Welcome back. We'd like to welcome Gossamer Bio, trades on the NASDAQ under the symbol GOSS. It's a late-stage biopharma focused on pulmonary hypertension. The company's lead program, seralutinib, is in phase 3 in PAH and expects to commence a phase 3 in PH-ILD in the near term. Joining us today for the update is Bryan Giraudo, Chief Operating Officer and Chief Financial Officer. Bryan, it's good to have you back.
Great to be here and thanks so much. Really starting a very exciting time for Gossamer as we expect to have the phase 3 readout for the PROSERA study in pulmonary arterial hypertension announced in February of next year. We are on our way to what we think will be data and building a company that will be a true market leader in the $7 billion PAH marketplace.
Fantastic. What near-term milestones should investors watch for?
I think certainly the two that you had mentioned. Obviously, the top-line data from the PROSERA phase 3 study we think will be a very, very important catalyst for not only our company but the stock because we expect it obviously to be positive data, statistically significant, and that will commence a regulatory process to get approval to commercialize the drug in the United States and around the globe with our partners at Chiesi. Secondarily, we expect to commence hopefully by the end of this year a phase 3 in an adjacent indication, pulmonary hypertension associated with interstitial lung disease. As we've talked previously in our conferences together, that is a marketplace that is two to three times the size of the $7 billion market that we currently see in PAH with very little competition, only one approved drug and only approved in the United States.
We think we're sitting on an opportunity here where we could have two commercial launches before the end of the decade in a marketplace that could be well in excess of $20 billion.
Great. What have you done to increase the probability of success in the ongoing phase 3 PROSERA study you mentioned?
Great question. What we've done is we've employed a number of tools to ensure that we have a sicker patient population than we had previously in phase 2. That includes using an enrichment strategy called the REVEAL Lite Risk Score, but importantly having the right quality control over the endpoint here, which is six-minute walk distance, as well as going to geographies that our competitors have found the greatest amount of efficacy. That includes going to places like Eastern Europe, NATO members, not former Soviet republics, but also places like South America, going where there's just patients with less comorbidities, folks that really have PAH. If you were to look at precedent studies, both the severity of disease that we've been able to enroll is sicker than other studies, and we've gone to those geographies that yield the greatest efficacy.
We think we've really put our thumb on the scale for ensuring the probability of success.
Please talk about what plans your company has in PH-ILD and how it views that opportunity.
Great question. Certainly, we think PH-ILD is a tremendous, unfortunate opportunity for us because there are about four times as many patients around the globe that have pulmonary hypertension with interstitial lung disease. However, only one approved therapy, only approved in the United States. It is really a global opportunity where the epidemiology is rather significant, but more importantly, the absence of any sort of real treatment paradigm we think is a tremendous setup, not only for our clinical work that we're going to be doing, but importantly commercially, where we expect to have the same price as therapies in pulmonary arterial hypertension. The absence of competition in a much bigger patient population suggests that it could be quite lucrative in the interim and long term for our shareholders.
How do you envision seralutinib to be used in the PAH and PH-ILD treatment paradigms?
Absolutely. What we rest our hat on with seralutinib is certainly through our phase 2 work and the associated open-label extension part of the study, where we track patients out over 18 months. Seralutinib has shown not only best-in-class safety, where we do not have the deleterious side effects that the current market leader, sotatercept, has. Just as we remember, that includes with sotatercept, intracranial bleeds, gastrointestinal bleeds, pericardial effusion, and death. We have a little bit of cough. Moreover, the data we've shown to date shows that seralutinib is unprecedented in both its durability of treatment and its continued deepening of efficacy. Said differently, you can put a patient on seralutinib for many, many years, not have to worry about safety, and the depth of our efficacy is potentially getting patients back to having normalized lifestyle and pulmonary and heart function.
We think that seralutinib will be used after the first two approved therapies, which are ERAs, endothelin receptor antagonists, and PDE5s. Think of Cialis, think of Levitra, think of Viagra. Those are all generics. The next drug, the branded drug that will be used the most, that will have the most number of patients will be seralutinib. We're very excited to disrupt very meaningfully the PAH marketplace that's been fairly static for the past 30 years.
You recently announced an option to acquire Respira Therapeutics and RT234, an investigational inhaled on-demand therapy for pulmonary hypertension. How does this complement seralutinib and your broader pulmonary strategy with hypertension?
Great, great question. The Respira asset is an inhaled form of vardenafil, or we would know it commonly as Levitra. Levitra is really going to be a better, I think, PAH drug than it was an erectile dysfunction drug. That is because it's very fast-acting and wears off rather quickly, obviously not ideal in the ED world, but quite good for an as-needed therapy. Think of it this way. A PAH patient is sitting in their car. They have to have trouble with exercise capacity, being able to walk into the grocery store, go into a mall, walk across the field at their kid's soccer game. You could take a puff of RT234 and in about 15 minutes, you feel a burst of energy, a decrease in breathlessness, and able to do basic activities with more energy and less pulmonary distress.
We think it'll be an absolute supplement to what we're doing with seralutinib, which is a chronic treatment that's fixing the underlying plumbing of the disease. Inhaled vardenafil will be a lifestyle therapy for folks that will allow them, which I think is really important for patients, to feel like they are participating in normal activities and not having to be constantly reminded of their disease.
Given some reimbursement challenges for sotatercept in Europe, could this signal similar hurdles or maybe opportunities ahead for seralutinib?
I think it's a great question in regards to reimbursement hurdles with sotatercept. The biggest issue that sotatercept is having when it comes to reimbursement is mostly in the U.K. That's because the U.K. regulators have said, if we're going to price a therapy at the price you, Merck, want, we have to take into account that there are significant costs in managing the side effects that are inherent with sotatercept. As I said, brain bleeds, gut bleeds, pericardial effusion, that's fluid around the heart. We're seeing incidences of colon cancer. European payers have to have a sidecar of money to be able to pay for these very, very significant side effects that are now being seen in the real world.
In regards to seralutinib, if you have a safer, more efficacious drug and one that can be taken at home, I think will be the reimbursement winner because you're not going to have to have a sidecar for a little bit of cough that really can be mitigated with folks taking a sip of water as they inhale the therapy. We do think that when it comes to the battle for patients outside the United States, we're uniquely positioned based upon our efficacy and safety profile.
Perfect. Thank you, Bryan, for this important update. We appreciate you.
Great to see you guys. Thank you.
All right, everyone. We'll be right back.
That's not my dog this time.
My dog heard it. Okay. Welcome back, everyone. Yes, here we go. We have an update from Regen BioPharma, Inc., trades on the OTC Pink sheets under the symbol RGBP. It's a biotech company in the immune-oncology and autoimmune disease space. Happy to welcome back President and CEO David Koos and Senior Scientific Consultant Harry Lander. Welcome, gentlemen.
Thank you very much. We're happy to be here.
Great. Take it away, David.
Get the show on the road. Okay, we've only got 10 minutes today. I'd like to hit the ground running on this. We're going to talk about Orphan Drug status, money that we've raised so far in the Reg A and where that is going, and then also where we sit with regard to finalizing everything on the clinical phase 1. First step is the orphan drug status. We have gone back and forth on a couple of comments with the Orphan Drug division of the FDA. I think we've got it to a point where they said they'll get back to us within 90 days. That's no guarantee that it's pass/fail, whatever. It'll be at least 90 days, especially with the government shutdown. I look at it, we're making headway there. The other thing that's going on is that we've been doing the Reg A.
The limiting factor is that the Reg A itself is small enough in size that participants that don't want to be over 5% shareholders can only buy a certain amount of stock. We have, to this point, sold about 9 million, 9.5 million roughly, shares of the Reg A, and that equates to about $95,000. The goal to get into clinical phase 1 is $105,000, which I think we'll get that fairly quickly. We've been building up the number of shares that can be sold into the system, and no one is really being abusive about it. I think today I noticed that we've sold something like 2.7 million shares in the market or 2.7 million shares are traded in the market. That's extremely good volume, extremely good liquidity, and the price was up most of the day and closed flat on the day.
Those are just off of my observations off of the apps that I use to look at it. I think that I'm excited to see things getting close. It's sort of feeling like when you put the spaghetti in the hot water and you're waiting for it to loosen up and become malleable. That's where I feel that we're getting to with the market, or at least in the way we're advancing our program. I'm very excited. I think we're just right around the corner from getting the clinical phase 1 kicked off, and nothing's going to make me happier than to see that happen. Harry, do you have anything you want to add to that?
No, I was surprised that the FDA continued to respond back to us even during the shutdown. That was a pleasant event. Things are continuing to move ahead with the Orphan Drug application, which is important. It's good. I do feel like we're very close to being able to start the phase 1 trial at six months' setting time.
Yeah, I'm very excited about it. I think we're moving things right along. Were there any areas that you felt like you wanted to address today?
I think until the phase 1 trial has started, we're just, I don't have a lot to report on that end.
Yeah, so the phase 1 trial, basically, we see that starting as soon as we've got the funds raised. I have commitments on those right now. It's just a matter of how quickly people actually move. I think that's good to see. I think the fact that we're trading well in the marketplace gives people a little more encouragement, a little more excitement about stepping up. No one wants to step up and be the person that buys the stock and it sits there. I think the activity has been good. I'm excited about the people that are interested in what we're doing. The thing that we need to look at is that as we get into phase 1, and it adds a lot more credibility to what we're doing, I think people will get very, very excited about providing better financing, better terms, and larger sums.
I know that there have been some comments that I've seen that are obviously from people who haven't been watching the videos that have said that they think that I'm getting rich off of the company while they're getting poor. I'm sad that they think they're getting poor. I do not take a paycheck out of the company. That is just something I haven't done since I came back to the company. I'm focused on one thing, and that's getting this company into clinical phase 1. That represents a huge milestone for the company, and I'm very excited about it. That being said, the people that are making comments to the opposite of that are ignorant. All right. That being said, I think we're running close on time. I'd like to get some questions. Anna, do you have any questions for us?
We sure do. Trevor wants to know, have you done another drawdown notice issuance in the past couple of weeks pursuant to the equity line agreement?
No, the equity line agreement is completely done. That's been done for a long time. The answer to that is no.
Are you more or less confident since the last conference call that Orphan Drug status will be approved?
After what we've experienced so far, I'm fairly confident. I don't know what they're going to come back to us with. If they're going to say they want some more data, they'll get that as soon as we get into phase 1 and we get the data that they need.
Since the last conference, have you engaged or in discussions with new investors? If so, what role will they play with the company and at what price?
I think that's a sort of a vague question because you can't really answer that. We always have people that are interested in the company, and I've actually turned away quite a few because I'm trying to keep the Reg A offering in just the hands of three different entities. That means that the Reg A offering can be successful without killing the price.
When it comes to the funds, how soon do you anticipate you will have necessary funds to start the clinical trials with HemaAccelerate?
I would say if we had this conference next week, we might have a bit of a different answer than this week. This week, we're very close. Next week, I think that we're probably over the hump.
Can you talk about any patents for HemaAccelerate?
Right now, we need to focus on getting into clinical phase 1. I don't know. Do you have anything you want to address on the patents, Harry?
We certainly haven't submitted any new patents on it recently. We do have some patented material around its use and around its production. No, David's, of course, focused on using our resources now to get us into phase 1.
Yeah, I think that the idea is that you're going to get material coming out of clinical phase 1 that you want to patent, and that's where you go with it. People don't understand it's very expensive to file and maintain patents. You want to make sure that there's value in what you're patenting.
All right. Do you have any closing remarks for our viewers today?
Next month, I think we're going to be on the 30-minute on the first presentation. I would expect we'll have a treasure trove of information for people. I'm looking forward to it. I wish we had more time now. I appreciate everybody's interest in following us along and going for the ride with us.
Perfect. Thank you, David. Thank you, Harry. We look forward to seeing you again real soon.