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2 days ago
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Gossamer Bio Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
SAN DIEGO, June 06, 2025--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced that the Compensation Committee of Gossamer's Board of Directors approved the grant, effective June 5th, 2025, to three non-executive employees of non-qualified stock option awards to purchase up to an aggregate of 69,875 shares of the Company's common stock under the Gossamer Bio, Inc. 2023 Employment Inducement Incentive Award Plan ("2023 Inducement Plan"). The awards were granted as an inducement material to the employees entering into employment with Gossamer in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $1.26 per share, which is equal to the closing price of Gossamer's common stock as reported by The Nasdaq Global Select Market on June 5th, 2025. The options have a ten-year term and will vest over four years, with 25% vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive monthly installments thereafter, subject to the employees' continued employment with Gossamer on such vesting dates. The options are subject to the terms and conditions of the 2023 Inducement Plan and the terms and conditions of a stock option agreement covering the grants. About Gossamer Bio Gossamer Bio is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. View source version on Contacts For Investors and Media: Bryan Giraudo, Chief Operating Officer and Chief Financial OfficerGossamer Bio Investor Relationsir@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
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16-05-2025
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Q1 2025 Gossamer Bio Inc Earnings Call
Bryan Giraudo; Chief Financial Officer, Chief Operating Officer; Gossamer Bio Inc Faheem Hasnain; Chairman of the Board, President, Chief Executive Officer, Co-Founder; Gossamer Bio Inc Richard Aranda; Chief Medical Officer; Gossamer Bio Inc Caryn Peterson; Executive Vice President - Regulatory Affairs; Gossamer Bio Inc Bob Smith; Chief Commercial Officer; Gossamer Bio Inc Joseph Schwartz; Analyst; Leerink Partners LLC Andreas Argyrides; Analyst; Oppenheimer & Co. Inc. Yasmeen Rahimi; Analyst; Piper Sandler & Co. Paul Choi; Analyst; The Goldman Sachs Group, Inc. Olivia Brayer; Analyst; Cantor Fitzgerald & Co., Inc. Patrick Trucchio; Analyst; H.C. Wainwright & Co., LLC Laura Chico; Analyst; Wedbush Securities Inc. Operator Good afternoon, ladies and gentlemen. Welcome to the Gossamer Bio Q1 2025 earnings call.I will now turn the program over to Brian Giraudo, Chief Financial Officer and Chief Operating Officer. Bryan Giraudo Thank you, operator. Thank you, all, for joining us this afternoon.I'm joined on today's call by Faheem Hasnain, Gossamer's Founder, Chairman, and Chief Executive Officer; Dr. Richard Aranda, Chief Medical Officer; Caryn Peterson, Executive Vice President - Regulatory Affairs; and Bob Smith, Chief Commercial this afternoon, Gossamer Bio issued a press release announcing its first-quarter 2025 financial results and provided a corporate note that certain information discussed on the call, today, is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act. We caution listeners that, during the call, Gossamer management will be making forward-looking statements. Actual results may differ, materially, from those stated or implied by these forward-looking statements, due to risks and uncertainties associated with the company's forward-looking statements are qualified by statements contained in Gossamer's news releases, SEC filings, including the annual report on Form 10-K and subsequent conference call also contains time-sensitive information that may be accurate only for a limited period of time. Gossamer Bio undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference I'd like to turn over to Faheem. Faheem Hasnain Thank you, Brian. Good afternoon, everyone. Welcome to our first-quarter 2025 earnings very excited to provide an update on the significant progress and momentum with seralutinib, which is an investigational treatment for pulmonary hypertension, including Pulmonary Arterial Hypertension, or PAH, and Pulmonary Hypertension associated with Interstitial Lung Disease or the past year and a half, we, at Gossamer, have dedicated immense time, effort, and hard work to enroll our pivotal PAH study: the Phase 3 PROSERA study. In particular, I want to recognize the efforts of our global clinical operations, development, and field medical team, who, quite literally, have been working across the globe, around the clock, to get us to this I'm incredibly proud to announce that we have achieved a significant milestone in the PROSERA study, with a closure of new patient while nearing completion of enrollment is a significant achievement in and of itself, what really matters is enrolling the correct patient population to best position PROSERA for a successful outcome. In this case, that successful outcome is a demonstration of a significant treatment effect in 6-Minute Walk Distance at 24 with this context in mind, we're thrilled to report that the baseline characteristics of the patients enrolled, thus far, are precisely what we have targeted. And we are more optimistic than ever about the likelihood of achieving positive I'll dive, more deeply, into that, in a this year, we've experienced great momentum in rolling the study, as growing appreciation of the 72-week TORREY open-label extension data from patients and physicians sparked strong interest in the PROSERA this late additional surge of interest, the PROSERA study has a substantial number of patients currently in screen. And when those potential patients are added to the 343 patients already enrolled or scheduled to randomize, there are more patients to complete full enrollment by early owe the PAH community a great deal of gratitude for entrusting us. And we will honor that trust by allowing every patient, in screening, the opportunity to enroll in the PROSERA study, if they we expect to complete the blinded portion of the study, including the 24-week 6-Minute Walk Distance primary endpoint, by the fourth quarter of this year, we anticipate announcing top-line results in February timeline ensures that we can lock the database and thoroughly clean, analyze, and adjudicate the substantial data collected in this robust 48-week double-blind study, without sacrificing data quality or operational now, review, in detail, the baseline characteristics of those enrolled in PROSERA and how this patient population helps set up seralutinib for the learnings from the Phase 2 TORREY study helped us to identify specific patient characteristics that would likely respond favorably to seralutinib by carefully selecting patients with impaired 6-Minute Walk Distance and elevated risk at use of the REVEAL Lite 2 Risk Score and other criteria, we aim to enroll a population where a greater magnitude of effect could be seen on the 6-Minute Walk Distance at 24 weeks, which is the primary endpoint; thereby, increasing the likelihood of success of PROSERA.I am happy to say that given the baseline characteristics that we've seen, thus far, the eligibility criteria was successful in enrolling the exact, intended patient take a closer look at the baseline characteristics: those that are currently available to us of the first 324 patients enrolled in the PROSERA study, as of May 12. ' important to remember that this 324 patient number is distinct from the previously mentioned 343 patients, which includes additional patients that randomized after the May 12 date and patients that are scheduled to be start, we find that the average 6-Minute Walk Distance is approximately 376 meters, much lower than the TORREY baseline, where 6-Minute Walk Distance averaged 408 meters. For comparison, the Phase 3 STELLAR study of sotatercepts had a baseline 6-Minute Walk of 401 our mean NT-pro BNP, which is an important biomarker of heart failure, is 906 nanograms per liter in PROSERA, which denotes a materially more severe population than the TORREY study where the mean NT-pro BNP levels were only 628 nanograms per additional reference, sotatercepts' STELLAR Phase 3 had a baseline mean NT-pro BNP of 1,121 nanograms per liter, nearly double what we enrolled in TORREY and much more similar to what we are seeing in the baseline characteristics of let's address the functional class. Consistent with other precedent positive PAH trials, in our Phase 2 TORREY study, seralutinib demonstrated a larger magnitude of effect in the Functional Class III patients. But a functional class imbalance in the treatment arm versus the placebo arm created, what we believe, was a major limiting factor in the magnitude of effects seen on the 6-Minute Walk Distance in that the placebo arm was 52% Functional Class III, the seralutinib arm only had 32% of its patients classified as Functional Class III, at baseline, in the TORREY study. In contrast, 74% of the patients currently enrolled in our PROSERA study are categorized as Functional Class III at baseline, a significantly larger portion than in will also have a higher proportion than the STELLAR study, which mandated that at least 50% of its patients be Functional Class III and ended up enrolling 51% of these of these Class III prevent an imbalance, we have incorporated a stratification factor for functional class to ensure a balanced population between the why are we spending so much time walking through these baseline characteristics? Well, in short, study after study, in, PAH has shown us that patients who are sicker (inaudible) baseline; those with more room to improve tend to have better outcomes, particularly on the 6-Minute Walk Distance in the 24-week saw (inaudible) Centauri, where patients with higher baseline Reveal Risk Score and those with Functional Class III disease had a much more dramatic improvement in their 6-Minute Walk and their was also seen in both the Phase 2 and Phase 3 studies of sotatercepts were Functional Class III patients had better outcomes than the Functional Class II patients. Even going back to the pivotal studies of Tyvaso and oral imatinib in PAH, the pattern holds the was designed to enroll more of these patients to increase the study's probability of success. Our team has executed against this goal, while maintaining the commercial applicability of the study's findings to a broader population of PAH believe that the baseline characteristics in PROSERA represent a population of both Functional Class II and III that is consistent with contemporary studies in PAH, evaluating 6-Minute Walk at 24 of all this, we believe that we are closer, than ever, to potentially providing patients with a first-in-class new treatment for PAH that addresses the underlying with that progress in mind, let's now shift our focus to the exciting prospects ahead for before I hand it over to Richard to discuss PH-ILD, I want to take a quick moment to thank our partner the Chiesi Group. Their partnership has enabled seralutinib to immediately enter a global registration on Phase 3 study in PH-ILD. This is one of the key rationale for our joint development and commercialization are a world leader in relevant disease areas such as respiratory, cardio metabolic, and rare disease. And we feel proud and highly validated that Chiesi sees the same vision for seralutinib as we do. And more than that, they are a committed partner and proponents of this trailblazing clinical development plan in that, I'll hand it over to Richard for discussion of PH-ILD and the Phase 3 SERANATA study. Richard? Richard Aranda Thank you, addition to what Faheem mentioned, I am thrilled to spotlight our planned Phase 3 SERANATA study in patients with Pulmonary Hypertension associated with Interstitial Lung Disease or remind you: PH-ILD is a progressive disorder, characterized by the development of pulmonary hypertension in the setting of chronic and progressive lung poses a severe burden on patients' quality-of-life diagnosis. The three-year survival rate has been reported to be 40%, which is quite dismal. With only one approved treatment available for PH-ILD in the US and limited availability outside of the US, there remains a substantial unmet need for effective SERANATA study aims to fill this critical gap, offering a potentially transformative treatment option to a patient population that has long-awaited effective treatment this end, our development program at PH-ILD underscores our unwavering commitment to innovation, excellence, and our focus on enhancing the lives of jointly, with Chiesi, the SERANATA study will be a global, double-blind, placebo-controlled registrational Phase 3 480 patients will be randomized, evenly, to receive either 90-milligram seralutinib -- twice, daily; 120 milligram seralutinib -- twice, daily; or placebo. The primary endpoint is the change in 6-Minute Walk Distance from baseline, as compared to placebo at secondary endpoints included time to clinical worsening and change from baseline and force vital capacity. A successful outcome on this latter key measure would provide differentiated results, as compared to the currently-approved believe that, in addition to targeting the pulmonary hypertension of PH-ILD patients, the PAH, so to say, seralutinib could also target the underlying interstitial lung disease. With pre-clinical data demonstrating seralutinib anti-fibrotic and anti-inflammatory attributes, treatment with seralutinib could also improve lung function, separately, from its effect on pulmonary hypertension by targeting the underlying lung fibrosis, which is characteristic of bile (inaudible).Recent pre-clinical modeling has led us to believe that there is value in testing a higher dose because increasing lung exposure may provide a greater improvement to the lung component of PH-ILD. This potential for a dual mechanistic benefit has led us to incorporate a 120 milligram, twice, daily dose-level of seralutinib, in addition to the 90 milligram, twice, daily dose level in SERANATA the same painstaking detail with which we planned and enrolled the PROSERA study, we are diligently collaborating with our partners to identify the most suitable sites, globally, for this Phase 3 our unique non-vacillatory mechanism, there is high investor and patient demand. But, given the complexity and significance of this program, we are proceeding with thoughtful there are no successful registrational, global PH-ILD clinical trial precedents to follow. Therefore, we hope the SERANATA study will be the first. We expect to begin first-site activations in the fourth quarter of this this, we are extremely excited about the possibilities that this trial holds and the profound impact it could have on the lives of so I will hand it over to our CFO and COO, Bryan Giraudo, for a financial update. Bryan? Bryan Giraudo Thank you, now review the end-of-quarter financial results for the first quarter of ended the quarter with $257.9 million in cash and cash equivalents and marketable continue to maintain a robust balance sheet and anticipate that our financial resources will provide sufficient capital for the first half of the quarter ended March 31, 2025, recognized revenue was $9.9 million. Our revenues associated with our collab with Chiesi includes $6.6 million in cost reimbursements for the quarter.R&D expenses were $38 million, compared to $32.4 million for the same period in 2024. G&A expenses for the first quarter of 2025 were $8.7 million, compared to $9.6 million for the same period in net loss for the three months ended March 31, 2025, was $36.6 billion or $0.16 per share, compared to a net loss of $41.9 billion or $0.19 per share for the same period in I'll turn the call back over to Faheem for closing remarks. Faheem Hasnain Yeah. Thanks, we take questions, I just want to remind everyone of the substantial unmet need in PAH and PH-ILD. These are progressive diseases, with high mortality, that need new, safe, and effective to this dire need and historical lack of innovation, even approved therapies with limited efficacy or poor tolerability have achieved commercial success. Patients and physicians are eagerly awaiting new therapies, particularly those with differentiated mechanisms and improved its potential first-in-class mechanism and growing body of evidence of the potential for reverse remodeling in this disease -- paired with the safety profile observed, to date -- we can envision a future where seralutinib becomes a backbone therapy and PAH and a multi-billion dollar [opportunity] is not confined to the United States. It extends to international markets, as -- which is the second largest PAH market, globally, after the US -- has a number of clinical sites participating in the PROSERA seralutinib recent Orphan Drug Designation and the participation of Japanese patients in PROSERA, we believe that, with positive result, this could support a [PMDA] and a subsequent approval in if there's one takeaway from today's discussion, let it be that Gossamer is doing everything that we can to increase the chances of long-term clinical and commercial success for seralutinib. And we're committed to maintaining the highest standards to accomplish this focus is not to just achieve a provable results, that's the bare minimum. Our focus is on generating comprehensive, definitive, and differentiated outcomes in both of our Phase 3 trials that will set seralutinib apart from other therapies on the market, helping lay the groundwork for a seralutinib you may now open the line to questions. Operator (Operator Instructions)Joe Schwartz, Leerink Partners. Joseph Schwartz Great. Thanks so much for taking my questions. I have With 343 patients enrolled in PROSERA, to date, have you considered stopping enrollment there, in order to be able to still report data this year? Could you give us some insight into your (inaudible) here? And why you've decided to enroll these last patients and push the data into '26?And then, I have a follow-up. Faheem Hasnain Yeah. Thanks, Joe. Thanks for your really relates to the fact that there's been such incredible demand to study, Joe. Obviously, as we started to signal that we were nearing the end of enrollment, that demand got even it's really important that we honor the commitment we have to patients and to their physicians to ensure that we have worked alongside of all of these physicians and continue to do so into the future; not only with seralutinib but, also, with the PH-ILD Phase 3, which many of these physicians will also be investigators so, we wanted to honor that commitment and decided to honor -- and we closed off screening. So we will no longer be screening there is a bolus -- a large bolus -- of patients that are in the screening funnel, now. And our commitment was to follow through: determine which of those patients would qualify for the study. And then, if they qualify, enroll them. So that should take us into somewhere around the June just as we think about the timing for that: first and foremost, we care about the quality of the study; first and foremost, we care about bringing the right patients into the study; and timelines (inaudible) course (inaudible).So we will conclude the study. Last-patient-out will certainly be in the fourth quarter, near the end of the fourth quarter. But by the time we scrub, analyze, or collect the data -- scrub the data, analyze the data, and get it ready for a top presentation, that will take a little bit of time. That's the February date. Joseph Schwartz Very helpful. then, could we delve more into baseline characteristics in PROSERA? Since the TORREY trial enrolled patients primarily from North America, whereas PROSERA will be more global, I was wondering if we could get your thoughts on how this factor could influence the results. Faheem Hasnain Yeah. In TORREY, we had sites, also, globally; but not as extensively as we have with PROSERA. So PROSERA has a much broader global footprint, in the context of the sites that we've an example, there is a significant portion of patients that will come out of places like Latin America, South America, Eastern European countries, and Asia-Pacific. And the reason I highlight that is it's really interesting because what we find in those jurisdictions are really excellent patients for us to enroll in this by that, I mean, low morbidities and patients that, in historical trials from those regions, have shown a much larger magnitude of effect on their 6-Minute as an example, the STELLARs study for sotatercepts, the patients that they enrolled in South America saw somewhere in the neighborhood of mid-70-meter improvement in walk versus the US patients in that study, who were around 26 meters. That, largely, we believe because these patients are just more pure PAH patients, with less comorbidity and an easier opportunity to show that magnitude of I don't know if you have anything else you want to add to that? Richard Aranda No. Faheem, I think that's exactly younger patients, the different treatment regimens, also, contribute to those patients that you've outlined. Faheem Hasnain Bryan? Bryan Giraudo Joe, I'd also just remind you that part of the reason why we had a disproportionately large number of patients from North America and the United States in TORREY was because many of our US sites were closed because of the COVID-19 pandemic and those physicians were not actively doing clinical we do believe the combination of operating in a normal time and in a broader global reach is going to give us (inaudible) that much more patient population. Joseph Schwartz Thanks for the color. Faheem Hasnain Thanks, Joe. Operator Andreas Argyrides, Oppenheimer. Andreas Argyrides Great. Thanks for taking our questions. Congrats on all the progress on your completion of enrollment. And, also, thanks for the comparisons, the various baseline characteristics for STELLAR. You pre-empted one of my questions -- (inaudible) very we only have a couple here. We'll keep it as short as we baseline in PROSERA now in hand, have power and assumptions changed, at all?And then, was stringent enrollment criteria the reason that the enrollment took a little longer than previously expected?And then, last, when it comes to safety, seralutinib has a clean profile, to date. How do you think these upcoming results can address the generalized concern that (inaudible) have off-target effects and seralutinib doesn't?Thanks. Faheem Hasnain Yeah. I'll take a portion of that question and have Richard, as well, jump in -- anybody else on the as it relates to the baseline characteristics that you've seen, I think your question, Andreas, was, really, does that lend to the focus on those baseline characteristics; and the stringent entry criteria lend to the time that it took to enroll the study? I would say, unequivocally, an example and to just further highlight that point, Andreas: we screened somewhere in the neighborhood of 750 patients to this day, which is a significant number of patients. And the fact that that's about double what we'll actually will end up enrolling, that should tell you two things:One. That we've been incredibly stringent to our entry criteria into this study for all the reasons that we've talked about. We think we've given this criteria that we put into place and, now, have been able to achieve. We think that really enhances our probability of I think the second thing that that says, in terms of the number of screening opportunities that we've had, is the significant demand for this study. That's a significant number of patients. And there was a tremendous amount of demand from physicians -- the treaters -- to be able to have their patients evaluated for their entry into the I think that's a vote of confidence, if you will, from the physician community about the promise of Richard Aranda I think one of your first questions around the baseline characteristics impact the power of the study -- the answer is from a technical standpoint, we have over 90% power, given the sample size. In fact -- just to reiterate what Faheem mentioned -- the study, intentionally, was designed to enroll this in anticipation of the treatment effect that we would observe -- which is complementary to the sample size and the expected power, based on that treatment effect and standard deviation -- we're basically right on target. Bryan Giraudo I think, Andreas, your last question was around safety. Certainly, to date, we remain very pleased with the safety profile we have seen -- again, that it's a function of both design of the molecule, the route of administration, as well as the fact that we've designed everything to be on target, which we think, again, as Bob has spoken many times about, long term, in addition to what (inaudible) robust efficacy, our safety profile and ease of use will be a competitive advantage. Faheem Hasnain Yeah. Andreas, if I could just add just to what Brian said -- just for one last comment safety profile, combined with the efficacy that we expect to see -- certainly, the efficacy that we saw in the Functional Class III; and higher-risk patients in TORREY; and the open-label extension experience that showed that we continue to see improvement, over time -- possibly, related to the reverse remodeling effect that that we hypothesized is going on -- really positions us well, commercially, to be used across not only a broad swath of PAH patients but, also, to suggest that there's an opportunity for positioning this drug as the backbone of therapy for earlier use to prevent longer-term we all know, this is a progressive disease, where every patient progresses. And if we can delay, halt, that progression, that's an incredibly meaningful outcome for patients. Andreas Argyrides Fantastic. I appreciate the color. Congrats on all the progress. Faheem Hasnain Yeah. Thank you. Operator Yasmeen Rahimi, Piper Sandler. Yasmeen Rahimi Good afternoon, team. Really excited for you. Congrats on so many milestones, right, enrollment completion, unveiling the baseline, and the PH-ILD is kicking that all off -- really incredible progress; and updates, questions through for first question, team, is for the baseline measures. Did you look at baseline PVR in the PROSERA study? Question 2. Once the study finishes, fully, enrollment, are you planning to give us another cut of the baseline and, maybe, a little bit additional information? I don't know if there's going to be another disclosure around it, before we get the data in then, the third one is: given that the end points for both of these -- between the PH-ILD and the PAH study are the 6-Minute Walk Test, is there anything we can infer from read-through from PROSERA to SERANATA, now that we have the study design?Appreciate if you could take three questions. Faheem Hasnain Thanks for your question, it relates to the question around further updates: I think, as it relates to the baseline, we've given you baseline data on 323 patients. We don't expect that to materially change, given just the number of patients that we've been able to evaluate baselines I think we can be pretty clear with you that we will, complete enrollment by, latest, mid-Junne. And so, there won't be any mystery there. Just we know that, now, with great certainty; given that we know exactly how many patients are in the I think there should be no uncertainty as to when our last-patient-in will be. As I said, it'll be by mid-June. And I think it's fair to conclude that the baseline that we've given you will be very close to the baseline that we'll end up within this Richard Aranda Yasmeen, to answer your question about the PVR: we did have a PVR-entry criteria of 400 or greater. We did not mandate to have a PVR as an endpoint so we won't have that in this particular yes, we did have minimal criteria for a PVR. And that could have been based on some historic data, at the time of screening. It's in line to what you would expect, given the requirement that that we terms of your question around read through: of course, assuming that PROSERA is positive, that portends the possibility that the PH-ILD would also be positive. Having said that, we also know that PH-ILD patients are going to have lower 6-Minute Walks than in group 1 patients. They're actually sicker, so, under the thesis that, in PROSERA, we have an enriched population of greater severity -- I think, just implicit in studying the group 3 population, those patients are sicker, so if the drug is effective in that population, we should also see a very good treatment effect on 6-Minute Walk, as well as other parameters such as NT-proBNP, et cetera. Faheem Hasnain Yeah. And so, I think that definitely does increase the probability of success and there would be a I think the other dimension, here, that's exciting about the PH-ILD population and the opportunity for seralutinib is that, certainly, pre-clinically, we've been able to determine that seralutinib also has some anti-fibrotic properties infecting really important markers of as you think about this next patient population, those with interstitial lung disease, that could be a significant added benefit to the treatment of those patients. Yasmeen Rahimi Excellent. Thank you so much, team. I'm really excited for you. I'll jump back in the queue. Faheem Hasnain Thank you, Yasmeen. Operator Paul Choi, Goldman Sachs. Paul Choi Hi, everyone. Good afternoon. Thank you for taking our questions. Congratulations on all the progress.I want to return to baseline characteristics, for a moment. Can you share or do you plan to share, with the final baseline, just what baseline sotatercepts usage is, given that it's been available both in the US and ex-US for a few quarters now?And then, in terms of a clinical impact from that, can you maybe just comment on how you're thinking of what is considered clinically meaningful now ,in in terms of 6-Minute Walk, given that it has been available commercially -- if there have been any evolution and change of thought among the KOL community on 6-Minute walk here, given (inaudible) stuff has been on the market for a few then, one for Bryan. Can you just remind us what key related milestones are baked into your cash runway guidance? Is there anything else that we should be factoring in what the pushes and pulls are that could potentially extend your cash runway?Thank you for taking our questions. Bryan Giraudo Sure, Paul. I'll start with the first one, around backgrounds sotatercepts. As you'll recall, we had expectations that we would probably have about 10% of the study or roughly 35 patients on backgrounds if you were on background sotatercepts, there were two important components to that. You had to meet our entry criteria, which would suggest that sotatercepts wasn't working for you; or/and you would have to have been on stable sotatercepts dosing for six months.I think we were very surprised on how few patients were on stable backgrounds sotatercepts dosing. So of the a couple of dozen inquiries we had about patients coming in, to date, I think we've enrolled three or four patients on background sotatercepts, which we think, again, speaks to the real-world experience of sotatercepts being not as linear as we were regards to clinical effect, I'll it turn over to Faheem. Faheem Hasnain Yeah. Paul, it's a really interesting question that that you've asked and one that I think is really important: the clinically meaningful effect for 6-Minute Walk.I'll start off by saying seralutinib appears to be differentiated from any other PAH treatment, thus far, that we've seen. In that, we see continued improvement over time, as evidenced by our open-label extension data, where patients -- even the less sick patients in TORREY that didn't have as profound a result -- saw improvement out to week 72.(inaudible), even those patients with a more profound improvement, the more sick patients, also saw an that is a fairly unprecedented result. Assuming that we continue to see that trend in the open-label extension portion of the PROSERA study, what I believe that the treating community is thinking about is that the week-24 data will just be a point in time to which, then, they can expect patients to improve beyond so, that really starts to then, ask and play into the question that you've asked -- is what is a clinically meaningful effect for PROSERA? Certainly, in the dialogue that we've had with our experts, our Key Opinion Leaders, our steering committee, I would say that anything in the in the 20-meter-plus improvement in 6-minute Walk becomes a very clinically meaningful effect, given the safety profile of the drug, the opportunity to use it earlier in line of therapy to try to prevent longer -term progression, and the promise of improvement over that's unprecedented, had not been seen in this environment. So I think it's erroneous to actually just say sotatercepts was at X and, therefore, you need to be at X or Y. Because the basic point is this: every one of these patients will will see really profound effects in a subset of patients somewhere in the neighborhood of 30% -- it's what we've seen from the trials -- which leaves a large swath of patients with significant unmet there will still be patients who experience intolerable side effects with sotatercepts. We're seeing that continuing to build in the real-world database. And we will see patients who wane in their effect with sotatercepts and are, also, left with a by the time we get to the market, there is going to be a large portion of patients that really need something. And the promise of a drug like this -- that has the potential to show reverse remodeling effects -- can be pretty Richard Aranda Just to add: I think it's also important that the treatment effect needs to be interpreted without the context of the influence of hemoglobin that, probably, influenced the response that was observed with sotatercepts, for example; plus, the population that we've been talking about is a much more sicker population, I think those are some additional considerations. Faheem Hasnain Bryan , do you want -- Bryan Giraudo I think, Paul, your question on (inaudible) milestones -- our cash runway does not have any of the big milestones that we would expect on (inaudible) milestones.I think the biggest influence on our financials, with the Chiesi relationship, is the cost sharing. And we expect that cost sharing to meaningfully increase, as we bring the cost in, from the PROSERA study; and kick off the SERANATA study, where we'll be cost sharing on a fifty-fifty basis. Paul Choi Great. Thank you very much. Operator Olivia Brayer, Cantor. Olivia Brayer Hi. Good afternoon, guys. Thank you for the question. Congrats on all the progress you've been making this you disclose what treatment effect you're targeting, as it relates to your powering assumptions?And then, as you think about the regulatory bar for success, do you know whether FDA is looking for a certain thresholds on 6-Minute Walk improvement, both with respect to key value but, also, meter improvement?And then, just, maybe, in terms of timing of the disclosure, does that include a safety period? Or was anything else added to that protocol that's maybe, changing the time of those data? Richard Aranda To answer your question about the powering, the initial powering, which is the same, is based on a 30-meter treatment effect on 6-Minute Walk, with a standard deviation of 70 [meters], which gives us greater-than-90% power. But that hasn't the other question was around -- the time of the data read-out does include that the safety follow-up. And that, also, hasn't changed. Faheem Hasnain Did we capture all your questions there?(multiple speakers) you regulatory guidance, as well. Olivia Brayer Maybe, just to follow up on that safety close-out period: was anything added to the protocol that's actually, maybe, shifted timing of the data read-out? Bryan Giraudo No. Olivia Brayer Okay. And then, the other question, Faheem, was just on the regulatory bar and how the FDA is thinking about 6-Minute Walk's improvement. Have they said anything, in terms of what key value or an act or improvement that they're looking to see for approval? Faheem Hasnain I'll turn that question over to Caryn Peterson, our Head of Regulator Affairs. Caryn Peterson Yeah. We had this discussion with the FDA, when we designed the protocol, as well as (inaudible). They agreed to both the powering and how it was powered, in terms of the distance and the magnitude of the fact that we were looking. Olivia Brayer Okay. Great. Helpful. Thank you, guys. Faheem Hasnain Thank you. Operator Patrick Trucchio, H.C. Wainwright. Patrick Trucchio Thanks. Good afternoon. I have a few questions on first is just on baseline. Do we know the number of patients who discontinued sotatercepts, previously?And then, separately, you've presented open-label extension data that shows continued PVR and 6-Minute Walk distance benefit. What read-through from this data do you see to PROSERA, if any? And, separately, what are the commercial implications of that (inaudible) data?And then, a few on first is just the doses -- the rationale behind the doses selected for this then, separately, it was mentioned the data could demonstrate seralutinib as having a beneficial impact on underlying interstitial lung disease: what data -- or if you're able to demonstrate this benefit, what are the implications for the (inaudible) profile? What data should we be looking for to show that potential? And what are the implications, then, for the potential addressable patient population? Bryan Giraudo Thanks, Patrick. I'll take the first one, as far as patients who discontinued to the long half-life of sotatercepts, our requirement is that you need to have a five half-life [wash-out] before you can come in. We had very few sotatercepts discontinuations in the memory serves me correct, I think it was high single digits, to I'll turn it over for the other part. Richard Aranda You just remind me what the other question -- Patrick Trucchio (multiple speakers) the second part on PAH was just around the open-label extension data, the read-through from that data (inaudible) to PROSERA; and, as well, just commercial implications of that (inaudible) data. Faheem Hasnain Yeah. I'll have Bob Smith, our Chief Commercial Officer, to touch on that one. Bob Smith Yeah. I think there's a very positive read-through there. As we have taken the (inaudible) data out into the community, the KOL community, we've just had really impressive we saw, as well, that, being a key lever for the increased enrollment in PROSERA, when they started to realize the benefits, over time, which, as Faheem mentioned, is to seralutinib and -- Faheem Hasnain Yeah. I think the open -label extension implications on commercial are what I've already mentioned, Patrick, which is: if that data is replicated as we hope it will be in the context of the PROSERA study, it is -- and we've had this feedback from the community that, as I said, it was largely studies, you see and would expect to see, just, a plateauing of [effective]. So it really has an impact on positioning of the drug in the that is -- like other progressive diseases, we see the desire and the hope to be able to use these drugs earlier, assuming that they've got the right safety profile. Because if you're using a drug earlier in the line of therapy, quality of life matters because they're going to be on treatment for a long period of time -- longer duration of treatment. And they're being treated in the earlier stage of their disease, which means they're, otherwise, living a reasonably normal safety really matters. And if there's a promise there or potential to actually remodel both lung and heart, as we've seen by our imaging data and our echo data, that's hugely impactful, in terms of the potential to stave off progression for a longer period of that will be an important positioning concept, commercially. Bob Smith Yeah. Cause what we're hearing a lot in the community is the desire to use these "disease-modifying", if you will, therapies, earlier, in the I think if our profile plays out from the (inaudible) through to PROSERA, we'll have a very safe, tolerable, and effective agent that can be used very early along with the (inaudible).So, yeah, that's one of the rationale for the interest that we're getting for early utilization. Richard Aranda I could further comment on your question around the PH-ILD, around dose and the potential let me start off by saying that we're confident in the 90 milligram dose in PH-ILD, given the results that we have in group we believe it's important to acknowledge that, as we mentioned, PH-ILD represents basically two -disease processes. One, a vascular component with a PAH. And then, a lung component, characterized by the lung factoring in some of the pre-clinical work that we had performed and was presented at the (inaudible) Conference in 2024, using fibrotic models, using human lung and fibroblast cells, which (inaudible) showed a favorable effect, the thought process is we wanted to deliver more drug to the lung; factoring in the fact that the lung architecture is already distorted due to the lung fibrosis so we want to ensure that sufficient exposure is occurring in the setting of that differences in the that we have elevated the functional (inaudible) vital capacity as a secondary endpoint. That was done, intentionally, because we believe that this could be a clear differentiating feature of this molecule in treating both the PAH part and the lung disease so, assuming that we have positive results, not only would it be differentiating for us but we would obviously have a discussion with regulators about potential mentioning of it or positioning of it in the product maybe, Bob would just want to comment on some of the commercial implications of this approach, of the (inaudible). Bob Smith Okay. Yeah. Commercially, it'd be a huge differentiator because, right now, Tyvaso looked at (inaudible) as a safety endpoint in the study; whereas, we're looking at it as an efficacy endpoint in the study. So that would be a significant commercial differentiator for seralutinib. Bryan Giraudo And I also think, Patrick, importantly, in conjunction with our partners at Chiesi, having an (inaudible) signal on (inaudible) would also be a significant barrier-to-entry in the European Union, where no drugs are approved. Patrick Trucchio Terrific. Thanks so much. Faheem Hasnain Thank you. Operator Laura Chico, Wedbush. Laura Chico Hey. Good afternoon. Thanks very much for taking the questions. I just have a couple -- and I apologize -- I'm just trying to reconcile some of the commentary around the geographic split on recruitment in PROSERA and some of the commercial dialogue you've had there. How do you think about the types of patients that would be more suited for seralutinib, presuming success in PROSERA versus a sotatercepts patient.I'm just curious: Is there certain characteristics that might skew the market, one or the other?And then, related to the SERANATA -- I think I missed this -- could you elaborate a little bit further? This is blazing new trails here so trying to understand the powering assumptions around the primary endpoint; specifically on treatment effect and how you derive very much. Bob Smith Yeah. On the commercial side, assuming positive PROSERA, we will launch seralutinib at roughly three years after sotatercepts launched in the that point, what you'll see is basically a market reset. So all of the prevalent patients that are currently out there will have tried sotatercepts, probably three-quarters of them. Not all patients are going to be good candidates for sotatercepts. But call it 70%.So by the time of the launch, you'll have this mark reset where patients have been on sotatercepts, have come off sotatercepts, that now have advanced in their progression of their disease. And that's the large patient population that Faheem spoke of we could potentially look at having a 70% to 80% of the market opportunity out there because sotatercepts will probably have a 30% of the market in that three years because of the discontinuations and just the normal progression of the market and the addition, I think there's a lot of interest, as well, to using both seralutinib and sotatercepts, in Bryan mentioned, we only have very few patients in the study on that combination. But there are data that are being looked at both pre-clinically -- and then, we'll have a little bit of clinical data to suggest how these therapies could be used in combination. Faheem Hasnain If I take my crystal ball up to say, let's fast forward to the time that we launched, as Bob said, say, early the points that Bob made is exactly right. What we're going to see is not only the patients that have either tried sotatercepts, failed; the patients that weren't eligible for sotatercepts for one reason or another; and the patients who've been on sotatercepts and overall treatment is weighing those patients that have been on sotatercepts that may still be on sotatercepts -- but we're starting to see a waning of the effect, one can imagine doctors are going to be very encouraged to use combination therapy, especially given the pre-clinical evidence that's been generated, thus far, around the potential synergy between these two I think that seralutinib gets positioned as a drug to try first before seralutinib, once we're in the market, as we see newer patients coming in. I think that is the potential just because -- as you see it -- for the reason that I mentioned -- to be able to see the potential to prevent longer-term progression but, also, to be able to put these patients on a product with a safer profile, I think, will be incredibly encouraging for docs.I think it'll an interesting marketing concept and positioning concept, once we get approved. Richard Aranda I could answer your question on some of the powering assumptions around our PH-ILD 6-Minute Walk. I think, as you mentioned and as we stated, there's not a lot of precedent for randomized controlled trials. But we do have the increased trial -- we could get the 6-Minute Walk data from that particular trial. And so, we had to do some add to, maybe, three points around trying to provide a framework; and then, I'll get into the to the power assumptions that we did:As I mentioned, this is a very sick population. They're going to have lower 6-Minute Walks in group 1. And, furthermore, over the course of a trial, they're likely going to deteriorate much more in group I want to go back and look at the increased trial. That was a 16-week trial. Our trial is 24 weeks. So the assumption here is that those that are randomized to placebo are likely going to get worse than even in the increased trial. So that that's one to that, then, as in the active arm, we have assumed at least a 30 meter difference; much like what we did for group 1. But we have some latitude there. If it's slightly -- less likely more, we still have greater than 94%, 95% power, comparing the active arm versus that's also assuming a standard deviation of about [70]. Laura Chico That's super helpful. Thank you, guys. Faheem Hasnain Thank you. Operator Eliana Merle, UBS. Hey, this is [Jasmine], on for Eli. Congratulations on all the progress. Thanks so much for taking our a follow-up to an earlier question in your comments. Are you allowing such (inaudible) drop-ins in PROSERA? And then, more generally, how are you thinking about how looking at a combination of fact, here, could impact the opportunity, commercially?And, then, secondly, can you just talk about the population you're aiming to enroll in SERANATA for PH-ILD? Do you think that, similarly to PAH, (inaudible) feel greater effects in the more severe range of patients here?Thanks. Faheem Hasnain Yeah. In terms of the -- allowing sotatercepts patients who are on sotatercepts into the PROSERA study: we actually do allow for patients who are on sotatercepts but, of course, in order for them to get into the study, they need to actually qualify for the study, which means there is a period where they need to be on stable you can outline the criteria for sotatercepts -- eligible patients. Richard Aranda Yeah. They have to be on background sotatercepts for six months, at a stable dose, without changing due to hemoglobin or platelet changes. And then, they still have to meet our PVR criteria of greater than 400 Reveal Lite 2 Risk Score (inaudible) or a PVR greater than 800. Bob Smith After 24 weeks. Faheem Hasnain Yeah. 24 so, just given the stringent application of the entry criteria, we will probably just get a handful of patients on sotatercepts. There really won't be a substantive number in this study, given the timeframe under which it's been launched and the access to patients who've been on for six months, as Richard just laid the short answer is yes. We allow sotatercepts patients in. But they got qualify in the context of the entry criteria, which will equate to a small then -- Richard Aranda Yeah. I could comment (inaudible) the target population for the best way to frame this is -- suggest to go back and look at the increased trial and their population. We have some similarities. But, clearly, some difference. And I can just highlight some of those of all, our, hemodynamic criteria are (inaudible). We have four (inaudible) units for PVR. They have three (inaudible) units. That's because we do want to leverage the fact that there are more severe patients. And we would anticipate a greater treatment effect in those addition we are targeting Idiopathic Interstitial Pneumonia, IPF -- systemic autoimmune disease-related PAH, fibrotic interstitial pneumonitis, and occupational interstitial lung increased, however, we're not allowing for a combined pulmonary fibrosis or emphysema. We're not allowing sarcoid in then we're much more stringent upon criteria around having CT scans reviewed by (inaudible) and other things like probably, related to your question is do we anticipate the more severe population -- that we would also observe of a greater treatment effect? I think the answer is yes to that question. Okay. Great. That's to clarify: patients are not allowed to drop in or begin sotatercepts during PROSERA? Bryan Giraudo As far as dropping in with sotatercepts, no. When you are enrolled, you have to be on (inaudible) therapy. Great. Thanks so much for answering my questions. Faheem Hasnain Thank you. Operator Vamil Divan, Guggenheim. Hi. This is [Daniel], on for Vamil. Thanks for taking our first one is you described seralutinib a multi-billion dollar PAH franchise, potentially. Can you, maybe, compare the commercial opportunity for this drug in PAH versus PH-ILD?And then, my second question is just if you'd go into more details around the expected geographic distribution of enrollment for the PH-ILD trial? Do you think it'll be similar to what we saw in PAH, with the majority seen, internationally? Or is there less of a need for this imbalance, without the (inaudible) dynamic at play?Thanks. Faheem Hasnain Bob? Bob Smith Yeah. In terms of the multi-billion dollar opportunity: if you look at PAH, there's about 50,000 patients in the you look at the current pricing of the newer therapies, obviously, we haven't presented anything, publicly, but if you look at sotatercepts price, quickly -- sotatercepts, right now, is on about a 1.5 billion downgrade in its second full year. Right now, they're sitting at, I think, 5,800 patients or 5,200 patients have already started to drug. And that continues to you can see the opportunity within the PAH marketplace, in terms of the number of patients and the potential price associated with terms of, the ILD-PH, that market is probably 3 times to 4 times greater than PAH; call it, roughly, worldwide, 400,000 -- something like 400,000 again -- and if you look at what Tyvaso is doing with their price point and number of patients, despite a very high number of discontinuations on that therapy, their run rate in in PH-ILD is roughly 2 billion. Bryan Giraudo To answer your question about geographic mix for SERANATA, I do think it will be similar to PROSERA, anything -- it may be an even larger contribution from the European Union. And that's really a function is -- remember: the dynamics in PROSERA is that, well, sotatercepts was not available in the European was an expectation that it was coming. So patients were saying, I'll wait for sotatercepts before I go on (inaudible). That dynamic doesn't exist because (inaudible)Tyvaso has not been approved. And there is, at least, what we can tell from looking at regulatory processes, there is not a plan for United's partner,(inaudible), to get the drug registered in the European there is an even greater unmet medical need in Europe for PH-ILD therapies than there was for PAH therapies. Faheem Hasnain So in summary, you've got a patient population, PH-ILD, that is much larger, significantly underserved, with only one drug approved in the US -- being Tyvaso.I think Tyvaso is now available in a couple other smaller jurisdictions; but, for the most part, only available in the a sicker patient population than PAH, so the unmet need is substantial. And the opportunity, therefore, is also substantial. Okay. Great. Yeah. Thank you very much. Faheem Hasnain Thanks. All right. Any other questions in the queue, operator? Operator At this time, there are no further questions in queue. Faheem Hasnain Okay. I would just like to, first off, thank everybody for your participation on this call. We've enjoyed the opportunity to be able to speak with you and be able to outline the progress that we've made on of course, eagerly await the top -line results from this for all the reasons that we've discussed today, we're very excited about the potential of seralutinib making a huge difference for I just want to end this call by, first and foremost, thanking those patient who contributed themselves to this study and to their physicians for having the confidence in Gossamer and seralutinib; to entrust us with treating their patients, the ability to treat their lastly, I just want to thank the Gossamer organization for the tireless effort, over the last couple of years, to be able to get us to where we are thank you, all. We look forward to being able to talk to you, again; and, certainly, look forward to the top-line results on everybody. Operator With that, ladies and gentlemen, that does conclude your may now disconnect your you, again, for joining us today. 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15-05-2025
- Business
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Gossamer Bio (GOSS) Reports Q1 Loss, Tops Revenue Estimates
Gossamer Bio (GOSS) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 11.11%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.17 per share when it actually produced a loss of $0.15, delivering a surprise of 11.76%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Gossamer Bio , which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $9.89 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 167.27%. This compares to zero revenues a year ago. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Gossamer Bio shares have added about 11.7% since the beginning of the year versus the S&P 500's gain of 0.2%. While Gossamer Bio has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Gossamer Bio: mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.18 on $4.13 million in revenues for the coming quarter and -$0.66 on $26.3 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 28% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Roivant Sciences Ltd. (ROIV), another stock in the same industry, has yet to report results for the quarter ended March 2025. This company is expected to post quarterly loss of $0.16 per share in its upcoming report, which represents a year-over-year change of +30.4%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Roivant Sciences Ltd.'s revenues are expected to be $67.33 million, up 132.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Gossamer Bio, Inc. (GOSS) : Free Stock Analysis Report Roivant Sciences Ltd. (ROIV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
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15-05-2025
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Gossamer Bio Announces First Quarter 2025 Financial Results and Provides Business Update, Including Closure of New Patient Screening in Phase 3 PROSERA Study
- Enrollment Completion for Ongoing Registrational PROSERA Phase 3 Study in PAH Expected in Early June; New Patient Screening Closed - - Topline Results Announcement from PROSERA Phase 3 Expected in February 2026 - - To Date, Blinded Baseline Characteristics Align with Intended Study Population - - First Site Activations for Planned Registrational Phase 3 SERANATA Study in PH-ILD Expected in the Fourth Quarter of 2025 - - Cash, cash equivalents and marketable securities totaled $258 million as of March 31, 2025 - SAN DIEGO, May 15, 2025--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced its financial results for the first quarter ended March 31, 2025, and announced the closure of new patient screening for the ongoing registrational Phase 3 PROSERA Study in PAH patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. "I am incredibly proud to announce that, following the recent closing of new patient screening, we are just weeks away from fully enrolling the PROSERA Phase 3 Study in PAH," said Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer Bio. "This achievement is the result of our team's unwavering dedication, tireless effort, and steadfast commitment to our mission. We expect to publicly announce topline data from this pivotal study in February of 2026. Enrolling the appropriate patients for this study was of paramount importance, and the baseline characteristics of those who have been randomized to date demonstrate that our diligence and focus on study quality has paid off. This reinforces our optimism for meaningful results and brings us one step closer to the potential of having a new, first-in-class therapy for patients with PAH." Chief Medical Officer Dr. Richard Aranda added, "We are also delighted to unveil the clinical trial design for the Phase 3 SERANATA Study in PH-ILD, a landmark moment in our pursuit to address unmet patient need. A product of close collaboration and alignment with global regulatory authorities, including the FDA and EMA, this study represents a groundbreaking effort to offer new hope to patients with PH-ILD." Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor On May 14th, we closed new patient screening for the ongoing PROSERA Study in Functional Class II and III PAH patients. To date, 343 patients have been enrolled or are scheduled to randomize into the PROSERA Study. With the additional patients currently in screening, we expect to complete enrollment with over 350 PAH patients in early June. The Phase 3 PROSERA Study is a double-blind, placebo-controlled, global registrational clinical trial evaluating seralutinib in PAH patients, on top of background PAH therapy. Patients are assigned 1:1 to either the seralutinib or placebo arms. Patients receive blinded treatment for up to 48 weeks. The primary endpoint of the PROSERA Study is change in six-minute walk distance (6MWD) from baseline as compared to placebo at week 24. Included in the key secondary endpoints is time to clinical worsening, as compared to placebo, up to week 48. In addition to other secondary and exploratory endpoints, safety and tolerability will be evaluated. The patient population enrolled in PROSERA aligns with the target demographic, as evidenced by available baseline characteristics. The PROSERA Study utilizes enrichment criteria, including the REVEAL Lite 2 Risk Score and other criteria, to identify patients more likely to show a greater magnitude of effect on 6MWD at week 24, as informed by the Phase 2 TORREY study. Seralutinib Clinical Trial Baseline Characteristics: Phase 3 PROSERA Study* v. Phase 2 TORREY Study PROSERA Phase 3* TORREY Phase 2 Study Participants n = 324 (target: 350) n = 86 Mean 6MWD 376 meters 408 meters Mean NT-proBNP 986 ng/L 628 ng/L Functional Class III Patients 239 (74%) 36 (42%) Geographic Distribution North America: 61 (19%) Rest of World: 263 (81%) North America: 59 (69%) Rest of World: 27 (31%) *Characteristics shown are for the first 324 patients enrolled in the PROSERA Study, and all PROSERA Study percentages are out of 324. Given the patients scheduled to randomize and those still in screening, we expect to complete full enrollment in early June. Final baseline characteristics for the PROSERA Study are subject to change. We expect to announce topline results from the ongoing Phase 3 PROSERA Study in February 2026. We expect to activate clinical sites for the global, registrational Phase 3 SERANATA Study in PH-ILD patients in the fourth quarter of 2025. Achieved alignment on study design and endpoints with global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The planned SERANATA Study will be a 24-week, randomized, double-blind, placebo-controlled, global clinical trial in PH-ILD patients. Approximately 480 patients will be randomized 1:1:1 to receive either 90mg seralutinib twice-daily, 120mg seralutinib twice-daily or placebo. The primary endpoint of the SERANATA Study is change in 6MWD from baseline as compared to placebo at week 24. Key secondary endpoints will include time to clinical worsening and change from baseline in forced vital capacity (FVC). One poster related to seralutinib will be presented at the American Thoracic Society (ATS) 2025 International Conference, taking place from May 16th through 21st, in San Francisco, California. Poster Presentation Title: Seralutinib in Pulmonary Arterial Hypertension: Exploring Mechanisms of Reverse Remodeling Versus Vasodilation Poster Number: P920 Session: A76 Finger on the Pulse: Cardiopulmonary Dysfunction in Lung Disease Date: Sunday, May 18th Time: 11:30am – 1:15pm PDT Location: Area G, Hall F (North Building, Exhibition Level), Moscone Center Following its presentation at the ATS 2025 International Conference, the poster will also be made available on the "Posters & Publications" section of the Gossamer Bio website at Financial Results for Quarter Ended March 31, 2025 Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2025, were $257.9 million. We expect the combination of current cash, cash equivalents and marketable securities will be sufficient to fund our operating and capital expenditures into the first half of 2027. Revenue from Sale of Licenses and from Contracts with Collaborators: For the quarter ended March 31, 2025, revenue associated with our collaboration with Chiesi was $9.9 million, including $6.6 million of cost reimbursement revenue. Research and Development (R&D) Expenses: For the quarter ended March 31, 2025, R&D expenses were $38.0 million, compared to $32.4 million for the same period in 2024. General and Administrative (G&A) Expenses: For the quarter ended March 31, 2025, G&A expenses were $8.7 million, compared to $9.6 million for the same period in 2024. Net Loss: Net loss for the quarter ended March 31, 2025, was $36.6 million, or $0.16 basic net loss per share, compared to a net loss of $41.9 million, or $0.19 basic net loss per share, for the same period in 2024. Conference Call and Webcast Gossamer's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, May 15th, to discuss its first quarter 2025 financial results and business update. The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company's website at Alternatively, the conference call may be accessed through the following: Domestic Dial-in Number: (800) 285-6670International Dial-in Number: (713) 481-0091Live Webcast: A replay of the audio webcast will be available for 30 days on the "Investors" section of the Company's website, About Gossamer Bio Gossamer Bio is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. Forward-Looking Statements Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing of enrollment completion and a data readout from our Phase 3 PROSERA Study; the potential or likelihood for a meaningful data readout from our PROSERA Study; the development potential of seralutinib; the anticipated timing on commencing a Phase 3 clinical trial in PH-ILD; and the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer's business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from unexpected events, including clinical trial delays; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer's clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer's ability to obtain and maintain intellectual property protection for seralutinib; Gossamer's ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Gossamer Bio Statement of Operations Condensed Consolidated Statement of Operations (in thousands, except share and per share amounts) (unaudited) Three months ended March 31, 2025 2024 Revenue: Revenue from contracts with collaborators $ 9,889 $ — Total revenue 9,889 — Operating expenses: Research and development 38,041 32,392 General and administrative 8,658 9,567 Total operating expenses 46,699 41,959 Loss from operations (36,810 ) (41,959 ) Other income (expense) Interest income 294 344 Interest expense (2,746 ) (3,129 ) Other income, net 2,624 2,816 Total other income, net 172 31 Net loss $ (36,638 ) $ (41,928 ) Net loss per share, basic and diluted $ (0.16 ) $ (0.19 ) Weighted average common shares outstanding, basic and diluted 226,818,051 225,735,236 Condensed Consolidated Balance Sheet (in thousands) BALANCE SHEET DATA: March 31, 2025 December 31, 2024 (unaudited) Cash, cash equivalents, and marketable securities $ 257,934 $ 294,518 Working capital 227,252 264,878 Total assets 280,589 315,292 Total liabilities 286,839 285,800 Accumulated deficit (1,305,206 ) (1,268,568 ) Total stockholders' equity (deficit) (6,250 ) 29,492 View source version on Contacts For Investors and Media: Bryan Giraudo, Chief Financial Officer & Chief Operating OfficerGossamer Bio Investor Relationsir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
15-05-2025
- Business
- Business Wire
Gossamer Bio Announces First Quarter 2025 Financial Results and Provides Business Update, Including Closure of New Patient Screening in Phase 3 PROSERA Study
SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced its financial results for the first quarter ended March 31, 2025, and announced the closure of new patient screening for the ongoing registrational Phase 3 PROSERA Study in PAH patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. "I am incredibly proud to announce that, following the recent closing of new patient screening, we are just weeks away from fully enrolling the PROSERA Phase 3 Study in PAH," said Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer Bio. "This achievement is the result of our team's unwavering dedication, tireless effort, and steadfast commitment to our mission. We expect to publicly announce topline data from this pivotal study in February of 2026. Enrolling the appropriate patients for this study was of paramount importance, and the baseline characteristics of those who have been randomized to date demonstrate that our diligence and focus on study quality has paid off. This reinforces our optimism for meaningful results and brings us one step closer to the potential of having a new, first-in-class therapy for patients with PAH.' Chief Medical Officer Dr. Richard Aranda added, "We are also delighted to unveil the clinical trial design for the Phase 3 SERANATA Study in PH-ILD, a landmark moment in our pursuit to address unmet patient need. A product of close collaboration and alignment with global regulatory authorities, including the FDA and EMA, this study represents a groundbreaking effort to offer new hope to patients with PH-ILD." Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor On May 14th, we closed new patient screening for the ongoing PROSERA Study in Functional Class II and III PAH patients. To date, 343 patients have been enrolled or are scheduled to randomize into the PROSERA Study. With the additional patients currently in screening, we expect to complete enrollment with over 350 PAH patients in early June. The Phase 3 PROSERA Study is a double-blind, placebo-controlled, global registrational clinical trial evaluating seralutinib in PAH patients, on top of background PAH therapy. Patients are assigned 1:1 to either the seralutinib or placebo arms. Patients receive blinded treatment for up to 48 weeks. The primary endpoint of the PROSERA Study is change in six-minute walk distance (6MWD) from baseline as compared to placebo at week 24. Included in the key secondary endpoints is time to clinical worsening, as compared to placebo, up to week 48. In addition to other secondary and exploratory endpoints, safety and tolerability will be evaluated. The patient population enrolled in PROSERA aligns with the target demographic, as evidenced by available baseline characteristics. The PROSERA Study utilizes enrichment criteria, including the REVEAL Lite 2 Risk Score and other criteria, to identify patients more likely to show a greater magnitude of effect on 6MWD at week 24, as informed by the Phase 2 TORREY study. Seralutinib Clinical Trial Baseline Characteristics: Phase 3 PROSERA Study* v. Phase 2 TORREY Study We expect to announce topline results from the ongoing Phase 3 PROSERA Study in February 2026. We expect to activate clinical sites for the global, registrational Phase 3 SERANATA Study in PH-ILD patients in the fourth quarter of 2025. Achieved alignment on study design and endpoints with global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The planned SERANATA Study will be a 24-week, randomized, double-blind, placebo-controlled, global clinical trial in PH-ILD patients. Approximately 480 patients will be randomized 1:1:1 to receive either 90mg seralutinib twice-daily, 120mg seralutinib twice-daily or placebo. The primary endpoint of the SERANATA Study is change in 6MWD from baseline as compared to placebo at week 24. Key secondary endpoints will include time to clinical worsening and change from baseline in forced vital capacity (FVC). One poster related to seralutinib will be presented at the American Thoracic Society (ATS) 2025 International Conference, taking place from May 16th through 21st, in San Francisco, California. Poster Presentation Title: Seralutinib in Pulmonary Arterial Hypertension: Exploring Mechanisms of Reverse Remodeling Versus Vasodilation Poster Number: P920 Session: A76 Finger on the Pulse: Cardiopulmonary Dysfunction in Lung Disease Date: Sunday, May 18 th Time: 11:30am – 1:15pm PDT Location: Area G, Hall F (North Building, Exhibition Level), Moscone Center Following its presentation at the ATS 2025 International Conference, the poster will also be made available on the 'Posters & Publications' section of the Gossamer Bio website at Financial Results for Quarter Ended March 31, 2025 Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2025, were $257.9 million. We expect the combination of current cash, cash equivalents and marketable securities will be sufficient to fund our operating and capital expenditures into the first half of 2027. Revenue from Sale of Licenses and from Contracts with Collaborators: For the quarter ended March 31, 2025, revenue associated with our collaboration with Chiesi was $9.9 million, including $6.6 million of cost reimbursement revenue. Research and Development (R&D) Expenses: For the quarter ended March 31, 2025, R&D expenses were $38.0 million, compared to $32.4 million for the same period in 2024. General and Administrative (G&A) Expenses: For the quarter ended March 31, 2025, G&A expenses were $8.7 million, compared to $9.6 million for the same period in 2024. Net Loss: Net loss for the quarter ended March 31, 2025, was $36.6 million, or $0.16 basic net loss per share, compared to a net loss of $41.9 million, or $0.19 basic net loss per share, for the same period in 2024. Conference Call and Webcast Gossamer's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, May 15 th, to discuss its first quarter 2025 financial results and business update. The live audio webcast may be accessed through the 'Events / Presentations' page in the 'Investors' section of the Company's website at Alternatively, the conference call may be accessed through the following: Domestic Dial-in Number: (800) 285-6670 International Dial-in Number: (713) 481-0091 Live Webcast: A replay of the audio webcast will be available for 30 days on the 'Investors' section of the Company's website, About Gossamer Bio Gossamer Bio is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. Forward-Looking Statements Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing of enrollment completion and a data readout from our Phase 3 PROSERA Study; the potential or likelihood for a meaningful data readout from our PROSERA Study; the development potential of seralutinib; the anticipated timing on commencing a Phase 3 clinical trial in PH-ILD; and the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer's business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from unexpected events, including clinical trial delays; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer's clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer's ability to obtain and maintain intellectual property protection for seralutinib; Gossamer's ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading 'Risk Factors' in the Company's annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Condensed Consolidated Balance Sheet (in thousands) BALANCE SHEET DATA: March 31, 2025 December 31, 2024 (unaudited) Cash, cash equivalents, and marketable securities $ 257,934 $ 294,518 Working capital 227,252 264,878 Total assets 280,589 315,292 Total liabilities 286,839 285,800 Accumulated deficit (1,305,206 ) (1,268,568 ) Total stockholders' equity (deficit) (6,250 ) 29,492 Expand
