Acelyrin Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 7, 2023

There are 8 speakers on the call.

Operator

Day and thank you for standing by. Welcome to the Celeron Q3 2023 Earnings Conference Call. At this time, all participants are in listen only mode. After the speakers' presentation, there will be a question and answer is raised. Please be advised that today's conference is being recorded.

Operator

I would now like to hand the conference over to Tyler Marciniak, Vice President of Investor Relations, Communications and Corporate Operations, please go ahead.

Speaker 1

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Before we begin, I'd like to remind the audience that this conference call will contain forward looking statements, such as those related to progress of our clinical trials and anticipated data readouts, our future financial and operating results and investments and our ability to commercialize our product candidates. These forward looking statements involve risks and uncertainties that could cause our actual results and events to differ materially. We urge you to review the Risk Factors section of our Form Thank you for the quarter ended June 30, 2023, filed with the SEC and also available on our website at acellerin.com.

Speaker 1

Along with statements in today's press release and our slide presentation, which identify certain factors that could cause our actual results, performance and events to differ materially. Additionally, these statements are based on information available to us today, November 7, 2023, and we undertake no obligation to update them as circumstances may change. Joining us on today's call are Doctor. Shao Lee Lin, Our Founder and CEO and Gil Labroussery, our Chief Financial Officer. I will now turn the call over to Doctor.

Speaker 1

Lin. Charlene?

Speaker 2

Thank you, Tyler. Good afternoon, everyone. Thank you for joining us for Acelon's 3rd quarter update call. As we approach the end of 2023, we feel fortunate for the progress we have made throughout the course of the year. We began in January with the transformative expansion of our portfolio through the acquisition of another private I and I company.

Speaker 2

And in May, we were pleased to close a successful IPO in a challenging market environment. We are grateful to our investors for walking alongside with us in our journey as we remain focused on building a leading I and I company and continuing to advance programs across multiple autoimmune and inflammatory diseases with the goal to deliver transformative medicines for patients. Our strategy remains steadfast to identify candidates we believe are diamonds in the rough, Where based on molecule characteristics, our collective experience and expertise and the evolving scientific and medical understanding, We can establish development plans to test our hypotheses around clinical differentiation and the potential benefit for patients. We are advancing our portfolio of programs across multiple indications, including isekyta, a next generation inhibitor of IL-17A ING studied in multiple trials with registrational potential within the rheumatology, dermatology and ophthalmology settings. Lonagutumab, a subcutaneously delivered inhibitor of IGF-one receptor being developed for thyroid eye disease And Accel-five seventeen, an earlier stage program we are evaluating for allergy related mast cell driven diseases such as chronic urticaria.

Speaker 2

In addition to our clinical progress, we continue to build our organizational capability and capacity to support our portfolio. Most recently, we announced the appointment of Patricia Cherney as our Chief Technical Operations Officer, responsible for overseeing technical operations, Patricia brings to Acelain more than 25 years of biopharmaceutical experience across R and D, Clinical and Commercial Supply Management and expands our capacity for multi asset late stage manufacturing at a pivotal time as we advance a robust portfolio with multiple large scale clinical trials underway and prepare for potential regulatory filings and commercial launches. We also welcomed in September Doctor. Shep Makofu, our Senior Vice President of Development, responsible for Clinical Development and Translational Sciences. Cheuv brings more than 20 years of industry experience, including a long tenure at Novartis, where he most recently served as Senior Vice President and Chief Medical Officer for Novartis Gene Therapies.

Speaker 2

Prior to that, Chip was the global lead for cevitumab, where he advanced the product from early development through to multiple approvals across the indications, including psoriatic arthritis or PSA, higher adenitis on patina or HS, Uveitis and Axios Spondyloarthritis or axSpA. His extensive experience will While Gail will review our financials in greater detail later on the call, I do want to underscore our strong financial position. With nearly $800,000,000 on our balance sheet, we can execute on our strategy over the coming months years and achieved numerous key milestones across the entire portfolio of programs and indications. Let's turn now to a review of our progress As a recap, isotype up as a small protein therapeutic designed to inhibit IL-17A with a high potency Through tight binding affinity that has the potential for robust tissue penetration due to its small molecular size, which is about oneten the size of a monoclonal antibody and has an algorithm binding domain that extends half life. We have hypothesized that the high potency and small size of isatyka can lead Clinically meaningfully differentiated responses for patients across multiple indications where this mechanism of action has been validated And that this can be achieved with the safety profile consistent with that of the IL-17A class as has been demonstrated by the currently marketed monoclonal antibody IL-17A as a target has not demonstrated dose limiting toxicity Over 10 years of post marketing and millions of patient years of safety experience.

Speaker 2

This will be important as we discuss what appears to be an evolving understanding around targeting the IL-seventeen access more broadly than selectively targeting IL-17A. Let me begin with psoriatic arthritis, which is our most advanced program and represents the largest potential indication for isokayla. Psoriatic arthritis is a chronic inflammatory disease With multiple clinical manifestations, including arthritis, psoriasis, spondylitis, dactylitis and importantly, emphyseitis, Which is an inflammation of the strong, dense, poorly vascular tissues that anchor our ligaments and tendons to bone. Endocitis impacts the majority of moderate to severe psoriatic arthritis patients and has been historically very difficult to treat. It is a marker of disease severity and a source of residual pain and physical dysfunction, which impacts quality of life for patients.

Speaker 2

There are approximately 1,600,000 PSA patients in the U. S. And The 2022 PSA treatment market was valued at $8,800,000,000 globally and is estimated to grow to nearly $18,000,000,000 by 2,030. Historically, PSA treatments have been more effective in the joints and skin, but not the harder to treat manifestations Rapid, deeper and more durable resolution of disease across clinical measures is the key to improving overall quality of life, which is ultimately our goal for patients. We have already shared results from a Phase and increasing over time.

Speaker 2

This included an ACR50 response of 50% at week 12 or 44% placebo adjusted. Resolution of Emphyseitis as measured by the leads Emphyseitis Index was 82% at week 8 at our 80 milligram every other week dose. Week 12 was not a protocol specified time point for this measure. FDI resolution is the standard approach to reporting improvements for Emphasize. To enable comparison with recently reported emphasize data for 1 of the IL-seventeen AF inhibitors, we also analyze subjects with LEI of 2 plus At baseline, with an improvement of 2 plus points at our week 8 versus the other agents' data at week 12.

Speaker 2

This analysis showed 100% response at week 8 in patients receiving 80 milligrams of isekaibe versus 0% in placebo. These results are relative to 71% reported at 120 milligrams for the IL-seventeen AF agent at 12 weeks, without disclosure of a placebo as a reference for that agent. At UR in June of 2022, We presented primary endpoint 16 week data showing that isakayabab demonstrated clinically meaningful benefits across These manifestations including 52 percent ACR50 response, 85 percent PASI75 response and 88% resolution of Emphyseitis, Switch to our knowledge is a level of resolution not previously reported for any other agent. These clinical benefits subsequently drove significant improvements in all beef life across all domains. And importantly, this included statistically significant improvements in pain, Functional capacity and sleep disturbance as measured by the psoriatic arthritis impact of disease questionnaire or pSED.

Speaker 2

The PSA is a validated psoriatic arthritis specific patient reported outcome measure. Furthermore, earlier this year, we were delighted to report initial long term efficacy from the same Phase 2 trial that showed With longer duration of treatment, patients experience durable and deepening resolution of disease across clinical manifestations of PSA, leading to further improvements in quality of life as measured by the VSIP. Additional data demonstrating that increased duration of therapy Continues to enhance resolution of disease will be presented in both poster and oral podium sessions taking place next Monday during the upcoming American College of Rheumatology Convergence in San Diego. At 46 weeks, of participants receiving isacidebac 80 milligrams every other week, 79% achieved ACR50 response, up from 52% at week 16. And even higher orders of clinicals of response in measures Approximately resolution of disease were observed with 52% achieving ACR70, 71% achieving PAUSI-one hundred at 89% achieving enthesitis resolution.

Speaker 2

Notably, patients who switch from placebo to 80 milligrams every other week at week 16 Responded quickly with more than 60% of patients in both the switch group as well as the original 80 milligram every other week group Achieving minimal disease activity by week 46. Importantly, this efficacy was delivered with a safety profile consistent with Modeling from the Phase 2 PSA data predicted the potential to increase response over time as has been demonstrated with 46 week data. The modeling further predicts the potential for increased efficacy with higher doses Over the 80 milligrams every other week utilized in the Phase 2 trial. To that end, the ongoing Phase 2bthree trial with PSA is evaluating both Aside from the higher dosing, the design of this trial is consistent with that of the Phase 2 with a few notable exceptions. Firstly, this is a truly global study with 3 52 patients across 71 sites, including 40 in the U.

Speaker 2

S. And 30 internationally to enable the potential for registration across geographies. In addition, there is an increased percentage of emphyseitis at baseline And an increased percentage of TNF failures, meaning individuals who have had an inadequate response in tolerance or contraindication. These aspects all have the potential to impact the specific point estimates relative to Phase 2, but are important in understanding the potential benefits of ezetizumab for PSA patients. Both are important given the contribution of ensitus to severity of disease, including continued pain and disability And also the increasing number of patients who have not simply been exposed to TNF inhibitors, but have demonstrated an inadequate clinical response.

Speaker 2

This Phase 2bthree trial in PSA completed enrollment in the Q2 of 2023. Over 75% of patients have We did through the primary endpoint at week 16 and the discontinuation rate is 5.9%. Top line data continues to be expected in the Q1 of 2024. Now we'll turn our attention to hidradenitisumpertiva, which continues to be an area of rapid evolution. Just last week, only the second treatment for HS and the first new option for patients in almost a decade was approved by the FDA.

Speaker 2

We have the great fortune at AcelRin of having members of our team who held important roles in the context of each of these approved therapies. And for all of us, It's always gratifying to see new treatment options for patients. At the same time, while the IL-17A safety profile is well established, We have also seen, especially recently, our understanding of the safety profile of targeting subunits beyond IO-17A Continues to evolve and may become a more important consideration. Targeting both ANF leads to dose responsive increase in fungal infections. This was seen in data from both agents targeting inhibition of IL-seventeen ANF.

Speaker 2

After 24 weeks of treatment, 1 demonstrated an approximate doubling of fungal infection risk from 12 weeks, which increased to about 20% in the planned dose and almost 30% in their higher dose with the beginnings of reports of occurrence of these fungal infections in areas beyond just skin. Additionally, the risk of suicidal ideation and behavior was noted in the recent label of an IL-seventeen AF inhibitor. This has been noted previously in the label of an anti IL-seventeen receptor inhibitor, which swaps all the subunits of IL-seventeen, including IL-17F. Cumulative data from these two agents over the registrational programs This raises the question of relationship between inhibiting IL-seventeen more broadly than IL-17A, specifically The potential association with the inhibition of lysodine F. His recent label also noted the requirement for routine laboratory monitoring for liver toxicity, which has not previously been noted for the iosaphene A inhibitors.

Speaker 2

So the landscape is actively evolving in terms of balancing efficacy and safety hurdles for new treatments for HS patients. We believe in its entire best potential in HS With roughly 25% of patients achieving Highscore 100 responses within 12 weeks, which means they rapidly achieve resolution of all accesses and nodules without new training tests. This is a level of responders achieved in half the time reported by others and without the safety or tolerability considerations of targeting IL-17F in addition to IL-17A. As we previously shared, both our Phase 2Q3 and our ongoing Phase 3 trial are moving forward and discussions with the FDA will help inform next steps to advance our registrational program. We expect to have an update by end of this year or early next year.

Speaker 2

And in addition to PSA and HS, we continue to explore the potential for risottagam to make a meaningful difference Endocitis is a central feature of ActSpa and we believe the rates of endocitis resolution demonstrated in the Phase 2 PSA So just the potential for clinically meaningful differentiated benefits for patients with this disease. We will use the optimal dose from the PSA program We also continue to enroll our Phase 2bthree clinical trial of bisakimab as a treatment for uveitis. Previously reported data for another IL-17A inhibitor delivered intravenously has validated the inhibition of IL-17A as a potential therapeutic for uveitis. While isokaybev is the lead program in our portfolio, we have 2 other programs, Slonagutumab and AcelREN-five seventeen, which we are developing in thyroid eye disease and mast cells of the diseases. Thyroid disease is a vision threatening progressive chronic autoimmune disease and similar to HS, the test landscape is evolving rapidly.

Speaker 2

Our team has deep experience in this indication with many involved in developing the only currently approved treatment. Recent clinical data demonstrating the effectiveness of inhibiting IGF-one receptor in chronic TED supports our approach to developing lonaglumab, Not just for acute disease, but also more like treatments for chronic inflammatory autoimmune diseases. This includes targeting greater depth and durability of response with longer term dosing and the goal of achieving resolution of disease. Recent updates from the FDA to warnings and precautions of the currently approved therapy We also highlight hearing impairment as a serious potentially permanent side It may be directly related to the inhibition of the normal function of IGF-one given its full and regenerating cells of the inner ear The unique characteristics of olenubimab may Allow us to optimize efficacy by maintaining minimum drug levels needed to achieve improved depth and durability of response, Limit safety liability, including hearing impairment, potentially associated with high maximum drug concentrations And maximize patient convenience through subcutaneous delivery. The Phase III trial of onadutumab delivered subcutaneously in 10 patients is ongoing.

Speaker 2

We anticipate initial proof of concept data, including proptosis response and clinical activity score by end of Q1 2024. Ecell-five seventeen is a fully human, highly potent IgG monoclonal antibody directed against cKIT with the potential to address mast cell driven diseases. We are conducting a Phase III proof of concept trial of CELLAR-five seventeen and expect top line results in the second half of twenty twenty four. With that overview of the portfolio, let me now turn the call over to Gil for a review of our financials. Gil?

Speaker 3

Thank you, Shao Lee, for that overview of our portfolio, and good afternoon, everyone. As Shao Lee mentioned, We are fortunate to be operating from a strong financial position as we not only advance our portfolio of clinical stage programs, but also build our organizational capability and identify potential additional diamonds in the rough to add to our pipeline. At September 30, 2023, cash and cash equivalents and short term marketable securities totaled $788,400,000 which we expect to fund operations through key value driving milestones across all three programs. Research and development expenses were $74,600,000 for the 3rd quarter as compared to $12,500,000 for the same period in 2022. Comparing 2023 to 2022, the company has undergone significant growth, Including expansion of the Isochibat program across multiple indications and the addition of 2 programs in 2023, both of which are now in clinical stage development.

Speaker 3

General and administrative expenses were $19,900,000 for the Q3 as compared to $2,900,000 for the same period in 2022. The quarter ended September 30, 2023, includes stock based compensation expense of 11,700,000 These increases in expenses were primarily a result of expanding our organizational capability to support the development of our broad portfolio of immunology product candidates. Finally, our net loss for the Q3 of or $8.17 per share for the Q3 of 2022. The total net loss for the current quarter includes stock based compensation expense of $15,300,000 As you can see, We continue to carefully allocate capital across our robust clinical portfolio, and we're delighted to have a strong financial position from which to continue And now I will turn the call back to Shao Lee. Shao Lee?

Speaker 3

Thanks, Gil.

Speaker 2

As you've heard, we continue to make steady progress in our efforts to build a leading immunology company. We feel fortunate to have an experienced team, a robust pipeline and a strong financial position providing runway for multiple key milestones across all three clinical programs. We remain committed to our long term vision to accelerate the development and commercialization of transformative methods to address unmet medical needs and to deliver sustainable value to our shareholders, partners and most importantly to the patients we serve. In the ever evolving landscape of our industry, we understand the importance of adaptability and resilience. We are committed to making data driven, disciplined decisions as well as being responsible stewards of our human and financial resources in navigating challenges Once again, I thank you for your trust and support.

Speaker 2

We look forward to your continued partnership as we journey ahead together. Operator, we are now ready to open the call to questions.

Operator

Thank you. We will now conduct a question and answer session. And wait for your name to be announced. Please standby while we compile the Q and A roster. Our first question comes from Yasmeen Rahimi from Piper Sandler.

Operator

Please go ahead.

Speaker 4

Good afternoon, team, and thank you so much for all your really thoughtful remarks for us. Team, as we're awaiting that PSA data early next year, could you maybe comment on Sort of how soon post the second Phase 2b Phase 3 would you be in a position to Get ready and file for approval in PSA and whether the data would be sufficient on the heels Both of the results, if you could just provide color in that regard. And then 2, if you could just maybe comment on how you're tracking You know, or have been tracking or tracking currently like suicide ideation, liver enzyme abnormalities to the extent you can across all studies. And I'll jump back into the queue and thank you again.

Speaker 2

Thank you, Yas. This is Shelly. So with regards to PSA, We anticipate that registration will require both the ongoing Phase IIbIII that we hope to be Part of that package as well as a confirmatory study, which is standard for these indications. We haven't yet provided guidance specifically at the time post Sort of post this study readout relative to when we think that will be. But obviously, we'll We move forward expeditiously as expeditiously as possible.

Speaker 2

With regards to the signals that you've noted, really since the birdalumab With this group, these have been endpoints that have been followed across the IL-seventeen class, And we're following the standard approaches there as well.

Speaker 4

Okay. Thank you. I'll jump back into the queue. Thanks.

Operator

Our next question comes from Tyler Van Buren from TD Cowen. Please go ahead.

Speaker 5

Hi. This is Beth on for Tyler. Thank you guys for taking our questions. We have 2 for you. So first, Looking forward to the top line PSA Phase twothree readout in Q1, how are you thinking about the bar for success given the tizumab Phase 3 data and other recent competitor readouts.

Speaker 5

And then 2 for the longagutinib, Mab PET patient readout in Q1, How many patients' worth of data might we see across the 3 to 4 dose cohorts? And how derisking do you expect the early proph

Speaker 2

So your first question was about the upcoming PSA TB3 readout in Q1 of 'twenty four and the bar for success. The way we think about this is that the Phase 2 study that we've already completed that went up to 80 milligrams in order to share the Long term data, even additional measures of resolution of disease at the upcoming ACR meeting. We feel like that study already demonstrated the potential for differentiation with With isekai Vab, especially the top dose 80 milligrams every other week. We've seen top range results with regards to joints and skin So we've seen primary endpoint and really outsized Emphyseitis results as we recap today within that timeframe and that Just haven't been seen before with other agents. And we shared that at the 46 week time frame, we see sort of Even continued deepening of those responses, again, as we shared today with ACR 50s or Sorry, ACR 70s up at above 50%, PASI 100 scores up over 70%, and Emtekide is still in the kind of 80% to 90% So we're very, very pleased with those results.

Speaker 2

We think that they fundamentally derisk the 2B3 that's coming up. We conducted that QB3 really because our modeling from that Phase 2 suggested to us that we could get some additional Efficacy out of additional pushing the exposure a bit more within the context of this And so that's the reason for the additional dose ranging, the 2b portion, if you will, of the 2b3 that's upcoming. As a for instance, we know from our earlier psoriasis experience that moving from 80 every other week To 160 every other week and psoriasis did give us a bit of a bump with regards to efficacy. So at a minimum, we hope to recapitulate that. But already we feel like we have a differentiated

Speaker 1

offering.

Speaker 2

And then your second question was about mongolutinib and how much data we would have moving forward and how derisking that is sort of overall. I think what you can anticipate is that from a initial proof of concept perspective, we'll have We'll have a number of patients that are very similar to what's been demonstrated previously for The Viridian and Immunovance compounds on the order of 6 So patients in those experiences have been sufficient to really demonstrate the potential for signal Across both proptosis as well as clinical activity score. So we'll have those measures within the context of 10 patients To evaluate, we may have more patience than that, but as we move forward, we'll have a better beat on that. And because of the strong signal in terms of efficacy that we see with this access, We anticipate it's not going to take much more than that to see a signal for these agents, again, as has been demonstrated Already.

Operator

Thank you. One moment for our next question. Our next question comes from Vikram Parohit from Morgan Stanley. Please go ahead.

Speaker 3

Hi, everyone. This is Casper on for Frickin. We have two questions regarding PSA and HS. So for PSA, I was wondering what the competitor data readout has Data tells you, if anything, about the importance of molecule size for the treatment of PSA. And then in regards to HS, I was wondering, have you been able to further analyze the results to better understand the placebo response And discontinuation rate observed?

Speaker 3

If so, did you currently see any read across to the ongoing PSA readouts? And are there measures that have been put in place for that study to prevent similar issues from arising? Thank you.

Speaker 2

Thank you for that, Don Skol. Maybe I'll start backwards a little bit to tie it back in, which is And I appreciate the question. Obviously, given our HS readout that we shared in September, We've been extraordinarily hyper vigilant with regards to putting in any measures such that we understand real time Our we'll continue to understand and ensure that we are understanding in real time any discontinuations as well as Putting into place anything that could help from a placebo response perspective. We don't anticipate any read through to our PSA and we think that our sort of blinded continued analysis haven't suggested to us any issues in that regard. We have continued further deep dives with regards to the HS data set.

Speaker 2

And as I shared in our prepared remarks, we anticipate having More information with regards to that program by end of year, early next year to share when we have relevantly compiled Both are conversations with the health authorities as well as the deep dives that continue to be ongoing. So bottom line is, HS continues to move forward with regards to the 2b3 study that readout its primary as well as the ongoing Phase 3, as planned as we had previously discussed. We don't anticipate a read through to PSA. And from the PSA perspective, we do think that There is importance still with regards to the molecule size and the potential for differentiation. We think our Phase 2 Results, especially in Emphasitis, point to that, exactly where the threshold was for The size cut off that could enable us to get into that dense, strong sort of, wholly vascular tissue relative to Other Molecules wasn't entirely clear.

Speaker 2

I will say that the data more recently Suggest that not only is the threshold between our 18 kilodaltons and the 150 or so for the market in monophonals, But perhaps it's even between the 18 and the 40 that was So we released AS data, given the difference in Enthesitis. I've shared with you today In our prepared remarks, our best attempt at an apples to apples comparison, given the data that was presented, not with regards to LEI Resolution, which we've shared previously, but with regards to LEI 2 plus at baseline improving more than 2 plus points over the course of the study. And recall that, that was for us As we gave an earlier time point because we did select in Q12, a 100% response for That degree of change or improvement versus the placebo of 0% relative to 71% without the placebo report.

Operator

Thank you. One moment for our next question. Our next question comes from Emily Bottner from H. C. Wainwright.

Operator

Please go ahead.

Speaker 5

Hi. Thanks for taking the questions. Kind of along the lines of some of the other questions on PSA, I was wondering if you can maybe discuss What endpoints or metrics that physicians are most looking to see improved upon or Where they kind of see the largest unmet need where you think you can differentiate. I know you've talked about Emphyseitis already, but Are there any other places where you kind of see the type of differentiating? And then maybe just on expenses, if you can Touch on, it looks like in 3Q, the expenses kind of doubled from the Q2.

Speaker 5

So is that kind of a base level for you going forward? Or Any guidance you can give on expenses for the remainder of the year or next year? Thank you.

Speaker 2

Yes. Thanks for that, Emily. Maybe I'll Start with PSA sort of disease state manifestations, etcetera, and I'll let Gil handle the second question. So with regards to where we think the field is going and what's important for patients And therefore for our investigators and PULs as well is that we really need to do better with regards to our Treatment offerings for these patients. We've traditionally been talking about an ACR50 response in the 50% sort of range.

Speaker 2

And what that means is that half the people will get 50% better with regards to their joint disease, which is A pretty low bar still if you think about how much unmet need, how much better we should be able to do. So things like ACR 70s Our as close to remission as we've been able to have within the ACR scoring system, PASI 100s are sort of all clear skin. Emphasitis resolution means that I don't have any more enthesitis that I can measure, which is terrific. And so it's really the totality Of all of the manifestations of this disease, that therefore, as you can imagine, impact most the overall quality of life of a given patient. So it's important not just to hit the joints and the skin, although of course, one wants to hit them as hard as one can really be able to talk about Remission or resolution ACR 70s and the majority of people achieving ACR 70s, the vast majority of people achieving PASI 100.

Speaker 2

And now we feel like we've decided that the vast majority of people achieving resolution of their enthesitis, Which is again a marker of severity of disease, residual pain and dysfunction for these patients that obviously adds up to The quality of life. And one of the measures of sort of this overarching resolution of disease is also minimal disease activity. And as we've shared, both our switch from placebo to active in the Phase 2 study as well as the 80 milligram So we're excited about this. We think that the 2b3 gives us the potential to impact this even further. And we already know that the opportunity exists based on our existing data to do that from a skin improvement perspective.

Speaker 2

Gil?

Speaker 6

Great. And to the financial question, Emily, as I said in my prepared remarks, we ended the quarter with over $788,000,000 And cash on the balance sheet. So obviously, we're in a very strong financial position. We're at sufficient funding to go through catalyst across our pipeline. At this stage, we're not giving specific line item guidance, but I can tell you that we're thinking very carefully about how we allocate capital stage appropriate.

Speaker 6

We're scaling the investments as we scale the trials and, but there's still we are in obviously in 2024 planning and we're looking very close That being prudent with our capital, but we're really pleased with where we are at this point.

Operator

One moment for our next question. Our next question comes from Akash Tihari from Jefferies. Please go ahead. Hey, thanks so

Speaker 2

much for taking my questions. So I remember as of September, you had

Operator

mentioned the blinded dropout rate for your upcoming psoriatic arthritis trial.

Speaker 7

You had mentioned the blinded dropout rate for your upcoming psoriatic arthritis trial was around 5%. Any color on what that's tracking to as we get into November? And what level of dropouts do you plan with for this trial with your current powering assumptions? And then I guess maybe on HS, Can you go over precisely what your HS protocol deemed to be drug related or not? For example, in the circumstance by which a participant had an injection

Speaker 2

Thanks, Akash. So with regards to your first question about the PSA Study that's about to read out and discontinuation rates. So as I shared in our prepared remarks, We are at over 75% of patients within the context of that trial having completed through the primary endpoint And our discontinuation rate currently is 6.9%. So we feel apologies, 5.9%. And it just speaks to my mindset with regards to my next comment, which is really that anything below 10% is the usual threshold that we think about for clinical trials in general.

Speaker 2

And if it bounces around within the context of that number, But it's below 10%. We really aren't concerned. So we're feeling very good about where we are with that study at this juncture. And as I said earlier to These comments really don't feel like there's any read through that and we wouldn't have expected that, but we don't think we're seeing that. Separately, with regards to HS and scoring of ISRs and whether or not those are adverse events.

Speaker 2

We keep that As reported to us, ISRs and whether or not they were dropouts due to ISRs, When we talk about our dropouts, as discontinuations, we were responders without adverse events. We actually went back through and didn't just take FA's value whether or not it was reported to us as a whether it was a loss to follow-up or with We went back to the entire electronic data set and evaluated for whether or not there was a pattern, including looking for ISRs That weren't necessarily reported as an AE and that pattern also does not exist, which I think is probably your underlying question.

Speaker 7

Awesome. Thanks so much.

Operator

Thank you. I am showing no further questions. I will now turn the conference over to Tyler Marciniak for closing remarks.

Speaker 1

Thank you all for joining today's opportunity for us to share with you our Q3 financial results As Shali and Gil mentioned, thank you for your trust and support as we continue to build Celeron into a leading I and I company. We look forward to engaging with you regularly and transparently. And in that vein, I would like to highlight once again our upcoming PSA data presentations at ACR and the several investment conferences we are attending in the coming weeks. We hope to see you in person soon and would encourage you to view the fireside chats and other resources we regularly post to our website. And of course, please feel free to contact our Investor Relations team at any time if we can be of service to you.

Speaker 1

With that, we'll conclude our call for today. Thank you very much.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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