Gossamer Bio, Inc. Common Stock 0 Earnings Call

Hello, and welcome to the Gossamer Bio Business update call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star 1 on your telephone keypad. If you would like to withdraw your question, simply press star 1 again. I would now like to turn the conference over to Bryan Giraudo, CFO and COO. Please go ahead. Thank you, operator.

Thank you all for joining us today. Earlier today, we issued a press release announcing several important updates for Gossamer. The outcome of our Pre-NDA Type B meeting with the Food and Drug Administration and receipt of the official minutes, the reacquisition of worldwide development and commercial rights to seralutinib from Chiesi, and stockholder approval of the previously announced proposals related to our convertible note exchange and reverse stock split. The press release is available on the investors section of our website. Joining me today are Faheem Hasnain, our Chairman, Co-Founder, and Chief Executive Officer, Caryn Peterson, our Chief Development Officer. Robert Smith, our Commercial Officer, will also be available during the question and answer session.

Before we begin, I would like to remind listeners that today's discussion includes forward-looking statements, including statements regarding our planned NDA submission, potential regulatory review and approval timing, the development and commercialization of seralutinib, the anticipated benefits of the rights reacquisition, our capital structure, and our financial position and runway. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Please refer to our SEC filings and today's press release for a discussion of these risks. We undertake no obligation to update these forward-looking statements except as required by law. With that, I will turn the call over to Faheem.

Thanks, Bryan. Good morning, everyone. Today marks an important step forward for Gossamer and for seralutinib. We now have a clear regulatory path toward an NDA submission in PAH, worldwide control of the program, and stockholder approval of the capital structure actions needed to support the company's next phase. I will start with the transaction with Chiesi. We made the decision to reacquire Chiesi's rights and consolidate worldwide ownership of seralutinib under Gossamer. This was a deliberate decision to invest in our own program at an important moment in its development. Based on the totality of the clinical evidence, the progress we have made with FDA, and our view of seralutinib's global commercial potential, we believe the right decision is to bet on ourselves. We wanted Gossamer and its shareholders to own substantially more of the program's future value. The outcome is exceptionally compelling for Gossamer.

We regain worldwide development and commercial rights, secure full global strategic and operational control, and retain the substantial majority of seralutinib's worldwide economics with no upfront cash payment. In fact, Chiesi will make a $5 million payment to Gossamer shortly after signing. Under the prior collaboration, Gossamer shared U.S. profits equally with Chiesi and participated outside the United States through a royalty. Under the new structure, Chiesi will remain entitled to a capped royalty on worldwide net sales and specified success-based milestone payments, giving Chiesi defined participation in the program's future success while allowing Gossamer to retain the substantial majority of the worldwide value. Chiesi's remaining economics are tied to the future success of seralutinib. The royalty is payable from commercial sales and ends once the agreed cap is reached. The milestones are payable only upon achievement of specified success-based events.

This replaces the prior perpetual sharing arrangement with defined finite and contingent obligations. Put simply, we're buying back substantially more of seralutinib's global upside at a point when our conviction in the program has never been stronger. We're also consolidating all decision-making within Gossamer. One team will set the worldwide strategy across regulatory, manufacturing, pricing, market access, commercialization, and lifecycle development. This should allow us to move faster, maintain clear accountability, and respond more flexibly as we approach the planned NDA submission and consider the potential of seralutinib beyond PAH. This was a negotiated outcome that both parties determined was appropriate for their respective organizations. Chiesi retains defined participation in seralutinib's success, while Gossamer has secured worldwide control and the substantial majority of the program's long-term economics. Caryn will now walk through the regulatory update and what we've heard from the FDA. Caryn? Thank you, Faheem. Following the PROSERA readout, the central regulatory question was whether the complete body of evidence could support an NDA filing.

Based on the clinical benefit observed in PROSERA, the independent confirmatory evidence from TORREY, and the consistency of the broader data set, we believed it could. We took that question directly to FDA. We rapidly developed a clear submission strategy, requested a formal Pre-NDA Type B meeting, and presented FDA with a proposed evidentiary framework built around PROSERA's one adequate and well-controlled clinical investigation, together with the confirmatory evidence from TORREY and other supportive analyses. We held that meeting in person in mid-June and have now received the FDA's official written minutes memorializing the discussion. In those minutes, FDA characterized the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA as review issues rather than filing issues.

The discussion also provided feedback on the format and the content of the planned submission. The acceptability of the individual elements of the application, including the efficacy and safety evidence, will be determined by FDA during its review of the complete NDA. As the basis of the submission, our approach is to have PROSERA serve as an adequate and well-controlled phase III study, with TORREY providing independent confirmatory evidence from a separate randomized placebo-controlled study. We believe the supportive analyses provide additional evidence of the consistency, clinical relevance, and biological coherence of the overall seralutinib data set. We are on track for the planned NDA submission September 2026. To be clear, FDA has not accepted our NDA for filing or completed its substantive review of the application. The degree of statistical significance, the clinical meaningfulness of the treatment effect, and the overall risk-benefit profile will be evaluated during that review.

The key outcome of the meeting is that these are review issues rather than barriers to a filing. If the NDA is accepted for filing and the review proceeds on the expected timeline, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027. Reaching this point reflects years of work and contributions from patients, investigators, and employees around the world. It is a very important moment for our company, and we are optimistic about the future of seralutinib. With that, I'll turn the call back to Bryan to discuss the capital structure update.

Thank you, Caryn. At our special meeting of stockholders held on July 14th, 2026, stockholders approved the proposals related to the previously completed exchange of our 5% convertible senior notes due 2027 and authorized the board to effect a reverse stock split. Through the exchange, we exchanged approximately $181.1 million of the $200 million aggregate principal amount of the 2027 notes for approximately $65.2 million of 7.5% convertible secured notes due 2030, together with the applicable equity securities and warrants. The transaction reduced the aggregate principal amount of our debt by approximately $115.9 million. Eligible holders that tendered by the applicable early deadline also received purchase warrants. The details of the new secured convertible notes, equity consideration, and warrants are included in our prior announcements and SEC filings.

Stockholder approval authorized the shares issued in the complete exchange and gives the board flexibility to effect a reverse stock split. The reverse stock split authorization is intended to support compliance with the Nasdaq's minimum bid price requirements and an improved capital structure. The timing and ratio of any reverse stock split remains subject to final board action. These actions provide flexibility as we execute the NDA submission and prepare for the potential next phase of seralutinib. As of June 30th, 2026, cash equivalents, and marketable securities total approximately $57 million. With that, I'll turn the call back over to Faheem for concluding remarks.

Thanks, Bryan. Stepping back, today's updates bring together three important pieces of the Gossamer story. First, FDA confirmed that the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA are review issues rather than filing issues. We are therefore proceeding with our plan to submit an NDA for seralutinib in PAH in September 2026, supported by PROSERA together with confirmatory evidence from TORREY and other supportive analysis. Second, we have reacquired worldwide rights to seralutinib, giving Gossamer global control of the program and the substantial majority of its long-term economics. Third, our stockholders have approved the capital structure actions designed to reduce near-term debt and better position the company for the work ahead. We enter the second half of 2026 with a clear regulatory objective, worldwide rights to seralutinib, and a stronger capital structure.

We are focused on executing the NDA submission and working to bring a new therapy that targets an important pathway implicated in the underlying pathology of the disease to PAH patients who need better options. I want to thank our employees, investigators, patients, and caregivers, as well as our shareholders and partners for their continued support. Operator, we're now ready to open the line for questions.

Thank you. If you have a question, please press star one on your telephone keypad to raise your hand and join the queue. If you wish to remove yourself from the queue, simply press star one again. One moment please for your first question. Your first question comes from the line of Yasmeen Rahimi of Piper Sandler. Your line is open. Good morning, team.

Congrats to the incredible great news. I know a lot of work went into it. Maybe as you're preparing through September for the filing, maybe give us a little bit color around a lot of additional analyses have been completed to be part of the filing that maybe you haven't had a chance to disclose to us yet. How do you envision sort of the cadence of additional data to really strengthen the positioning of seralutinib, and educating investors around the high reward and low risk profile of the drug? Two, second question for you is, do you anticipate, and I don't know if at this point an AdCom discussion came up or not, that would also be really helpful if you could shed some light.

The third one is, do you have any financial obligations to Chiesi by taking seralutinib back? Thank you again for allowing me to ask these questions.

Thanks, Yasmeen, for your questions. I'll answer the last question first, and then Caryn, I'll turn it over to you for the first two questions. As it relates to financial obligations to KZ, fundamentally, no financial obligations to KZ other than the royalty on worldwide sales and some success milestones. Really, that's fundamentally, it becomes a fairly clean break, which, as I said in my earlier remarks, really allows Gossamer to retain a substantive portion of the seralutinib opportunity, far greater than what was available to us when we were in the partnership. Caryn? Thank you, Faheem. With regard to the additional analyses that we'll be conducting, there are a number of pre-specified subgroups that have probably characterized best as continued disease burden.

Those analyses all very much support the efficacy of seralutinib. In addition, FRI is very supportive of seralutinib's effect on the underlying pathology of the disease. We have a number of different translational medicine approaches that we took during PROSERA, and those analyses are all ongoing. Those are all confirmatory evidence of what we've seen in both TORREY and PROSERA. With regard to the AdCom, this is something that we would not probably hear until the middle of the review. It's nothing that we discussed at the FDA meeting.

Thank you so much. Yes, to your question about when that data may be available, we are expecting a robust presence at the European Respiratory Society.

For much of what Caryn did as far as the supportive data for the discussion with the FDA, much of that foundation has already been disclosed publicly. It's been really, as Caryn said, diving into those subgroups, and we plan to disclose those at major medical meetings as well.

Yep. Wonderful. Your next question comes from the line of Joseph Schwartz of Leerink Partners.

Your line is open. Great.

Thank you, congrats on the progress. It's great to see the hard work paying off. I had a few questions. Namely, I was just wondering how much insight you were able to obtain into how the FDA views the appropriate p-value threshold and how sympathetic they appear to your analyses suggesting that a limited number of sites who relaxed enrollment criteria disproportionately contributed to the miss. Did you get the sense that the FDA is willing to look beyond the headline result and evaluate the consistency of efficacy in the appropriately enrolled population, how much they view an unmet need remaining? Thank you. Karen, do you want to jump in on that, we can add in?

Sure. Be happy to. There wasn't very much discussion at all around the p-value. It was really around the continued unmet medical need in PAH, the totality of evidence that we presented to them across the entire population, obviously looking at regional differences. There was no discussion at all on the p-value per se.

That's helpful. Thank you. Go ahead, Bryan.

I was going to say, Joe, I think the other piece that's helpful is three days after our meeting with the FDA, the FDA did put out guidance where again, they were suggestive that in orphan diseases, rare diseases, and things with a high unmet medical need, an appropriate p-value is 0.05. Clearly there has been a shift when it comes to situations like ours that the FDA provided guidance on. I do think that as opposed to them having a direct conversation with just Gossamer, they have provided the industry with a very robust update.

That makes sense. Thanks again.

Thanks, Joe. Your next question comes from the line of Elli Murrell of Barclays.

Your line is open. Hi, this is Jasmine on for Elli.

Thank you for taking our question, and congratulations on all the updates and the hard work. Just one question. What are the plans for PAH-ILD now that you've regained the rights to seralutinib? Thank you. Yeah. Thanks for the question.

Look, we actually have even greater conviction now with the data that was generated in PROSERA. We have greater conviction around the ILD opportunity given the really, I think, striking results that we've seen with the connective tissue disease subgroups in this study. That really gives us confidence and belief that this drug can have a meaningful impact for patients with PAH-ILD. From our view, obviously, we need to get the PAH indication approved first, which we would hope would be sometime around August 2027, would be the PDUFA that we'd be looking at. Subsequent to that and that approval happening, we would be looking to initiate a PAH-ILD study shortly thereafter.

It is even possible, and of course, much conversation still needs to be had with the FDA, but it is possible that as part of a confirmatory process, the FDA would look for further confirmatory data post-approval. We would see PH-ILD, and we've had past conversations with the FDA about PH-ILD as being part of that confirmatory component. So we'd be very, very happy with that outcome.

Okay, great. Thank you. Your next question comes from the line of Patrick Trucchio of H.C.

Wainwright. Your line is open.

Good morning. This is Luis in for Patrick. Thank you for taking our questions. Going back to the Chiesi reacquisition of worldwide rights from them, did their view change? Did Chiesi's view change on PAH approvability, the commercial opportunity, and development risk? How does your current financial position support commercialization and launch, assuming approval? Then I have a follow-up.

Great. Brian, do you want to jump in, and I'll add where necessary?

Yes. The practical reality is our friends at Chiesi are going through a bit of a reorganization of their own business and are really, with the recent acquisition, pivoting their business really towards the very rare ultra-orphan disease marketplace. Ultimately, I think you can see some recent announcements which include some significant management changes on their end. That, combined with the effort that would be needed to commercialize seralutinib globally, it just felt like the right time for us to part ways. Faheem, any other thoughts? Yeah.

Look, I don't really think that their perspective on the opportunity changed as much as what really appears to be changing, and I really can't speak for Chiesi. Certainly, from our perspective, as Brian said, their focus has shifted in the context of how they think about the U.S. opportunities, given what was in their pipeline and given some of the challenges that they've had in the context of their pipeline. From Chiesi's perspective, I think it's more about their focus and their shift towards the ultra-rare orphan disease. Of course, they are needing to juggle many more priorities than our singular priority here at Gossamer. In the context of their strategic decision-making, they made the decision that they wanted to reprioritize towards some of their other assets in their pipeline.

Look, from our perspective, and we can only speak from confidence about how we view things, we are tremendously excited about regaining the economic profile that we've got around seralutinib. Obviously, we've got conviction around the potential for approvability here of this drug. We have conviction around the meaningfulness of this drug. With that conviction, being able to get back worldwide rights gives us substantially greater upside. We're absolutely thrilled with the outcome here.

Yeah. Luis, this is Robert Smith. I think you put also a question on the commercialization and launch readiness. Obviously, we had slowed many of those activities once we got the top-line data while we were kind of sorting through what all of that looked like in order to preserve our capital as much as possible. We fully expect to resume the launch readiness on the back half of this year, which will give us a solid year to prepare the organization for a successful launch in, call it, August or September of 2027.

Mm-hmm. Great. Thanks. That's really helpful. For your NDA strategy, what are you going for in the label? Are you going for the raw PAH population, an intermediate high risk, maybe CTD focused, or yeah. How should we think about it given the subgroups and pre-specified sensitivity analysis?

Yeah. I'll ask Caryn to jump in, obviously, many of those questions are very much linked to future conversations with the FDA as we negotiate the label. Caryn, do you want to comment?

Yeah. Thank you, Faheem. Obviously, label negotiations towards the end of the review will dictate what that indication statement is, we do believe the data supports a broad indication.

Obviously, this is what we are planning to have in the NDA, is a broader indication, but that is up for negotiation with the agency.

Did the agency raise any safety issues on the data available? Any box warning expected? REMS?

That is not something that they discuss at a pre-NDA meeting. That will be discussions that'll be had throughout the review of the NDA.

Okay. Great. Thank you so much.

Yeah. Just to add on to that, I know Caryn mentioned the broad label, and that's what our anticipation is. Even if you look at the numbers from PROSERA in the intermediate to high-risk group, represented over 80% of the population in PROSERA. We know that that patient population did extraordinarily well. As it relates to the connective tissue disease population that Bryan had mentioned earlier, really the results there are unprecedented in PAH with a walk above, I think up to 37 meters. The totality of the patient population that benefited from seralutinib will be a very, very high percentage of the overall market potential.

Thank you. Your next question.

Again, if you would like to ask a question, please press star and the number one on your telephone keypad. Your next question comes from the line of Paul Choi of Goldman Sachs. Your line is open. Hi.

Good morning, thank you for taking the question. I was just wondering, in your meeting with the agency, did they perhaps any offer direction or guidance on filing for a specific subpopulation? Just if you could provide some clarity there, if they were more favorably inclined for one subgroup versus the entire ITT population. Then second, just with regard to the global opportunity, can you provide your latest thoughts on potentially filing in Europe and any other major geographies? Thank you. I'll take the last part of that question first.

Then Caryn, you can handle the first part. As it relates to filing in other locations, that's very much in our sights. Obviously, the ensuing discussions with the FDA are first and foremost the highest priority for us. Shortly thereafter, we would be setting our sights to EMEA and other appropriate locations. That's very much part of our plan as we go forward. Caryn? Thank you, Keith. We did discuss with the agency all of the various subgroups that Bob just spoke about.

The basis of the NDA is the intent-to-treat population with PROSERA, and all of the pre-specified subgroups are supporting. Until we get again to label negotiations, it is not clear whether or not that the label will be specific to a subpopulation or to the intent-to-treat population, which is the totality of the evidence in PROSERA.

Okay. Thank you. In Europe, we're already reengaging the team over there and the assets that we have over there.

Just because based on if you look at the regional differences, we know that particularly Western Europe did extraordinarily well. We feel confident that there is going to be a sizable market, particularly with some of the pricing we're seeing over there with these newer clinical pathways such as sotatercept. I think that makes it a very viable and robust market that we can walk into in Europe.

Paul, again, I think you should take comfort in the fact that when you look at the combination of the two subgroups that really mattered, which is North America and Western Europe, we had a six-minute walk distance north of 25 meters at a p-value of 0.02. Those are the geographies that the FDA has acknowledged that the practice of medicine and PAH have been consistent for the past 35 years. The geographical differences that you recall we saw in PROSERA, specifically some of the activities we saw in Latin America, have been acknowledged as well by the FDA. Again, what's really important here is that, as Caryn said, the totality of the evidence, they have gone soup to nuts, if you will, on everything that we have submitted with them.

We believe that that is, again, the foundation for not only the basis for approval, but we think a very, very robust opportunity for seralutinib.

Your next question comes from the line of Vamil Divan of Guggenheim Securities. Your line is open. Great.

Thanks for taking my questions. Two follow-ups, if I could. One, the comments on the PH-ILD side, I was just trying to understand that a little better. It sounds like you're saying that may be used in some way to help confirm the PAH approval or support it in some ways. Can you just clarify? I assume this would be on the PAH side, a full approval, not some sort of accelerator or contingent approval. Or is it in some way tied to the PH-ILD data later on? Second, just back to the ex-U.S. opportunity. I'm curious how you're thinking about the commercial side of it. I think you gave some updates on the regulatory progress now, but is this something you'd look to or continue to do on your own, or would you look to bring in another partner to help with that effort?

Thanks. Yeah. As it relates to PH-ILD, just to be clear, the question that was asked is, are we still interested in PH-ILD?

As I mentioned, we have even greater conviction. Think about as it relates to PH-ILD, there's two scenarios. One is We get the approval on PAH, with no further confirmatory evidence needed, we would proceed with initiating a PH-ILD study in that context. In the context where the FDA makes a decision that they need further confirmatory evidence, a post-approval study, we'd be very happy with that outcome as well because we would initiate a PH-ILD in that study, in that scenario, likely. Obviously, it's linked to discussions and confirmation with the FDA, but we'd be happy to do a post-confirmatory study and use PH-ILD patients in that process. I hope that answers that question.

At this point in time, it's not linked, but those are possibilities. The other part of your question was related to would we establish partnerships. Our intention is to proceed as an independent company. We've got the capabilities, and certainly, we believe, given the U.S. opportunity, is substantial, but also quite manageable in the context of our commercial effort. At this point in time, we don't have in our sights the need to be able to establish another partnership.

Yeah. Vamil. Go ahead. I would just say that I was going to give timing on regulatory.

Vamil, the EMA process is about a year behind where we are with the FDA. We have time to get things very right outside the United States for commercialization. Go ahead, Vamil. Just to add on, and despite KZ's position on previously taking the lead in Europe, we had done ourselves a lot of market assessment.

We did a lot of work on pricing strategy. There's a number of resources and assets and people over there who have just a ton of experience in PAH. Most notably, a lot of the people that were at Actelion and then J&J over there. We have a lot of expertise that we're able to leverage as we move forward and think about particularly Europe and then other regions such as Japan.

Okay. Thank you. Thanks, Vamil.

There are no further questions at this time. I'll now turn the call back over to CEO Faheem Hasnain for closing remarks.

Okay. Thank you, and thanks for all of your questions. We greatly appreciate you participating with us on this call today. I'll just close it by reiterating our conviction and enthusiasm for this path forward. Obviously, much conversation to be had in the context of approval and discussions with the FDA around label. Nonetheless, we've gone through some really important milestones here through our first conversation with the FDA. We remain incredibly encouraged and excited about the opportunity going forward. Thank you all, and thanks for spending time with us today. Take care. This concludes today's conference call.