Q1 2025 BioAtla Inc Earnings Call
And normally mode. Later, you will have the opportunity to ask questions. During the question and answer session I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Bruce Mackle with life side Visors. Please go ahead.
Bruce Mackle: Thank you operator, and good afternoon, everyone with me today on the phone from bio at our Doctor Jay short sure.
Richard Waldron: Chairman, CEO, and cofounder and Richard Waldron, Chief Financial Officer.
Jay Short: We're still above the... Yeah, we're still above 50% and extending. So I think the cross-trial comparison on slide 26 of that really emphasized that, especially when you consider that our data have... Patients have three prior lines of therapy, whereas the other comparators have... They're in second line, basically, and we're performing very well there. And I think, in addition, I really... While we're not... While we're focused more on lung, I think the sarcoma overall survival there was quite interesting. Here's another independent indication, different set of potential therapies downstream, and yet we're seeing pretty... And a really exceptional overall survival there across two different indications.
Following today's call Dr. Eric Siebert, Chief Medical Officer, and Sharon <unk>, Chief Commercial officer will join Jay and risks in a short Q&A.
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Richard Waldron: Earlier this afternoon, <unk> released financial results and a business update for the first quarter ended March 31 2025.
Richard Waldron: A copy of the press release and corporate presentation are available on the company's website.
Richard Waldron: Before we begin I'd like to remind everyone that statements made during this conference call will include forward looking statements, including but not limited to.
Richard Waldron: Statements regarding <unk> business plans and prospects and whether its clinical trials will support registration.
Jay Short: And really, this... I'll just remind everyone, this is where drugs fail, especially in non-small-cell lung cancer, is in this overall survival quadrant. And wow, this is great.
Richard Waldron: Plans to form collaborations and other strategic partnerships for selected assets.
Jay Short: Randy, maybe I'll just add a few points to that.
Richard Waldron: Results conduct progress and timing of its research and development programs and clinical trials.
Jay Short: Really looking at slide 26 and, you know, the mutated KRS non-small-cell space is certainly changing with Revolution Medicine and others. But we also know that SodaRacid and their efforts to confirm clinical benefit were not successful. They had a non-evaluable trial for confirmation of clinical benefit. And really, overall survival is the bottom line here. We have to do that. So we have an antibody-drug conjugate approach for these mutated KRS patients that express axle at a very high rate. And so I think it's interesting. Our approach is orthogonal to the new KRS inhibitors that we're hearing about.
Richard Waldron: The expectations with respect to enrollment and dosing in its clinical trials plans and expectations regarding future data updates clinical trials regulatory meetings and regulatory submissions.
Richard Waldron: The potential regulatory approval path for its product candidates and expectations about the sufficiency of its cash and cash equivalents to fund operations and the expected R&D expenses.
Richard Waldron: These statements are subject to various risks assumptions and uncertainties that can cause actual results to differ materially and are described in the filings made with the SEC, including the most recent annual report on Form 10-K, and subsequent quarterly reports on.
Jay Short: I'm thrilled for patients that they have these options.
Jay Short: But I think in the second-line setting, our data are really standing quite strongly. And obviously, they need to be confirmed in a prospective randomized trial. Got it.
Richard Waldron: Form 10-Q.
Richard Waldron: You are cautioned not to place undue reliance on these forward looking statements, which speak only as of today may six 2025 and.
Wren Benjamin: Two other maybe just quick ones for me. One, you're talking about partnerships and discussions, you know, are ongoing.
Richard Waldron: <unk> disclaims any obligation to update such statements to reflect future information events or circumstances, except as required by law.
Jay Short: What is the ideal deal kind of look like for you guys? And number two, I think that you had mentioned that, you know, during the the workforce, you know, cutting and, you know, trying to save your cash. You're going to focus on. two internal programs. So, you know, and I'm counting three, the Epcam, MEC-V, and OZ-V. Can you just help clarify for me which are the two that you'll be focusing on? Well, the headcount reduction was to align with the number of programs that we're taking forward internally. So we're obviously very excited about ROR2, but we also obviously can't take four programs, even if they're all showing strong data to ourselves.
Jay Short: With that I'd like to turn the call over to Dr. Jay short.
Richard Waldron: Jay.
Richard Waldron: Thank you Bruce and thanks to everyone for joining us for our first quarter 2025, <unk> of our earnings call.
Richard Waldron: Details related to what we will share today are available in today's press release, and our updated company presentation, both of which are available on our website.
Richard Waldron: Also the posters, which were recently presented at the 2025, a CR annual meeting are available on our website.
Richard Waldron: Just a few short weeks ago I've provided updates on our traditionally active biologic or tab platform clinical programs that we're advancing internally and by our outlook.
Richard Waldron: As well as the clinical programs, we are currently advancing toward corporate partnerships.
Jay Short: So we selected two initially, but ROR2 and CTLA-4 programs for partners. That doesn't mean we're not listening to potential partnerships, one might be, or the actual asset, and we do have those kind of discussions going on. So I think, so I think we're pretty enthusiastic about, there's not a program that we dislike, really, but we have to talk. And so we focus the workforce, we're focusing internal versus external.
Richard Waldron: All of these cab based programs are designed to increase both the potency and safety of our therapeutic candidates targeting solid tumors in areas of high unmet medical need.
Richard Waldron: Today, I will begin with our phase one dose escalation study evaluating the dual conditionally binding F Cam and CD three T cell engagement.
Richard Waldron: As a brief update to our call in March the study is progressing well.
Richard Waldron: And the maximally tolerated dose has not yet been reached we continued to observe multiple patients achieving tumor reduction and tolerating the therapy over many months without progression.
Jay Short: And so they would say, the next part of your question, what's the ideal kind of partnership? You know, I think of it in terms of more than one partnership. And I think at least one of those partnerships, I'd like to see us be able to maintain substantial value in North America, at least. And with another one, I would say I'd be more leaning into something that generates substantial cash value between up-front and near-term milestones. And so those combinations gives us the power to help drive a phase three through either independently or with a partner. And so that combination is really what I'm looking for.
Richard Waldron: Further all three patients of the 100 microgram treatment dose cohort have cleared the dose limiting toxicity period.
Richard Waldron: We are also dosed the first three patients at the treatment dose of 300 micrograms and we remain on track for our dose escalation clinical data readout in mid 2025.
Richard Waldron: We also anticipate a data readout for the cohort expansion portion of the study in the first half of 2026.
Richard Waldron: We continue to believe that our dual cab <unk> cab CD three bi specific T cell engagements has the potential to be at the forefront of a novel approach to harnessing the body's immune system to target and destroy cancer cells and has the potential to treat a wide range of metastatic tumors, including <unk>.
Jay Short: And we have those kinds of discussions underway that could deliver both of those types of things. So, you know, while it's, as we learned last, late last year in August, when we thought we might close, you know, two partnerships, we got in one, we closed the smaller of the two. But I think we're in a good position to at least advance some partnerships here. And We remain optimistic and we are managing our cash runway to make sure that we get into next year and with some key redoubts on top. and of course milestones along the way or potential there we may be able to add those as well.
Richard Waldron: <unk> of the colon lung breast pancreatic and prostate among others.
Richard Waldron: Next onto our cab axle ADC.
Richard Waldron: <unk>.
Richard Waldron: <unk> continues to demonstrate exceptional overall survival at the one eight Meg per kg Q2, W. Dosing regimen with a two year landmark survival of 59% and <unk> non small cell lung cancer patients.
Richard Waldron: This is particularly compelling given the previous studies among patients treated with standard of care agents have reported a two year landmark survival of only less than 20%.
Wren Benjamin: Perfect. Thanks for taking the question.
Operator: Once again, for your questions, that is star and one.
We continue to observe a high correlation of excellent Mek RAF expression and the study follow up is ongoing.
Arthur Heath: We'll move next to Arthur Heath with H.C. Wainwright. Your line is open. Hey, good afternoon, JNT. Congrats on the progress.
Richard Waldron: Of particular note, we recently observed a similar exceptional overall survival using mcvie across several subtypes of soft tissue sarcoma, including Leiomyosarcoma undifferentiated pleomorphic sarcoma, and Lymphosarcoma with a one year landmark survival of 73%.
Arthur Heath: Just a couple of quick questions on the FKN program. So when we are looking at the mid-year readouts from the dose escalation part, I'm sure we probably get the data from the 300-microgram cohort. So how about the D cohort with the 3,100, 300-microgram?
Richard Waldron: Observing exceptional overall survival in two different heavily pretreated solid tumor types strengthens our conviction that <unk> is fundamentally improving the natural history of the disease, enabling patients to live considerably longer regardless of the subsequent treatment they receive.
Jay Short: That's question one. And the question two is, when we are at the readout for the dose escalation part, are you guys going to declare the expansion cohort dose level? I don't know. I would say we're...
Richard Waldron: We remain focused on positioning this asset for our future pivotal trial with phase II data readout in the first half of 2026.
Richard Waldron: Transitioning to the phase II clinical programs that are planned for advancement through corporate partnerships.
Jay Short: I don't think we'll be declaring it at that point, but we'll allow our data to teach us that, because I think so far I'm encouraged where we're headed, and we're going to stick to this mid-year readout no matter where we are in lactose escalation when we get some visibility to the data.
Richard Waldron: We remain committed to aligning with a partner that can maximize the value of these assets and we are very encouraged by our active discussions with multiple potential collaborators.
Richard Waldron: First regarding our cab or two ADC.
Richard Waldron: We continue to observe a compelling signal in patients with metastatic HPV positive head and neck cancer.
Eric Sievers: So I'll let Eric add to this and also maybe comment on the B cohort as well. Sure. And so, Martha, you had two questions, and we'll do everything we can to include data from the D cohort that you see listed on slide 19. We'll, you know, We opened that because we had such interest in the program from investigators and patients, and we wanted to also explore that two-step dosing regimen. as well as the One Step.
Richard Waldron: This group of patients represents a significant and growing segment of the head and neck cancer population with high unmet need.
Richard Waldron: This large patient population is currently poorly served by agents that inhibit egfr as well as other standard of care agents.
Richard Waldron: More specifically other studies using standard of care agents have reported MLR of only zero percent to three 4% among HPV positive head and neck cancer patients.
Eric Sievers: So we'll try to provide as fulsome of an update as we can at the Medical Congress. And you asked the question about would we declare the dose for the expansion cohort. I would imagine that we would, but at this time, we haven't defined that dose yet.
Richard Waldron: As of the March 2004th data cutoff.
Richard Waldron: 11 treatment refractory HPV positive head and neck patients who had three prior lines of therapy treated with the one eight <unk> per kg Q2 W. Dosing regimen showed a remarkable 100% disease control rate.
Eric Sievers: And so, as Jay said, I'll just echo, you know, we're letting the data really teach us about this drug, where we want to take it next, how we want to deliver it, and whether we want to stick to this weekly dosing regimen or move to the every other dosing, every other week regimen. That's another possibility as well. So lots of optionality built into our protocol.
Richard Waldron: A 45% overall response rate with 27% confirmed to date.
Richard Waldron: We continue to collect data on duration of response median progression free survival and median overall survival, Paul all of which are ongoing and we plan to share. These data at an upcoming medical meeting.
Arthur Heath: Gotcha, that's very helpful.
Arthur Heath: And the second, another question is regarding the... the CRS control regimen.
Richard Waldron: So far we have received timely responses from the FDA and are now utilizing our fast track designation for additional discussions with the FDA regarding treatment refractory metastatic HPV positive squamous cell carcinoma of the head and neck, we believe our extended experience with Q2 <unk>.
Eric Sievers: So could you tell us what's the regimen you guys using to control the CRS in the study? Sure. The approach that we're using is a pretty standard approach and I want to emphasize the importance of step dosing to give a relatively low dose and then subsequently a higher dose. We see that with marketed products, in particular the marketed product for small cell lung cancer. The second is to really use industry standard approaches for CRS prevention. So, patients are hospitalized, we follow them very closely. We do employ a tocilizumab prophylaxis strategy, and we really try to keep steroid use as modest as possible because steroids can affect T cell function, as you know.
Richard Waldron: Dosing of RSV also has the potential to satisfy project Optimus requirements and we plan to share our results with the FDA to see confirmation regarding our proposed recommended phase III treatment regimen.
Richard Waldron: Moving now to our <unk> four antibody of Elster tug.
Richard Waldron: Discussions are ongoing and we continue to believe that <unk> has the potential to be best in class with a differentiated clinical profile relative to other <unk> four antibodies.
Richard Waldron: To date, we have observed a 67% overall response rate and a 92% disease control rate in 12, evaluable patients with metastatic cutaneous melanoma.
Eric Sievers: And, as you see on slide 19, we've marched through the A, the B1, B2, all the way up through C1 up to C5, where we're dosing, and then the D cohort as well. So, we continue to dose escalate, and I've been really pleased by what we're seeing, and look forward to speaking to more data at an upcoming medical meeting. Awesome. Thank you very much for the interesting coverage. You're welcome.
Richard Waldron: These results are notable given that 10 or 12 patients had received prior PD, one adjuvant or neo adjuvant treatment.
Richard Waldron: We look forward to sharing additional data update at a medical meeting later this year.
Richard Waldron: With respect to our ongoing clinical communications I am pleased to report our progress with the medical and scientific communities as acknowledged with ongoing abstract acceptances at prestigious conferences, including the American Society of clinical oncology, The American Association of cancer research and the ESMO gas.
Operator: And it does appear that there are no further questions at this time.
Richard Waldron: Throw intestinal cancers Congress.
Jay Short: I would now like to turn it back to Jay Short for any additional or closing remarks. Thank you for your attendance and we look forward to communicating again very shortly again. So take care.
Richard Waldron: Additionally, we are invited to give a presentation at the upcoming <unk> conference around our dual cab fkm in cab CD three bi specific T cell engagement.
With that I would now like to turn the call over to Rick to review the first quarter 2025 financials.
Operator: This does conclude today's program. Thank you for your participation.
Richard Waldron: Rick.
Rick: Thank you Jay.
Operator: You may disconnect at any time and have a wonderful afternoon.
Rick: Research and development or R&D expenses were $12 4 million for the quarter ended March 31, 2025, compared to $18 9 million for the.
Rick: The same quarter in 2024.
Rick: The decrease of $6 $5 million was primarily due to lower clinical development expenses in 2025.
Phase II trials for <unk> with Dotan Zurich to man, the dotan and about the tug as we complete trials for certain indications.
Rick: These decreases were partially offset by a $5 million charge related to a workforce reduction announced in March 2025.
Rick: We expect our R&D expenses should continue to decrease for the remainder of 2025 due to our recent restructuring.
Rick: And as we complete phase III trials for several indications and focus our ongoing development on our prioritized programs.
Rick: General and administrative or G&A expenses were $5 3 million for the quarter ended March 31, 2025, compared to $5 6 million for the same quarter in 2024.
Rick: The $3 million decrease was primarily due to lower stock based compensation and lower D&O insurance premiums offset by a $100000 charge related to a workforce reduction announced in March 2025.
Rick: Net loss for the quarter ended March 31, 2025 was $15 $3 million compared to a net loss of $23 2 million for the same quarter in 2024.
Rick: Net cash used in operating activities for the quarter ended March 31, 2025 was $16 $3 million compared to net cash used in operating activities of $38 million for the same period in 2024.
Rick: Cash used for the quarter ended March 31, 2025 was $16 7 million.
Rick: Cash and cash equivalents as of March 31, 2025 were $32 $4 million compared to $49 million as of December 31, 2024.
Rick: We expect that the significant cost reductions to be subsequently realized from our realignment of resources and focus on our two internal priority programs will provide the company with sufficient runway to fund operations and achieve key clinical readouts in the first half.
Rick: 2026, excluding any funds from potential new partnerships.
Jay Short: Now back to Jay.
Jay Short: Thank you Rick.
Jay Short: I am encouraged with the progress across our <unk> platform, particularly with our phase one dose escalation study evaluating our dual conditionally binding <unk> and CD three bi specific T cell engagements.
Jay Short: I am also encouraged with the maturing phase two datasets, including the exceptional overall survival among patients treated with <unk>.
Jay Short: As well as the compelling anti tumor activity demonstrated with RSV and HBV positive head and neck cancer.
Jay Short: These assets continue to be differentiated and some of the most challenging solid tumor types and have the potential to make a meaningful impact for patients suffering from these debilitating cancers.
Jay Short: With that we will turn it back to the operator to take your questions.
At this time, if you would like to ask a question. Please press the star and one on your telephone keypad.
Jay Short: You may withdraw yourself from the queue at any time by pressing star two.
Scott: Once more for your question Scott is star and one will pause a moment to allow questions to queue.
Scott: Again that is star and one well.
Speaker Change: We'll take our first question from Jeet Mukherjee with <unk>.
Speaker Change: Your line is open.
Jeet Mukherjee: Great. Thanks for taking the question I was wondering will the poster presentation for the <unk> program at <unk> contain an updated data cut for.
Jeet Mukherjee: For the <unk> update in July when we have data from the 300 microgram dose as well as the 900 microgram dose.
Speaker Change: Eric Once you answer the first question.
Speaker Change: The first question.
Speaker Change: Are you inquiring about.
The Aurora two ADC asset.
Speaker Change: That's correct yes.
Speaker Change: Yeah. So we do have an updated data cut we include <unk>.
Speaker Change: Additional safety data from the every other week dosing regimen of $1 eight mix per kg.
Speaker Change: And then we also will have some additional update on long term outcomes.
Speaker Change: And then you had a second question about <unk> and I think there I would anticipate.
Speaker Change: Round of 25% to 30 patient update from our dose escalation dataset and that will occur mid this year.
Speaker Change: Got it I don't think we have events, we don't have inside of the 900 microgram low oil at this point as we got closer to it just depends on timing of the patients.
Got it okay, and if I could just ask a follow up just any thoughts on a pivotal design for the <unk> program and options for accelerated approval that might be there.
Alright.
Speaker Change: Yes, we can talk a little bit about the absolute program I think the key finding there is a remarkable overall survival and I think thats nicely illustrated on slide 26, our corporate deck.
Speaker Change: With all the caveats, we're looking cross trial comparison, you can see that the now eight patients with an extended overall survival of 18 months or more.
And so it really is striking difference compared to the standard of care, which is docetaxel.
Speaker Change: Yeah.
So I think that the pivotal trial with likely the second and third line patients.
Speaker Change: With mutated <unk> non small cell lung cancer, a randomized one to one against Docetaxel.
Speaker Change: <unk> seen that approach employed by many sponsors and we've received FDA guidance to that effect their support to top that randomization.
Speaker Change: I think from our accelerated approval standpoint, we think the award of two seven times that cancer second line, plus probably does have that opportunity.
Speaker Change: <unk> positive patient, so that's kind of exciting and we've certainly got some.
Speaker Change: Interesting discussions going on about potential partnering front because of that potential acceleration.
Speaker Change: And that's for the foodservice to managed services.
Speaker Change: <unk> two <unk>.
Speaker Change: Yeah.
Ren Benjamin: Well move next to Ren Benjamin with citizens. Your line is now open.
Speaker Change: Hey, guys. Thanks for taking the questions.
Speaker Change: I guess also starting off with maybe the <unk> program can you provide.
Speaker Change: Some color regarding the types of tumor regressions.
Speaker Change: We're seeing Jay I think in your prepared remarks, you mentioned youre seeing tumor regressions as well as.
Speaker Change: And staying on therapy for months can you give us a range maybe of.
Speaker Change: Of how long these patients have been on therapy and any toxicities of notes that had been seen to date that I have a follow up.
Speaker Change: This is great for Eric.
Speaker Change: Yes.
Speaker Change: So I'm going to answer this question.
Speaker Change: With an attention that midyear will be provided.
Speaker Change: A more fulsome update in medical Congress.
Speaker Change: There have been two individuals both with colorectal adenocarcinoma that has had a remarkably extended progression free interval one for more than great more than a year and another for about eight months and ongoing.
Speaker Change: We have three patients that have double digit tumor reductions, but I want to be clear that we haven't yet to observe a formal.
Speaker Change: Resist response.
Speaker Change: And.
Speaker Change: The maximally tolerated dose has not been reached we continued dose escalation we anticipate that.
Speaker Change: A biologically optimal dose might be 200 micrograms or more.
How long these patients have been on therapy, and any toxicities of notes that had been seen to date that I have a follow up.
Speaker Change: And then you also asked about safety and I've been pleased by what we're seeing to date I think art.
Speaker Change: Stepwise dosing approach that is consistent with how other marketed T cell engagements are given is.
Yes.
This is great for.
Yes.
So I'm going to answer this question.
Speaker Change: <unk> working.
With the attention that midyear will be provided.
Speaker Change: John.
Speaker Change: So so I think that the safety issues.
A more fulsome update in medical Congress.
Speaker Change: We are really not concerning and we.
Speaker Change: We continued to dose escalate, we have a lot of enthusiastic and rollers.
There have been two individuals both with colorectal adenocarcinoma that has had a remarkably extended progression free interval one for more than great more than a year and another for about eight months and ongoing.
Speaker Change: Great.
Speaker Change: And then just regarding Mcvie.
Speaker Change: I guess I'm I'm kind of curious as to.
Speaker Change: How we should be thinking about these landmark survival curves that you have and the readouts that you're reading.
We have three patients that have double digit tumor reductions.
To be clear that we haven't yet to observe a formal.
Speaker Change: Especially as.
Speaker Change: That compares to not just maybe the standard of care, but also as you guys probably look at other drugs in development the competitive landscape.
Resist response.
And.
The maximally tolerated dose has not been reached we continued dose escalation we anticipate that.
Speaker Change: As it is kind of evolving could you maybe give us a sense as to how you're viewing this data in regards to that.
Speaker Change: Uh huh.
Speaker Change: Biologically optimal dose might be 200 micrograms or more.
Speaker Change: And then you also asked about safety.
Speaker Change: Well I think it's very exciting.
Speaker Change: I've been pleased by what we're seeing to date I think our.
Speaker Change: The reason, we're talking about landmark.
Speaker Change: Violence is because we haven't built for medium survival, yet we're still above that we are still above 50%.
Speaker Change: Stepwise dosing approach, that's consistent with how other marketed T cell engagements are given.
Speaker Change: Extending so I think the cross traffic competitors settled on slide 26 for exact really emphasize especially when you consider that our data have patients had three prior lines of therapy, whereas the other competitors.
Speaker Change: Is working.
Speaker Change: And.
Speaker Change: So so I think that the safety issues.
Speaker Change: Really not concerning and.
Speaker Change: We continue to dose escalate, we have a lot of enthusiastic and rollers.
Speaker Change: There is plenty of volume basically and we're performing very well there and I think in <unk>.
Speaker Change: Great.
Speaker Change: And then just regarding Mcvie.
Speaker Change: Sure.
Speaker Change: A related.
Speaker Change: I guess I'm kind of curious as to.
Speaker Change: While we're not where we're focused more on lung.
Speaker Change: How we should be thinking about these landmark survival curves that you have and the readouts that you're reading.
Speaker Change: I think the sarcoma overall survival data was quite interesting here's another independent of indications different side of him.
Speaker Change: Especially as it compares to not just maybe the standard of care, but also as you guys probably look at other drugs in development the competitive landscape as it's as it is kind of evolving could you maybe give us a sense as to how you're viewing this data in regards to that.
Speaker Change: Potential therapies downstream and yet we're seeing.
Speaker Change: Okay.
Speaker Change: And a really exceptional overall survival their pass through diversification and really this I'll just remind everyone. This is where the drugs fail.
Speaker Change: Especially in non small cell lung cancer is in this overall survival QUADRA.
This is Greg.
Speaker Change: Yeah.
Speaker Change: Maybe I'll just add a few points to that.
Speaker Change: Well I think it's very exciting we are seeing the reason we're talking about landmark.
Speaker Change: Really looking at slide 26.
Speaker Change: Survival is because we haven't hit the median survival yet we're still above that yes, we're still above 50%.
Speaker Change: The mutated K Ras non small cell space, certainly changing with Revolution medicine and others.
Okay.
Speaker Change: So I think the cross traffic compared to a settlement on slide 26 for exact really emphasize especially when you consider that our data have patients had three prior lines of therapy, whereas the other competitors.
Speaker Change: But we also know that.
Speaker Change: Set of assets in their efforts to confirm clinical benefit.
Speaker Change: Not successful.
Speaker Change: They had unaudited valuable trial for confirmation of clinical benefit.
Speaker Change: And really overall survivals.
Speaker Change: Second volume basically.
Speaker Change: Performed very well there and I think in addition.
Speaker Change: Bottom line here, we have to do that so we have an antibody drug conjugate approach for these mutated K Ras patients that.
Speaker Change: I really while we're not what we're focused more on a longer.
Speaker Change: Express axle, but very high rate and so I think it's interesting our approaches for a <unk> to the new.
Speaker Change: I think the sarcoma overall survival data was quite interesting here's another independent indications different sand.
Speaker Change: Potential therapies downstream and yet we're seeing pretty good.
K Ras inhibitors that we're hearing about.
Speaker Change: I'm thrilled for patients that they have these options, but I think in the second line setting our data are really standing quite strongly and obviously they need to be confirmed in a prospective randomized trial.
Speaker Change: And they're really exceptional overall survival there cost due to modifications and really this I'll just remind everyone. This is where the drugs fail, especially in non small cell lung cancer is in this overall survival QUADRA.
Speaker Change: Got it okay. Two other maybe just quick ones for me one.
Greg: This is Greg.
Greg: Yes, maybe I'll just add a few points to that.
You're talking about partnerships and discussions are ongoing what does the ideal deal kind of look.
Greg: Looking at slide 26.
Greg: The mutated kiosks non small cell space is certainly changing with resolution medicine and others.
Speaker Change: For you guys.
And number two I think that you had mentioned that you know during the B.
Greg: But we also know that.
Greg: Asset in their efforts to confirm clinical benefit were not successful.
Speaker Change: The workforce, you know cutting and trying to save your cash youre going to focus on.
Greg: They had unaudited valuable trial for confirmation of clinical benefit.
Speaker Change: Two internal programs.
Speaker Change: No.
Speaker Change: I'm counting three yep Cam Mcafee an oddity.
Greg: And really overall survivals.
Greg: The bottom line here, we have to do that so we have an antibody drug conjugate approach for these mutated K Ras patients.
Speaker Change: Can you just help clarify for me, which are the two that you'll be focusing on moving forward.
Speaker Change: Yeah.
Express axle, but very high rate and so I think it's interesting our approaches for fog and all to the new.
Speaker Change: Well.
Speaker Change: Now a reduction was to align with the number of programs that we're taking forward internally. So we're.
<unk> inhibitors that we're hearing about.
Speaker Change: We're obviously very excited of outdoor too.
Greg: For patients that they have these options.
Speaker Change: Also.
Speaker Change: Obviously can't take four programs in both they are all showing strong data through ourselves. So we selected two additionally warrant two.
Greg: And the second line setting our data.
Greg: Really standing quite strongly.
Greg: Obviously, they need to be confirmed.
Greg: Post fact, if randomized trial.
Speaker Change: So totally for programs for partnering.
Speaker Change: Got it maybe just quick ones from me one you are talking about partnerships and discussions are ongoing what does the ideal deal kind of looked like for you guys.
Speaker Change: That doesn't mean, we're not listening to potential partnerships or might be or the actual asset and we do have those kind of discussions going on.
Speaker Change: So I think.
Speaker Change: So I think we're pretty enthusiastic about.
And number two I think that you had mentioned that during the <unk>.
Speaker Change: There's a lot of progress I believe the slide really but we have to focus.
The workforce cutting and trying to save your cash youre going to focus on two.
Speaker Change: So we're focused on workforce, we're focusing.
Speaker Change: Our internal versus external.
Speaker Change: Two internal programs.
Speaker Change: So let's say.
Speaker Change: No.
Speaker Change: I'm counting three yep Cam Mcafee an oddity.
Speaker Change: The next part of your question, what's the ideal.
Speaker Change: Kind of a partnership.
Speaker Change: Can you just help clarify for me, which are the two that you'll be focusing on moving forward.
Speaker Change: I think of in terms of more than one partnership.
Speaker Change: I think at least one of those partnerships I'd like to see us.
Speaker Change: Yeah.
Speaker Change: Well.
Speaker Change: Eric.
Speaker Change: Being able to maintain substantial value on North America at least.
Speaker Change: Reduction was to align with the number of programs that we're taking forward internally so well.
Speaker Change: And with another one I would say on a beam.
Speaker Change: We're obviously very excited about or two but we also.
Speaker Change: More leaning into something that generates substantial cash value.
Speaker Change: Obviously can't take four programs, even though they're all showing strong data through ourselves. So we selected two additionally, we wanted to.
Speaker Change: Between upfront and near term milestones and so those combination gives us the power to help drive a phase III through either independently or with a partner.
Speaker Change: C totaling four programs for partnering.
Speaker Change: So that combination is really what I'm looking for.
Speaker Change: Doesn't mean, we're not listening to potential partnerships or might be or the actual asset and we do have those kind of discussions going on.
Speaker Change: And we have those kinds of discussions underway that could deliver both of those types of things so walnuts.
Speaker Change: So I think so.
Speaker Change: As we learned last late last year in August where we thought we might close.
Speaker Change: So I think we're pretty enthusiastic about.
Speaker Change: Two partnerships, we guided one we closed the smaller of the two but I think we're in a good position.
Speaker Change: There's another program that we have the slide really.
Speaker Change: Yes.
Speaker Change: So we focus the workforce we're focusing.
Speaker Change: So at least.
Speaker Change: Advanced some partnerships here.
Speaker Change: Terminal versus external.
Speaker Change:
Speaker Change: So.
Speaker Change: We remain optimistic.
Speaker Change: The next part of your question, what's the ideal.
Speaker Change: Were managing our cash runway to make sure that we get.
Speaker Change: Kind of a partnership.
Two next year and with some key readouts on top.
I think of in terms of more than one partnership.
I think at least one of those partnerships I'd like to see us.
Speaker Change: And of course milestones along the way of our potential there.
Speaker Change: Being able to maintain substantial value in North America at least.
Speaker Change: But as those as well.
Speaker Change: Perfect. Thanks for taking the questions.
Speaker Change: And with another one I would say.
Speaker Change: Okay.
Speaker Change: More leaning into something that generates substantial cash.
Speaker Change: Once again for your question that is star and one well.
Speaker Change: Between upfront and near term milestones and so those combination gives us the power to <unk>.
Speaker Change: Well move next to Arthur he with H C. Wainwright Your line is open.
Speaker Change: <unk> drive phase III sort of either independently or with a partner.
Speaker Change: Hey, good afternoon Jan Kees.
Speaker Change: Congrats on the progress.
Speaker Change: So that combination is really what I'm looking for.
Speaker Change: Just a couple of quick question on the <unk> program.
Speaker Change: So we are looking at the midyear, we announced from the dose escalation part.
Speaker Change: We have those kinds of discussions underway that could deliver both of those types of things so.
Speaker Change: As we learned last late last year in August where we thought we might close.
Speaker Change: I am sure, we probably get the data from the 300 microgram cohort.
Speaker Change: Two partnerships, we guided when we close the smaller of the two.
Speaker Change: So.
Speaker Change: How about the <unk>.
Speaker Change: I think we're in a good position.
Speaker Change: <unk> cohort with the 3100 300 microgram.
Speaker Change: Uh huh.
Speaker Change: Advanced partnerships here.
Speaker Change: That's question one and question too is when we had the readout for the dose escalation part.
Speaker Change: Sure.
Speaker Change: We remain optimistic we are managing our cash runway to make sure that we get.
Speaker Change: Are you guys going to declare the expansion cohort dose level.
Speaker Change: Through next year and with some key readouts on top.
Speaker Change: And then of course milestones along the way of our potential there.
Speaker Change: Add those as well.
Speaker Change:
Speaker Change: Perfect. Thanks for taking the questions.
Speaker Change: I would say.
Speaker Change: I don't think we'll be declaring and at that point.
Speaker Change: Okay.
Speaker Change: Once again for your questions that is star and one will.
Speaker Change: Well, our data as a future set.
Speaker Change: We'll move next to Arthur he with H C. Wainwright Your line is open.
Speaker Change: So I think so far I'm encouraged where we're headed.
Speaker Change: And we are we're going to stick to this busier readout.
Speaker Change: Hey, good afternoon John.
Speaker Change: No matter, where we are in that dose escalation were limited.
John: Congrats on the progress.
Speaker Change: To the data.
John: Couple of quick question on the <unk> program.
Speaker Change: Let Eric add to this and also maybe comment on what the cohort as well sure and so Martha you had two questions and we'll do everything we can to include data from the <unk> cohort that you see listed on slide 19.
John: So.
John: Looking at the mid.
John: Midyear, we announced from the dose escalation part.
John: I am sure, we probably get the data from the 300 microgram cohort.
Speaker Change: Will.
John: So.
Speaker Change: We opened that because we had such interest in the program from investigators and patients and we wanted to also explore that two step dosing regimen.
John: How about the.
John: The <unk> cohort with the <unk>.
John: 100, 300 microgram.
John: That's question, one and question too.
Speaker Change: As well as the one step so we'll try to provide us.
John: When we had the readout for the dose escalation part.
Speaker Change: To sum up and update as we can at the medical Congress.
John: Are you guys going to declare the expansion cohort dose level.
Speaker Change: And you asked the question about what we declare that dose for the expansion cohort.
I would imagine that we would but at this time.
John: I would say.
Speaker Change: We haven't defined that dose yet and so I guess, Jay said I'll just echo we're letting the data really teach us about this drug where we wanted to take it next how we wanted to deliver it.
Speaker Change: I don't think we'll be declaring Elisa.
Speaker Change: While our data as a future set.
Speaker Change: So I think so far on the Kurdish where we're headed.
Speaker Change: And whether we want to stick to this weekly dosing regimen or move to the every other week dosing.
Speaker Change: And we are.
Speaker Change: To stick to this Goodyear retail.
Speaker Change: Every other week regimen, that's another possibility as well so lots of optionality built into our protocol.
Speaker Change: No matter, where we are in that dose escalation.
Speaker Change: The data.
Speaker Change: Eric.
Eric: And also maybe comment on the <unk> cohort as well sure.
Speaker Change: Got you that's very helpful and the second.
Speaker Change: Two questions.
Speaker Change: <unk> is.
Speaker Change: We do everything we can to include data from the <unk> cohort that you see listed on slide 19.
Speaker Change: Regarding the.
Speaker Change: Sure.
Speaker Change: D C.
Speaker Change: <unk> can show regimens, so could you tell us whats the regimen you guys using to controlling the Crs in this study.
Speaker Change: Will.
Speaker Change: We opened that because we had such interest in the program from investigators and patients and we wanted to also explore that two step dosing regimen.
Speaker Change: Sure.
Speaker Change: The approach that we're using is.
Speaker Change: As well as the one step so we'll try to provide this full setting up an update as we can at the medical Congress and you asked the question about when we declare that dose for the expansion cohort.
Speaker Change: This is a pretty standard approach.
Speaker Change: Wanted to emphasize the importance of step dosing to give a relatively low dose and then subsequently a higher dose we see that with marketed products in particular, the marketed product for small cell lung cancer.
Speaker Change: I would imagine that we would but at this time, we haven't defined that dose yet and so I guess, Jay said I'll just echo we're letting the data really teach us about this drug where we wanted to take it next how we wanted to deliver it.
Speaker Change: The second is to really use industry standard approaches for Crs prevention.
Speaker Change: So patients are hospitalized we follow them very closely.
Speaker Change: Do employ a total as a mab prophylaxis strategy.
Speaker Change: And whether we want to stick to this weekly dosing regimen or move to the every other day dosing.
Speaker Change: And we really tried to keep a steroid use as modest as possible because steroids can affect T cell function as you know.
Speaker Change: The other week regimen, that's another possibility as well so lots of optionality built into our protocol.
Speaker Change: And as you see on slide 19, we March through the <unk>. The <unk> all the way up through <unk>, one up to <unk>, five where we're dosing and the detailed board as well.
Speaker Change: Got you that's very helpful and the second question is.
Regarding the.
Speaker Change: Yes.
Speaker Change: Crs can show regimen, so could you tell us whats the regimen you guys using to control of the Crs in this study.
Speaker Change: We.
Speaker Change: To dose escalate and.
Speaker Change: I've been really pleased by what we're seeing and look forward to.
Speaking to more data.
Speaker Change: Sure.
Speaker Change: Upcoming medical meeting.
Speaker Change: The approach that we're using is.
Speaker Change: Thank you very much for that color.
Speaker Change: Is it pretty standard approach and I want to emphasize the importance of step dosing to get a relatively low dose and then subsequently a higher dose we see that with marketed products in particular, the marketed product for small cell lung cancer.
Speaker Change: Youre welcome.
Jay Short: And it does appear that there are no further questions. At this time I would now like to turn it back to Jay short for any additional or closing remarks.
Speaker Change: The second is to really use industry standard approaches for CN Crs prevention.
Thank you for your attendance and we look forward to communicating again very shortly.
So patients are hospitalized we follow them very closely.
Jay Short: Take care.
Jay Short: This does conclude today's program. Thank you for your participation you may disconnect at any time and have a wonderful afternoon.
Speaker Change: We do employ in total is a mab prophylaxis strategy.
Speaker Change: And we really tried to keep steroid use as modest as possible because steroids can affect T cell function as you know.
Speaker Change: And as you see on slide 19, we March through the a b one b two all the way up through <unk>, one up to six five where we're dosing and the detailed board as well.
Speaker Change: No.
Speaker Change: We continue to dose escalate and.
Speaker Change: I've been really pleased by what we're seeing and look forward to.
Speaker Change: Speaking to more data.
Speaker Change: Upcoming medical meeting.
Speaker Change: Thank you very much for that color.
Speaker Change: Youre welcome.
Jay: And it does appear that there are no further questions. At this time I would now like to turn it back to Jay short for any additional or closing remarks.
Jay: Thank you for your attendance and we look forward to communicating again very shortly.
Jay: Take care.
Jay: This does conclude today's program. Thank you for your participation you may disconnect at any time and have a wonderful afternoon.
Jay: Goodbye.
Jay: Okay.
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