Q3 2025 AbCellera Biologics Inc Earnings Call & Business Update
Broadcast all lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end if he would like to ask a question. Please press star followed by 100 telephone keypad and if you're having any issues. During the call. Please press star followed by zero on your telephone keypad at this time I would like to turn the call over to <unk> <unk>.
<unk> Chief legal and compliance officer you May proceed.
Thank you Hello, everyone.
Thank you for joining us for a seller is third quarter 2025 earnings call I'm trying Stein Mart and seller as chief legal and compliance officer, Dr. Carl Hanson et cetera, as president and CEO and Andrew Booth accelerates Chief Financial Officer are also on todays call.
During this call, we anticipate making projections and forward looking statements based on our current expectations and in accordance with the Safe Harbor provisions of the private Securities Litigation Reform Act of $19 95 or.
Our actual results could differ materially due to several factors outlined in our latest Form 10-K, and subsequent forms 10-Q, and 8-K filed with the Securities and Exchange Commission et seller is not obligated to update any forward looking statements, whether due to new information future events or otherwise 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 it's not promotional as we transition to our prepared marks remarks. Please note that all dollars referred to during the call are U S dollars. After our prepared remarks, we will open the lines for questions and answers now I'll turn the call over to Carl.
Thanks, Ken and thank you everyone for joining us today.
Last quarter, we completed our transition from a platform company to a clinical stage biotech with initiation of our phase one clinical trials for <unk> <unk>, five and <unk> 575.
Both trials are progressing to plan and remain on track for Readouts next year.
I am pleased to report that this quarter. We have also started activities at our new clinical manufacturing facility and we have substantially completed our platform investments.
We ended the quarter with approximately $680 million and available liquidity to execute on our strategy and as we close out the year. We are confident in achieving all our corporate priorities, including advancing at least one more development candidate into IND, enabling studies.
A highlight of this quarter with the appointment of Dr. Sarah <unk> as Chief Medical Officer.
There is a physician scientist with over 20 years of clinical drug development experience.
She has a broad pardon me. She has worked across a broad range of modalities and indications and has led programs through all stages of development from discovery through to approval.
You can expect Sara joined future earnings calls to provide updates on our clinical pipeline.
With <unk>, taking the helm, Dr. Geoff Nichol, who will be stepping down as our SVP of development.
I'd like to thank Jeff for his leadership in building development as we transitioned from a platform company to a clinical stage biotech.
And with that I will hand, it over to Andrew to discuss our financials Andrew.
Thanks Carl.
As Karl pointed out of solar continues to be in a strong liquidity position with approximately $520 million in cash and cash equivalents and with roughly $160 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 CMC and GMP investments.
Looking at our business metrics in the third quarter. We started work on one additional partner initiated program, which takes us to accumulative total of 103 programs with downstream participation.
With phase one trials for <unk> <unk>, five and <unk> 75 underway, we maintained a cumulative total of molecules to reach the clinic at 18.
Including both our own pipeline and those led by partners.
As we have stated previously we view the overall progress of molecules in the clinic as potential source of near and midterm revenue from milestone from downstream milestone fees fees and royalty payments in the longer term.
Turning to revenue and expenses revenue for the quarter was $9 million predominantly from research fees relating to work on partner programs. This compares to revenue of approximately $7 million in the same quarter of last year.
With respect to research fee revenue as we have mentioned in the past we expect these to continue to trend lower as we increasingly focus on our internal pipeline.
Our research and development expenses for the quarter were $55 million approximately.
<unk> $14 million more than last year. This expense reflects the focus on investment in our internal and co development promo programs.
The increase over the recent run rate expense levels. In Q3 is largely due to specific investments of $15 million on to internal programs.
In sales and marketing expenses for Q3 were just under $3 million.
A small reduction relative to the same quarter of last year and in general and administration expenses were approximately $22 million compared.
Compared to roughly $19 million in Q3 of 2024.
Included in these expenses are the ongoing expenses related to the defense of our intellectual property.
Looking at earnings we are reporting a net loss of roughly $57 million for the quarter compared to a loss of about $51 million in the same quarter of last year.
In terms of earnings per share. This result works out to a loss of <unk> 19 per share on a basic and diluted basis.
Looking at cash flows.
Operating activities for the first nine months of 2025 used approximately $97 million in cash and equivalents.
Excluding investments in Mark Little marketable securities investment activities amounted to $49 million year to date.
This is predominantly in property plant and equipment driven by investments in establishing clear clinical manufacturing, which are now substantially complete as we had expected.
The investments in PP&E were partially offset by government contributions.
And as a part of our Treasury strategy, we have $413 million invested in short term marketable securities are.
Our investment activities for the quarter included a $62 million net divestment of these holdings.
Altogether, we finished the quarter with $523 million of total cash cash equivalents and marketable securities and.
And as a reminder, we have received commitments for funding for 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 and with over $520 million in cash and equivalents and the unused portion of our secured government funding, we have approximately $680 million in available liquidity to execute on our strategy.
In addition, we have available liquidity and our ownership of both Vancouver based lab and office buildings as well as well as our GMP manufacturing facility, both of which have been financed off of our balance sheet.
The operating cash usage for the remainder of 2025, we will continue to prioritize advancing our two lead programs through their phase one clinical studies and building a strong preclinical pipeline.
With respect to our overall company expenditures our capital needs are very manageable and we continue to believe that we have sufficient liquidity to fund well beyond the next three years of increasing pipeline investments.
And with that we'll be happy to take your questions operator.
Thank you we will now begin the Q&A session. If you would like to ask a question. Please press star followed by one on your telephone keypad, if you'd like to remove your question Press Star followed by two again to ask a question press Star one and as a reminder, if you were a speaker phone. Please remember to pick up your handset before asking a question.
And we will pause here to briefly ask questions are registered.
The first question comes from the line of Malcolm Hoffman with BMO you May proceed.
Hi, Thanks.
Thanks for taking our question.
To ask how to think about initiated programs in the clinic.
Somewhat segment since 2024 and to be clear, we appreciate the conversion to more accelerated development.
Just wanted to understand why these partner initiated programs may not be progressing clinically.
It's a timing issue.
Then a second one doctor noon Berg in her new role as CFO.
Can you comment on why you felt like now was the appropriate time to bring Doctor Newmar again, and what do you think she uniquely brings to absorb the company may have flagged before thanks.
Sure I'm happy to take that one Carl Hansen here, So first on the partner initiated programs.
As you know.
In the early stages of the company and through until 2023, our business was primarily focused on our partnership mode, where we were doing discovery on behalf of partners and keeping a position in the resulting molecules bulk and royalties and milestones.
We have handed off a large number of those and as Andrew mentioned I believe we have initiated about a 103 programs to date we.
We do expect that some fraction of those are going to move forward into clinical development and we continue to report on that.
I would say that our experience has been that it takes longer than we had initially anticipated. So we have examples where programs.
That were handed off ultimately go into clinical as much as six years later.
So it's difficult to make an assessment as to what will be the number of those that ultimately make it into clinical development.
We do think that there is value there thats going to accrue over time as mentioned by Andrew on his prepared remarks.
Moving to the question of bringing Sarah.
Obviously in 2023, we made the definitive decision to back away from that partnership business and to move into doing drug development on our own behalf.
Over the past few months, we've succeeded in bringing the first two programs into clinical development.
We have a robust pipeline coming behind that.
And as the portfolio matures, we definitely thought it was time to bring in a senior executive with experience in clinical development and also that the company was at a position where we would be able to attract someone that was absolutely top notch. So we're thrilled to have Sarah on board.
And we look forward to working with her and with you over the coming years as the pipeline matures.
Appreciate it guys. Thanks for the color.
The next question comes from the lineup Andrea Newkirk with Goldman Sachs. You May proceed.
Hi, everyone. Good evening. Thanks, so much for taking my question. Karl I was just wondering if you might be willing to speak a little bit on the data disclosure strategy there.
On taking for the phase <unk> study.
And particularly given your view that the various cohorts.
Dosing is launched.
And the proof of concept.
Action, where you're evaluating efficacy just curious if this will all come in then one disclosure and then if you could help frame expectations for the profile you would deem supportive.
Advancing.
Further into the Phase II study and then I have one follow up.
Following that thank you.
Thanks Andrea.
<unk>.
To your first question our expectation is to make a single disclosure. After we have completed the proof of concept part where we have a double blind placebo controlled evaluation of <unk> 65 in.
The patient population that is intended for we do expect that will come sometime in the new year. I think we had we had said before around mid new year, but.
Give that to a.
A couple of months on either side for Airbus.
What we're looking for is that we have a safety signal and we have efficacy.
It shows that we're in the game to have a competitive product against the other products that are now in the market.
And the study is powered to do that so.
Somewhere around mid point next year, we should know a lot about this program.
So far we're encouraged by what we're seeing everything is on track.
And if that continues on track and we're getting ready to be in position to aggressively move it into later stage trials.
Okay, and if you can.
You achieve your desired target product profile.
When you see that data emerge next year, how validating with that piece of your platform and technology and do you think there is returning to the rest of your pipeline.
It's a great question.
So.
We.
We have highlighted before that one of the areas, where we've been investing for a long time, and where I believe we have world class capabilities in making antibodies against ion channel and GPC our targets, obviously <unk> the GPC our targets. It was the first from that platform to move forward.
Operator: You know, facilitate the audio portion of today's interactive broadcast. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. If you would like to ask a question, please press star followed by one on your telephone keypad, and if you are having any issues during the call, please press star followed by zero on your telephone keypad. At this time, I would like to turn the call over to Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. You may proceed.
The game to have a competitive product against the other products that are now in the market.
And the study is powered to do that so.
I think that's strong evidence that the platform is working and that we can make highly differentiated molecules of course evidence of a platform doesn't happen with a single asset and our intent is to follow that up again and again with other molecules from that pipeline that.
We're around mid point next year, we should know a lot about this program.
So far we're encouraged by what we're seeing everything is on track.
And if that continues on track and we're getting ready to be in position to aggressively move into later stage trials.
We're equally excited about.
Tryn Stimart: Thank you. Hello, everyone. Thank you for joining us for AbCellera's third quarter 2025 earnings call. I'm Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. Dr. Carl Hansen, AbCellera's President and CEO, and Andrew Booth, AbCellera's Chief Financial Officer, are also on today's call. During this call, we anticipate making projections and forward-looking statements based on our current expectations and in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially due to several factors outlined in our latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission. AbCellera is not obligated to update any forward-looking statements, whether due to new information, future events, or otherwise. Our presentation today, our earnings press release, and our SEC filings are available on our Investor Relations website.
Okay.
Can you achieve your desired target product profile.
Okay. Thanks, so much for the time.
When you see the data emerge next year, how validating would that be for your platform and technology and do you think there is really three to the rest of your pipeline.
The next question comes from the line of Stephen Willey with Stifel. You May proceed.
Hey, Good afternoon. This is Josh on for Steve Thanks for taking our question.
It's a great question.
So.
We.
Is there anything you can tell us about how enrollment is going in the phase one trial for 575, maybe.
We have highlighted before that one of the areas, where we've been investing for a long time, and where I believe we have world class capabilities in making antibodies against <unk> channel and GPC our targets, obviously <unk>. The GPC. Our targets was the first from that platform to move forward I think that's strong evidence that the platform is working and that we can make heavy differential.
So some color on some of the doses you've reached in this cohort.
Sure. So in terms of enrollment as I mentioned.
The program is going as expected so everything is on track and at the pace that we anticipated.
<unk> molecules of course evidence of a platform doesn't happen with a single asset and our intent is to follow that up again and again with other molecules from that pipeline that that we are equally excited about.
We are not disclosing preliminary results in terms of how far we got in dosing, but as I said, we're encouraged by what we're seeing and so far everything is as expected.
Tryn Stimart: 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 all dollars referred to during the call are US dollars. After our prepared remarks, we will open the lines for questions and answers. Now, I'll turn the call over to Carl.
Yes.
Okay, Great and then.
Okay. Thanks, so much for calling.
Just another quick one.
I know you said on the Q2 call.
Okay.
The next question comes from the line of Stephen Willey with Stifel. You May proceed.
You were in line to declare a potential for us.
But.
Im seller lead candidate by the end of this year or are you guys still on track to do so.
Hey, Good afternoon. This is Josh on for Steve. Thanks for taking my question.
Yes.
Yes, that's correct I think I said that in my prepared remarks that we are on track before the end of the year.
Carl Hansen: Thanks, Tryn, and thank you, everyone, for joining us today. Last quarter, we completed our transition from a platform company to a clinical-stage biotech with the initiation of our phase one clinical trials for ABCL-635 and ABCL-575. Both trials are progressing to plan and remain on track for readouts next year. I'm pleased to report that this quarter we have also started activities at our new clinical manufacturing facility, and we have substantially completed our platform investments. We ended the quarter with approximately $680 million in available liquidity to execute in our strategy, and as we close out the year, we are confident in achieving all our corporate priorities, including advancing at least one more development candidate into IND enabling studies. A highlight of this quarter was the appointment of Dr. Sarah Nunberg as Chief Medical Officer.
Is there anything you can tell us about how enrollment is going in the phase one trial for 575, maybe.
To bring in additional development candidate forward and that would be the fourth in the pipeline.
Finally, some color on some of the doses you've reached in this cohort.
Okay, great. Thanks for taking our questions.
The next question comes from the line of <unk> <unk> with Leerink partners you May proceed.
Sure. So in terms of enrollment as I mentioned.
The program is going as expected so everything is on track and at the pace that we anticipated.
Hey, guys. Thanks for taking questions. Thank you for taking the question on 605 could you speak to us about whether there is a specific benchmark our bar.
We are not disclosing preliminary results in terms of how far we got in dosing, but as I said, we're encouraged by what we're seeing and so far everything is as expected.
We want to see on testosterone reduction in healthy male volunteers.
Okay, Great and then.
Yeah.
Just another quick one.
Sure So I wouldnt punch out a specific level, but there is.
I know you said on the <unk> call you were in line to declare a potential fourth.
Good.
<unk> out there disclosing testosterone levels from small molecules that were in development, particularly at <unk> and so we would within the power of the study look for something that shows that we're we're.
But several of seller a lead candidate by the end of this year are you guys still on track to do so.
Carl Hansen: Sarah is a physician scientist with over 20 years of clinical drug development experience. She has worked across a broad range of modalities and indications and has led programs through all stages of development, from discovery through to approval. You can expect Sarah to join future earnings calls to provide updates on our clinical pipeline. With Sarah taking the helm, Dr. Jeff Nickel will be stepping down as our SVP of Development. I'd like to thank Jeff for his leadership in building development as we transitioned from a platform company to a clinical-stage biotech. With that, I will hand it over to Andrew to discuss our financials. Andrew.
Yes, that's correct I think I said that in my prepared remarks that we are on track before the end of the year.
We're getting engagement that is at least as good as that to move forward.
To bring in additional development candidate forward and that would be the fourth in the pipeline.
Okay.
Got it Okay, and then could you also discuss.
Okay, great. Thanks for taking our questions.
The risk of engaging this target with a map you ladies and CNS target.
The next question comes from the line of <unk> <unk> with Leerink partners you May proceed.
Sure sure. That's a great question I think it's one that I touched on on an earlier call.
So we believe that the pathway. The <unk> pathway is very well validated and so if we can engage in <unk>.
Hey, guys. Thanks for taking questions. Thank you for taking the question on 605 could you speak to us about whether there is a specific benchmark our bar.
In the relevant neurons that it's highly likely to be an efficacious drug.
Andrew Booth: Thanks, Carl.
You would want to see to start showing reduction in healthy male volunteers.
Carl Hansen: As Carl pointed out, AbCellera continues to be in a strong liquidity position with approximately $520 million in cash and cash equivalents, and with roughly $160 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 CMC and GMP investments. Looking at our business metrics, in the third quarter, we started work on one additional partner-initiated program, which takes us to a cumulative total of 103 programs with downstream participation. With phase 1 trials for ABCL-635 and ABCL-575 underway, we maintained a cumulative total of molecules to have reached the clinic at 18, including both our own pipeline and those led by partners.
The.
Right.
Okay.
Okay.
Sure So I.
The.
Wouldn't a punch out a specific level, but there is.
<unk> is expressed in Kenny neurons in the arguing nucleus.
Good.
And those neurons.
<unk> out there disclosing testosterone levels from small molecules that were in development, particularly federal when a tenant and so we would within the power of the study look for something that shows that we're.
Connect bulk of the endocrine system and also go through the blood brain barrier into the Thermo regulatory center of the brain.
We expect that we should be able to engage and Keith you arent accurate nucleus and given our understanding of the biology, we believe that that should be sufficient to be efficacious in treating <unk>.
We're getting engagement that is at least as good as that to move forward.
Okay.
Got it Okay, and then could you also discuss the.
Yes.
But of course, we have not yet proven that and so we need to wait for the proof of concept study in that readout to have conviction to move the program forward.
The risk of engaging this target with a mapping of any CNS target.
Sure sure.
Great question I think it's one that I touched on on an earlier call.
Got it thank you.
Yeah.
So we believe that the pathway the NK through our pathway is very well validated.
Carl Hansen: As we have stated previously, we view the overall progress of molecules in the clinic as a potential source of near and midterm revenue from downstream milestone fees and royalty payments in the longer term. Turning to revenue and expenses, revenue for the quarter was $9 million, predominantly from research fees relating to work on partnered programs. This compares to revenue of approximately $7 million in the same quarter of last year. With respect to research fee revenue, as we have mentioned in the past, we expect these to continue to trend lower as we increasingly focus on our internal pipeline. Our research and development expenses for the quarter were $55 million, approximately $14 million more than last year. This expense reflects the focus on investment in our internal and co-development programs.
Next question comes from the line of Steve Desert with key Corp. You May proceed.
So if we can engage in <unk>.
In the relevant neurons that it is highly likely to be an efficacious drug.
Hey, Thanks, guys, Steve on for Scott I was hoping you could talk about what the benefits are 605 versus existing hormonal treatment for hot flashes and then as a follow up are there any molecule currently being developed that would compete or.
The.
Yeah.
The.
The.
<unk> is expressed in cannae neurons in the argument nucleus.
Compete directly with 635, thank you.
And those neurons.
Connect bulk of the endocrine system and also go through the blood brain barrier into the Thermo regulatory center of the brain.
Sure so.
605 is not being developed as a substitute for hormonal therapies.
We expect that we should be able to engage and Keith you earn your accurate nucleus and given our understanding of the biology, we believe that that should be sufficient to be efficacious in treating <unk>.
It's being developed as an alternative to menopausal hormone therapy.
I think as I mentioned on our previous call there roughly.
Yes.
But of course, we have not yet proven that and so we need to wait for the proof of concept study in that readout to have conviction to move the program forward.
12% of women that have a strong country indication against using menopausal hormone therapy and in addition to that about 8% that ended up discontinuing because of adverse events or tolerability.
Carl Hansen: The increase over the recent run rate expense levels in Q3 is largely due to specific investments of $15 million on two internal programs. In sales and marketing, expenses for Q3 were just under $3 million, a small reduction relative to the same quarter of last year, and in general administration, expenses were approximately $22 million, compared to roughly $19 million in Q3 of 2024. Included in these expenses are the ongoing expenses related to the defense of our intellectual property. Looking at earnings, we're reporting a net loss of roughly $57 million for the quarter, compared to a loss of about $51 million in the same quarter of last year. In terms of earnings per share, this result works out to a loss of $0.19 per share on a basic and diluted basis.
Got it thank you.
There is a significant portion of women that.
Yeah.
Next question comes from the line of Steve Desert with key Corp. You May proceed.
They have fewer options or cannot availed themselves of MH D, which is the first line therapy for treating BMS.
In terms of alternative therapies of course, there are now two molecules that have approval one is visa.
Hey, Thanks, guys, Steve on for Scott I was hoping you could talk about what the benefits are fixed refi versus existing hormonal treatment for hot flashes and then as a follow up are there any molecule currently being developed that would compete or compete.
By Astellas and one is linked quit by Bayer.
Those are both now on the market, we believe that we.
Compete directly with 635, thank you.
We have we're in a great position to have these two products out there providing good options for people that need need these treatments.
Yeah.
Sure so.
Six five is not being developed as a substitute for hormonal therapies.
And build the market for us so that we can come in with a molecule that we believe can be differentiated in dosing and safety and potentially also in efficacy depending on how we do with target engagement.
It's being developed as an alternative to menopausal hormone therapy.
I think as I mentioned on our previous call there roughly.
Carl Hansen: Looking at cash flows, operating activities for the first nine months of 2025 used approximately $97 million in cash and equivalents. Excluding investments in marketable securities, investment activities amounted to $49 million year to date. This is predominantly in property, plant, and equipment, driven by investments in establishing clinical manufacturing, which are now substantially complete as we had expected. The investments in PP&E were partially offset by government contributions, and as a part of our treasury strategy, we have $413 million invested in short-term marketable securities. Our investment activities for the quarter included a $62 million net divestment of these holdings. Altogether, we finished the quarter with $523 million of total cash, cash equivalents, and marketable securities. As a reminder, we have received commitments for funding for the advancement of our internal pipeline from the Government of Canada's Strategic Innovation Fund and the Government of British Columbia.
12% of women that have a strong country indication against using menopausal hormone therapy and in addition to that about 8% that ended up discontinuing because of adverse events or tolerability.
Great.
The next question comes from the line of Brendan Smyth with TD Securities You May proceed.
Hi, This is Jackie on for Brandon just a quick one maybe just to remind us with earlier in competitors like <unk> and Sanofi is asset what do you expect we need to see from the phase one data for 575 as it relates solidify the drug's positioning within the pretty competitive landscape.
So there is a significant portion of women that they.
We have fewer options or cannot availed themselves of MH D, which is the first line therapy for treating BMS.
In terms of alternative therapies of course, there are now two molecules that have approval one is visa.
By Astellas and one is linked quit by Bayer.
Yes.
Sure so.
Those are both now on the market we believe that.
575 is obviously coming behind <unk> and also rocket two amount from from Amgen.
We have we're in a great position to have these two products out there providing good options for people that need need these treatments and build the market for us. So that we can come in with a molecule that we believe can be differentiated in dosing and safety and potentially also in efficacy depending on how we do with target engagement.
And our differentiation thesis when we began this program was really about less frequent dosing.
What has happened recently, particularly with the readout in the coast trial.
With <unk>.
Is that they have shown that the classes efficacious, although not as efficacious as was expected.
Carl Hansen: This available capital does not show up on our balance sheet, and with over $520 million in cash and equivalents and the unused portion of our secured government funding, we have approximately $680 million in available liquidity to execute on our strategy. In addition, we have available liquidity in our ownership of both Vancouver-based lab and office buildings, as well as our GMP manufacturing facility, both of which have been financed off of our balance sheet. The operating cash usage for the remainder of 2025 will continue to prioritize advancing our two lead programs through their phase one clinical studies, and building a strong preclinical pipeline. With respect to our overall company expenditures, our capital needs are very manageable, and we continue to believe that we have sufficient liquidity to fund well beyond the next three years of increasing pipeline investments.
Great.
The next question comes from the line of Brendan Smyth with TD Securities You May proceed.
<unk> had been on previous trials.
So it looks like it's going to be approved as a second line therapy, but they also showed that the one month dosing of three month dosing were relatively equivalent.
Hi, This is Jackie on for Brandon just a quick one maybe just a reminder, with earlier in competitors like <unk> and Sanofi asset what do you expect me to see from the phase one data for 575 to really solidify the drug's positioning within the pretty competitive landscape.
So at this point, we have a drug that the data would suggest would allow for even less frequent dosing, perhaps six months, it's unclear how important that's going to be in a clinical setting.
So our position in 575 right now is that we have.
Terrific molecule the early Readouts youre going to show safety, obviously, but also PK and half life that would support that dosing hypothesis and probably the most important.
Sure so.
Hi.
575 is obviously coming behind <unk> and also rocket to amount from from Amgen.
Catalysts are going to come from outside of et cetera, and they will be readouts on <unk> mab or the ox 40, ox 40 ligand class and other indications that are being evaluated by Sanofi and by others.
And our differentiation thesis when we began this program was really about less frequent dosing.
What has happened recently, particularly with the readout in the coast trial.
Carl Hansen: We'll be happy to take your questions. Operator.
With <unk>.
Is that they have shown that the classes efficacious, although not as efficacious as was expected.
Great. Thank you.
Operator: Thank you. We will now begin the Q&A session. If you would like to ask a question, please press star followed by one on your telephone keypad. If you'd like to remove your question, press star followed by two. Again, to ask a question, press star one. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question. We will pause here briefly as questions are registered. The first question comes from the line of Malcolm Hoffman with Piper Sandler. You may proceed.
There are currently no questions registered so as a brief reminder, if you would like to ask a question. Please press star followed by one on your telephone keypad.
As depicted had been on previous trials.
So it looks like it's going to be approved as a second line therapy, but they also showed that the one month dosing of three month dosing were relatively equivalent. So at this point, we have a drug that the data would suggest would allow for even less frequent dosing, perhaps six months, it's unclear how important that's going to be in a clinical setting.
There are no additional questions waiting at this time I would now like to pass the conference back for any closing remarks.
So our position in 575 right now is that we have.
Thank you everyone for joining us today.
This is an exciting time for accelerating we're moving into 2026 with some exciting progress in the pipeline. Both in programs that are coming on what's in the clinic and we look forward to updating you on future calls.
A terrific molecule. The early Readouts are going to show safety, obviously, but also PK and half life that would support that dosing hypothesis and probably the most important catalysts are going to come from outside of et cetera, and they will be readouts on <unk> or the ox 40, ox, where you're lagging class and other indications.
Malcolm Hoffman: Hi, Malcolm Hoffman for Evan. Thanks for taking our question. I want to ask how to think about partner-initiated programs in the clinic. These look somewhat stagnant since 2024, and to be clear, we appreciate the conversion to more AbCellera-led development, but just wanted to understand why these partner-initiated programs may not be progressing clinically. Just a timing issue. Then a second one about Dr. Nunberg and her new role as CMO. Can you comment on why you felt like now was the appropriate time to bring Dr. Nunberg in, and what do you think she uniquely brings to AbCellera that the company may have lacked before? Thanks.
So much.
That concludes today's call. Thank you for your participation and enjoy the rest of your day.
<unk> that are being evaluated by Sanofi and by others.
Great. Thank you.
There are currently no questions registered so as a brief reminder, if you would like to ask a question. Please press star followed by one on your telephone keypad.
Carl Hansen: Sure, I'm happy to take that one. Carl Hansen here. First, on the partner-initiated programs, as you know, in the early stages of the company and through until 2023, our business was primarily focused on a partnership mode where we were doing discovery on behalf of partners and keeping a position in the resulting molecules, both in royalties and in milestones. We have handed off a large number of those, and as Andrew mentioned, I believe we have initiated about 103 programs to date. We do expect that some fraction of those are going to move forward into clinical development, and we continue to report on that. I would say that our experience has been that it takes longer than we had initially anticipated, so we have examples where programs that were handed off ultimately go into clinical development as much as six years later.
There are no additional questions waiting at this time I would now like to pass the conference back for any closing remarks.
Thank you everyone for joining us today. This is an exciting time, perhaps seller and we're moving into 2026 with some exciting progress in the pipeline. Both in programs that are coming on what's in the clinic and we look forward to updating you on future calls thanks, so much.
That concludes today's call. Thank you for your participation and enjoy the rest of your day.
Carl Hansen: It's difficult to make an assessment as to what will be the number of those that ultimately make it into clinical development, but we do think that there is value there that's going to accrue over time, as mentioned by Andrew on his prepared remarks. Moving to the question of bringing Sarah on, obviously, in 2023, we made the definitive decision to back away from that partnership business and to move into doing drug development on our own behalf. Over the past few months, we've succeeded in bringing the first two programs into clinical development. We have a robust pipeline coming behind that. As the portfolio matures, we definitely thought it was time to bring in a senior executive with experience in clinical development, and also that the company was at a position where we would be able to attract someone that was absolutely top-notch.
Yes.
Carl Hansen: We're thrilled to have Sarah on board, and we look forward to working with her and with you over the coming years as the pipeline matures.
Malcolm Hoffman: Appreciate it, guys. Thanks for the call.
Operator: The next question comes from the line of Andrea Newkirk with Goldman Sachs. You may proceed.
Andrea Newkirk: Hi, everyone. Good evening. Thanks so much for taking the question. Carl, I was just wondering if you might be willing to speak a little bit on the data disclosure strategy that you plan on taking for the phase 1 635 study, particularly given you do have the various cohorts, SAD, MAD, dosing, as well as the proof of concept section where you're evaluating efficacy. Just curious if this will all come within one disclosure, and if you could help frame expectations for the profile you would deem supportive to continue advancing this further into a phase 2 study. I have one follow-up following that. Thank you.
Carl Hansen: Thanks, Andrea. To your first question, our expectation is to make a single disclosure after we have completed the proof of concept part where we have a double-blind, placebo-controlled evaluation of ABCL-635 in the patient population that it's intended for. We do expect that'll come sometime in the new year. I think we had said before around mid-new year, but give that a couple of months on either side for error bars. What we're looking for is that we have a safety signal, and we have efficacy that shows that we're in the game to have a competitive product against the other products that are now in the market. The study is powered to do that. Somewhere around midpoint next year, we should know a lot about this program. So far, we're encouraged by what we're seeing. Everything is on track.
Carl Hansen: If that continues on track, we're getting ready to be in position to aggressively move it into later stage trials.
Andrea Newkirk: Got it. Okay. If you do achieve your desired target product profile, when you see the data emerge next year, how validating would that be for your platform and technology? Do you think there is re-through to the rest of your pipeline?
Carl Hansen: It's a great question. We have highlighted before that one of the areas where we've been investing for a long time and where I believe we have world-class capabilities is in making antibodies against ion channel and GPCR targets. Obviously, NK3R is a GPCR target, so it's the first from that platform to move forward. I think that's strong evidence that the platform is working and that we can make highly differentiated molecules. Of course, evidence of a platform doesn't happen with a single asset, and our intent is to follow that up again and again with other molecules from that pipeline that we're equally excited about.
Andrea Newkirk: Okay, thanks so much for the call.
Operator: The next question comes from the line of Stephen Willie with Stifel. You may proceed.
Malcolm Hoffman: Hey, good afternoon. This is Josh on for Steve. Thanks for taking our question. Is there anything you can tell us about how enrollment's going in the phase 1 trial for 575 and maybe potentially some color on some of the doses you've reached in this cohort?
Carl Hansen: Sure. In terms of enrollment, as I mentioned, the program is going as expected, so everything is on track and at the pace that we anticipated. We are not disclosing preliminary results in terms of how far we got in dosing, but as I said, we're encouraged by what we're seeing, and so far, everything is as expected.
Malcolm Hoffman: Great. Just another quick one. I know you said on the Q2 call, you were in line to declare a potential fourth AbCellera-led candidate by the end of this year. Are you guys still on track to do so?
Carl Hansen: Yes, that's correct. I think I said that in my prepared remarks, that we are on track before the end of the year to bring an additional development candidate forward, and that would be the fourth in the pipeline.
Malcolm Hoffman: Okay. Great. Thanks for taking our questions.
Operator: The next question comes from the line of Faisal Kershid with Leerink Partners. You may proceed.
Carl Hansen: Hi, guys. Thank you for taking the question. Thank you for taking the question. On 635, could you speak to us about whether there's a specific benchmark or bar that you would want to see on testosterone reduction in healthy male volunteers? Sure. I wouldn't punch out a specific level, but there is good literature out there disclosing testosterone levels from small molecules that were in development, particularly fezolinetant. We would, within the power of the study, look for something that shows that we're getting engagement that is at least as good as that to move forward. Got it. Okay. Could you also discuss the risk of engaging this target with a MAD because it is a CNS target? Sure. That's a great question. I think it's one that I touched on on an earlier call.
Carl Hansen: We believe that the pathway, the NK3R pathway, is very well validated. If we can engage NK3R in the relevant neurons, it's highly likely to be an efficacious drug. NK3R is expressed in KNDy neurons in the arcuate nucleus, and those neurons connect both to the endocrine system and also go through the blood-brain barrier into the thermoregulatory center of the brain. We expect that we should be able to engage NK3R in the arcuate nucleus, and given our understanding of the biology, we believe that should be sufficient to be efficacious in treating VMS. Of course, we have not yet proven that, and we need to wait for the proof of concept study and that readout to have conviction to move the program forward. Got it. Thank you.
Operator: Next question comes from the line of Steve Detchert with KeyBanc Capital Markets. You may proceed.
Malcolm Hoffman: Hey, thanks, guys. Steve on for Scott. I was hoping you could talk about what the benefits are of 635 versus existing hormonal treatments for hot flashes. As a follow-up, are there any molecules currently being developed that would compete directly with 635? Thank you.
Carl Hansen: Sure. 635 is not being developed as a substitute for hormonal therapies. It's being developed as an alternative to menopausal hormone therapy. I think, as I mentioned on a previous call, there are roughly 12% of women that have a strong contraindication against using menopausal hormone therapy. In addition to that, about 8% that end up discontinuing because of adverse events or tolerability. There's a significant portion of women that have fewer options or cannot avail themselves of MHT, which is the first-line therapy for treating VMS. In terms of alternative therapies, of course, there are now two molecules that have approval. One is Veozah by Astellas Pharma, and one is elinzanetant by Bayer. Those are both now on the market. We believe that.
Carl Hansen: We're in a great position to have these two products out there providing good options for people that need these treatments, and build the market for us so that we can come in with a molecule that we believe can be differentiated in dosing, in safety, and potentially also in efficacy, depending on how we do a target engagement.
Malcolm Hoffman: Great.
Operator: The next question comes from the line of Brendan Smith with TD Securities. You may proceed.
Andrea Newkirk: Hey, this is Jackie on for Brendan. Just a quick one, and maybe just to remind us, but with earlier in competitors like Dupixent and Sanofi's asset, what do you expect we need to see from the phase 1 data for 575 to really solidify the drug's positioning within the pretty competitive landscape?
Carl Hansen: Sure. 575 is obviously coming behind amlitalamab and also rocitalamab from Amgen. Our differentiation thesis when we began this program was really about less frequent dosing. What has happened recently, particularly with the readout in the COAST trial with amlitalamab, is that they have shown that the class is efficacious, although not as efficacious as was expected, as Dupixent had been on previous trials. It looks like it's going to be approved as a second-line therapy. They also showed that the one-month dosing and the three-month dosing were relatively equivalent. At this point, we have a drug that the data would suggest would allow for even less frequent dosing, perhaps six months. It's unclear how important that's going to be in a clinical setting. Our position in 575 right now is that we have a terrific molecule.
Carl Hansen: The early readouts are going to show safety, obviously, but also PK and half-life that would support that dosing hypothesis. Probably the most important catalysts are going to come from outside of AbCellera, and they will be readouts on amlitelimab or the OX40, OX40 ligand class, and other indications that are being evaluated by Sanofi and by others.
Andrea Newkirk: Great. Thank you.
Operator: There are currently no questions registered, so as a brief reminder, if you would like to ask a question, please press star followed by one on your telephone keypad. There are no additional questions waiting at this time. I would now like to pass the conference back for any closing remarks.
Carl Hansen: Thank you, everyone, for joining us today. This is an exciting time for AbCellera, and we're moving into 2026 with some exciting progress in the pipeline, both in programs that are coming and what's in the clinic. We look forward to updating you on future calls. Thanks so much.
Operator: That concludes today's call. Thank you for your participation, and enjoy the rest of your day.