Good day and welcome to the CSU Data Update Webinar. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing star, then zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-toned phone. To withdraw your question, please press star, then two. Please note, this call is being recorded. I would now like to turn the conference over to Alex Gray, Head of Investor Relations. Please go ahead.
Thank you, operator, and thank you to those listening in today. Joining us for the prepared remarks are Ronald Martell, CEO, and Dr. Edwin Tucker, CMO. Also on the line is Herb Cross, CFO, who will be available during the Q&A session. We will be presenting slides on today's call, which are available via the webinar link and are posted to our Investor Relations website. During today's event, we will be making forward-looking statements based on our estimates and assumptions and our current expectations and projections about future events. All statements other than statements of historical facts made during today's event are forward-looking statements. These statements are subject to a number of risks, assumptions, and uncertainties, any of which may be significant, and our actual results may differ materially and adversely from those stated or implied in any forward-looking statements.
For a description of risks and factors that could affect our future financial results and business, please refer to the disclosure in the accompanying slides, our most recent Forms 10-K and 10-Q, and the reports that we may file on Form 8-K with the Securities and Exchange Commission. All our statements are made as of today, July 7, 2025, based on information currently available to us. We can give no assurance that these statements will prove to be correct, and you should not rely on any forward-looking statements as predictions of future events. We undertake no duty to update any forward-looking statements except as required by law. I'll now hand the call over to Ronald Martell. Ron?
Good morning. I'm Ronald Martell, CEO of Jasper Therapeutics. Thank you for joining today's webinar to review updated data from the Beacon trial, as well as initial data from the open-label extension study evaluating Briquilimab in patients with chronic spontaneous urticaria. Before handing it over to Ed to walk through the data in detail, I'd first like to say that we are very pleased with the new data collected from the 240-mg and 360-mg dose cohorts and from the open-label extension, which continue to indicate that Briquilimab has the potential to serve as a differentiated therapeutic option with rapid, deep, and durable disease control in patients with CSU, along with an attractive safety and tolerability profile.
A greater than 25-point drop in UAS-7 was observed in the 240-mg and 360-mg single-dose cohorts, with 78% complete response and 89% well-controlled disease by week four, along with deep reductions in serum tryptase to LLOQ, lower limit of quantification, sustained through week six. Briquilimab was also highly effective in the OLE, open-label extension study, treating patients at 180 mg q.8 weeks, with 73% complete response and 82% well-controlled disease at 12 weeks. We also continued to observe favorable safety profile with no dose-limiting toxicities observed and kit-related adverse events generally limited to low grade that resolved while on study. I'd like to also address the two Beacon cohorts that appear to be confounded. We believe there is an issue with an additional drug product lot introduced in the 240-mg q.8 week and 240-mg followed by 180 q.8 week cohorts.
This is based on an observation of lower than expected drops in mean tryptase level and no discernible effect on UAS-7 in 10 out of 10 patients dosed with this lot, while two participants achieved complete response following dosing with drug product confirmed as coming from a different lot. We are obviously very disappointed with this result and are currently investigating the drug product lot in question and expect to have these results of that investigation in the coming weeks. Meanwhile, drug product from different lots is being provided to clinical sites to transition impacted patients to a new drug for their next administration.
We also plan to enroll an additional 10 to 12 patients in total across the 240-mg q.8 week cohort and the 240-mg followed by 180 q.8 week cohorts to ensure a robust data set to inform the phase 2B CSU study, which is now expected to commence mid-2026 and expect to report the data from the additional Beacon patients later this year. I'll now turn the call over to Ed. Please go ahead.
Thank you, Ron, and good morning. Before we review the updated Beacon results, I'd like to quickly remind the audience of our Beacon trial design and the cohorts from which we'll present clinical data today. Beacon is a double-blind, placebo-controlled, multi-dose trial in participants with moderate to severe CSU who are either intolerant or refractory to antihistamines. Investigator sites were located in the United States and in Europe. The Beacon study tested doses ranging from 10 mg to 360 mg of Briquilimab in different dosing intervals. Today, we'll focus on the last four cohorts on this slide: the 240-mg single dose, 360-mg single dose, 240-mg q.8 weekly, and 240 mg followed by a 180-mg q.8 weekly, as well as the open-label extension study. As a reminder, in January, we reported data from the first three participants treated with Briquilimab in the 240-mg single dose cohort.
As Ron noted, in light of the apparent drug lot issue, we plan to enroll an additional 10 to 12 patients across the 240-mg q.8 weekly and 240-mg followed by 180 q.8 weekly cohorts. The key assessments of this trial are safety, PK, and efficacy, which is measured by the UAS-7 and UCT scores. A complete response in CSU is defined as a UAS-7 score of zero, and well-controlled disease is defined as a score of six or less. We will now review the data from the 240-mg and 360-mg single dose cohorts, beginning with the preliminary PK results, where we see an early Cmax consistent with the rapid clinical responses and serum tryptase reductions described earlier. At both the 240 and 360-mg doses, we see a Tmax of five to eight days and an approximate half-life of nine days, consistent with results from the prior Briquilimab trials.
The next slide shows the reduction in serum tryptase, a biomarker of mast cell biology, in relation to Briquilimab administration in the 240 and 360-mg single dose cohorts. We observed a rapid decline after dosing in all patients in the first week following dosing, with tryptase levels below the limit of quantification reported for 8 of 10 patients at 80% of the participants across both cohorts, consistent with the rapid decreases in UAS-7 scores observed. Now moving to efficacy, on this slide are the UAS-7 scores over time for the 240 and 360-mg single dose cohorts, demonstrating deep and rapid reductions in both cohorts. A greater than 25-point drop in mean UAS-7 was observed, with 8 of 9 participants enrolled across both cohorts achieving a complete response and with 7 of 9 participants maintaining well-controlled disease through week eight.
Now moving to the 240-mg q.8 weekly and 240-mg followed by the 180 q.8 weekly cohorts. As Ron stated, we believe that the results from these cohorts are confounded by an issue with a new product batch used to treat 10 patients enrolled across both of these cohorts. 10 of 10 patients dosed with lot A34954 showed no UAS-7 reductions and lower than expected reductions in tryptase, while 2 of 2 patients confirmed to have been dosed with a different lot achieved rapid complete responses and deep tryptase reductions. Importantly, we did not observe any safety signals in participants dosed with the drug from lot A34954. We are currently investigating the issue with the impacted lot, with results expected in the coming weeks.
Meanwhile, we are shipping drug product from a different lot to the sites for dosing patients enrolled into the 240 q.8 and 240 followed by 180 q.8 cohorts. We are planning also to add 10 to 12 patients across the two cohorts to provide additional clinical data. The next slide shows the UAS scores through eight weeks of participants dosed with drug product from lot A34954 compared with participants dosed with drug product from other lots dosed at 240 mg. The fact that none of the 10 participants dosed with drug from the impacted lot achieved clinical complete response compared with 7 of 8 participants dosed with the other lots strongly suggests that lot A34954 may have insufficient potency. Now moving to the safety results from the Beacon trial, Briquilimab continues to be well tolerated and demonstrates a favorable safety profile.
As the table shows, there are no dose-limiting toxicities reported. Treatment emergent adverse events were of a similar rate in both the Briquilimab and placebo populations. The next slide reflects the safety observations possibly related to kit blockade, which were infrequent and generally limited to low-grade events. The majority of events were mild, transient, self-resolved during repeat dosing and non-resulted in discontinuations or dose delays. There were no reports of skin discoloration in the active arm. We did see mild low-grade taste change in hypergousia in 6 of 9 participants enrolled into the 240 and 360-mg single dose cohorts. The median time to resolution of hypergeusia across all cohorts was 31 days. Mild taste changes were described as a reduction of salt, bitter, or umami taste. Neutrophil count reductions, as reported by the investigator, are also shown in the table.
All events observed in the 240 and 360 mg cohorts were grade one, and across all cohorts, the median time to resolution for neutrophil count reductions was 15 days. The next slide shows the observed neutrophil counts to week 12 for the 240 and 360 mg single dose cohorts. As you can see, there is a predictable reduction observed, and the mean values remained within the normal limits for both cohorts. More importantly, one can see the neutrophil count recovery beginning at week four. Now moving to the open-label extension, this slide depicts the design of the study. Following completion of their dosing and follow-up period, patients from the Beacon trial and the SPOTLIGHT Study were eligible to roll over into the open-label extension, evaluating 180 mg of Briquilimab on an eight-weekly dosing schedule.
As a reminder, participants must see their symptoms return before they're eligible to roll over into the study. Today, we are showing data from 25 patients with chronic spontaneous urticaria (CSU), including 11 patients for whom we have 12-week data. We ultimately expect to see around 80 patients roll over into the open-label extension from the Beacon and SPOTLIGHT studies. The next slide shows the UAS-7 scores over time in the open-label extension. As you can see, Briquilimab administration again resulted in rapid, deep, durable disease control in open-label extension participants dosed at 180 mg q.8 weekly, with disease control seen as early as week one. 73% of participants achieved complete response, and 82% achieved well-controlled disease at week 12 assessment, with a mean reduction from baseline in UAS-7 scores of greater than 25 points.
We are also pleased to see the responses deepen with each subsequent dose and with patients for whom we have longer-term data. Moving to the OLE safety, Briquilimab has been well tolerated and includes 28 weeks of repeat dosing for participants enrolled into the study. We did observe a single case of grade three leukopenia eight weeks after the last dose of Briquilimab, which self-resolved during the study follow-up. The patient in question achieved a complete response at week three and remains on study, maintaining a CR through six months. On the next slide are the safety events observed in the OLE that are potentially related to kit blockade, which again were mild, transient, and limited to low-grade hypergeusia and one case of leukopenia as previously described.
Overall, we're very pleased with the safety profile observed following repeat dosing of Briquilimab at 180 mg q.8 weekly, which we believe suggests the potential for a differentiated profile. I will now turn it back over to Ron to summarize the data and discuss next steps.
Thank you, Ed. Firstly, I'd like to reiterate our disappointment in the setback resulting from the confounded results in the 240-mg and 240-mg followed by 180-mg cohorts. An investigation of the impacted lot is ongoing, and results are expected in the coming weeks. New drug product is being provided to clinical sites to transition the 10 patients who were initially dosed with drug from the lot in question to drug product that has demonstrated efficacy in earlier and ongoing cohorts. In addition, we are adding 10 to 12 new patients across the affected cohorts. Data from re-dose patients and the additional 10 to 12 patients is expected in the fourth quarter. We determined that patients in the Atessian trial in asthma were dosed with the same drug product from the lot under investigation. As a result, we are halting the study.
Turning to the positives, single-dose Briquilimab continues to demonstrate rapid onset and deep clinical response with a 78% complete response rate and 89% well-controlled disease observed by week four. We also saw strong and potentially differentiated efficacy and safety in the OLE study at 180 mg q.8 week with deep and sustained UAS-7 reductions observed, along with a 73% complete response rate and 82% well-controlled disease rate at week 12. Together with the safety data, we believe these results indicate the potential for Briquilimab to have a positively differentiated profile at 180 mg q.8 week. With that, I'd like to open the line for questions. Operator?
We will now begin the question and answer session. To ask a question, you may press star, then one on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. We ask that you please limit yourself to one question. At this time, we will pause momentarily to assemble our roster. The first question today comes from Yaron Werber with TD Cowen. Please go ahead.
Great. Thanks for doing the call and for this information. I got a couple of questions. The first one, do you have any sense what caused this lot issue? I mean, it sounds like it's potency and not safety. It sounds like there's a new second grade two case of hypersensitivity that I don't think that we've seen before. Please correct me if I'm wrong. Can you give us any information about that?
Sure. Good morning, Yaron. I'll address the lot question and then turn it over to Ed. We are doing a comprehensive investigation of this lot, looking at everything starting with the drug product or drug substance coming out of the manufacturer all the way through to the end user. We're in the process of running potency assays on that product. We're not sure exactly what happened to this lot. All that we know at the moment is that it's limited to that lot. We will come back with more information regarding that lot here in the near future.
Yaron, good morning. Yes, there is a second hypersensitivity case. This is a patient who was treated within the C9 cohort, very mild symptoms occurring about two hours after the patient was discharged to home. Those symptoms were not observed by any clinician, and they resolved spontaneously at home. This was only brought to the attention of the investigator when the patient returned to their subsequent follow-up visit. The TI indicated that this patient had an underlying degree of anxiety and attributed a lot of the signs and symptoms, which were very mild, to those manifestations. I think it's a very weak case. We'll adjudicate it. It's going to be very difficult because no clinician was observing this patient. As I said, it resolved, according to the patient, within about an hour. The manifestations were very mild, some sweating of the skin and some tickling of the throat.
That was it.
That was after the first dose of 240 in that patient?
Yeah, that's correct.
Got it. Maybe one more question. On the open-label extension, the 180, you mentioned 8 out of 11 CRs or 73%. That CR data you're not showing in the slides, can you give us a sense how durable were those CRs? Maybe just perhaps why you didn't have that as a graph. Thank you.
Yeah, thanks, Yaron. This is an ongoing study. We wanted to show the data from this, and we'll continue to provide additional data for that. What we're demonstrating here is that, as you see, the patients that go further out continue to have sustained reductions in their UAS-7s, with a high percentage of patients at about week 12 achieving a CR. Very typically, the 12-week time point is an industry standard for measuring CRs. That is the reason why we've issued that information today.
Yaron, to be clear, that 73% that had the CR, that was at 12 weeks. That's showing you the durability at 12 weeks. Great. Thank you.
The next question comes from Leonid Timoshiev with RBC Capital Markets. Please go ahead.
Hey, thanks for taking my question. I guess in all your preclinical work and clinical work with Briquilimab, have you seen any evidence of attenuation or any sort of potential tachyphylaxis? I know at one point you had mentioned that 34% of patients had antidrug antibodies. I guess, have you looked at that since or maybe looked at that with this new lot? If I can squeeze a second one in, I guess, is there any ability for you guys to actually test these lots to be able to assure that the new lots you're going to be dosing patients with are not going to have the same issue? I guess, is there any indicators of differences between the lots beyond essentially clinical efficacy?
We are absolutely testing the lots, and that will be part of the ongoing investigation here. We have active surveillance here, and we also will be testing for the antidrug antibodies. Ed, maybe you want to speak a little bit more to any attenuation or antidrug antibodies that have been observed?
Yeah, thanks, Ron. No, throughout the course of the study, we have seen minimal antidrug antibodies, both subsequent to first dosing and then subsequent to multi-dosing. We also do not see any dose response with regards to the presence or absence of antidrug antibodies. We have not seen neutralizing antibodies to date with Briquilimab throughout the course of the program. With regards to the potential for antidrug antibodies impacting these two particular cohorts, it would be highly unusual because we haven't seen the precipitous drops in serum tryptase with the drug on first administration in these two cohorts. It would be highly unlikely that an antidrug antibody would be formed in such a short time that would prevent the potency of this drug.
We think there's something more structural with the molecule that has basically not delivered the potency that we've seen in the previous cohorts and also in the data I've shown you today.
The next question comes from Jay Olson with Oppenheimer. Please go ahead.
Oh, hey, thanks for providing this update. For the identified lot in question, since tryptase levels should be lowered rapidly, how early was the issue discovered? How soon can you re-dose those 10 patients that were dosed with the lot in question? How fast can you enroll an additional 10 to 12 patients? Can you talk about any communications you've had with the FDA on the suspicious lot and any feedback? Thank you.
Sure. We just became aware of this data late last week. The study was blinded, so we didn't have any visibility to serum tryptase, UAS-7, or otherwise from this lot until late last week and spent the weekend analyzing this data. We didn't have any knowledge or understanding of the impact here. In addition to that, we didn't have any safety issues that were reported with the patients in this cohort. There was no signal here at all.
Understood. Do you have a timeline for how long it will take to enroll an additional 10 to 12 patients?
One other thing, I'll turn it over to Ed. As part of our plan, we've already begun the shipping of product to the sites. Patients this week will be dosed for their next dose. Patients will not miss a dose. They will be dosed this week again with a lot that we know has been efficacious in the ongoing study. Ed, maybe you want to talk about enrolling the additional patients?
Yes, thanks, Ron, and thanks, Jay. We will be able to enroll further patients into those two cohorts. The protocol enables us to do that, and we will have the investigator sites up and running and active. They've been very successful in recruiting into this study. We anticipate a similar rate of recruitment, and we're guiding to having results towards the end of this calendar year. As Ron said as well, we are very keen to switch the investigational product on the existing patients so we can start to establish potency in those existing studies in those existing patients that are already on the study.
To be completely clear here, Jay, this is not a drug recall. There is not a safety concern with this lot. Having said that, we clearly see the impact on the efficacy. We have drugs that we can ship to the sites to keep the patients on their regular schedule here with product that we know to have been or continues to be active in other patients.
Okay, great. Thanks for taking the questions.
The next question comes from Gavin Clark Gardner with Evercore ISI. Please go ahead.
Hey, guys. Thanks for taking the questions. First, could you just walk us through your new expected cash runway? Second, on the data, was there anything new that you learned on the relationship between serum tryptase reductions and correlation to efficacy? Thanks.
Yeah, hey, Gavin. Thanks for the question. On the cash runway, our current guidance of into the fourth quarter is unchanged at this point. As Ron noted, we just unblinded that study in recent days here. As we articulated in the release, we are going to be going back looking at our cost structure. The Atessian asthma study, unfortunately, will be ceased given it has investigational product from that batch in question. We'll be obviously kind of winding down any other activities around SCID, the ISTs that is non-CSU, non-Beacon, OLE, CSU related to really drive a laser focus on spend and burn around those studies. I think with data coming now in the fourth quarter of this year, as we've talked about before, we're clearly going to need to put some additional capital on the balance sheet.
We'll continue, as we firm up our cost-cutting plans, we'll be coming back with additional guidance around that. That'll put us in a window where we can start to explore either equity or strategic capital as a means to extend that runway further.
Gavin, I'll answer your question about what have we learned about tryptase with regards to efficacy. Certainly, the depth of tryptase reduction is indicative of the depth of UAS-7 reductions, driving those patients to a CR or a well-controlled status. The other part of that, which has been a thesis of ours at Jasper Therapeutics, is driving down the tryptase to enhance durable effects as well. I think that's what we're seeing now in the 180 mg open-label data, which we've disclosed today. There, we're seeing durable effects with the 180 mg, which is encouraging. Of course, we have the 240 and 360, which again is driving down the tryptase as indicative of reducing mast cell activity. Therefore, this is encouraging for us in terms of the efficacy signal based upon those observations.
Okay, great. Thanks, guys.
The next question comes from Matt Fitz with William Blair. Please go ahead.
Good morning. Thank you for the update and taking my questions. I guess just curious if you have verification of cold chain logistics throughout the supply chain for that lot. It doesn't seem like you're seeing much of a difference between a 240 and 360-mg single dose, both on even the PK appears pretty similar. Do you think you're just kind of maxing out on kit at this point or anything else between those two dose levels?
Yes, regarding the investigation, Matt, and thank you for the question. Good morning. We are, again, looking at the entire chain of custody on this product lot, starting back with the drug substance through drug product through in depot to end user. We will leave no stone unturned to evaluate that as we move forward. Ed, maybe you want to address the second part of Matt's question?
Yeah, thanks. Thanks, Ron. Thanks, Matt. I think that the 360 and the 240 certainly looks like it's about the higher end of the efficacy curve. I think what that provides for us is information around dose selection. We want to look at a number of covariates as we're examining the performance of those higher doses, such as the 180, the 240, and the 360. That will enable us to really make a good dose selection for our Phase 2B, which we're still planning to initiate next year.
I can just ask a quick follow-up. I guess what activity assay is currently used as part of the release specs for Briquilimab? Obviously, we need to see the investigation results. Are you confident that future lots aren't going to have any issues there?
This assay or assays that we use have been very reliable to this point. We will continue to evaluate that as well. Having said that, there does not appear to be any issue with the assay.
Okay, thanks.
The next question comes from Trung Hien with UBS. Please go ahead.
Hi, guys. Thanks for the question. I've just got two. Just quickly following up on the tryptase reduction in the compromised lot. You gave us the UAS-7 scores. I'm just wondering what the actual observed tryptase reductions were and how much they differed from what you expected. If you look at the hypergeusia and the neutrophil count, it looks like it was seen less in the compromised lots. That follows the reduced pharmacological activity due to that lot issue. They were still there, so there are on-target effects. Just wondering if that presents any concern on dose selection or longer-term tolerability as you move into Phase 2. Thank you.
Yeah, just to be clear on the safety component there, we did not see any impact on any adverse events, c-KIT-related, from a safety standpoint on the 10 patients in the compromised lot. Ed, maybe you want to speak about the tryptase?
Yeah, happy to, Ron. Thanks for the question. I think with regards to the tryptase, as you've seen in our presentation today, to effectively drive down UAS-7, that is tied very closely to achieving those deep reductions in tryptase. We do see those, as we presented today, some reductions in tryptase. There is some potency with this impaired lot. It's just not driving down to what we have seen in other cohorts. That correlates with the absence of UAS-7 reductions in those impacted lots. Of course, with impaired potency, you can anticipate also as well that the ANCs and the taste effects, which is associated with kit inhibition, are also lessened as well. This enabled us to really hone in and correlate UAS-7, tryptase, and safety profiles to really, as soon as we saw the data, we were able to really pinpoint and begin the investigation around this potential lot.
The next question comes from Sylvain Turton with Citizens. Please go ahead.
Good morning. Thanks for taking my question. This is just a clarification on the previous question on the safety in the lot-impacted cohorts. Could you walk us at a high level through your thinking of the AE profiles at the 360 versus the 240? If we were to strip out those patient numbers that were maybe on an inactive dose, if there are two patients that hadn't had hypergeusia in the 240 mg to 180 mg, for example, does that mean that the two patients that didn't receive active drugs, all of them got hypergeusia? Could you highlight at a high level the safety in those high-dose cohorts as you think of them today? Thank you.
Yes, thanks, Sylvain. Yes, those in the active lots within those two impacted cohorts did indeed have typical kit adverse events. They were mild, impacting the salt, bitter, umami, quite classically now kit inhibition. Not surprising at all. No patients are discontinued or dose delayed as a result of this. It does look as though potentially it's a first-dose phenomenon. We want to explore that further with the multi-dose cohorts. It does not appear to be a problem for patients with chronic spontaneous urticaria (CSU) and they seem to be able to tolerate very well and continue on the study.
Great, thank you.
The next question comes from Kostas Billouris with BMO Capital Markets. Please go ahead.
Good morning, everyone. Thanks for taking our question. Maybe a clarification first. If we look at slide 8, the 240-mg cohort seems to be above LLO-2. In the previous update, this was below LLO-2. Can you please clarify where the difference comes from between this and the previous tryptase levels? On slide 9, it seems that there is no dose response between 240 mg and 360 mg. Actually, the UAS-7 is flipped compared to tryptase level between 240 and 360 mg. Any clarification around the dynamics between these two doses here? Thank you.
Yeah, thanks for the question. I think I'll take the second question first. I think once you're at the higher doses, there potentially are some covariates that can affect the absolute elimination of mast cells or tryptase reduction or completion on UAS-7. The UAS-7 is also a patient-reported outcome as well. There is some potential variability there. I wouldn't make a huge separation between a 240 mg and a 360 mg. I think within the realms of the cohorts we have, it looks as though we're heading towards the maximum efficacy with the 240 mg and the 360 mg doses. I think your other question, if you wouldn't mind just repeating that question again.
Yeah, if we look at slide 8, it seems that the 240-mg dose tryptase levels are above LLO-2. In the previous presentation that you presented data before, these levels were below LLO-2. Has anything changed and the levels moved from below LLO-2 to above LLO-2 here?
Yes. We did bring in one patient who had a high baseline, and that actually skewed the small cohort. That patient had a baseline above 20 coming in. That can be associated with a phenomenon called HAT. This patient didn't have any constitutional symptoms of HAT but did have medical eligibility for CSU to come into the trial. We saw significant reductions in the patient's serum tryptase, and they responded very well in the study with a complete response.
Thank you.
Next question comes from Justin Zelen with BTIG. Please go ahead.
Thanks for the update and for taking our questions. Do you think the QA/QC for release for lots and the potency assays that you run just to ensure that this may not happen again in the future?
I'm sorry, could you repeat that?
Yeah, I was wondering, Ron, if you could talk about your QA/QC release criteria for the lots to ensure that you don't see impotent lots moving forward. If you talk about your potency assays and the release criteria from the manufacturer.
Sure. That will all be part of the investigation. Again, we're not sure exactly what impacted this lot, and we will evaluate all of that. Having said that, the lot release assays up to this point have all been consistent with the efficacy findings. We will be evaluating that as well. That is part of the reason why the drug product that we're shipping to these patients is from a lot that we know to be efficacious in the ongoing other cohorts in the study.
Got it. As far as dose selection for the Phase 2B, would you look towards the update in the fourth quarter to make a determination?
Certainly. As we've stated before, the totality of the data will inform us what doses to take forward. Having said that, we are very encouraged by clearly the data we've seen from the 240 and 360. We are really maxing out on efficacy there. To one of the previous questions, in fact, all of the patients in the 240 hit the LLO-Q. The 360 optically appears slightly different, but it's really hard to beat 100% complete response and to drive below LLO-Q. That's by definition, right, the lower limit of quantification. Having said that, the 240/360 single dose from an efficacy standpoint looked really good. Looking at the safety profile, as we previously discussed, all mild, transient, self-resolved before what would have been the next dose. Revisiting that 180 q.8 week, those data look really good.
Compare it to any of the other competitors out there, either in development or approval. Seeing the level of response that we see here, a complete response and well-controlled at 12 weeks looked really good. That dose cohort is absolutely a viable cohort moving forward.
Great. Thanks for taking our question.
The next question comes from Emily Bodnar with HC Wainwright. Please go ahead.
Hi. Thanks for taking the questions. I was curious from the two patients who got CRs from the active doses. Could you confirm which dosing regimen those patients received? It also looks like there were 13 patients based on the safety slide in those two cohorts. Is the last patient not eligible for efficacy yet, or what's the status of that patient?
Yeah, thanks, Emily. We're still establishing the lot number for the 13th patient. This is an ongoing investigation. Once we've established that, we can identify if that's the impacted lot or it's actually the potent lot. That's what we're waiting for there. We don't have that information to share right now. We've only got 12 out of 13 to share today. With regards to the two responders, that was in cohort 9, which is the 240-mg dose.
It is the 240/180.
Okay. Got it. Were the 10 patients who received the inactive dose notified of that? Are all 10 of them still on the trial?
This is work which we'll do with the sites today. We'll be reaching out, communicating as part of the remediation. We will be reaching out to the sites to inform them of this observation. This data came in very late last week where we were running the analysis. We'll be communicating with them today, as I said, switching the IP. As Ron had said earlier, and I communicated as well, there's no safety implications here. This is simply a potency. Therefore, the patients can continue in the study with no additional risk. I don't anticipate any of the patients leaving the trial. We will be making a thorough communication with the investigators. We will not communicate directly with the patients.
The study will remain blinded to the patients and the physicians. They will just know that they're getting new kits for their patients.
This concludes our question- and answer session. I would like to turn the conference back over for any closing remarks.
Thank you, Operator. On behalf of the Jasper team, I'd like to thank both the investigators and the patients who participated in the Beacon and OLE studies, along with their families and caregivers. With that, thank you all for attending the call today.
The conference is now concluded. Thank you for attending today's presentation. You may now discontinue.