Welcome back, everyone. We have an update from Gossamer Bio. Trades on the NASDAQ under the symbol GOSS. It's a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. Please welcome CFO and COO Bryan Giraudo . Nice to see you again, Bryan . What's your update today?
Good to see you too, Anna. Thanks for having us. I think the update that's most critical is that we announced last week that we have completed screening for the phase III global registration study, the PROSERA study, which we now expect to have top-line data in February of 2025. We expect to complete enrollment here in about a week and a half. We are very, very excited that the enrichment strategy we were using to ensure we got patients that would respond to seralutinib at week 24 via six-minute walk were obtained. In fact, we feel very, very confident that we have truly one of the sicker patient populations that's ever been studied in a clinical study in recent years for pulmonary arterial hypertension.
This is critically important because, Anna, you remember our phase II study, which was conducted during the height of the pandemic, enrolled a much less sick patient population. The treatment effect was not as significant as we hoped for. Needless to say, the combination of our enrichment program as well as going to 31 different countries has allowed Gossamer to put its thumb on the scale to assure that we will have a positive study here that we'll announce in February of 2026.
Wonderful. That is good news and a good update. Give us a little bit more of a thorough update of the clinical trial process. Where are you?
Again, we closed screening. There was so much enthusiasm for the study that we originally were hoping to enroll 350 folks. We'll enroll more than that. As you know, Anna, when you've got lots of enthusiasm, you can't just shut things down because you will certainly anger important constituents and physicians. That's critically important for us at Gossamer because we also announced in the fourth quarter of this year, we will begin a second global registration study for pulmonary hypertension associated with interstitial lung disease, which we've talked about in the past, which is roughly two times the size of the PAH market, yet only one approved drug, inhaled Tyvaso, so only approved in the United States. Truly a very, very important disease area for us to go into with very little competition.
It's why we're ensuring that the folks that wanted to put their patients in the phase III study for PAH, we let them in because we want to keep our customers happy.
Can you talk a little bit more about that? Give us some more background information about those patients in the phase III and PAH. Why is that so important?
Because most of the patients, especially here in the United States, that are the physicians that treat patients with PAH, also treat patients with pulmonary hypertension with interstitial lung disease. If you're going to roll into another global registration study, you would like to have those physicians knowing that Gossamer took care of their PAH patients and will take care of the PH-ILD patients. A happy clinical community leads to, I think, better timeframes and long-term robust sales.
Gossamer recently presented preclinical data at the American Thoracic Society Conference in San Francisco. How was that presentation and how was it received?
The presentation was received very well because it was further scientific evidence that seralutinib, through its multi-kinase inhibition, is truly a groundbreaking and first-in-class therapeutic. American Thoracic Society, or ATS, is probably the biggest meeting of the year for pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease in the United States. I would tell you the enthusiasm over the four days here in San Francisco for seralutinib and Gossamer, given our safety, our efficacy, and potential for what we could do for patients, was extremely, extremely high.
Is there potential for this treatment beyond PAH?
Certainly. As I said, we'll be going into pulmonary hypertension with interstitial lung disease. Along with our partners at Chiesi Pharmaceuticals, we're looking at, and this is why this preclinical data was very important, looking at possibilities in idiopathic pulmonary fibrosis, which is known as IPF, which is another significant market. If PAH is roughly 50,000 people in the United States, PH-ILD is roughly 100,000, IPF is in the millions. Again, significant unmet medical need. We think that certainly seralutinib is that drug that could be truly a portfolio within a compound.
What is Gossamer's cash situation like?
We entered the quarter with about $230 million of cash. I think what's important, our relationship with Chiesi Pharmaceuticals is critically important because other than PROSERA, everything will be a 50/50 cost share. To have the deep pockets of Chiesi, the deep experience that they bring for global markets outside the United States, it really is a match made in heaven.
Can you talk about what is protected with IP delivery formula? How is this protected?
We have composition of matter patents, including a five-year extension that would take us to 2039. New formulation work that we're working on with our friends at Chiesi could take us to 2042, 2043. Quite some time. Hopefully, Anna, when our patents expire, you and I won't still be doing this crazy business.
A question from Kian asking if patients have seen inflammation come back after it shrunk.
It's a very good question. We have seen to date our open-label extension data from our phase II study, as well as things from phase Ib, have patients out over five years where both the inflammation, fibrosis, and the proliferation, that cellular overgrowth that happens in the vasculature of the lungs, has certainly been abated. If anything is true, we've seen patients be able to resume near normal life.
All right. Closing remarks from you today about Gossamer?
The time is coming for us to be able to report the top-line data from our phase III study. We've done everything we possibly can to ensure the probability of success is very high. Certainly, please stay tuned as we give updates through the balance of the year and into early next year.
Wonderful. Thank you, Brian, for this update. We will see you again real soon.
Thanks, Anna.
All right, everyone, we'll be right back.
CEO Barry O'Shea, Highland is advancing the Copperwood Project in Michigan to a near-term construction. They recently announced strong progress on site work and detailed engineering as they move towards providing much-needed domestic copper supply right here in the U.S.. Welcome back, Barry. Nice to see you. And we're looking forward to your update today.
Thanks, Anna. It's nice to be back to provide an update. Listen, as it says on the screen, Copperwood is one of very few fully permitted copper projects in the U.S., I think, at a really important time. You know, if you look at the headlines recently, the conversation is really intensifying around domestic critical mineral production and in particular copper. I think that's where Highland truly stands ready. You know, what the U.S. really needs right now is domestic production, and Copperwood is ready to go. It is one of the most advanced U.S. copper developer assets that there is. What that means is that in the 15-20 year cycle that it takes from first drill results to building a mine, you know, we're at the year mark around 16. Feasibility study is complete. Geology is done. Permitting, most importantly, is done.
Really an asset that is ready to go. Nicely sequenced with it is our 1/3 owned asset, a joint venture asset, the White Pine Project, also in the Upper Peninsula of Michigan. Really well placed here. The focus now and the reason of the update is to provide, you know, an update on execution. At the end of the day, to have those building blocks in place is fantastic, but you need to get ready to build your project. Step one through 2024, we did a lot of our initial site impacts. Now in 2025, we have the environmental mitigations in and around those. You know, a really nice opportunity to prove that we're going to be good stewards of the environment. We're setting up a 700-acre wetland preservation area.
We've created new wetland on site and, of course, managing our streams, our stream diversion structure. All really nice opportunities to work within the regulation of Michigan. Of course, acknowledging that mining does have an impact. This is a capacity to, you know, keep that impact minimal, of course, offset it, and then in conjunction with regulation in time, responsibly close the project. The next key piece to execution is detailed engineering. In January, we initiated detailed engineering with DRA Global on the mine and process plant, in February with both on the water management side, and most recently with Tetra Tech on the tailings disposal facility. This work is really critical to prepare your project, de-risk it, optimize it, really understand the construction schedule, operating and capital costs, all things needed to prepare yourself from the due diligence and truly be ready for a construction decision.
Another piece is metallurgical drilling. We did a campaign about two months ago on time, on budget, collected about 450 kg of sample that are now with the lab. You know, as a starting point, you retest that you can replicate your original network and seem to be in, seem to, we seem to have had good success there. Most importantly is testing the ultrafine flotation technology. You know, aside from copper price being one of the most influential aspects of a project is its recovery. Improving the grade recovery curve through the application of ultrafine flotation technology is something that we're looking forward to proving out over the coming couple of months. Certainly not to be missed is community engagement. At the end of the day, you need to be welcoming your region.
A host of townships and counties, particularly Wakefield and Ironwood, have doubled down on their support with further resolutions of support for the project. We have had EGLE, the permitting authority at site, recently again monitoring and ensuring that we're operating well and we continue to have their endorsement. The U.P. delegation or the legislators, state legislators, that's three members of Congress and one senator, have all penned a really strong letter of support for the project. Interestingly, again, at the federal level, U.S. Congressman Jack Bergman wrote a letter to his federal colleagues, again, demonstrating his support. This is all really important from our perspective. We want to be welcome in this region at a local, state, and federal level and look forward to progressing with that license to operate. While we're active at Copperwood, our partners, Cantera, are equally active at our second project, White Pine.
We will look to benefit from their activity. They're putting their time, capital, and energy. They did significant drilling to collect geotech and met samples in 2024. They're now progressing on through environmental baseline and prepare that project for further engineering studies and permitting. A very exciting time, truthfully, for both projects. With that, this is the last slide here. You know, what we want to do is make sure that we hold ourselves as management accountable to key catalysts. We have a whole host of them through the balance of this year. I won't walk you through them, but they're solid, tangible catalysts that allow us to step along the path, you know, with the ultimate goal of getting the project ready for a construction decision and project financing in early 2026.
With that, Anna, I'm happy to pass back to you for any questions that you have.
Perfect. Talk about the recent executive order to increase domestic critical mineral production. How does that impact your ability to source federal funding?
Yeah, I think it's quite a game changer for mining and for smelting in the U.S. I think, you know, people have come to learn that there is a massive domestic supply demand imbalance for copper specifically, and also from a smelting capacity perspective. That executive order really is looking to prioritize both of those. Looking at permitting timelines, that's obviously a little less critical to us as we have our permits in hand already, but also looking at ways to prioritize funding into domestic miners. We think it's going to open up a host of avenues for us, which we're excited to chase down.
Perfect. You talk a lot about community engagement support. Why is this so important?
You know, it's important to be welcome. Having your permits, of course, that's, you know, from a legal standpoint, what you need to build. Of course, we're very happy that Michigan has strong regulation in place, regulation that is environmentally forward, certainly from our perspective. You also want to be welcome. That's why we spend a lot of time in the community, at town hall meetings, just making sure that we have education into that area and so on and so forth. You know, it's been quite resounding, certainly at the very local Western U P region in terms of the support. It's a historic mining district, and they're looking to bring it back.
A large component of your current site work is around environmental mitigation. Why is that necessary at a mining project?
Yeah, you know, like I said, you know, mining has an impact. We understand that, but you have an opportunity to minimize it. You know, for instance, this is an underground mine, not an open pit, so a modest surface footprint. Of course, you have an obligation and a desire to mitigate. As and when we disturb any land, we have an obligation to offset that with new wetland and new streams, as an example. Lastly, you know, through responsible closure. There is a whole host of ways to mine well, you know, where you know the environmental controls certainly do not have to be at risk, you know, relative to, you know, the employment that naturally remains to the region and of course the domestic supply of copper.
What's the relevance of getting detailed engineering to 40% complete?
Yeah, that's a mark that we think allows us to defend ourselves in a project financing and a due diligence. When you look to put debt in place, naturally, debt providers go through a host of technical diligence on the mining process, water management, tailings side. That 40% really allows you to finalize your design, really understand the risk profile of all of the work packages and defend yourself. Interestingly, on the tailings management area, certainly an area of risk, we're looking to detail engineer that more up to the 80%-85% range to make sure that we have sound design and fundamentals as we consider construction.
Given you have two projects in your portfolio, is there a larger regional play in the district?
Yeah, listen, I would certainly say that's the case. You know, the UP and the Western UP in particular, it's referred to as Copper Country. There were many mines scattered along the east-west corridor over the last hundred years. There's a really nice opportunity to bring that economic boost back into the region. You know, acknowledging that, you know, Michigan put new mining legislation in place that is current and modern in 2004, it really takes into account all of the elements from a mining perspective. So we think it's an opportunity to come back in. There are others, Talon as an example, Lundin with the Eagle Mine are in the region. We look forward to responsibly building it out as others are doing at the same time.
Do you have an opportunity to secure external financing through any partnerships?
Yeah, listen, there are a host of ways to secure funding from a debt perspective. Naturally, there are private equities and otherwise that will be looking to financial institutions, of course, soliciting interest from strategics, particularly in the U.S. to the extent that's available. We think that will be over time. Naturally, from state and federal sources, I think there's other opportunities. You know, given the profile of copper at the moment, I think that Copperwood simply is a project that needs to be built.
Barry, thank you so much for this update. Do you have any closing remarks for our viewers today?
No, just that we will continue to hold ourselves to these nice catalysts. We'll continue to report out our progress. I think particularly, you know, keep your eye out for the network in the next couple of months, transitioning from phase one to phase two engineering. Of course, we'll continue to update the market on advances on both state and federal funding. Excited to get this project moving towards construction in 2026.
Great. Exciting times for you. Thank you so much for joining us back on the conference.
Thank you, Anna.
All right, everyone. That is it. On behalf of all of us at Emerging Growth, thank you to all of our presenters and attendees for making this a success. Remember, a complete replay of the conference separated by company will be on our YouTube channel. Please follow us on X @EmergingGrowthC. We always post new information on X first. I'm Anna Berry, and you guys have a great rest of your week, and we'll see you next month.