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spk01: Good day and thank you for standing by. Welcome to the Gossamer Bio Q3 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Brian Truetto, Financial and Chief Operating Officer. Thank you. Please go ahead.
spk05: Thank you, Operator, and thank you all for joining us this afternoon. I am joined on today's call by Gossamer Bios Chairman, Co-Founder and Chief Executive Officer Faheem Hasnain, Laura Carter, Gossamer Bios Chief Scientific Officer, and Richard Aranda, Gossamer Bios Chief Medical Officer. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the third quarter ended September 3, 2021, in addition to providing a corporate update. Please note that certain information discussed on this call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this 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 business. These four looking statements are qualified by the statements contained in Gossamer's news releases and SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that may be accurate only for a limited period of time. Our ability to meet our guidance, especially that related to the timely initiation and completion of clinical studies, in addition to our ability to release results from our clinical trials in a timely manner, may be adversely affected by the ongoing COVID-19 pandemic. Gossamer Bio undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the day of this conference call. Now, I'd like to turn the call over to Fahim. Fahim?
spk08: Thanks, Brian. And thank you all for joining us today on Gossamer Bios' third quarter earnings and update call. At the end of today's call, we'll conduct a question and answer session. But first, we will discuss our inhaled kinase inhibitor for the treatment of pulmonary arterial hypertension, serolutinib. In the press release we issued earlier today, we shifted our guidance for the top-line data readout for the Torrey Phase II study of serolutinib to the second half of 2022. And as I'm sure all of you are aware, the COVID-19 pandemic has created unprecedented challenges in conducting clinical trials, including a shortage of medical professionals. And we believe that these challenges, given the nature of COVID, were more impactful for our clinical trials in the arenas of pulmonary and critical care. We started screening patients for the Torrey study in December of 2020. Prior to the full effect of the Delta variant in the U.S. and Western Europe, we experienced a meaningful uptake in screening and enrollment this spring and through the midsummer, and we leveraged many of our learnings with COVID from our completed Phase 1b trial. At the time of our second quarter call on August 7th, we were confident on meeting expected timelines, especially with the uptake in both screening and enrollment at U.S.-based sites. However, With the emergence of the Delta variant, many of our investigators and nurses were called back into COVID ICU wards in mid-August and September. Further lockdowns on national, regional, and municipal levels created an additional obstacle, and enrollment in many locations throughout the Western world essentially ground to a halt. Moreover, we also experienced competition from COVID-related trials, specifically pediatric and booster vaccine work, as well as from some of the COVID antibody and therapeutic trials. I'm pleased to say now that the Delta appears to be passing, we're seeing increased engagement with sites and investigators as they've gone back to their non-COVID research and clinical programs. And we're actively working to translate that into screenings and enrollment. Remember, we first encountered COVID-based enrollment obstacles in the Phase 1B study. While getting patients enrolled remains an issue, once on study, we have designed the study protocol with COVID in mind, and we've incorporated measures to keep patients on study once they're enrolled. Despite COVID, of those patients that have already completed the 24-week TORI Phase 2, all have enrolled into the OLE. With nearly all of our 70 plus sites online and engaged, we're confident that we can continue to navigate these challenges to complete enrollment in the first half of next year and read out top line data in the second half of 2022. Now, moving on to GB004. We are extremely pleased today to announce that last month we completed an enrollment for the SHIFT-UC Phase 2 study in mild to moderate ulcerative colitis patients with active disease. We were able to enroll this group of patients despite the pandemic for a number of reasons. GB004's mechanism of action is distinct from systemic immunosuppressants, and with COVID a real concern for investigators and patients alike, GB004 became an attractive option for those institutions focused on clinical trials in inflammatory bowel disease. We believe this also speaks well to the target positioning of GB004 in an evolving ulcerative colitis commercial landscape. Patients with severe UC are inundated with treatment options that are lacking from a safety and tolerability perspective. But mild to moderate UC patients who fail five ASAs are hesitant to make the jump to biologics and immunosuppressive therapies. This dynamic has buttressed GB004 trial enrollment throughout COVID, and we believe it bodes well for the commercial potential of the molecule. Additionally, the contributions from many capable team members, including from the legacy Receptus of Zanamon team, were instrumental in building a global clinical trial infrastructure, leveraging longstanding relationships, and positioning this trial for successful enrollment. The primary endpoint of this trial is clinical remission after 12 weeks. Once all patients complete 12 weeks and an additional month of safety monitoring, we expect to announce top-line results early in the second quarter of 2022. After the 12-week primary endpoint, patients will stay on randomized therapy for an additional 24 weeks. After completion of 36 weeks of randomized therapy, we expect to announce the results of the 36-week treat-through endpoint in the fourth quarter of 2022. Following completion of the trial, patients will be presented with the option to enroll in our open-label extension study, where we hope to generate longer-term data. Now, before I ask Brian to run through the financial results for the quarter, I wanted to remind listeners today that Gossamer recently unveiled its next clinical stage product candidates, a pair of CNS penetrant BTK inhibitors, known as GB5121 and GB7208. These candidates are the product of intensive behind-the-scenes internal development work. We believe that these molecules have differentiated properties, including superior brain penetration, that position the candidates to treat neuroinflammatory and neurodegenerative conditions in oncology and autoimmune disease. including primary CNS lymphoma and multiple sclerosis. And we're also pleased today to announce that we have dosed our first subject with 5121, GB5121, in a phase 1 trial in Healthy Volunteers this month. We expect to initiate a potentially registrational phase 1B-2 trial in the first half of next year. GB7208 is expected to enter a first-in-human clinical trial in the second half of next year. Please visit our website at gossamerbio.com to see a recent Investor Day presentation that details both of these candidates and our development plans. I'll now turn it back to Brian.
spk05: Thank you, Fahim. We will now review the financial results for the third quarter of 2021. We ended the quarter with $366 million of cash and cash equivalents. We anticipate our cash, cash equivalents, and marketable securities, along with our access to our debt facility, to provide us sufficient capital resources to fund operations and capital expenditures well into the second half of 2023. Research and development expenses in the third quarter of 2021 were approximately $43.2 million as compared to R&D expenses of $41.8 million in the same period in 2020. G&A expenses were $12.5 million in the third quarter as compared to G&A expenses of $11.4 million for the same period in 2020. And our net loss for the quarter was $60.2 million, equating to $0.80 per share. For the same period in 2020, we reported a net loss of $57.8 million, which also equated to $0.80 a share. With that, I'll turn the call back over to Fahim prior to Q&A.
spk08: Thanks, Brian. I'd just like to give my thanks to the Gossamer team for their incredible passion and commitment towards making a difference for patients. And I'd like to thank all of you for joining us today. We're excited to share our progress with you. Operator, you can now open the line for questions.
spk01: All right. As a reminder, to ask a question, you will need to press star 1 on your telephone. Once again, you will need to press star 1 on your telephone. To resolve your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Yasmeen Rahimi. Your line is open.
spk00: Hi, Saeem. Hi, Brian. Thank you so much for sharing all the updates with us. I have two questions for you. Maybe the first one is in regards to Tori's study. I knew you noted that about 100% of the patients enrolled into the open label. Can you provide me with how many patients that are have entered open label? And then are you planning on to turn on additional sites so that top line data is on track for second half of 2022? And then the second question is around shift you see. Have you maybe commented on sort of the statistical hierarchy in regards to the secondary endpoints as we think about clinical response and mucosal healing. So if you could provide some color around that, it could be very helpful. And thank you for taking my questions.
spk08: Yeah, Yasmeen, this is Faheem. Thanks very much for your question. As it relates to the number of patients that are into OLE, as I'm sure you're aware, we don't comment on the specific numbers of patients enrolled and certainly patients into OLE. Having said that, we're pleased with the progress that we're now starting to see in enrollment. And the fact that all of the patients that have been enrolled have gone into OLE is an early encouraging sign.
spk05: As it relates to the number of sites, Yasmeen, we have, as we said in our remarks, almost all of our 70 sites are either up and running or on the verge of reopening due to COVID issues. Obviously, that is the variable, but we feel very good that with the sites that are online, on board, that we will be able to deliver the results of the timing that we put forth, again, subject to meaningful changes in the COVID landscape.
spk08: And the UC question, I'll turn that over to Richard to give you some thoughts.
spk07: Sure. The secondary endpoints in our SHIFT-GC study involve clinical response, endoscopic improvement or healing, and mucosal healing. And our study is appropriately powered to also achieve those endpoints.
spk00: Thank you, Tim, for that.
spk01: Your next question comes from the line of Joseph Schwartz. Your line is open.
spk06: Hi, thanks very much. It looks like your expectation of being able to report top line data from Tory in the second half of 22 is still subject to the extent of potential ongoing COVID-19 disruption. So I was wondering if you can characterize how much of a stretch the second half of 22 could be. And as part of that question, if enrollment continues at the same rate as it has been most recently, where would that put the data release within the second half of 22? And then I have a follow up.
spk08: As it relates to 2022, I mean, we're, again, we're encouraged by the rate of enrollment that we're seeing today. But, you know, Joseph, I think we absolutely have to continue to put that COVID asterisk on the plan in that, you know, while we're seeing declining rates of Delta, you know, hopefully we don't see the next variant or resurgence. So, again, I think it's only prudent for us to continue to apply that COVID asterisk until we can kind of get to the other side of where we're at with the pandemic.
spk05: Yeah, I would just say, Joe, at the end of the day, we wouldn't put out the guidance if we didn't believe we could hit it. But as Fahim said, as we sat down, in the same conference room here at Gossamer a quarter ago, we thought we were going to hit the end of the year, and we clearly did not expect the ferocity of Delta and what it did to, again, just the practice of medicine and pulmonary and critical care. So ultimately, you know, we certainly have the plan, the people, the infrastructure to do that. There is a variable that's beyond our control that got us to the back end of the summer, and our fingers are crossed that we won't have that happen again.
spk08: But obviously, you know, our forecasting and projections based on where we are today, we believe that that's pretty reasonable guidance.
spk06: Okay, that's helpful. Thank you. And then have you considered doing an interim analysis for the TORI study? Or how about some protocol amendments to simplify things, such as perhaps making the PVR undertaking a sub-study, if that's the main rate limiting factor, for example, and a six-minute walk study could be more alone could be more straightforward?
spk07: Yeah. This is Richard. We've designed the study. As a reminder, we've had some experience with PH patients from our Phase 1b in the setting of COVID. So we added several lessons learned from that study, and hence we designed our Phase 2 from the get-go, if you will, with certain provisions in mind to allow for some flexibility without compromising the integrity or quality of the study. A typical Phase II program, it's important for PVR because you want to demonstrate hemodynamic changes, and actually the sample size requirement for a PVR endpoint is much more relaxed, if you will, than a six-minute walk-in point. We feel that the way the study is currently designed, we do not plan to do an interim analysis, and that was not something that we are planning to do.
spk05: Joe, I'll just add that Again, the components of the Torrey study were not what impeded enrollment. It was the fact that literally many of our investigators got called to work in ICU wards. All of the management team has been out visiting with our investigators. And more often than not, we hear, we have patients, we just don't have nurses. So it really has to do with just what's going on at, again, pulmonary and critical care centers of excellence, around the world are struggling and we're struggling with COVID. We do think that that is starting to lift and we're seeing that engagement, but really not about Tori, more about just the infrastructure of treating patients on a macro basis.
spk06: Right. Okay. That's super helpful. Thanks for the color.
spk01: Your next question comes from the line of Carter Gold. Your line is open.
spk02: Great. Good afternoon. Thanks for taking the question. I guess to start, it'd be helpful if you could just comment even at a high level around, I guess, your satisfaction with the homogeneity of the population you enrolled in Shift UC. It seems like you were clearly the beneficiary of differentiated positioning in the marketplace. And so even at a high level, any comments on that front would be helpful. And then just given some of the setbacks that have, I guess, beset some of your oral competitors in the UC landscape, if that's I guess, changed any of your viewpoints as you think about that moderate to severe population going forward? I recognize the early efforts around mild to moderate, but the landscape around you has sort of shifted, no pun intended. Thank you.
spk08: Yeah, certainly as it relates to the landscape of UC, you're absolutely right. There's definitely some shifting that is occurring. And while we're in a very interesting position mild to moderate segment, and given the pace of enrollment, I think it's a reasonable view to the attractiveness of the profile of this drug. I think clearly we would have the opportunity to be able to move not only earlier in therapy, but possibly even up later in therapy, and potentially, if the safety continues to play out, view this as an opportunity to try to really change remission rates through combination use. I think the profile of this drug has just been made more attractive, quite frankly, with the cloud that sits around now on safety associated with, say, the JAK class as an example. So I think all of that speaks to a bit of a tailwind for this program.
spk07: In terms of the patient population, we designed it to target a population mild to moderate based on Mayo score and with an endoscopic subscore of two. We'll have to wait until we get the top-line results first half of next year to figure out the full demographics, but based on what our enrollment characteristics have been, we're confident that we've targeted the right population.
spk02: Thank you.
spk01: Your next question comes from Olivia Breyer. Your line is open.
spk09: Hi, guys. Thanks for the questions. I wanted to ask on your latest expectations for efficacy measures in the TORI study. I know you've talked about wanting to see some more PVR reduction, so tatter set, and I think that was, you know, 18 to 32 percent range, and then also on six-minute walk in that 20 to 30-meter improvement, at least directionally. So, Is that still the bar you're looking to hit, or are there any updates to how you're thinking about that readout? And then I've got a follow-up on UC.
spk07: We still believe that those are the right guideposts for what we want to see, and hence there's been no changes in our thought process.
spk09: Okay, got it. And then on 04, I know you guys talked a little bit about the landscape earlier, there are still a number of orals in development and there could be more than one oral modality on the market by the time your asset moves through development. So I guess the question is, how do you think about the possible treatment hierarchy for those different oral agents? And where do you think O4 could be most differentiated there?
spk08: So as we know, unfortunately, none of these treatments can be viewed as cures. And like many other autoimmune indications, patients often cycle through treatment. So the availability of a number of treatment choices that have kind of the patient-friendly attribute of being an oral, daily oral, I think is incredibly attractive. The market is pretty large. So I think that's kind of the first dimension is that a number of orals on the market I think is great for patients, but also there's plenty of room in that context. I think the second dimension here is the positioning that at least the first level of positioning in that kind of mild to moderate segment, that post-5ASA failure, pre-immunosuppressant, pre-biologic. That's a very unique positioning that doesn't have... the same kind of oral competition, so to speak. In other words, Ozanamod, which is a drug we know well, really doesn't play in that space, of course, nor does Jax. So I think there's a very unique element of profile for this drug that I think bodes well for the future, assuming that the data plays out.
spk09: Great. Thank you, guys.
spk01: Your next question comes from Patrick . Your line is open.
spk04: Hi. Thank you for taking my question. And this is Jason speaking for Patrick. And so I guess I just have a two-part question about the GB BTK inhibitors. And so the first question is, what is your expected pace of enrollment for your GB5121? And possibly if you can give us some insight on your future study for GB7208. And the second question is, what is your primary endpoint for your first-in-human study for your GP5121? And thank you.
spk07: Yeah. So, as mentioned, we're currently conducting a normal healthy volunteer study. Our primary endpoint is typically for normal healthy volunteers is safety tolerability. We'll obviously look at pharmacokinetics. The nice thing about BTK inhibitors, there's a lot of science behind target engagement biomarkers and receptor occupancy, so we'll also assess those. Your question, furthermore, was around... Yeah, it's a normal healthy volunteer, so typically they're done in phase one units where patients are identified. and screened and put in queue. So we anticipate that it would go relatively quickly. Thank you. And then I think you had a question. I think you had a question about 7208. We anticipate also doing a first in human normal healthy volunteer. Given that it's a BTK, we'll likely have a similar trial design as our current normal healthy volunteer with 5121. All right.
spk04: Thank you very much.
spk01: Your next question comes from Brian Chang. Your line is open.
spk03: Hey, guys. Thanks for taking my question. So maybe first one on GB5121. I'm just curious if you have any early thoughts on the inclusion or exclusion criteria for PCNSL using learnings from other BTK inhibitors for this indication. And are you going to be including, are you planning to include patients with intraocular or CSF involvement? And then I have one quick follow-up.
spk07: So, yes, we are going to include patients with intraocular and CSF involvement. Obviously, we're going to enroll patients that have refractory or recurrent primary and secondary CNS lymphoma as our initial priority. patient population in our dose escalation. Once we define a recommended Phase 2 dose, we will then focus on our PCNS patient population as part of our Phase 2 study and then as part of a dose expansion component.
spk03: Okay. And maybe back on Sarah Lewinib, I'm just wondering if we would be getting additional OLE updates for the compound from the phase 1b study near term given that we saw the two patients update last quarter and i'm just and also i'm curious if you have any if you've started looking into any signs of vascular remodeling or hemodynamics in those two patients thanks yeah so as you recall we had two patients complete the open label extension of the phase 1b one of those patients
spk07: still continues in a open-label experience as we have another protocol that this patient rolled over in. They continue to do well. The other patient decided to go on to another trial and therefore did not go forward in the open-label extension of serolutinib. In terms of vascular remodeling, we did not specifically have any assessments of that. It's difficult. So the only thing we do have is, for example, indirect measures such as NT-ProVMP and obviously six-minute walk that we're continuing to follow.
spk03: Okay, thank you.
spk01: I am showing no further questions at this time. Please continue.
spk08: All right. If there's no further questions, we thank everybody for spending time with us today. And again, my thanks to the team and thanks to all the patients that have enrolled in the trials. We look forward to next quarter being able to continue to give you updates on progress. Thanks, everybody.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect.
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