Earnings Call Transcript - ABCL 2026-11-09

Kara, Host

Good afternoon. And welcome to Abcelera's Q3 2026 Business Update Conference Call. My name is Kara, and I will facilitate the audio portion of today's interactive broadcast. After today's prepared remarks, we will host a question and answer session. If you'd like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. At this time, I would like to turn the call over to Trin Steimert, Chief Legal and Compliance Officer. You may proceed.

Trent Steimart, Other

Hello, everyone. Thank you for joining us for Abcelera's Third Quarter 2026 Earnings Call. I'm Trinh Steimart, Abcelera's Chief Legal and Compliance Officer. Speaking on today's call are Dr. Carl Hansen, Abcelera's President and CEO, Dr. Sarah Neunberg, Abcelera's Chief Medical Officer, and Andrew Booth, Abcelera's Chief Financial Officer. During this call, we may make statements about our strategic priorities and financial outlook based on our current expectations and in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our statements are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those described. Please review the Risk Factor section of our most recent Form 10-K and subsequent 10-Q filings with the SEC for a more detailed discussion of these risks. Webseller assumes no obligation to update any forward-looking statements to reflect events or circumstances after today's date. Our presentation today, our earnings press release, and our SEC filings are available on our Investor Relations website. The information we provide about our pipeline is intended for the investment community and is not promotional. As we transition to our prepared remarks, please note that this call is being recorded and will be available for replay on our Investor Relations website and that all dollars referred to during the call are U.S. dollars. After our prepared remarks, we will open the line for questions and answers. I will now turn the call over to Carl.

Carl Hansen, CEO

Hey, thanks, Trent, and thank you, everybody, for joining us today. Q3 was a transformative quarter for Abcelera, driven primarily by our positive top-line phase two results for ABCL635, which is an investigational antibody for the non-hormonal treatment of moderate to severe basal motor symptoms or hot flashes. The phase two study was designed to evaluate efficacy and safety at four weeks following a single 600 milligram Injection, a BBC L635. The data, which we announced on August 10th, show that ABCL 635 has strong potential to redefine the standard of care for non-hormonal treatment of hot flashes. On the strength of these data, we have an exciting opportunity to develop a potential category-defining women's health product with clear differentiation across efficacy, safety, and convenience. In line with this, we believe our data also significantly expands the commercial prospect for ABCL635, and we are fully committed to bringing it into late-stage development next year. In the next few slides, I'll review the key results and put them into context with respect to existing therapies. Our first key efficacy endpoint was reduction in the frequency of moderate and severe hot flashes. This slide shows the effect of ABCL 635 plotted as change from baseline values using both the primary analysis on the left, which included only values from weeks 2, 3, and 4, as well as a pre-specified sensitivity analysis on the right that included week 1 data as well. I first note that our data shows rapid onset of benefit, with a significant placebo-adjusted treatment difference of 2.6 events already present at week one, and then increasing improvements over the full four-week period. At four weeks, the ABCL 635 group has a mean reduction of 8.8 events per day compared to a mean reduction of only 3.5 events per day in the placebo group, representing a placebo-adjusted treatment difference of 5.3 events. Expressed as a percent change from baseline, the ABCL635 group experienced an 83% reduction from baseline in daily events compared to a 33% reduction in the placebo group for a placebo-adjusted treatment difference of 50%. Notably, the benefit of ABCL635 was highly consistent across subgroup analyses, and the data were robust to a variety of sensitivity analyses. Our second key efficacy endpoint was reduction in the severity of VMS, which is reported on a three-point scale, representing mild, moderate, and severe events. As with frequency, we see a rapid onset of benefit, with significant improvement at the one-week time point and increasing improvement out to four weeks. At four weeks, the mean severity score is decreased by 1.4 points in the ABCL 635 group versus 0.3 points for the placebo group. For a placebo-adjusted difference of 1.1 points. When expressed as a percent change from baseline, the ABCL635 group experienced a 58% mean reduction in severity from baseline compared to a 12% mean reduction in the placebo group for a placebo-adjusted difference of 46%. As an alternative to reporting population averages, another valuable way to look at the data is to assess the fraction of patients that have experienced different ranges of treatment benefit. In the table on the left, you can see that 37% of ABCL 635 participants had complete, or 100%, resolution of moderate or severe events at four weeks. This compared to only 2.2% of placebo patients. To our knowledge, these levels of complete resolution of moderate and severe events have not been reported for any non-hormonal VMS treatments and are at least comparable, if not superior, to reports from studies of hormone therapy. Furthermore, nearly 61% of ABCL635 participants had at least a 90% improvement from baseline in the number of moderate to severe events, compared to only 8.7% of placebo patients, and a full 78%, more than three-quarters of patients, had over 75% reduction. These large and clinically meaningful benefits were also observed for severity, as shown in the table on the right. While acknowledging the potential limitations in making cross-trial comparisons, it is worth evaluating our observed treatment effects against data collected similarly at four weeks from the registrational studies of the two approved small-molecule NK3R antagonists, Fezzalinitant and Elenxanitant. Looking at the placebo-adjusted reduction in frequency of moderate and severe VMS, expressed as a percentage of the baseline levels, our placebo-adjusted treatment effect is 50%, which is approximately twice as large as the 20 to 25% reductions reported in Phase III studies of Fezzolinotant and Elenxanotant. An even greater difference in treatment effect was observed in improvements in VMS severity, with a roughly 3.5 to 5-fold greater benefit as compared to the registrational studies of Fezzolinotant and Alenxanotant. Importantly, these markedly enhanced treatment effects were achieved without any clear signal of gastrointestinal or liver toxicity. This slide summarizes adverse events reported in at least two patients in either treatment group, regardless of relationship, occurring during the first four weeks of treatment. ABCL 635 demonstrated a favorable tolerability profile across the data set. Overall, there was a numerically higher number of patients with at least one adverse event in the ABCL635 group compared with the placebo group. There were no serious or severe adverse events in the ABCL635 group compared to one placebo patient with a serious adverse event and two placebo patients with severe adverse events. Similar to the data in the Phase I study, ABCL635 was associated with an increased incidence of headache, with the majority rated as mild and transient across both treatment groups. Fatigue was also reported more often in the ABCL635 group, although all events were mild. Importantly, we did not see any evidence of gastrointestinal toxicity in this study, despite it being consistently reported with the two approved small molecule NK3R inhibitors. In fact, we observed a lower incidence of nausea in the ABCL635 group and no events of diarrhea or abdominal pain compared to multiple patients reporting these events in the placebo group. Summing up, our Phase II data showed a combination of breakthrough efficacy and favorable tolerability. Based on this, we believe ABCL635 has the potential to redefine the standard of care for non-hormonal treatment of hot flashes. Looking forward, we are committed to advancing ABCL 635 into late-stage development and are actively working through the FDA's Model-Informed Drug Development, or MIDD, program to gain alignment on dose selection for subsequent studies. We expect to disclose additional data through 12 weeks and the Open Label Extension, or OLE, data in early 2027. As a reminder, in terms of efficacy, the primary objective of the Phase II trial was to evaluate the benefit of a single dose of ABCL 635 over the course of four weeks. This is the data we have just reviewed. The remaining portion of the 12-week data is to monitor the decline in efficacy over the final eight-week washout period, with this data used to support exposure response modelling for late-stage dose selection. Following the initial 12-week period, OLE data will provide an additional four-week assessment, allowing us to characterize repeat dose dynamics in the treatment group alongside initial active exposure in the placebo group. We expect to initiate late-stage development for menopause, VMS, in 2027. And in parallel, we are expanding the indications for ABCL-635 to include hot flashes caused by hormone suppression associated with breast and prostate cancer treatment, and we expect to initiate clinical trials in these two populations in 2027. Finally, today we are pleased to announce a new program, ABCL-992, which is a next-generation half-life extended analog of ABCL-635. ABCL-992 entered IND enabling activities in Q3. Building on our landmark data from ABCL 635, we believe this program will advance another therapeutic option that provides even greater convenience to patients through an extending dosing interval and facilitates broader patient reach. Moving on from ABCL 635, and as previously guided, today we are presenting Phase 1 results from our second clinical candidate, ABCL 575, which is a long-acting investigational antibody targeting OX40 ligand. ABCL-575 entered clinical development as a potential best-in-class follower of Sanofi's amlotilumab, which at the time was in Phase III studies for atopic dermatitis. Earlier this year, based on disappointing clinical data, development of amlotilumab was discontinued in atopic dermatitis. Separately, late-stage clinical studies of Amgen's rocatilumab and OX40-targeted antibody also led to discontinuation. Based on these external results, we will not pursue development of ABCL575 and atopic dermatitis. And while we believe the OX40-OX40 ligand class has potential in other autoimmune conditions, we do not currently have plans to develop it beyond Phase I. With that, I'll hand it over to Sarah to discuss our top-line results from the Phase I study. Sarah?

Sarah Noonberg, Other

Thank you, Carl. Despite setbacks in the OX40-OX40 ligand class, the top-line results from the Phase I clinical trial of ABCL-575 demonstrated a favorable tolerability and PK profile that were very much in line with our target product profile. As a reminder, our Phase I study was a randomized, double-blind, placebo-controlled, single-ascending dose study in 40 healthy volunteers aged 18 to 65. Participants were randomized three to one to receive a single dose of ABCL575 at a dose of 75 mg to 900 mg subcutaneously or a matching placebo. Given the expected long half-life of ABCL575, participants were followed for approximately one year. Study endpoints included safety, tolerability, and pharmacokinetics. The following data reflects a near-complete data set with the final participants approaching their last study visit. 30 participants received a single dose of ABCL575, and 10 received a single dose of placebo. The overall study population had a roughly even split between males and females and an average age of 44 years. There were no clinically important imbalances among treatment groups. ABCL-575 demonstrated a favorable tolerability profile in this dataset. This slide summarizes adverse events reported in at least two participants in either treatment group, regardless of relationship. There were no serious or severe adverse events in the ABCL-575 group and one severe adverse event in the placebo group. The overall adverse event rate was comparable between the two treatment groups. With about 57% of ABCL575 participants reporting at least one adverse event, compared with 60% on placebo. The most common adverse events were injection site reactions and headache that were neither dose-dependent nor markedly different between ABCL575 and placebo groups. There were no safety findings indicative of clinically important immunosuppression in this dataset. In terms of pharmacokinetics, ABCL575 showed sustained exposure that was approximately dose proportional across the dose range. With the data available to date, the mean half-life was approximately 65 days, ranging from 43 days in the lowest dose cohort to 79 days in the 600 milligram cohort. This is in line with a mean half-life of 67 days predicted from our preclinical data. We also compared our exposures against an efficacy target threshold of four micrograms per milliliter. That threshold is inferred from published clinical data on amlitilumab. At clinically relevant dose levels, exposures were maintained well above that threshold for over 12 weeks. Taken together, these data support dosing once a quarter or less frequently, which was a key aspect of our target product profile. In summary, our Phase I study met its primary endpoints, including a favorable tolerability and PK profile that supported extended dosing intervals. As Carl mentioned, based on external developments in the OX40-OX40 ligand class, we do not intend to pursue clinical development further at this time. I would like to thank the study participants, investigators, and the site team for their contributions and commitment to this study. I'll turn the call back to Carl, who can share additional corporate development updates for the quarter.

Carl Hansen, CEO

Thanks, Sarah. Having just reviewed our clinical results for ABCL 635 and ABCL 575, I'd like to pull back and share some perspective on what these mean for Abcelera. A little over a year ago, we were in preclinical studies and working to make the difficult transition from a platform company to a clinical biotech. As of today, we have brought our first two programs successfully through early-stage clinical development. With ABCL 635, we have delivered breakthrough results that opened a path to creating a transformative product in women's health. And by next year, Epcelro will transition into a late-stage clinical development company. Clinical success has created an exciting opportunity, and taking advantage of this opportunity requires resources. Following the release of our Phase 2 data for ABCL 635, we completed a significantly oversubscribed $200 million capital raise. With a strengthened balance sheet, we can bring ABCL 635 into late-stage development while continuing to invest in our broader pipeline. Turning to this pipeline, while investor attention has been overwhelmingly focused on ABCL 635, we believe this is but the first example of our platform delivering value. Our goal is to prove this by repeatedly inventing and developing programs that emphasize innovation and that have potential to be breakthrough medicines. Today, we have several updates to our pipeline. First, our previously disclosed programs, ABCL-688 and ABCL-386, continue to progress through IND-enabling activities. As mentioned earlier, we have added a new program, ABCL-992, which is a next-generation version of ABCL-635, engineered for less frequent dosing. And today, we are also announcing two additional programs, ABCL 385, a new program for an undisclosed indication in oncology, and ABCL 646, a potential first-in-class antibody antagonist against an undisclosed ion-channel target. As with previous programs, we do not expect to disclose further information on ABCL 385 and ABCL 646 until they enter clinical development. In summary, Q3 was a breakthrough quarter for Abcelera. We delivered compelling clinical data for ABCL 635 that sets the stage for late stage development next year. In parallel, we successfully completed our studies of ABCL 575, have advanced ABCL 688 and ABCL 386, and have added three new programs, ABCL 992, ABCL 385, and ABCL 646, to our pipeline. With these accomplishments, we have successfully delivered on all our stated 2026 corporate priorities. With completion of our financing, we are in an excellent financial position as we close out 2026, and we're expecting that 2027 will be another significant year for Abcelera. And with that, I'll hand it over to Andrew to discuss our financials. Andrew?

Andrew Booth, CFO

Thanks, Carl. As Carl pointed out, Epcelera continues to be in a strong liquidity position with over $790 million in cash and equivalents, and with over $100 million in available committed government funding to execute on our strategy. We are continuing to execute on our plans with a focus on internal programs and leveraging our process development and clinical manufacturing investments. Turning to revenues and expenses, revenues for the quarter were over $10 million, compared to a total revenue of approximately $9 million in the same quarter of 2025. The revenue this quarter consisted mostly of research fees. Our research and development expenses for the quarter were approximately $44 million, as we continue to focus on investments in our internal programs. R&D expenses in the same quarter last year were approximately $12 million higher due to a couple of specific investments in internal programs in Q3 of 2025. In sales general and administration, expenses were approximately $14 million compared to $25 million last year. The large decrease in SG&A expenses relates to the conclusion of our intellectual property litigation and to changes in teams following the focus on our internal pipeline. Looking at earnings, we are reporting a net loss of roughly $41 million for the third quarter of 2026, compared to a loss of about $57 million a year earlier. In terms of earnings per share, this result works out to a loss of $0.13 per share on a basic and diluted basis. Looking at cash flows, altogether we finished the quarter with over $790 million of cash and marketable securities. Operating activities for the first nine months of the year generated $19 million in cash. Included in the operating cash flow are the receipt of upfront payments under our TCE deals with Jazz and Vertex, as well as the Bruker litigation settlement paid out in 2026. As Carl mentioned, we concluded our oversubscribed equity raise of $200 million in the quarter. The proceeds from this raise, combined with government funding and employee stock option exercises, resulted in $214 million of financing cash inflows. Excluding marketable securities, investment activities year-to-date included approximately $8 million of capital expenditures, offset by a similar amount in government grants received. As a part of our Treasury strategy, we now have about $600 million invested in short-term marketable securities. Our investment activities for the quarter included a $197 million net investment in these holdings. As a reminder, we have received commitments for funding the advancement of our internal pipeline from the Government of Canada's Strategic Innovation Fund and the Government of British Columbia. This available capital does not show up on our balance sheet. With over $790 million in cash and equivalents, and the unused portion of our secured government funding, we have over $890 million in available liquidity to execute on our strategy. In addition, we have further available liquidity from our ownership of our other Vancouver-based lab and office building, as well as our GMP facility. With respect to overall company expenditures, our capital needs are very manageable, and we continue to believe that we have sufficient liquidity to fund at least the next three years of pipeline investments. And with that, we'll be happy to take your questions. Operator?

Kara, Host

We will now begin the question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes to the line of Evan Siegerman with BMO Capital Markets. Your line is open. Please go ahead.

Evan Siegerman, Analyst — BMO Capital Markets

Hi, guys. Thank you so much for taking my question, and congrats on all the progress this past quarter. So I know you presented 635 to 635 data at two conferences this past quarter following the data disclosure. Can you share what feedback you got from clinicians in the field and kind of what their level of excitement is? And more importantly, what did you learn from those clinicians that helped you inform kind of next steps in development of this asset? Thank you so much.

Sarah Noonberg, Other

Hi, Evan. Thanks for the question. And really, it was a remarkable reception that we had both at IMS in Rio and TMS, the Menopause Society, in San Diego this past month. I would say the reception that we've gotten was nothing short of incredible, fantastic, can't wait to participate. When are we starting phase three? And I would say that, you know, we were hearing that these results are, you know, even better than what physicians have been experiencing with hormonal therapy. And certainly the hormonal therapy data that was presented with the latest hormone therapy, Estetrol, was... At least on a side-by-side comparison, much stronger. So they are anxiously awaiting our next steps. We've had consultant meetings with KOLs at both meetings, and we have gotten a lot of good encouragement to move as quickly as we can.

Evan Siegerman, Analyst — BMO Capital Markets

Thank you.

Kara, Host

Your next question comes to the line of Steve Seedhouse with Cantor. Your line is open. Please go ahead.

Steve Seedhouse, Analyst — Cantor

Hey, great. Thanks so much. Congrats on all the progress. I wanted to ask two slightly different questions. First is just on 992, the new asset, new NK3R long-acting asset. Anything in your market research? So this suggests this extended dose interval could meaningfully change sort of the receptivity or the market adoption of that asset, and just how do you plan to develop it in parallel? Thinking, obviously, you're in a few different indications with 6.35. I don't know if you're planning on maybe one in oncology or one in postmenopause, if you could talk about that. And then I have a quick follow-up.

Carl Hansen, CEO

Sure, Steve. Carl here. I'll maybe start the answer, and, you know, Sarah might be able to add something after the fact. So, first of all, we did some market research early on on 635, where we did ask questions looking at, you know, the importance of dosing, like, once daily as a pill versus once one month versus three months. You know, the general trend was that people preferred, there's a majority preference for a once monthly injectable. And I'd say that the people that believed that you could deliver a molecule that would last for three months were also very excited about that. But in the interviews, you had, you know, some patients that just thought, hey, that's too good to be true. So we view that as very positive. In terms of, you know, our view of the opportunity here, you know, first of all, we find ourselves in an unbelievable position having, you know, this type of data with this kind of strength, and there aren't a lot of competing molecules around. We anticipate that there will be, you know, groups out there that immediately think, well, I'm going to follow that up with a half-life extended version. And so we've had this molecule in the wings, ready to go, and we're able to bring it into IND enabling activities immediately following the data. So we're well ahead of that response that we expect to see from the market. And that's part of shoring up our position and making sure we make the most out of the opportunity. You know, in addition to patient convenience, the other part, and I did, I think, mention this slightly in my prepared remarks, is that a longer dosing interval means that you have to make fewer doses per patient. That, of course, improves the cost of goods, but also makes it easier to satisfy a broader reach of demand, and we think that's going to be an important, at least, optionality as this program goes forward.

Steve Seedhouse, Analyst — Cantor

Very good. Thanks, Carl. My follow-up was just you have a handful of new lines in the pipeline here. The internal pipeline is expanding pretty rapidly. I was curious, are you thinking about this as Accelera just has the desire and capacity to develop all of these wholly owned, broad internal pipeline, or are you looking to or open to licensing out some of these assets as they translate into the clinic? Continue to advance. Separate from OX40, I mean, because obviously that one's parked for now. Thank you.

Carl Hansen, CEO

Sure. So, I mean, our stated strategy for some time has been not to be a one-trick pony, but to be able to show we can reproducibly generate medicines that are exciting and worth bringing into clinical development. You're seeing that now come into play as the pipeline fills up. You know, everything we've brought forward, you know, we have conviction in. Of course, we're going to see how they work, and we'll get the early clinical data. That'll be part of deciding what to bring forward. And then at every moment, we decide to bring a program forward, we're having to make a decision as to, you know, resource allocation and bandwidth. Today, we feel like we have got our hands around this well, that we can fund it in the early stage, and that it's going to create value. We're going to keep looking at that as we move forward. But there may well be opportunities to outlicense. It's going to depend on the program. Thank you, Carl.

Kara, Host

Your next question comes from the line of Roger Song with Jeffries. Your line is open. Please go ahead.

Roger Song, Analyst — Jefferies

Great. Thanks for the update and taking all questions. Maybe just regarding the early next year data update. With the strong four-week data, understanding the single-dose, you know, eight-week washout period, just curious if possible we can see the eight and then 12 weeks comparable to orals, and then what's your internal modeling suggesting here? And then regarding the open-label extension, you said the bar high for yourself, but just in terms of the open-label, what's the design the patient could potentially see some difference between the first four weeks versus the extension four weeks? Thank you.

Sarah Noonberg, Other

Hi, Roger. I'll take this. In terms of what we expect from the 8-week and 12-week, just as a reminder, this was a single-dose study, so the expectation is we see our Most pronounced results around the four-week time point. That's why we chose that as our pre-specified efficacy analysis time point. And the goal of continuing to follow patients for efficacy and safety through eight and 12 weeks was to see how efficacy decreases as exposure decreases and to build an exposure response model that would then support dose selection. So given that this is only a single dose, we don't expect that efficacy is maintained through the full 12 weeks. And in fact, if that were the case, it'd be harder to build that exposure response model for dose selection. So the goal is to watch as drug washes out, and we've already disclosed our half-life, so we expect that drug washes out to look at how efficacy changes, and that supports our model-informed drug development pathway. So the four-week efficacy is what we expected in terms of our efficacy data. And if you say, well, what are our expectations in the open label? I think what we would like to see is when placebo patients cross over, they have a similar degree of benefit. I think that will provide orthogonal data supported. And then we look forward to sharing what happens when the active patients receive a second dose. So there'll be both an efficacy and a safety data set that will come early next year, and I think, you know, it just will provide continued conviction that we have in this program to move it into late-stage development.

Carl Hansen, CEO

If I could just add one more thing, Roger. You asked about the comparison to the small molecules and efficacy. So, you know, we did mention that, you know, at week one, we already have efficacy that looks comparable to the small molecules, and as Sarah mentioned, as the drug washes out, we're going to see efficacy decline. Since we're starting so much better, we expect that, you know, at some point, we're going to cross over that. But of course, that isn't the goal. Our goal is not to make a drug at this point that is equal in efficacy, but one that has a formidable advantage in efficacy. So we're looking to preserve that as we decide on the final dosing.

Roger Song, Analyst — Jefferies

Got it. Thank you.

Kara, Host

Your next question comes in line of Brian Chang with J.P. Morgan. Your line is open. Please go ahead.

Brian Chang, Analyst — J.P. Morgan

Hey, guys. Thanks for taking our questions today. Maybe just first, as we think about the next data cut from the Washout and also the OLE, just curious if you can talk about, you know, the size of the OLE portion, just how many patients have been rolled over so far into the OLE, and I have a quick follow-up.

Sarah Noonberg, Other

Brian, I'll take that. I don't want to preclude the data that we'll be sharing, but I can say that the uptake of the open label extension was extremely high, as you might expect, given the efficacy results seen at four weeks. So you will see the vast majority of patients as part of that data set.

Brian Chang, Analyst — J.P. Morgan

Great. And then on 992, as you think about the next step, moving into later stage development, what is the ultimate strategy to develop 992? Is it for, do you have a specific set of indications in mind that will be better served with a longer half-life, or is this more, should we think of it as more of a life cycle management behind 635?

Carl Hansen, CEO

I appreciate the question. So, you know, as mentioned, we see an opportunity to have a product that we could, you know, create for more patients and one that would have an extended dosing interval. I think that's got some important advantages commercially. We haven't yet run that to ground. So exactly how we're going to position the two products is probably not something we're ready to talk about today. What I will say is that the existence of 992 is in no way a move away from 635. We are all in on 635. We think that's going to be a terrific product, and we're just looking to reinforce that with one that's even better and that anticipates how we expect people to react to it.

Brian Chang, Analyst — J.P. Morgan

Great. Thanks for the color.

Kara, Host

Your next call comes from the line of Andrea Newkirk with Goldman Sachs. Your line is open. Please go ahead.

Andrea Newkirk, Analyst — Goldman Sachs

Good evening. Thanks for taking the question. I also have one follow-up on 992 there, just if you're able to share what specific modifications were utilized to extend the half-life. And Carl, I just wanted to follow up on the target half-life for injection interval that you believe would be advantageous here. Just curious what that target is. Is it the every three months that you mentioned? And then I have a follow-up.

Carl Hansen, CEO

Sure. So in terms of the modification, we haven't yet disclosed anything about the sequence of 992. What I will say is that we've used, you know, engineering practices that we're free to use and that have been well-trodden, and so we have high confidence that this will play out the way that we expect. In terms of dosing interval, ABCEL 635, originally the TPP was for a once-monthly dosing. Obviously, based on the data we've shown, we're well within that. And so the question now is, what exactly is the dosing to meet that? We do expect that the follow-on product would have, you know, a dosing interval that, you know, probably safely twice, perhaps three or even more in terms of dosing interval. But we have to do some studies still to nail that down. So I don't want to get ahead of ourselves here.

Andrea Newkirk, Analyst — Goldman Sachs

Okay. And then just, I guess maybe taking a step back and broadly, as you think about the progress that you've made with these first two internal programs, I'd be curious just your thoughts on what the primary translational or mechanistic read-through are from those initial programs to the broader pipeline that you have. Thanks so much.

Carl Hansen, CEO

I'm sorry, could you rephrase that question? I'm not sure that I got the full thrust of it.

Andrea Newkirk, Analyst — Goldman Sachs

Sure. Just, I guess, maybe on the back of 635 and 575 and the progress that you've seen there, I'm just curious on the read-through that you see to the rest of your pipeline.

Carl Hansen, CEO

Sure. So, you know, the progress on 575 and 635, as I mentioned, shows that we have successfully navigated that transition from being a platform company to standing up, you know, a clinical team and successfully executing those programs. On 635, you know, the next big lift is going to be to build that out into late-stage development and to be able to take it forward to approval. So that's the read-through on the operational side. In terms of, you know, read-through on the platform, 635, I think, is a good archetype of the type of program we're trying to bring forward. So, well-validated biology, large unmet need, very sparse competition, and a difficult target where our platform has been able to deliver. We've got other programs behind coming like that. You know, I might call out, for instance, 646 that today we disclosed is an antagonist against an ion channel target. That's an area where we've been working for a long time, where we think we have a very strong competitive advantage. And if it were to go forward and ultimately be a drug, it would be the first antibody against an ion channel target that's been done. So trying to get into that new target space is definitely something that we are focused on. And we think that's important in what is becoming an increasingly competitive world.

Kara, Host

Your next question comes from the line of Creepa de Veraconda with Truist Securities. Your line is open. Please go ahead.

Creepa de Varaconda, Analyst — Truist Securities

Hi, guys. Thank you so much for taking my question, and congratulations on the progress the last few months. I just want to clarify a timeline. From my understanding, the 12-week data were expected by year 2026, by end of the year. Am I right? And if so, wondering what has driven the move to early 2027. Kevin. I guess the question I really have is, do you have all the data internally for the finalization of the phase three trial design? You are in conversation with regulators, and then I have a follow up question.

Sarah Noonberg, Other

Thanks for the question. You know, there is nothing unusual from an operational standpoint. The data is coming in. We're doing the monitoring and analysis, and really it's the preferred timing of release of this data between late 2026 and early 2027. So there is nothing that fundamentally has changed.

Creepa de Varaconda, Analyst — Truist Securities

And you have all the data internally for the finalization of the pastry trial design or the conversations you're having with regulators?

Sarah Noonberg, Other

We are in the midst of regulatory discussions, KOL discussions about our clinical trial designs. I think we have a clear pathway that has been laid out by the two small molecules, so I think overall there are going to be little surprises, but there are additional endpoints and design aspects as well as sample size and populations that we're still under discussions with. So we have all that we need in terms of the feedback, but going through regulatory discussions and finalizing our dose takes a little bit of time, and while we're doing that, we're scaling up our manufacturing processes. So we remain on track to initiate late-stage studies in 2027.

Creepa de Varaconda, Analyst — Truist Securities

Okay. Just a follow-up question. In August, I think when we talked about it, you raised the possibility of a head-to-head study. Are you still considering including an active competitor, or is this something that we have to wait for once you're done with your trial design?

Sarah Noonberg, Other

At this point, we're not going to be sharing any more information about our pivotal study or late-stage designs, but we will be disclosing that in the coming months. Thank you so much.

Kara, Host

Your next question comes to the line of Alison Bratzel with Piper Sandler. Your line is open. Please go ahead.

Peter, Analyst — Piper Sandler

Hi there. This is Peter on for Alison. Thank you for taking the question. So you expect to advance us. 635 into VMS associated with breast and prostate cancer treatments next year, which populations and settings are you prioritizing? And what might those initial trials look like? Also, what needs to be established in the menopause program before those studies can begin? Thank you.

Sarah Noonberg, Other

Thanks, Peter. In terms of breast, I think the overall study design can be inferred from the OASIS-IV study of L-inzenitant, where they ran a pivotal study in the breast cancer population. So I would expect that you'd see a lot of similarity in that study design. And just as a reminder, the treatment effect seen with L-NZenitant was highly comparable in VMS associated with naturally occurring menopause and VMS associated with breast cancer treatment. So while we have not studied that patient population yet, we have a lot of conviction that we will see a similarly strong treatment effect. In terms of prostate cancer, that's much less data available, some case reports and early studies. So there we'll be doing a little bit more work in terms of defining the patient population and correct study endpoints. So there we expect to initiate mid-stage studies in 2027. But I think the expected treatment effect, just given what we have heard from urologists that have used oral small molecules in patient populations with fairly problematic BMS has been very encouraging. I think we have less of a handle right now on what the exact patient population should look like, but those are ongoing and very active discussions and certainly a lot of enthusiasm from the field.

Peter, Analyst — Piper Sandler

Great, thank you.

Kara, Host

Your next question comes to the line of Alice Nettleton with UBS. Your line is open. Please go ahead.

Avery, Analyst — UBS

Hi, this is Avery on for Alice. Thanks so much for taking our questions, and congrats on all the progress with 635 today. So a couple from us. First, since your last investor call, can you talk maybe a little bit about any important market developments in menopause that give you greater confidence in the market growth, and more specifically in the opportunity for 635? And then separately, you recently presented the phase one SAD-MAD data at TMS, where the immunogenicity looked quite low with 2% anti-drug antibodies. So what gives you confidence that this will hold with longer term and broader exposure? Thanks so much.

Carl Hansen, CEO

Thank you. Sure, I'll start on the market side. So, you know, I don't know if a lot has changed over the last quarter, but what we are seeing is quite a dramatic turn of attention towards treating VMS. I think that was, you know, probably in large part prompted by the removal of the box warning on hormone therapy, and what has been, you know, a dramatic increase in, you know, women that are seeking and expect to get treatment for problematic VMS. So that's that's for us as a tailwind. We've always positioned the product not as a substitute for hormone therapy, but as a great alternative for those that either cannot tolerate or have contraindications against or who choose that they don't want to take hormone therapy. The other the other thing I think that's interesting is the, you know, the way that the small molecules have played out. And, you know, I think one of the things that's happening in the market is there's, you know, some I won't say friction, but there is some discussion around the risk-benefit and the use of these over some other therapies that are being used as non-hormonal options, particularly SSRIs, for instance. And here we think we've got a product that will have a very clear efficacy advantage, and we intend or we hope to have a safety profile that looks like it has thus far. And so we think that we could be positioned to be, you know, really, you know, standing alone as a NK3R option and perhaps even any option for non-homeral treatment.

Sarah Noonberg, Other

And I'll chime in in terms of your question around immunogenicity. Ultimately, our conviction comes from in silico modeling as well as some early preclinical data. Ultimately, clinical data will give us a lot more conviction, so more data will come as we see repeat dose from the open-label extension, and that's something that we'll continue to monitor. But really, this is something that we'll need to play out with repeat and longer-term studies. So stay tuned, but certainly our current data set is very encouraging, and there's nothing in our modeling or what we've seen preclinically that gives us any concern.

Kara, Host

Thanks so much. Your next question comes from the line of Brendan Smith with TD Cohen. Your line is open. Please go ahead.

Brendan Smith, Analyst — TD Cohen

Great. Thanks for taking the questions, guys, and congrats on all the progress here. I wanted to actually ask about, you know, the earlier stage pipeline. I think you've got now four or five new assets in IND-enabling studies. So, I mean, how many of those should we reasonably expect to hit maybe phase one over the next year, let's say? I guess, how are you prioritizing the timing of those entering the clinic and maybe just what are some of the gating factors kind of dictating some of those decisions at this point?

Carl Hansen, CEO

Thanks. Sure. So, you know, just responding to your question about the timing of the assets, obviously 635 is a big focus right now. It's the one that has gone the furthest. Behind that, we're starting to build what we think is quite a compelling pipeline. As I mentioned before, ABCL 688 and 386 continue to go through IND enabling activities. Both of those have a timeline that would bring them into the clinic in 2027. Behind that, we've just announced 992. It started IND enabling activities this past quarter in Q3. So it'll be sometime, definitely not in 2027 that it would be in the clinic, but perhaps in 2028. And for 646 and 385, you know, we haven't given any further guidance, but we will update those as they get closer to clinical development.

Brendan Smith, Analyst — TD Cohen

Got it. Sounds good.

Carl Hansen, CEO

Thank you.

Kara, Host

There are no further questions at this time. I will now turn the call back to Carl Hansen for closing remarks.

Carl Hansen, CEO

Great. Thank you, everyone, for joining us today. It's been a great quarter, and we look forward to speaking to you again next quarter.

Kara, Host

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