Hemab Therapeutics Hldgs Q3 2026 Earnings Call Transcript

Hemab Therapeutics Hldgs (NASDAQ:COAG) reported third-quarter financial results on Tuesday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Hemab Therapeutics Hldgs reported the initiation of its Phase 3 trial of sutazomic in Glanzmann thrombasthenia and presented data from Phase 2b trials in Factor VII deficiency and menstrual bleed data treated with HMB003.

The company is focusing on developing therapies for blood coagulation disorders, with significant updates expected at upcoming ASH and EAHAD meetings.

Financially, the company reported cash and equivalents of $430.2 million, with increased R&D and G&A expenses compared to the previous year, and a net loss of $27.3 million for the quarter.

Management highlighted strategic hirings and the progress in its clinical programs as the company moves into late-stage development.

The future outlook remains positive, with expectations to reset the standard of care in coagulation conditions and continued dialogue with regulatory bodies.

Full Transcript

OPERATOR

Welcome to Hemab Therapeutics Hldgs Third Quarter 2026 Conference Call. Leading the call from management are Benny Sorensen, Chief Executive Officer, and Mads Berndt, Chief Financial Officer. After management’s prepared remarks, we will open the call to your questions. To ask a question during the session, you’ll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.

Please be advised that today’s conference is being recorded. Before we get started, I would like to remind everyone that some of the comments that management may make on this call about the company’s future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and events could differ materially from those expressed or implied in any forward-looking statements as a result of various important risks, uncertainties, and other factors, including those set forth in Hemab’s most recent filings with the SEC, including its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2026, and any other future filings that the company may make with the SEC. Any forward-looking statement represents our view only as of today and should not be relied upon as representing our view as of any subsequent date.

You are cautioned not to place any undue reliance on these forward-looking statements, and Hemab disclaims any obligation to update such statements, except as required by law. A replay of this call will be available on the Investors section of the Hemab Therapeutics Hldgs website approximately two hours after the conclusion of the call. I will now hand the call over to Benny Sorensen, Chief Executive Officer.

Benny Sorensen (Chief Executive Officer)

Thank you, operator, and thank you all for joining Hemab Therapeutics Hldgs’ first quarterly financial results call. We’re glad you’re here and we look forward to using this forum every quarter to share our progress. At Hemab Therapeutics Hldgs, we are developing targeted therapies that reimagine the treatment of blood coagulation disorders to sustain life and human resilience. Our philosophy is simple: all patients matter, and people living with serious blood coagulation conditions should not have to live with inadequate treatment options.

Let me start with the three pieces of news that matter the most for the coming months. First, yesterday we announced the initiation of our pivotal Phase 3 trial of sutazomic in Glanzmann thrombasthenia. Second, last week we also announced the first clinical data from our Phase 2b trial of sutazomic in Factor VII deficiency and new menstrual bleed data in nonhuman primates treated with HMB003. Updated data from the Factor VII deficiency trial will be presented at the ASH annual meeting on December 14, and the HMB003 data on December 13.

In February 2027, at the 20th EAHAD congress, we will present new data from our HMB002 program in von Willebrand disease. These updates follow a remarkable stretch for Hemab Therapeutics Hldgs. Since our IPO in May, we have not slowed down. In July we put our science on the global stage at ISTH with nine presentations and data updates across all three of our programs. We unveiled HMB003 and dosed the first participant in our Phase 1 trial, and we have now initiated SOLARA, our pivotal Phase 3 trial of sutazomic in Glanzmann thrombasthenia. It’s our first pivotal trial, and it’s the first pivotal trial of a subcutaneous prophylactic treatment in Glanzmann thrombasthenia.

Truly a defining moment for Hemab Therapeutics Hldgs and for the Glanzmann community. As we move into late-stage development, we are building the organization to match our ambition. In September we welcomed Kelly Wahlberg to our board. Kelly brings two decades of commercial leadership, including launches of medicines for conditions ranging from rare to very common, making her the perfect strategic match. We have also begun building our commercial strategy and team so we can position ourselves to bring our medicines to patients as quickly as possible.

Across our programs we listen to patients’ lived experience, we quantify the neglected unmet need, we apply our deep coagulation expertise, and we use validated technologies as well as high-quality clinical development strategies. We believe a different future is possible, one where prevention, not just management, becomes the standard of care. That vision comes to life across our first three programs: sutazomic is being developed for both Glanzmann thrombasthenia and Factor VII deficiency, with approximately 10,000 patients in our key markets.

HMB002 targets von Willebrand disease, the most common inherited bleeding disorder, with approximately 120,000 diagnosed patients in the same key markets. And HMB003 targets heavy menstrual bleeding, which affects more than 23 million women in the United States alone. I’ll walk through each program, Mads will review the financials, and then we will take your questions. HMB003 is a fatty acid–conjugated peptide that inhibits plasmin directly at its active site to stabilize clots. Preclinically it showed greater activity than tranexamic acid, today’s primary nonhormonal therapy for heavy menstrual bleeding, and PK properties supporting potential once-per-cycle dosing, potentially offering an improvement over current short-acting therapies. We are initially developing HMB003 for heavy menstrual bleeding, which has been called the missed vital sign and is too often ignored.

It is reported in roughly one in three women of reproductive age and is the leading cause of iron deficiency and anemia in this population. According to data compiled by Wellcome Leap, affected adult women miss an average of 3.6 weeks of work annually, costing the U.S. economy an estimated almost $100 billion. Millions of women and girls have no approved nonhormonal customized hemostatic treatment option for heavy menstrual bleeding, and that is the gap we are working to close with HMB003.

In September we dosed the first participant in our randomized, placebo-controlled, single-ascending-dose Phase 1 trial in healthy volunteers, which will inform dose selection and clinical development plans for HMB003 in heavy menstrual bleeding and across additional high-unmet-need bleeding conditions. We expect initial clinical data from the Phase 1 trial in mid-2027. We have also announced new preclinical data from a cynomolgus monkey model of menstrual bleeding, in which HMB003 reduced the proportion of severe bleeding days and shifted bleeding towards lower intensity compared with baseline.

We’ll present these data at ASH on December 13. HMB002 is a subcutaneous prophylactic monovalent antibody designed to shield von Willebrand factor from degradation, raising the body’s own levels of both von Willebrand factor and factor VIII without compromising function. At ISTH, data from the Velora Pioneer Phase 1/2 trial showed clinical proof of mechanism, and candidly the results exceeded our own expectations. We had set a 1.5-fold increase as the target product profile, but we saw peak increases of approximately 2.5-fold in both von Willebrand factor and factor VIII, with normalized thrombin generation and aPTT, and durability supporting potentially monthly dosing.

Most adverse events were mild to moderate, with no serious thrombotic events. The single-ascending-dose portion was not designed to measure efficacy, so the early clinical observations were descriptive in nature. Still, we find them encouraging. Based on prospectively collected data, eight out of nine evaluable patients had zero treated bleeds in the 28 days after dosing, with a mean annualized treated bleed rate of 1.6 compared with a baseline mean of 20.1 prior to treatment.

Velora Discover continues its successful enrollment, with now 110 patients in prospective run-in and identified for future interventional trials. At EAHAD in February we expect to present initial data from Part B, monthly subcutaneous dosing at 150 milligrams, and additional Part A data from single dosing at 300 milligrams. These data will cover patients with both Type 1 and Type 2A disease, adding data from 8 to 10 new patients, with a total above 20 patients already.

Lastly, let me turn to sutazomic, a bispecific antibody that binds and stabilizes the body’s own factor VIIa and recruits it to activated platelets to facilitate the formation of hemostatic clots and control bleeding. Starting with Factor VII deficiency, a severe bleeding disorder affecting about 1 in 500,000 people, where bleeds are recurrent, unpredictable, and potentially life-threatening. A Phase 2b trial is ongoing at a single site in the U.K. At ISTH, preclinical data showed binding to 22 of 25 tested severe to moderate Factor VII variants, or 88%, supporting broad patient applicability. Last week we announced our first clinical data from the single-ascending-dose cohort. As of July 24, two participants with severe congenital Factor VII deficiency had received a single subcutaneous dose. Adverse events were low grade and assessed as not related to treatment. Baseline prothrombin time of 180 seconds or more shortened by more than 50% in both participants.

In the participant with PK and PD data available, sutazomic produced sustained multifold accumulation of endogenous total Factor VII, with exposure maintained through day 22. Updated data from all those participants will be presented at ASH on December 14. And now Glanzmann thrombasthenia, and here is the part that matters the most. There is no approved prophylactic treatment, and care today is reactive rather than preventive. The burden is felt week after week. In Glanzmann360, an international natural history study, 88% of participants reported at least one bleed in the previous week, and 65% required a bleed-related hospital visit in the prior six months. These people have normalized living with unpredictable bleeds.

Against that backdrop, our Phase 2 extension data from ISTH give us real conviction in this program. They showed sustained bleed reduction in 34 participants at a median of 6.9 months and up to 15.9 months of exposure. Ninety-two percent of participants who bled during the run-in had fewer treated bleeds on sutazomic. The mean high-intensity annualized treated bleed rate was reduced by 62%, and in the low-dose weekly cohort the mean annualized treated bleed rate fell by approximately 80%.

There were no grade 3 or higher related adverse events. Three participants had grade 2 thromboembolic events in higher-exposure cohorts and/or with multiple risk factors, all managed with routine anticoagulation therapy. Based on these data, we have now initiated SOLARA, an open-label, single-arm, multicenter trial enrolling approximately 75 people with Glanzmann thrombasthenia aged 12 to 70 with at least four treated bleeds in the prior 12 months. After a 24-week run-in on current treatment, participants receive 48 weeks of once-weekly subcutaneous sutazomic at 0.2 milligrams per kilogram, a regimen chosen with the goal to optimize bleed reduction while avoiding the high peak exposures associated with the observed thromboembolic events.

The primary endpoint compares the annualized treated bleed rate on sutazomic with the run-in period, with each participant serving as their own control. Secondary endpoints include high-intensity bleed rate, safety, tolerability, immunogenicity, and pharmacokinetics, and participants who complete treatment will have the opportunity to continue sutazomic in a separate open-label extension study. SOLARA is being conducted under Hemab Therapeutics Hldgs’ active IND.

SOLARA is designed as a single-arm trial using intrapatient comparisons. The FDA recommended that we consider a randomized controlled trial. However, the FDA acknowledged our concern about the feasibility of randomization in Glanzmann thrombasthenia in light of substantial variability in treated bleed rates, the heterogeneity of the patient population, and the practical consideration of randomized trials in rare diseases. We’ve determined to proceed with the single-arm trial.

SOLARA is a landmark for the Glanzmann thrombasthenia community. The first participants have been consented and are scheduled to enter the run-in before end of the year. With that, I’ll hand it over to Matt.

Mads Berndt (Chief Financial Officer)

Thanks, Benny. I’ll do a brief financial review. Cash, cash equivalents and marketable securities were $430.2 million as of September 30 compared with $457.5 million as of June 30. We continue to expect our cash to fund operations into 2029. R&D expenses were $24.6 million for 3Q26 compared with $14.6 million for 3Q25. The increase was primarily driven by advancements of our clinical programs and higher personnel cost. G&A expenses were $5.1 million for 3Q26, compared with $2.5 million for the same period last year.

Net losses for the third quarter was $27.3 million, or $0.58 per share, compared with $17.1 million or $0.84 per share for the same period last year. With that, I’ll now hand over the call to the operator to open the line for questions.

OPERATOR

As a reminder, if you’d like to ask a question at this time, please press Star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press Star 11 again. Our first question comes from David Nierengarten with Wedbush Securities.

David Nierengarten (Analyst at Wedbush Securities)

Hey, thanks for taking the question. I had a couple. Just on the first one, with the FDA feedback on the study in Glanzmann thrombasthenia, did they give any other rationale for their desire to have a randomized controlled trial besides it being, you know, a gold standard, so to speak? It seems to be hard to match patients in this population. And then the second one was, as you reported out before in previous data, you know, the VTEs. One patient who had VTs was obese in that study. I was just wondering if you had a weight range for inclusion into the study. Thank you.

Benny Sorensen (Chief Executive Officer)

Thank you, David, for the question. Let me elaborate a little on Solara and the regulatory path there. As I just mentioned, Solara is designed as a single-arm trial using an intrapatient comparison, which is a common registrational path in bleeding disorders and in particular in Glanzmann thrombasthenia. We are really following the observed clinical data from the 34 patients in our Phase 2, as you may recall. In a bleeding disorder like Glanzmann that really has been, honestly, deprived of any innovation for decades, unfortunately, the treatment guidance and practices vary very significantly, and a single-arm trial is really the strongest way to control for that variability.

You guys also know that we have Breakthrough Therapy designation, Fast Track, Orphan Drug, and we do enjoy really close dialogues with the agency on how best to advance in Glanzmann thrombasthenia. So with the extensive amount of dialogue we’ve had, we have implemented lots of the constructive feedback. Yes, the FDA recommended that we consider a randomized controlled trial; however, at the same time they acknowledged the variability that we are seeing and the concern about feasibility of randomization, in particular given the substantial variability in treated bleed rates, the heterogeneity in the patient population, and some of the practical considerations for a randomized trial. We believe this is what the data is telling us is the right thing to do going forward.

And just lastly, as you all know, there are plenty of precedents for single-arm trials in bleeding disorders—just to mention a few in von Willebrand disease. Hemophilia A and B as well, and Tretten, which is a factor XIII concentrate in factor XIII deficiency, also ran prophylaxis registration trials as single-arm studies. So we have a high degree of confidence this is the right path forward. To your second question, David, on weight ranges, I forgot what the top weight range is in the eligibility criteria. But, hey, here’s the good news: the study will shortly be available on ClinicalTrials.gov, and I’m sure that specific eligibility is in there. David, I’ll have to follow up with that.

David Nierengarten (Analyst at Wedbush Securities)

Okay, thank you.

OPERATOR

Our next question comes from Cory Kasimov with Evercore ISI.

Josh (Analyst at Evercore ISI)

Hey, Benny and Matt, this is Josh on for Cory. Thanks for taking our question. Ours is on von Willebrand. Probably the most common investor question we get is what we should be expecting as far as amount of follow-up and any of the efficacy markers or PK/PD data that we should be focusing on into that data. Thank you so much.

Benny Sorensen (Chief Executive Officer)

Thank you, Josh. Yeah, let me elaborate on that. Too excited to kind of give an update on the HMB002 data at EAHAD in February, and just kind of go through it step by step. There’ll be additional single ascending dose data at 300 milligrams. We are hoping to see a maximum accumulation plateau around two- to three-fold, and I think that the 300 milligram will be particularly informative for that. And if we then look at the PK that we already have on 20 mg, 50 mg, and 150 mg, we might also see that the 300 mg is a dose that could last a little longer.

But, hey, let’s see the data and what it tells us. On the multiple ascending dose, it will be 150 mg. Similarly here, we are hoping to see an average of two- to three-fold accumulation of von Willebrand factor and a support for the once-monthly dosing. With regards to the clinical activity, we have said all along, right, we want to see more than 50% reduction in the annualized treated bleed rate. Yes, more is better, and it’s still somewhat early days.

And I think the last thing to emphasize: we will also be presenting data from both patients with type 1 and type 2A. And when you look into the population, that is really covering the vast majority of patients with von Willebrand disease.

Josh (Analyst at Evercore ISI)

Thank you.

OPERATOR

Our next question comes from Rich Law with Goldman Sachs.

Rich Law (Analyst at Goldman Sachs)

Hey, guys. Good morning. So I’m actually kind of surprised that the FDA asked for the randomized controlled trial since we saw many pivotal trials in hemophilia and VWD using single-arm trials that you pointed out. I mean, at this point, do you have full alignment with the FDA or do you believe you’re taking some risk with a single-arm trial? And also, like, how did you and the FDA end that discussion? And then I have a follow-up.

Benny Sorensen (Chief Executive Officer)

Yeah, I think, as I just alluded to, Rich, we have a high degree of confidence this is the right trial, in particular taking into account the patient population and the empirical data we generated in Phase 2, giving us deep insight to the variability of bleeds. And, you know, our regulatory friends here, they really acknowledge that. Right. I think when they are saying, you know, recommend/consider, that is probably for good order, and I think it’s equally important that they acknowledge, you know, the concern in running a conventional randomized controlled trial, particularly in a bleeding disorder that has never ever had a prophylactic drug developed. So I think the risk is very low here. And, you know, good news is we will continue dialogues with regulatory agencies, including the FDA, going forward.

The more we talk, the more we align. So I’m very confident that this is the right path forward. Rich, you had a second question, right?

Rich Law (Analyst at Goldman Sachs)

Yes. Yeah, the second question is that at the ASH—I think we saw the ASH abstract—you showed, I think there were two patients for that Factor VII deficiency. Just want to see, is there any more that we’re going to see? What’s the endpoint? What’s the final sample size that we should see at the ASH presentation? Thank you.

Benny Sorensen (Chief Executive Officer)

Yeah, I think—let me also go into that. I’m very excited about sharing our Factor VII data at ASH. And we’re really aimed here to generate what I call a binary data readout in a very small number of patients, pretty much trying to recapitulate the non-human primate study in patients with Factor VII deficiency and at the same time validate all of the molecular biology studies that we have done. We further aim to kind of show that our entire preclinical package with the preclinical NHP, the molecular insight into mutations leading to Factor VII deficiency, and that knowledge of what mutations generate Factor VII variants that can bind and what mutations are less likely to bind—pretty much hoping to see that the molecular diagnosis can be an immediate predictor of when you have a responder or whether you have a non-responder. We’re not elaborating on the number of patients, but I think I’ve been clear here that it’s a very small number of patients, a study conducted just at one site in the United Kingdom.

But I truly believe that this data is going to be sufficient for us, by the way, to make a substantial additional investment in Factor VII deficiency going forward.

Rich Law (Analyst at Goldman Sachs)

Great, thank you.

OPERATOR

Our next question comes from Maury Raycroft with Jefferies.

Maury Raycroft (Analyst at Jefferies)

Hi, good morning. Thanks for taking my questions. I was going to ask one on Glanzmann as well for the Phase 3. Just wondering if there were minimum ATBR reduction thresholds, run-in bleed rates for intrapatient control, or any statistical aspects discussed with FDA that you could talk more about today, and what bars for success would be that would give you confidence around the potential regulatory risk?

Benny Sorensen (Chief Executive Officer)

Yeah, I think, by the way, very shortly, Maury, the entire eligibility criteria will be available on ClinicalTrials.gov. We have a minimum annualized treated bleed rate for going in to make sure we—you know, we can’t completely eliminate a zero, but this should substantially reduce any patient coming in with zero.

Maury Raycroft (Analyst at Jefferies)

Got it. Okay. And maybe a follow-up: with ASH coming up, we’re expecting longer-term Insight, STAR open-label extension data there. There’s likely going to be compare and contrast with your 002 EAHAD data. So I’m wondering if you think we’ll get perspective into differentiation at EAHAD on bleed control—maybe safety profile or stronger activity across different subtypes for von Willebrand.

Benny Sorensen (Chief Executive Officer)

Yeah, you know, as I said, we will be presenting data on type 1 and type 2A. As you also know, it is really, really hard for us to do a direct comparison between HMB002 and other ongoing programs as we have taken kind of distinctly different approaches in the way that we are collecting the data. I think in particular we count bleeds that need treatment, and we are collecting those prospectively. We know that this is an endpoint that is used in registrational trials in bleeding disorders, so it’s giving us a high degree of confidence.

And I think it’s just very important for us to emphasize a treated bleed is one that is serious enough that the patient needed medical intervention to stop it. Importantly, we collect this prospectively using a validated electronic bleed diary. We have at least four months of baseline run-in, and what you will see at EAHAD is up to four months’ follow-up afterwards on treatment with HMB002. And I think the other thing I want to emphasize is, right now, enrolling both type 1 and type 2A, our Valora Discover study with more than 100 patients’ worth of prospectively collected natural history data is really a goldmine for Hemab right now and giving us an increasing amount of confidence on being really data-driven and smart in our next steps of development.

Maury Raycroft (Analyst at Jefferies)

Got it. Thanks for the perspective.

OPERATOR

Our next question comes from Joyce Choir with J.P. Morgan.

Joyce Choir (Analyst at J.P. Morgan)

Hey, guys, thanks for taking our question this morning. For Solara, can you provide any additional color on discussions with the agency around safeguards with respect to cardiovascular risk screening? Anything that came up in your discussions that was new relative to your expectations, or was everything fairly in line? Thanks.

Benny Sorensen (Chief Executive Officer)

Yeah, Joyce, I am super proud of the way we have approached this. We have got a lot of praise from the regulatory authorities here in the way that we have designed our safety monitoring plan, the way that we have developed the eligibility criteria to be for all patients with Glanzmann thrombasthenia, but of course safeguarding the molecule with the knowledge that we have. So I would say absolutely no surprises with regards to the way we have designed eligibility and safety monitoring.

And I’m super proud of that because that means we have done the right thing from a clinical development point of view.

OPERATOR

Our next question comes from Gaurav Maini with LifeSci Capital.

Gaurav Maini (Analyst at LifeSci Capital)

Hey, good morning everyone. Appreciate the update this morning. So one thing that KOLs have noted to us and that they really appreciated from our convos is that you can actually measure von Willebrand factor given the mechanism of HMB002. And some points in and out here, right—titrating inadequate responders, confirming patients aren’t pushed to, say, several hundred percent, et cetera. I guess with this, how do you think about potential differentiation here, especially as we think about other late-stage competitors out there?

And then I do have a quick follow-up.

Benny Sorensen (Chief Executive Officer)

Yeah, Gaurav, thank you for that point and that question. I think this is probably the ultimate strength of HMB002. It is simple, it’s intuitive, it directly targets and corrects the underlying pathophysiology, and it is readily available for clinicians to monitor whether the treatment is having the intended pharmacological effect. I think that is a key differentiator. And remember, we are pretty much standing on the shoulders of 50 years of clinical experience with regards to this as a mechanism.

Because this is exactly what you can do with DDAVP: you can give DDAVP, you can monitor von Willebrand factor, you can monitor factor VIII. We know that that’s a very effective way of controlling acute bleed management, but of course not possible at all to use as a prophylactic therapy. But mechanistically, this is right in the wheelhouse of practicing hematologists in bleeding disorders. So I think that’s a huge differentiator. We can simply measure what they’ve always measured: von Willebrand factor and factor VIII.

I’m excited about the data we presented at ISTH and just reflecting a bit more on those. Give or take, a 2.5-fold increase in von Willebrand factor and factor VIII. The population we are studying on average have about 20% von Willebrand factor and about 35% factor VIII. So you do that 2.5 times and you get, on average, into the normal range of von Willebrand factor and factor VIII. For a treating clinician, I think that could be very reassuring for a lot of patients.

So I think you are spot on. I think that is a very clearly differentiating part of the molecule.

Gaurav Maini (Analyst at LifeSci Capital)

Yeah, appreciate the color there, Benny. A quick follow-up. So for von Willebrand disease as well, this kind of bar that the company’s been guiding to have ABR of at least 50% reduction — can you just remind us where that number comes from?

Benny Sorensen (Chief Executive Officer)

Yeah, that comes from the last, I guess, 45 years of development of drugs for bleeding disorders. It has been a clinically meaningful criterion; it’s been a regulatory criterion. More than a 50% reduction in treated bleeds is considered clinically meaningful — and more is better, there’s no doubt about that. But while this is still a young, ongoing phase 1/2 trial, I think we’ll keep it there. If the data looks much more favorable, we can always dial up the expectations for that.

But I think for now that’s the right guidance to give.

Gaurav Maini (Analyst at LifeSci Capital)

Awesome. Thank you.

OPERATOR

Our next question comes from Michael King with Rodman & Renshaw.

Michael King (Analyst at Rodman & Renshaw)

Good morning, guys. Thanks for taking the question and congrats on your progress. I hate to drag you back to the regulatory discussions, but I just had a couple of follow-up questions about it. Was there any consideration given to alternative randomized trials such as either 2-to-1, 3-to-1 randomization, or brief periods where patients would be treated with tranexamic acid and then proceed on to zetasimig, or any other types of protocols that might have been a compromise with the agency?

Benny Sorensen (Chief Executive Officer)

Yeah, I think, Michael, thank you for that question. I can say it like this: we have turned every single possible stone to make sure that we design the best possible trial with the highest probability of technical success here. So, yeah, I think we have elaborated on all possible trial designs. The reality is, as I keep coming back to, that with the empirical data we have, we can acknowledge very substantial variability in the bleeding patterns and in the treatment patterns.

And, you know, one can then say, oh, couldn’t you just dial down that variability, assume that it will be better in the future? And then you could have designed all sorts of other designs. But, Michael, here’s the reality: when you do a phase 2 trial in about 15, 16 sites, you get that variability. When we dial it up to a pivotal trial with approximately 75 patients enrolled across multiple countries, multiple sites, that variability is rarely going down.

It is more likely to stay the same. So after a lot of iteration in that data and a lot of dialogue with our regulatory friends, this is the right study design to carry forward to give patients and us the highest probability of a drug going all the way.

Michael King (Analyst at Rodman & Renshaw)

Okay. And then was any consideration given to geographic split of the trials? I know that obviously this is something that affects consanguineous populations. So was there any minimums, maximums, or expectation of distribution of different geographies to make sure that there’s at least some variability in the populations?

Benny Sorensen (Chief Executive Officer)

Yeah, you know, by the way, we have really only selected countries and sites that fulfilled the extensive feasibility that we have conducted. So there will be a reflection of the variability of the population across geographic regions around the world. But we have been pretty strict with regards to countries and sites, investigator qualifications, to make sure that we somewhat control the study conduct process. So, yes, right now the study is open here.

It’s already approved in a couple of other regulatory jurisdictions. And we’ll keep on updating you as we progress with the trial on what that distribution will look like over time. Yeah, right now, you know, go on the Solara website and see our recruitment activities here in the United States. I’m super proud of the way we are prepared for this and the way we are conducting ourselves for this trial.

Michael King (Analyst at Rodman & Renshaw)

Okay, great. And then one quick one on von Willebrand: Insight’s got data at ASH and phase 3 right now. How do you anticipate navigating around their presence in the clinical trial setting?

Benny Sorensen (Chief Executive Officer)

Yeah, thanks, Mike. I think this is where I usually say innovation is good for patients. So I am first and foremost cheerleading for HMB002. I believe we have the molecule with the more intuitive, simple mechanism of action. I think we have a molecule that you can monitor. I’m super excited about the data we have so far. I really don’t pay much attention to where our competitors are, emphasizing instead the qualities and the strength of our molecule.

And I think what we have heard from the clinical community is that there’s a high degree of excitement for HMB002. So that’s the way we are running. I’m not worried about competition in this particular space here.

Michael King (Analyst at Rodman & Renshaw)

Thanks for taking the questions, Benny.

OPERATOR

That concludes today’s question and answer session. I’d like to turn the call back to Benny Sorensen for closing remarks.

Benny Sorensen (Chief Executive Officer)

Thanks. Let me just end here. I could not be more excited about where Hemab Therapeutics Hldgs is today and where we are going with Solara. Hemab Therapeutics Hldgs has now begun its transition to a late-stage clinical company. Over the coming year, we expect updates across all our programs, starting with ASH in December, Year Ahead in February. We believe we’re well positioned to reset the standard of care across coagulation conditions of every size.

At Hemab Therapeutics Hldgs, all patients matter and we are driven to give people living with serious coagulation conditions better options than they have today. And we are just getting started. Thank you to the Hemab Therapeutics Hldgs team, our partners and collaborators, and most importantly to all of the healthy volunteers and patients who participate, making this work possible. Thank you all.

OPERATOR

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

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.