00:55:40.161
And,

1654
00:55:40.661 --> 00:55:41.399
you know,

1655
00:55:41.860 --> 00:55:42.524
and then the bet

1656
00:55:43.079 --> 00:55:43.564
I had made.

1657
00:55:43.603 --> 00:55:44.040
But again,

1658
00:55:44.142 --> 00:55:44.501
thanks to,

1659
00:55:44.524 --> 00:55:44.907
you know,

1660
00:55:45.446 --> 00:55:47.485
the discussion we have had with,

1661
00:55:47.704 --> 00:55:48.329
for example,

1662
00:55:48.431 --> 00:55:48.946
Sofinova,

1663
00:55:49.368 --> 00:55:49.610
you know,

1664
00:55:49.611 --> 00:55:54.892
our partners who has been very critical in that period of time.

1665
00:55:55.735 --> 00:55:57.329
Also talking with KOLs,

1666
00:55:58.204 --> 00:55:58.439
you know,

1667
00:55:58.440 --> 00:56:01.517
I became convinced that this could be noise.

1668
00:56:01.758 --> 00:56:02.519
even though at the time

1669
00:56:03.279 --> 00:56:04.621
I was not 100%

1670
00:56:04.662 --> 00:56:04.861
sure.

1671
00:56:05.623 --> 00:56:06.064
But then we,

1672
00:56:06.385 --> 00:56:06.623
you know,

1673
00:56:06.705 --> 00:56:07.385
thanks to my team,

1674
00:56:07.482 --> 00:56:08.705
thanks to further work,

1675
00:56:09.588 --> 00:56:17.057
we got clear that it was more noise and that actually there would be some dose response in the phase three trial,

1676
00:56:17.135 --> 00:56:19.736
which we kind of saw.

1677
00:56:22.018 --> 00:56:22.143
Yeah,

1678
00:56:22.174 --> 00:56:22.299
so,

1679
00:56:22.361 --> 00:56:22.674
you know,

1680
00:56:22.752 --> 00:56:23.955
it's...

1681
00:56:23.956 --> 00:56:24.268
But again,

1682
00:56:24.299 --> 00:56:24.908
at the end of the day,

1683
00:56:24.909 --> 00:56:25.314
it's a bet,

1684
00:56:25.424 --> 00:56:25.627
right?

1685
00:56:26.299 --> 00:56:28.768
You have to say,

1686
00:56:28.846 --> 00:56:29.111
you know,

1687
00:56:29.502 --> 00:56:30.705
what are the plus of this drug?

1688
00:56:31.174 --> 00:56:31.955
What are the minuses?

1689
00:56:32.095 --> 00:56:33.077
You know,

1690
00:56:33.096 --> 00:56:37.840
what are the risks that exist with the profile after you see the phase two?

1691
00:56:38.262 --> 00:56:40.766
How do you mitigate those risks in a phase three?

1692
00:56:43.243 --> 00:56:43.985
And then you say,

1693
00:56:44.110 --> 00:56:44.250
yeah,

1694
00:56:44.329 --> 00:56:45.289
I go or I don't go.

1695
00:56:47.110 --> 00:56:49.719
If we had not done the mitigation in a phase three,

1696
00:56:50.360 --> 00:56:50.594
you know,

1697
00:56:50.860 --> 00:56:51.079
again,

1698
00:56:51.657 --> 00:56:52.922
this phase three could have blown up.

1699
00:56:53.313 --> 00:56:55.422
So even though it's a good drug.

1700
00:56:55.875 --> 00:57:00.500
So it reminds ourselves that execution is a...

1701
00:57:00.986 --> 00:57:06.031
an integral part of the success of a company.

1702
00:57:06.113 --> 00:57:06.812
And that's why,

1703
00:57:07.312 --> 00:57:07.554
you know,

1704
00:57:07.574 --> 00:57:09.738
when you come back to leadership of biotech,

1705
00:57:10.472 --> 00:57:10.753
you know,

1706
00:57:10.933 --> 00:57:16.441
I am convinced that after the end of phase one,

1707
00:57:17.496 --> 00:57:17.746
you know,

1708
00:57:17.949 --> 00:57:23.589
it's very important to bring leaders who have experience in drug development in phase two and phase threes.

1709
00:57:24.230 --> 00:57:24.496
Because,

1710
00:57:24.511 --> 00:57:24.683
again,

1711
00:57:24.949 --> 00:57:26.855
the technicality of,

1712
00:57:27.496 --> 00:57:27.730
you know...

1713
00:57:28.190 --> 00:57:32.434
developing a drug until phase one are very different from phase two and phase three.

1714
00:57:33.317 --> 00:57:33.516
And

1715
00:57:35.219 --> 00:57:36.641
I think that's one of the challenges.

1716
00:57:37.922 --> 00:57:38.540
When you have had,

1717
00:57:38.563 --> 00:57:39.000
for example,

1718
00:57:39.024 --> 00:57:46.727
a founder who has done a terrific job discovering a drug and bringing it to early human clinical trials,

1719
00:57:47.602 --> 00:57:56.993
very often those people are not the right ones to continue the story simply because that's not their skill set.

1720
00:57:57.650 --> 00:57:57.871
And,

1721
00:57:59.372 --> 00:57:59.612
you know,

1722
00:57:59.913 --> 00:58:00.172
that's,

1723
00:58:00.233 --> 00:58:00.534
I think,

1724
00:58:00.653 --> 00:58:03.395
one of the big considerations in drug development,

1725
00:58:03.415 --> 00:58:07.360
especially when you run these very large chronic,

1726
00:58:07.938 --> 00:58:08.204
you know,

1727
00:58:08.602 --> 00:58:09.383
clinical trials.

1728
00:58:10.625 --> 00:58:10.821
Yes,

1729
00:58:11.000 --> 00:58:13.852
to be able to see the risk,

1730
00:58:13.853 --> 00:58:14.586
the balance of risk.

1731
00:58:14.711 --> 00:58:15.055
Exactly.

1732
00:58:15.180 --> 00:58:17.368
And then to figure out how to have a good team.

1733
00:58:17.618 --> 00:58:18.493
Long-term opportunities,

1734
00:58:18.508 --> 00:58:18.899
yeah.

1735
00:58:18.900 --> 00:58:21.508
And to have a good team that can develop it,

1736
00:58:21.555 --> 00:58:22.618
you know.

1737
00:58:22.619 --> 00:58:22.743
Yes,

1738
00:58:22.758 --> 00:58:23.493
exactly.

1739
00:58:24.522 --> 00:58:25.223
At the end of the day,

1740
00:58:25.224 --> 00:58:25.764
it's my team,

1741
00:58:25.765 --> 00:58:26.004
you know.

1742
00:58:26.304 --> 00:58:27.965
I'm the chief of the orchestra.

1743
00:58:28.827 --> 00:58:30.506
I know when the music doesn't sound right,

1744
00:58:30.889 --> 00:58:33.053
but the people who play the music is a team,

1745
00:58:33.092 --> 00:58:38.717
and it's a team that makes the company successful.

1746
00:58:38.733 --> 00:58:38.858
Yes,

1747
00:58:39.194 --> 00:58:39.858
and you know.

1748
00:58:41.420 --> 00:58:41.842
It's a team.

1749
00:58:43.686 --> 00:58:43.858
Yes,

1750
00:58:43.905 --> 00:58:44.061
yes.

1751
00:58:44.702 --> 00:58:44.983
Thank you,

1752
00:58:45.030 --> 00:58:45.295
Marc.

1753
00:58:45.530 --> 00:58:45.858
I think,

1754
00:58:45.983 --> 00:58:46.170
yes,

1755
00:58:46.498 --> 00:58:49.873
I've had so many incredible stories in one hour.

1756
00:58:51.166 --> 00:58:52.627
Do you have other things we missed,

1757
00:58:52.807 --> 00:58:53.369
other stories?

1758
00:58:53.607 --> 00:58:54.128
No,

1759
00:58:54.369 --> 00:58:55.970
watch what's next.

1760
00:58:57.212 --> 00:58:58.033
We'll see what happens.

1761
00:58:58.334 --> 00:58:58.572
Yes,

1762
00:58:59.494 --> 00:58:59.712
wait.

1763
00:59:01.416 --> 00:59:01.978
You have two years,

1764
00:59:02.056 --> 00:59:02.478
you say now?

1765
00:59:02.955 --> 00:59:03.220
Yeah,

1766
00:59:03.221 --> 00:59:05.556
I have two years.

1767
00:59:06.681 --> 00:59:07.322
See you in two years,

1768
00:59:07.369 --> 00:59:07.509
Marc.

1769
00:59:07.525 --> 00:59:08.666
Okay.

1770
00:59:08.667 --> 00:59:10.462
For the conclusion of the story.

1771
00:59:10.541 --> 00:59:11.025
Thank you,

1772
00:59:11.072 --> 00:59:11.259
Marc.

1773
00:59:11.260 --> 00:59:12.853
Bye-bye.

1774
00:59:12.854 --> 00:59:15.087
Thank you for listening to this episode.

1775
00:59:15.384 --> 00:59:17.791
It was great to share this story about connection,

1776
00:59:17.884 --> 00:59:18.509
inspiration,

1777
00:59:18.666 --> 00:59:20.837
and creating a positive legacy.

1778
00:59:21.090 --> 00:59:25.881
Don't forget to subscribe to stay updated on future episodes and talk to you soon.

1779
00:59:26.263 --> 00:59:26.724
A bientôt.