Ridgeback Biotherapeutics Co-Founders On Potential Covid Pill Supply

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Following is the unofficial transcript of a CNBC interview with Ridgeback Biotherapeutics Co-Founders Dr. Wayne Holman and Wendy Holman on CNBC’s “Squawk on the Street” (M-F, 9AM-11AM ET) today, Friday, October 1st. Following are links to video on CNBC.com:

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Ridgeback Biotherapeutics Co-Founders On Potential Covid Pill Supply

Ridgeback Biotherapeutics Co-Founders On How Pill Can Tackle Covid-19

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DAVID FABER: Joining us now are Wendy Holman and Dr. Wayne Holman. They’re of course the co-founders of Ridgeback Biotherapeutics. It's great to see you both. It has been a long road in many ways, Wayne, I mean referring back to our March 2020 conversation. What gave you the confidence then that in fact we would get to this moment today?

WAYNE HOLMAN: Hi David, thanks so much for having us back. We're very happy to be here and very exciting day. You know, in drug development, the truth is when you have a molecule that's never been given to a human being before, you know, competence might not be the right word more and more like hope, but we were hopeful. We also thought that it was absolutely essential that we give this drug a chance. We thought it had a chance, we were concerned that the pandemic, this virus might cause a pandemic sadly the way it has unfolded and it would be a big need that was unmet and so, we took that chance. You know, we really started to get confident when we saw the human data, so we went into Phase 1, we were able to give the drug to people at every dose we gave it to people in Phase 1, we saw that it was very well tolerated similar similarly to placebo, and we were getting blood levels that suggested that there was enough drug in, in the people that if we treated people who were sick with COVID that we should be able to replicate what we saw in animals which is prevent people from getting sicker and happily today we're able to show that Phase 3 was stopped early as you mentioned in outpatients, and we're able to reduce hospitalizations by half, death and hospitalization by half, and we're able to reduce death to zero. You know, one out of 50 people sadly on the placebo arm actually died of COVID and, and no one died in the treatment group.

DAVID FABER: Wendy, you know, obviously, having been close to the two of you and watch this process I can remember when you were dealing with the US government early on before you even signed the deal with Merck & Co., Inc. (NYSE:MRK) but give us a little background there and your expectations now from your partner, Merck obviously which, which has this drug in terms of their ability to manufacture. How many courses can, can Merck potentially come up with as soon as this thing is approved under emergency usage?

WENDY HOLMAN: Thanks David. So, the primary reason that we originally went to the US government was for help with manufacturing. We were, we felt an obligation that if the drug were to work, we wanted to have enough for everyone. We never got government funding so we then turned to Merck, who is a tremendous commercial partner, to help us get this to the people so they have publicly announced that they'll have 10 million treatment courses available by the end of the year, as well as they've also entered into we've entered into voluntary license agreements with different generic manufacturers to allow it to get to sort of other parts of the world that would not be able to afford it.

DAVID FABER: And Wendy, what are your expectations then beyond that? You know, we were talking before we came to the two of you about countries where vaccination rates continue to be low where there's certainly the possibility of even other variants perhaps being as devastating as Delta has been. Is Merck going to be able to produce a lot more than 10 million courses into 2022?

WENDY HOLMAN: So, the great news about, the great part of the news today related to variants is that 80% of the patients that were valuable had either Gamma, Delta or Mu. So we've seen its power against the variants and the voluntary license agreements that we’ve entered into allow for generic manufacturers to sell it at as close to cost as possible for the rest of the world.

DAVID FABER: Wayne, I think it is important to sort of remind people it, you know, and again as you explained to me many times, maybe I finally understand that doesn't work against the, the spike protein the way the vaccines do, it actually works against all the variants because it has a different way of actually knocking down the virus. Can you explain to people why that's the case and why it's important so it may mean that any future variant would be susceptible to the drug?

WAYNE HOLMAN: That's right. So, this drug acts on the part of the virus that we could, that the virus uses to reproduce itself and so, it stops the virus from being able to do that or reduces its ability to do that. And that has nothing to do with variants, and in the genetic code of the spike protein, which is what we hear about a lot with variants. So not only does it work against all the variants that we've tested in vitro as Wendy mentioned happily, we've now shown in the human clinical trial, it worked equally well against all the variants that were tested in the Phase 3. And we know from other work that it works against other coronaviruses, as I mentioned back in March in SARS and MERS and it also works against unrelated viruses such as influenza, so it's a, it's a very fundamental mechanism to how viruses replicate themselves and it's very difficult to generate resistance and it's, should work against all variants that that we see hopefully.

DAVID FABER: Yeah, well let me come back to that actually I want to come back to, to Molnupiravir specifically and COVID but you just indicated that there might be indications for this drug far beyond even COVID-19? I mean, flu is that really a possibility and or other viruses why?

WAYNE HOLMAN: Absolutely. So, basically if it's a RNA virus, it uses a similar enzyme to SARS-CoV-2 which is the virus that causes COVID and to replicate itself. And this medicine tricks the virus into using it as a building block of the chain as it tries to make copies of itself, and it will do so and it has done so successfully in, in vitro as well as in animal studies for influenza, SARS, MERS, as well as other viruses.

DAVID FABER: Wendy, all three of us for example at this desk are certainly vaccinated as Jim just indicated he's got three in him already, but if one of us were to get a breakthrough infection, would our doctor advise us if this is available to actually take the five-day course? Would it be your expectation that that would be the case?

WENDY HOLMAN: Obviously that would come down to your physician but we've seen with the some of the breakthrough cases is that you still see hospitalization and bad outcomes and so I would imagine your physician would want you to take this to make sure that you stay out of the hospital and obviously avoid that.

WAYNE HOLMAN: Right, and we'll see what the FDA label is but ultimately as Wendy pointed out, it's a decision if you're symptomatic, your physician, you know, it's about having that option available to you.

WENDY HOLMAN: In addition, we announced in September that Merck and Ridgeback have started a prophylaxis trial, which we'll look at whether or not you've been exposed to somebody with COVID, taking this treatment, does it stop you from getting it?

DAVID FABER: Yeah, you know, Wayne and I referenced this of course I can remember a conversation you and I had on March 6th, I remember the date when you indicated to me that I better be very careful out there, stop taking the subway what you basically said, you said some other things too. In your mind, is this day a significant one in terms of our ability to deal with this virus?

WAYNE HOLMAN: Absolutely, you know, what we're afraid of with the virus is, is bad outcomes, right. There are four other coronaviruses that have been circulating naturally that give people mostly common cold symptoms and we handle that and we live a normal life. And the idea is that all these innovations that have been coming out of the biopharma industry are designed to help get us back to that normal life. And if you know that your risk of being hospitalized or having a bad illness or obviously death has been dramatically reduced by all of these countermeasures including hopefully Molnupiravir, then you feel more comfortable conducting activities the way we always did so that was the hope when we first spoke in March, and we're super excited and happy that, you know, this drug has worked the way we hoped it would. And that it's so easy to distribute and to manufacturer from, from a logistics standpoint, this can be distributed around the globe. And we can make large quantities available and our partners can as well and Merck’s manufacturing is really incredible. They've done an incredible job and we're super happy with what they've been able to accomplish. And you asked about how much—

DAVID FABER: Sorry, let me stop you there because I know Jim Cramer wanted to just get a quick question in. Sorry.

JIM CRAMER: It does feel like the polio moment and when we gave it to the sugar cube, Dr. Sabin. Congratulations both Wendy and Wayne. Let me just ask you a question. I do BinaxNOW four or five days. I do it's the Abbott test and I really like it. So, Dr. Holman, let's say it comes out positive. If I take it Monday, it's negative. Tuesday, it’s positive. What should I do how do I change my life the moment I see that that's a positive reaction to BinaxNOW?

WAYNE HOLMAN: So hopefully, after if we're fortunate enough to get emergency use or full approval from FDA and it's available, at that point you would very likely want to call your physician. Let your physician know you've tested positive and then your physician in consultation with you would decide if it's the right thing for you to reduce your risk of hospitalization or death based on the data that we've shared today.

DAVID FABER: Wendy, you know, this is also a big day obviously not just for Merck, but for Ridgeback Biotherapeutics as well and conceivably given the numbers that we're talking about from Merck, you guys are going to do quite well as well. I just wonder how are you going to change your approach. I mean I know, you know, Wayne, for I know as an investor for so many years, does this change sort of what you guys are doing at Ridgeback given what has been a long process here but ultimately one that does appear to be likely to end in great success?

WENDY HOLMAN: Not at all, it strengthens our resolve. When Wayne and I founded Ridgeback Biotherapeutics, our primary goal was to work on global health. We wanted to work on diseases that needed champions and where better to start but there. And we used our knowledge from our investment world and applied it to, looking into the antiviral field and that's how we started our work in Ebola and Ridgeback Bio was one of the few companies that was able to get a viral treatment for an acute illness approved in a pandemic setting and so we use those lessons learned and applied them to COVID and we're certainly going to use our lessons learned from COVID and use it on our pipeline.

DAVID FABER: And finally, Wayne, you know, Pfizer's got a therapy that may be out there as well. I think it's a different mechanism, is that something you welcome? Is it seen as a competitor from your perspective and do you think, frankly, from what you know that, that it's likely to work as well?

WAYNE HOLMAN: Yeah, great question, David and, you know, the way we look at it and the way I look at it is that we don't really have competitors in this COVID world. We have allies in the fight against this pandemic and we are very close to a lot of people at Pfizer and very happy that they're having a huge success they've had with both the vaccine and happy to see them getting into later stage studies with their antiviral as well. As you pointed out, it's a different mechanism and our compound inhibits the ability of the virus to replicate by stopping and inhibiting its ability to reproduce. There's, it's called a protease inhibitor, and that has an effect on an enzyme that's necessary for the virus to assemble itself and essentially, and so these things, history suggests that combinations and antiviral can be helpful but we welcome all effective therapies that can help this pandemic.

DAVID FABER: Well Wayne and Wendy, certainly appreciate you joining us this morning on obviously a big day for you and for the markets and for perhaps hopefully for global health as well. Thank you both.

WENDY HOLMAN: Thank you.

WAYNE HOLMAN: Thank you David. Thanks everybody.