The Time is Nau!


Podcast Episode 238

Click here to watch the video version of this podcast.

Host Ehsan Sadri, MD, is joined by Jeffrey Nau, PhD, who shares insights from a career in ophthalmology that has led to his current role as the CEO of publicly traded Oyster Point Pharma. In this interview, Jeff addresses some of the recent setbacks from COVID-19, conducting business virtually, different indications the company plans to address, and opportunities that lie ahead.

Full transcript below.

Intro:
Welcome back to The OIS podcast. Today’s guest Jeffrey Nau shares how an early career in ophthalmology eventually led to becoming the CEO of a publicly traded company. Jeff addresses some of their recent setbacks from COVID and opportunities that lie ahead. Let’s listen in.

Ehsan Sadri, MD:
Good afternoon, everybody. I’m Dr. Ehsan Sadri. I’m a board-certified ophthalmologist here in Newport Beach, California. I’m also the co-founder and GP of Visionary Ventures, also located here in Southern Cal and Aliso Viejo with I work along with my really good friend Jeff one off who’s our managing partner, and aka Toby Tyson, one of the other GPS. I’m really delighted to have our next guest here. He is coming in and discussing his new venture and we’ll talk about his background little bit, Jeffrey Nau how you doing?

Jeffrey Nau, PhD:
Very good. How are you?

Ehsan Sadri, MD:
Good. Good. Good to have you. On our podcast. We’re excited to have you and for those of you who don’t know, Jeff, Jeff is really, you know, had an illustrious career in developing sort of different therapies for about 15 years experiences bio technologies, medical device and you know, he was recently VP of clinical medical affairs at Opthotech. And prior to that, he was the medical science director of Genentech working on things on tensors like the back of the eyes. So now he’s in the front of the eye actually now in the nasal region, eye region, if you will make a huge unmet need dry eye. How you doing today? Tell us a little about yourself and what made you where you are what made you sort of fall in love with Oyster Point and kind of lead the team?

Jeffrey Nau, PhD:
Yeah, that’s great. So I would say I really started out in ophthalmology in the front of the eye. So although I’ve spent the vast majority of my career in the back of the eye my actual first foray into ophthalmology was when I was in high school actually worked as a technician in a multi-specialty practice. So primarily cataracts, although I was I was there for the first vision diode laser to roll through the door on the retina side and, and really was there when we started doing evening symposia for patients in the very outset of LASIK and so was an interesting time and that sort of sort of caught my eye. I loved being an attack while I was you know, really getting ready and sort of in that stage where you’re trying to get some clinical experience before you go off to college and go to medical school, and eventually work my way over onto the retina side and became the lead photographer for the practice at the time. And back then we you know, we injected our own dies and had a lot more autonomy than people do. Now. I think so that was exciting for me. And I’ll date myself but that was back when we had to actually take the photos into the darkroom and no digital at the time. But went from there and started working in actual eye banking, with cornea transplants and so all through my undergrad career worked in eye bank, collecting corneas and tissues, you know, taking a look at endothelial cell counts and grading tissue for transplant and so always, you know, sort of interested in ophthalmology and was very focused on the front of the eye. And then when I went off to medical school, I decided to actually take research here and I spent a year at Will’s Eye Hospital on the oncology service and so had a great year there with the shields in the operating rooms in the clinic, and, you know, spent some good time in seeing things that you know, I would say in every day ophthalmologists or even retina specialists, it would take them a whole career to see some of the things I saw in that year was so it’s really great for me to have that opportunity. And then after that transitioned over to industry and started out with a company, very early called Generic Corporation, which most people you know, may or may not recognize, but it was a drug called scopolamine lactate, which kind of came back around and at the time, you know, this was in the day before we had Anti-VEGF, and we were treating patients with things that were really chemotherapeutic agents. So, learned how to deliver IV therapy at the time when we were doing mask IV studies. So that was pretty exciting. And then, you know, had the opportunity to work at a number of other great companies so was with Acuity Pharmaceuticals when we injected the first RNA interference drug into the eye back then, you know, intro vitriol injections were a big deal. People were were a cautious about them, I would say and a little bit scared and usually reserved for infections of the the posterior chamber. And then, you know, had a great experience working on Lucentis. I mean, it’s just amazing drug and a great team of people that were there was able to be there for the launch of the diabetic macular edema indication and, you know, really enjoyed that was my first time in a big corporation. So, learned a lot of exciting things there learned good and bad about working in a, in a large company, and then, you know, really came back to the tech because, you know, I think I’m much more of a smaller company, startup entrepreneurial person at heart, and then had the opportunity through my relationships that had built over time to come to oyster point. And so, we started up Oyster Point, really, in earnest in 2017. And file the the IND for the product that we’re currently working on in 2018. And, and here we are today on the verge of filing an NDA. So, it’s been a bit of a whirlwind development program here. But it’s been really exciting.

Ehsan Sadri, MD:
I mean, that’s a really good overview of your past and is interesting that there’s so many different paths to success. And I think one of the things that you mentioned is networking. I think one of the things that I think we were not taught in medical school, you know, physicians, people and allied health, people in laboratory people in clinical trials, you know, you’re not taught that whereas in business school and law school, I think there’s a huge emphasis on networking. And I think that’s really for our listeners is really important for them to really hone in on. You know, there’s different ways you don’t have to have the best pedigree but you have to create your pedigree you have to create your network and that just takes a lot of effort as much as what you’re what you’ve done in the laboratory and also putting companies
So, so that’s great. And the other thing is I think I really liked about your background is your ability to really listen to your heart, because, you know, we have to be happy with what we do every day. And for from what I’m hearing that is you like the smaller startup, and so do I, and because a lot more challenges, but at the same time, a lot more opportunities. So that’s great to hear. And, you know, you mentioned the challenges. What about this COVID? How are you guys doing? Obviously, you missed sort of a lot of the, I would say probably the bulk of is this, you were already done and you’re now submitting to the NDA which is great as for your dry eye disease, which is you know, for those of you don’t know, and the audience is, you know, something in the order of 30 to 50 million depending on the study’s huge opportunity, huge unmet need. And how is that now affecting your strategy for the OC-01 for what we call neurotrophic keratitis which is now your earlier phase. How are you guys?

Jeffrey Nau, PhD:
Well, so as the pandemic unfolded? And, you know, I think we were, we were lucky in the sense that we really missed the height of the pandemic while our enrollment was going on, although it did curtail the last few sites, enrolling patients. So, you know, if you were to look at the data from our trial, you’ll see there’s some missing assessments on that last visit, which is the most important visit where we’re collecting a lot of the primary endpoint data. And then, you know, we had one site that that decided not to participate because of, you know, the pandemic beginning and so, you know, I would say from that front, it was a little bit of unlucky in that the end of the study had to curtail but we consider ourselves incredibly lucky that we were as far along as we work because if we were in the middle, we’d probably still be sitting here today trying to finish up that trial. And, you know, it’s really put us into a unique position in the sense that where we’re locked down as a company, so at the moment, everybody’s working remotely, which, you know, wouldn’t be conducive to being in the clinic, but it is really put us into a unique position for getting this NDA filed. And so people have been able to put their head down, we were not traveling all over the country. We don’t have as much clinical development going on. So really, the areas we focused are, let’s get the NDA filed. Let’s put together the best submission. And then we’ve really shifted more towards the pipeline in the preclinical work that we’ve been doing. And so, you know, unfortunately, we won’t be able to talk too much publicly about the preclinical work but we will at some point in time and we do have a number of projects that we continue to work on in the lab, which has been less impacted by the clinic. As we move into the, to the fall time, you know, we’re obviously keeping an eye on how the clinics are working. You know, I would say, one of the fortunate things we hear is that there’s still clinical development happening, still patients coming in, albeit at a slower pace. And, you know, ophthalmology, I think, is hurt a little bit more than other areas in the sense that we don’t have as many sort of necessary therapies, you know, that unlike oncology, or cardiology, where patients need to get back to the clinic and need to get their therapy, you know, I think it allows the patient to decide, you know, what’s the risk benefit of me going in for a dry eye trial, for example. So I’m really excited that we were able to finish because I certainly wouldn’t want to be beginning our enrollment this fall, not knowing what’s happening. So we’re still on track with neurotrophic keratitis development. I think our our plan is to continue to watch and be mindful of the clinic. But we’re poised to execute. And, you know, we’ll sort of see how the fall goes. I think based on, you know, what we see going on in the country today, it’s certainly not where we hoped to be. And I think, you know, we’ll continue to watch how things progress over the fall.

Ehsan Sadri, MD:
Yeah, it’s certainly challenging even for our clinics, we run local controls in my practice, and it’s it’s all how you position I was on a phone with a large glaucoma company, you know, earlier and you know, we’re just starting trying to talk about enrollments and we’ve knock on wood be able to enroll a lot of patients because I think part of it is because we really focus on clinical trials. I think that’s the hallmark, I think you would agree with that. I work with Aura. They’re phenomenal at doing what they do best and I there, I’ve recently got to know them a little bit. But I think the regardless, I think these patients that come in are pretty motivated that and then really wanting to get the care and are the people who what we found in our clinical trials is they’re motivated. They got and the doctor has a good relationship with them. There’s trust, they’ll come in as pro as long as you have obvious safety measures in place, which most people don’t. So they’re it’s interesting to see how some of your like you said you, some of the sites will curtail that a majority of them are pretty open. I’ve talked to you they’re busy, depending obviously, where they’re at in the country to because there is a little bit of a fear factor of people coming in older patients. So yeah, I like what you’ve done. I like the fact also that you’ve taken this selective molecule and you’re now targeting different disease states which really candidly are both unmet needs are novel and you guys are applying for public offerings that did that go through a name. Is that is that still going through? How’s that one?

Jeffrey Nau, PhD:
So we we actually went public in October of last year. And we actually did a follow on offering in May. So like, we were able to raise some additional capital on the back end of our phase three data. But I think going back to your comment, you know, one of the things that we see as a opportunity in this marketplace, and I think it’s also an opportunity with our molecule is, you know, if you look across the landscape, at many of the front of the eye therapies, they’re very targeted as for a single disease or a single state. And so, you know, this product and the way that it works, we think has applicability across a number of different disease areas. And so to be able to have multiple indications within your label is pretty unique. It’s something that we worked on and prided ourselves on with Lucentis where we were able to have the AMD label the RVO than the DMV and you sort of build those, those clinical data sets and the, just the totality of the data behind the molecule and we think that that could be also something here so, you know, we’re very interested in other disease states neurotrophic keratitis is one of them, you know, I think corneal neuropathic pain patients is another area that we might be interested in. This is also a product that can be delivered for, you know, patients where we’re looking at potentially having treatment for these higher order aberrations as patients are going to have, you know, surgeries, whether it be LASIK, whether it be cataract surgery, sort of pretreatment before they go in to make sure that that ocular surface is healthy and then maybe some treatment on the back end where we’re keeping the eye lubricated with the patient’s own natural tear film and keeping it healthy. looking at things like you know, corneal or sorry, a contact lens and tolerance, you know, the many of the products that are out there. You have to remove your contact lenses, you know we look at this product is something that can be delivered while the lenses are in place and you’re using really your own natural tear film, and all of the components that are a part of that to hydrate and lubricate the ocular surface. So we really want to look at this product, as you know, what other areas can we sort of build upon from the evidence based side and look at the indications that are applicable and it’s really just a unique way of delivering therapy.

Ehsan Sadri, MD:
Yeah, I think and I think the wonderful thing about dry eye is, like you said, clinically, is it sort of is, is a large net, so post cataract pre cataract outcomes, so much so much of the outcomes based on corneal or ocular surface issues, and, you know, patients swear by they take their jobs and, you know, at the end of the day, they’re preserved and the you know, I think that’s a big unmet need right there. You know, for me as a clinician is exciting because you’re not now worried about BAK hitting the eye. Right? You’re using your own natural system. And I think pharmaceutically is probably a more appealing than device side. I think that was part of the I was, you know, involved in the intranasal medical device. I think it’s a little bit of a different conversation. Yeah. Comfort wise as well. Yeah, we agree with that.

Jeffrey Nau, PhD:
To your point with the, the preservative, you know, one of the things that we’ve done in when you when you look at the nasal spray landscape, so I think it’s important to understand much like on the eyedrops landscape, they’re mostly preserved. So almost every product out there contains some sort of a preservative and just like on the ocular surface, where those preservatives can have an effect in the intranasal space, we see actually toxicity to the nasal mucosa, where we have lower beat frequency of the cilia. And there’s actually some negative impacts. And so, when we’ve developed this product, we developed it as a preservative free product, right from the beginning, as you think about, you know, how do Americans use their inter nasal products? You know, there are really four things that are like allergies, sinusitis, and so, Florida mt clinic, oftentimes, yeah, they’re delivered over a short period of time, but when you’re delivering a product, which you want the patient to take, chronically we took, we took a lot of pain to develop this as a preservative free product, we could have easily gone an easy route with it and put a preservative in there. And so we have a very special device that delivers the product and doesn’t allow bacterial Ingress into the solution. We think that’s important for the safety of the patient and like you said, you’re sparing the ocular surface and not putting anything on the ocular surface. This is a great way to hydrate the ocular surface and reestablish that tear from homeostasis without having any preservatives on there. And then outside of the US, interestingly, most nasal products outside the US are preservative free. So here in the US, we use a lot of preservatives in our products. So that also allows us from a business perspective, to step outside of the US go into the other marketplaces, and not have to reformulate the drug and worry about those preservatives.

Ehsan Sadri, MD:
That’s fascinating. So, you’re looking at a more global sort for reach. Tell us you’re going IPO obviously, before COVID was probably a good time, right? I mean, you feel that that’s something that’s difficult to do as opposed to getting acquired. But from your position standpoint, if you’re talking to other sort of entrepreneurs that are kind of in this process, What percentage of the companies go IPO versus getting acquired? And what is the challenges of going IPO?

Jeffrey Nau, PhD:
Yeah, well, and I think that, you know, the, the market dynamics sort of change how lucrative it is to go public. And so, at the time were when we were thinking about going public, you know, last year was a banner year for companies going public. And, and we’ve had, we’ve had great years and we’ve had bust years and, you know, last year had its ups and downs. But, you know, what we’ve tried to do with Oyster Point is really build a standalone, medium size pharma company, with aspirations to grow that business. And so, we look at this product, the OCR, one nasal spray product for dry eye disease as a great foundational product to build upon. And if you really look at our space, it’s changed since I began in ophthalmology. In that we have a lot of consolidation at the top, even the even the traditional companies that were the but big companies have consolidated themselves now, we’ve got a lot of entrepreneurial companies. But that middle space is a little bit of a whitespace. And so, you know, there’s very few folks that are at the top to be the acquirers anymore. And so to build your company, you know, I think what we said was, we’re going to really take a standalone approach, we’re going to build value in the company, we’re going to continue to create the pipeline, continue to develop our lead asset moving forward. You know, we’re poised and in a position to start to look at other molecules outside the company and bring it in. And, you know, my management team right now, although we’re very busy on a number of things, including this NDA. One of the things we’re focused in on is let’s look at our pipeline and let’s start to plug new molecules in at various stages of that pipeline so that we’ve got a good lifecycle management for the company. And so, you know, I think the public pieces is a good way to finance the company. And you’re also, obviously there’s, there’s a lot of complexity to it as well. So I wouldn’t say that. You know, I think there are a lot of CEOs that go through it and say, I’m never going back that way. Again. It was it was one time and done. I think also, you know, it you hear from a lot of people that it’s a sort of a younger CEOs job, because in the, in the old way of doing things, and I think that’s changing now, you know, you’re on the road a lot, right? So you’re out talking to investors, you are away from home, you’re really pounding the pavement getting ready for the IPO. And the IPO happens. It’s like going through a marathon for a week and it’s just crazy. Yeah. And then at the end, you know, you’re hoping that everything works out. But there’s no guarantees usually right up until the last minute, right. And so, it’s a great process to go through. It’s stressful. But I think the interesting thing that’s going to probably happen through this year, and we’ll see how it changes that landscape is the travel and the going face to face is really going to be different. So, anybody who’s I see people going public now and I envy them because they can do a zoom call from home. And they’re not roaming around the city getting picked up by a car every five minutes to go to investor meetings. And so, you know, you just wonder how much of this will sort of stick as we get out of the pandemic and move forward. Because obviously, it’s a lot more efficient the way that we’re doing things now, right? I’m not hopping on a plane between San Francisco and Denver in New York and you know, going to various meetings and setting up schedules and, and the capital that you invest in it as well as completely changed, you know, zooms pretty cheap compared to plane tickets.

Ehsan Sadri, MD:
So, yeah, it’s interesting. I don’t know if you saw I think it was Goldman they raised $2 billion in two hours using zoom for fund, they just launched and it was all before like you said it was before it would have been a roadshow dinners and you know, just Uber driver picks you up, go to dinner. Yeah. And that’s been changed and, like telemedicine. It’ll be interesting to see how much of that sticks, you know, post COVID yeah, you know, right. So, like, we’re seeing patients in the clinic and I love telemedicine because I you know, patients, like half of the patients that don’t even need to come in, they only come in for them and for me, it’s easier. And but, you know, part of it is like he said, like, I wanted to stick and I want it I want it to you know, there’s a blend there’s a there’s a balance. But, but I think ultimately I have a feeling that it’s going to stick I have a feeling that this has gone far enough that people are going to probably have different they’re going to say this if it’s easier to call more cost effective way of doing it. Why wouldn’t you do it? And I think at the end of the day that wins, whether we like it or not, and I think telemedicine for instance. It’s not going to go away. There’s no way and I think it’s just going to explode. I think the patients love it. Um, I think I think the roadshow will be another one to see what happens. Yeah, no, I’m interested.

Jeffrey Nau, PhD:
You know, we’ve it before the pandemic started, we invested in zooms room technology in our office, so we have all the offices wired up with speakers and cameras and things and you know, I think this has also made us think about you know, what is what is home look like what is the home office look like? But I do think that the technology is there for this to be something that sticks and you know, think about how much you get done when you have a half hour of time, and you’re not, you know, having to traverse to another meeting or get on a plane or, you know, you can get a lot of things done in a very short period of time between zoom meetings. What I worry is, you know, there’s the, to your point that you made at the outset of the call, though, we do have to think about how to keep that sort of personal peace there. And we it’s something we pay very much attention to with our employees. But I think, you know, the old adage of lots of business deals get done on the golf course, sticks as well. So, you know, what I what I do worry about and we’ll all have to work through this is, is that personal feeling that you lose when you’re not in the room with someone shaking their hand, going out to dinner, having that social interface, it’s going to trickle over to business in ways that we probably don’t totally understand today as well. So, you know, for you as well, I mean, I’m sure you have patients that half the reason they come in is because of a medical reason and the other half is because they want to have that interaction with you, right? For those patients that lose that. The other piece that that that I also think about with my employees is, you know, we there’s the mental health aspect of the whole thing for sure. For sure. Yeah, it’s definitely be interesting to see.

Ehsan Sadri, MD:
Well, with that said, I’d really want to thank you for coming on. And I know, you have very bright future and you’re in an important part of the ecosystem here and treating patients and treating in a novel ways, which I’m excited about personally, and I think, you know, for those of us who’s following you guys closely, it’s great to see the whole story evolve and see that you can kind of start as a young entrepreneur and then you know, end up where you’re at, what would you tell and I asked this of all my guests, what would you tell a young Jeff? Back in Hanuman? Yeah. You know, studying and trying to hustle or taking photos of the retina in the darkroom? Yeah. knowing who you are now What, what? What are some things you would tell that that guy?

Jeffrey Nau, PhD:
Yeah. So I think an important the couple of important pieces of information and advice would be, number one, I don’t think that you can value forward momentum enough. And, you know, look, you’re gonna run into road bumps along the way in your career, your career is going to take a right or a left turn that you didn’t expect it to. Yeah. And it’s the same thing with running a company, you know, forward momentum is a lot of what really has made us successful so far. You know, at the end of the day, you know, we’re all going to look back at all the things that caused us stress during the development of our various products that we’re trying to bring to market, but, you know, it’s continuing through those adversities and making sure that you’re problem solving and moving forward. And also understanding that you’re gonna run into these things. And I sort of look at my career that way, you know, at various stages along the career, my career did I think that I would be a CEO of a biopharmaceutical company, Probably not, but I really, I would say, relish all of the different experiences that I’ve had, you know, people, people say, Hey, you know, you do a lot of speaking, I’m nervous, how do I how do you do that on stage? Or how do you do that? When you’re standing in front of a group and I say, look, you know, I, I had to approach families about organ donation after they just lost the loved one. That’s way more stressful than anything I’m going to do on stage. I worked in a lumber yard as a kid talking to you know, grizzled contractors, that is not an easy thing to do, either. So, you know, you take these experiences that you’ve had over your career, and at the time, they don’t seem like they’re going to make you a better person down the road. At the end of the day, there’s a lot of these things that I did along the way, I would say make me the type of CEO that I am today.

Ehsan Sadri, MD:
Hmm. So what type of CEO are you?

Jeffrey Nau, PhD:
Well, I think if you were to ask my team, you know, I think I lead by example. And I definitely get my sleeves rolled up and get involved. And, you know, I’m not, I’m definitely not the guy who sort of sits back and directs traffic. I, I the part I love about being in biotech is I love the fact that you can be in the clinic, you could be at the benchtop. You can be in the business world and you know, every four or five years, it’s sort of a different thing that we’re focused and working on, it’s never the same thing. Science is evolving. What we’re working on is evolving. And so, you know, I love the fact that I can interface with all of those different aspects of the company. And, and I like to lead by doing and, you know, my team knows that there’s, there’s really nothing that I am going to ask them to do that I wouldn’t roll up my sleeves and do just as well. There’s a lot of days when I’m washing the dishes in the office and a lot of days when I’m, you know, putting PowerPoint slides together, it’s not, you know, getting a lot of people to direct to do those things.

Ehsan Sadri, MD:
Very good. Well, it’s been a pleasure having you on and we wish you best of luck.

Jeffrey Nau, PhD:
Yeah, thank you very much. Appreciate it.

Outro:
Thanks for listening. We hope you plan to join Jeff and other public company CEOs at the OIS public company showcase on Thursday July 16 podcast listeners can register for free at OIS.net. Stay tuned for next week’s OIS Retina podcast with Dr. Firas Rahhal, and Paul Hallen the Global Head of surgical retina at Alcon.

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