Q4 2023 BioAtla Inc Earnings Call
Operator: Greetings and welcome to the Bioatla fourth quarter and full year 2023 earnings call. At this time, all participants are in a listen-only mode.
Greetings and welcome to the Biolife <unk> fourth quarter and full year 2023 earnings call.
At this time all participants are in a listen only mode.
Operator: A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Bruce Mackle with Lifesci Advisors. Thank you, Mr. Mackle, you may begin. Thank you, operator. And good afternoon, everyone.
A brief question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
It's now my pleasure to introduce your host Bruce Michael with lifestyle advisors.
Bruce Mackle: Thank you Mr. Michael you may begin.
Bruce Mackle: Thank you operator, and good afternoon, everyone with me today on the phone from bio outlet or a doctor Jay short Chairman, CEO, and cofounder and Richard Waldron Chief Financial Officer.
Bruce Mackle: With me today on the phone from Bioatla are Dr. Jay Short, Chairman, CEO, and co-founder, and Richard Waldron, Chief Financial Officer. Following today's call, Dr. Eric Sievers, Chief Medical Officer, and Sheri Lydick, Chief Commercial Officer, will join Jay and Rick for a short Q&A. Earlier this afternoon, Bioatla released financial results and a business update for the fourth quarter and full year ended December 31, 2023. A copy of the press release and corporate presentation is available on the company's website.
Bruce Mackle: Following today's call Dr. Eric Sievers, Chief Medical Officer, and Sherry Lilac, Chief Commercial officer will join Jay and Rick for a short Q&A.
Bruce Mackle: Earlier this afternoon bio Atwood released financial results and a business update for the fourth quarter and full year ended December 31 2023.
Bruce Mackle: A copy of the press release and corporate presentation are available on the company's website.
Bruce Mackle: 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, statements regarding Bioatla's business plans and prospects and whether its clinical trials will support registration, plans to form collaborations and other strategic partnerships for selected assets; Results, Conduct, Progress, and Timing of its Research and Development Programs and Clinical Trials. Expectations with respect to enrollment and dosing in his clinical trials. Plans and Expectations regarding Future Data Updates, Clinical Trials, Regulatory Meetings, and Regulatory Submissions. The Potential Regulatory Approval Path for its Product Candidate. Expectations about the sufficiency of its cash and cash equivalents to fund operations and expected R&D expenses. These statements are subject to various risks, assumptions, and uncertainty 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 Form 10-B.
Bruce Mackle: 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 statements regarding bio Atlas business plans and prospects and whether its clinical trials will support registration.
Bruce Mackle: Plans to form collaborations and other strategic partnerships for selected assets.
Bruce Mackle: Results conduct progress and timing of its research and development programs and clinical trials.
Bruce Mackle: Expectations with respect to enrollment and dosing in its clinical trials.
Bruce Mackle: Lans and expectations regarding future data updates clinical trials regulatory meetings and regulatory submissions the.
Bruce Mackle: The potential regulatory approval path for its product candidates.
Expectations about the sufficiency of its cash and cash equivalents to fund operations and expected R&D expenses.
Bruce Mackle: These statements are subject to various risks assumptions and uncertainties that can cause actual results to differ materially and are described in our filings made with the SEC, including the most recent annual report on Form 10-K, and subsequent quarterly reports on Form 10-Q.
Bruce Mackle: You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, March 26, 2024, and Bioatla disclaims any obligation to update such statements to reflect future information, events, or circumstances, except as required by law. With that, I'd like to turn the call over to Jay Short. Jay.
Bruce Mackle: You are cautioned not to place undue reliance on these forward looking statements.
Bruce Mackle: Which speak only as of today March 'twenty, six 'twenty 'twenty four and.
Bruce Mackle: <unk> disclaims any obligation to update such statements to reflect future information events or circumstances.
Except as required by law.
Bruce Mackle: With that I'd like to turn the call over to Jay short Jay.
Bruce Mackle: Okay.
Jay M. Short: Thank you, Bruce, and thanks to everyone for joining us for our fourth quarter and full year 2023 BioLava earnings. Bioatla is the inventor and leader in the development of novel therapies using a proprietary conditionally active biologics or CABS platform, with improved selectivity for attacking tumor cells while avoiding healthy cells, thereby addressing critical unmet needs in oncology to improve patients' lives. We made considerable progress in 2023 across all of our ongoing clinical programs, including phase two trials for our first-in-class CAB, ABC product candidates, BA3011 and BA3021, targeting multiple solid tumor types. Our CAB CTLA-4 I-O antibody and our first dual-CAB bi-specific EPCAM CD3 T-cell engagement.
Jay M. Short: Thank you Bruce and thanks to everyone for joining us for our fourth quarter full year 2023 blah blah Blah earnings call.
Jay M. Short: What was the inventor and leader in the development of novel therapies, using a proprietary conditionally active biologics or clubs platform with improved selectivity for attacking tumor cells, while avoiding healthy cells, thereby addressing critical unmet needs in oncology to improve patients' lives.
Jay M. Short: We made considerable progress in 'twenty to 'twenty three across all of our ongoing clinical programs, including the phase III trials for a first in class cab ADC product candidates B, a 30 11, MBA 30, 21 targeting multiple solid tumor types.
Jay M. Short: Our cab seats only for I O antibody and our first dual cab by specific up Cam C. D. Three T cell engagement.
Jay M. Short: We continue the positive trajectory into 2024, focused on further advancing our prioritized CAB programs that generate data sets that potentially enable us to move into one or more registrational trials in the second half of the year. We believe that these near-term inflection points also support the formation of one or more strategic collaborations with major pharmaceutical partners this year, which can accelerate the development of selected assets and maximize their market opportunities. Additional details related to what I'm going to provide are available in today's press release and our updated company presentation, both of which are available on our website. Now, I will review our latest updates.
Jay M. Short: We continue the positive trajectory into 'twenty 'twenty four focused on further advancing prioritize cab programs generating datasets that potentially enable us to move into one or more registrational trials in the second half of the year.
Jay M. Short: We believe that these near term inflection points also support the formation of one or more strategic collaborations with major pharmaceutical partners. This year.
Jay M. Short: You can accelerate the development of selected assets and maximize their market opportunities.
Jay M. Short: Additional details related to what I was going to provide are available in today's press release and our updated company presentation, both of which are available on our website.
Jay M. Short: I will now review our latest updates.
Jay M. Short: Starting with our CAB C2A4 antibody, DA3071, which is applicable in areas of high unmet need across multiple solid tumor indications, both for refractory and for first-line patients, and represents a sizable commercial opportunity. We are pleased to report that our Phase II data at 350 mg flat dose continue to mirror our Phase I dose escalation data in terms of low incidence and severity of immune-related adverse events. In addition, I'm happy to report that we have cleared a higher dose of 700 milligrams of Tocilizumab for the first two cycles and are now evaluating the unprecedented one gram dose level. This is important since previous studies demonstrated improved overall survival in metastatic cancers, including melanoma, with higher levels of C-Tel-A4 inhibition.
Jay M. Short: With our KFC to lay for antibody D. A 30, 71, which is applicable in areas of high unmet need across multiple solid tumor indications both for refractory and for first line patients and represents a sizeable commercial opportunity.
Jay M. Short: We are pleased to report that our phase two data at 350 milligrams flat dose continues to mirror, our phase one dose escalation data in terms of low incidence and severity of the immune related adverse events.
Speaker Change: Sure I'm happy to report that we have cleared a higher dose of 700 milligrams with Tessa looser labs, where the first two cycles and our normal evaluating the unprecedented one gram dose level.
Speaker Change: This is important since previous studies demonstrated improved overall survival in metastatic cancers, including melanoma with higher levels of <unk> four inhibition.
Speaker Change: As a result, we are now enrolling patients at several hundred milligrams in first line melanoma patients.
Jay M. Short: As a result, we are now enrolling patients at 700 milligrams in first-line melanoma patients and in a significant targeted first-line non-small cell lung cancer population in combination with PD-1 for readouts later this year. These data are also anticipated to position the company for one or more potentially registrational trials and first-line indications in the second half of this year. In addition, as part of our evaluation of safety and tolerability of BA3071, we are completing the Phase II expansion in treatment-refractory melanoma and carcinoma with an initial data readout of approximately 20 patients in the second quarter. As already noted, the safety and efficacy data from the Phase I study demonstrating both a confirmed partial response and a confirmed complete response for 2 out of 6 patients are encouraging using the 350mg dose.
Speaker Change: Really significant targeted first line non small cell lung cancer population in combination with PD one for Readouts later this year.
These data are also anticipated to positioning the company for one or more potentially registrational trials in first line indications in the second half of this year.
Speaker Change: Additionally, as part of our evaluation of safety and Tolerability a be a 30 71, we are completing the phase two expansion in treatment refractory melanoma in carcinoma with an initial data readout of the approximately 20 patients in the second quarter as already noted the safety and efficacy data from the phase one study demonstrating both are confirmed.
Speaker Change: Partial response and a confirmed complete response for two out of six patients is encouraging using the 350 milligram dose and now we are all either remaining patients at the 700 milligram dose with our evolving clinical data. We believe D. A 30 71 has the potential to be best in class C. Kelly for that holds the.
Speaker Change: Promise to be used as often as a PD, one inhibitor and potentially expand the indications where combined immune checkpoint inhibition can be effective.
Speaker Change: In addition, the emerging safety profile suggests that V. A 30 71 with PD one immune modulation may be suitable for further combining with cab ADC therapies that target actual indoor wore two to achieve synergistic durable tumor control now turning to our cab work to a D C asset.
Jay M. Short: And now we are rolling the remaining patients at the 700mg dose. With our evolving clinical data, we believe DA3071 has the potential to be a best-in-class CtlA4 that holds the promise to be used as often as a PD-1 inhibitor and potentially expand the indications where combined immune checkpoint inhibition can be effective. In addition, the emerging safety profile suggests that BA3071 with PD-1 immune modulation may be suitable for further combining with CAB ADC therapies that target AXL and or WAR2 to achieve synergistic durable tumor control. Now, we turn to our CAB WAR2 ADC assay, BA3021.
Speaker Change: D a $30 41.
Speaker Change: For our ongoing phase II trials in treatment refractory were two agnostic patient populations. We previously reported encouraging responses in the phase II melanoma, and squamous cell carcinoma of the head and neck studies.
Speaker Change: As part of today's update we now have both 28 locations and 12 head and neck patients dosed using the one eight milligram per kilogram Q2, W regimen, and 'twenty head and neck patients dose using the more intense to Q3 W. Regimen for a total of 32 heading back.
Speaker Change: Patients, we anticipate having two plus scans in the melanoma cohort next month and two plus scans in the head and neck cohort.
Speaker Change: With anticipated top line data Readouts for both during our Q1 earnings call in May.
Jay M. Short: For our ongoing Phase 2 trials and treatment refractory Ward 2 agnostic patient populations, we previously reported encouraging responses in the Phase 2 melanoma and squamous cell carcinoma, and head and neck study. As part of today's update, we now have both 28 melanoma patients and 12 head and neck patients dosed using the 1.8 mg per kg Q2W regimen, and 20 head and neck patients dosed using the more intense 2Q3W regimen for a total of 32 head and neck patients. We anticipate having two plus scans in the melanoma cohort next month and two plus scans in the head and neck cohort in May, with anticipated top line data readouts for both during our Q1 earnings call in May. Given the encouraging emerging data sets, we believe BA3021 is well-positioned for a global strategic collaboration to maximize the potential of this CAB ADC across multiple solid tumor indications. On to our cab axle ADC BA3011.
Speaker Change: Given the encouraging emerging datasets, we believe be a 33, one is well positioned for a global strategic collaboration to maximize the potential of this cab ADC across multiple solid tumor indications.
Speaker Change: Onto our cap Axel a D C V. A 30 11.
Speaker Change: Phase two potentially Registrational study for other differentiated pleomorphic sarcoma or U P. S is on track to complete enrollment of approximately 20 asphalt agnostic patients at the one eight milligram per kilogram to Q3 W. Regimen next month with encouraging compliance and manageable safety.
We anticipate having multiple scans across the patient group potentially enabling a meeting with the FDA to discuss the remaining portion of the potentially Registrational study in the second half of this year.
Speaker Change: We also reported clinically meaningful antitumor activity among patients with treatment refractory bone and soft tissue, sarcomas, which remain a profound and tractable unmet need for new treatment options.
Speaker Change: Presented these data from phase II part one cohort enrollment as an oral presentation at the ESMO sarcoma and rare cancers meeting earlier this month and showed disease control at 12 weeks for 43% of the 87 patients treated with be a 30 11 monotherapy using the less intense regimen of 1.8 no.
Speaker Change: Rand per kilogram Q2 W.
Speaker Change: We believe this represents a promising disease control rate for patients with treatment refractory sarcomas.
Jay M. Short: Our Phase II Potentially Registrational Study for Undifferentiated Pleomorphic Sarcoma, or UPS, is on track to complete enrollment of approximately 20 actual agnostic patients at the 1.8 mg per kg 2Q3W regimen next month, with encouraging compliance and manageable safety. We anticipate having multiple scans across the patient group, potentially enabling a meeting with the FDA to discuss the remaining portion of the potentially registrational study in the second half of this We also reported clinically meaningful anti-tumor activity among patients with treatment-refractory bone and soft tissue sarcomas, which remain a profound and tractable unmet need for new treatment options.
Speaker Change: And the osteosarcoma cohort, we observed two partial responses out of 11 efficacy evaluable patients.
Speaker Change: Treatment was well tolerated associated with a manageable safety profile with no new safety signals to report.
Speaker Change: Now regarding our phase two study in non small cell lung cancer last quarter, we reported multiple durable clinical responses with a differentiated safety profile, a mugger challenging actual positive treatment refractory lung cancer population spin.
Speaker Change: Specifically among 15 patients with Egfr Wild type tumors, who had received prior PD one treatment. We observed five partial responses with a medium duration of response of approximately five months using 1.8 milligrams per kilogram Q2 W. Every other week dosing toxicity was manageable.
Jay M. Short: We presented these data from Phase 2 Part 1 Cohort Enrollment as an oral presentation at the Esmo Sarcoma and Rare Cancers meeting earlier this month and showed disease control at 12 weeks for 43% of the 87 patients treated with BA3011 monotherapy using the less intense regimen of 1.8 mg per kg Q2W. We believe this represents a promising disease control option for patients with treatment-refractory sarcoma. In the osteosarcoma cohort, we observed two partial responses out of 11 efficacy-evaluable patients. The treatment was well tolerated and associated with a manageable safety profile with no new safety signals to report.
Speaker Change: And few high grade related treatment emergent Aes were reported.
Speaker Change: We believe multiple responses in a treatment refractory actual positive poor prognostic group such as this one is clinically meaningful and relevant.
Particularly since these patients have experienced failure of a median of three prior lines of therapy.
Speaker Change: As part of today's update we have enrolled 33 target agnostic patients using the more intense 1.8 milligram per kilogram to Q3 W Regiment across both squamous and non squamous patients. We are on track to evaluate clinical benefit of the target agnostic non small cell lung cancer non squamous population in the second.
Speaker Change: Order of this year.
Speaker Change: Next onto our potentially first in class dual cab bi specific T cell engaging antibody cab Cam cab CD three or be a 31 to 82.
Speaker Change: The cameras are ubiquitous target expressed on the surface of cancer cells.
Jay M. Short: Now regarding our phase two study in non-small cell lung cancer, last quarter, we reported multiple durable clinical responses with a differentiated safety profile among a challenging axopositive treatment-refractory lung cancer population. Specifically, among 15 patients with EGFR wild-type tumors who had received prior PD-1 treatment, we observed five partial responses with a medium duration of response of approximately five months using 1.8 milligrams per kilogram, Q2 Toxicity was manageable, and few high-grade related treatment emergent adverse events were reported.
Speaker Change: Which requires the use of our cab technology to achieve optimal selectivity is safety.
Speaker Change: Our phase one two dose escalation study continues to progress and is on track.
Speaker Change: We anticipate completion of the phase one study with a full data readout anticipated in the second half of this year with potential initiation of a phase two study also in the second half of this year.
Speaker Change: If shown to be safe and effective among cancer patients enrolled our cab enabled T cell engage your has the potential to treat patients with a wide range of metastatic tumors, including cancers of colon lung breast pancreatic and prostate among others.
Speaker Change: As we have previously discussed a D. C is a promising treatment modality with broad applicability across multiple tumor types to further reduce the potential risk associated with neutropenia. Some off target toxicity, we developed a novel Nextgen carbohydrate linker system was superior serum stability solubility and tumor spin.
Jay M. Short: We believe multiple responses in a treatment-refractory, axopositive, poor prognostic group, such as this one, are clinically meaningful and relevant, particularly since these patients have experienced failure of a median of three prior lines of therapy. As part of today's update, we have enrolled 33 target agnostic patients using the More Intense 1.8 mg per kg 2Q3W regimen across both squamous and We are on track to evaluate clinical benefit in the target agnostic non-small cell lung cancer non-squamous population in the second quarter of the year. Next, on to our potentially first-in-class dual-CAB bispecific T-cell engager antibody, CAB-F-CAM, CAB-CD3, or DA-3182. EpChem is a ubiquitous target expressed on the surface of cancer cells, which requires the use of our CAP technology to achieve optimal selectivity and safety.
Speaker Change: <unk> payload release, yielding a first glycoconjugate cat NEC for ATC B, a $33 61.
Speaker Change: At the upcoming ACR meeting in April efficacy data will be presented demonstrating complete tumor regression in xenograft models, including superior efficacy compared to afford them that the Dayton analog in the patient derived pancreatic cancer model.
Speaker Change: We will also present, both PK and toxicology data in nonhuman primates as well as the influence of our linker technology and specific cancer models. These data indicate that our nextgen cabinet can for ADC potentially as a more effective treatment with reduced toxicity, we plan to submit the I N D at April.
And finally I'm pleased to report our progress with the medical and scientific communities and important ongoing communications with numerous publications and presentations, including our conferences, such as asthma sarcoma and rare cancers, such as spring and the ACR annual meeting in April which can be found on our website.
Speaker Change: With that I would now like to turn the call over to Rick to review, the fourth quarter and full year 2023 financials Rick.
Rick: Thank you Jay.
Rick: Research and development expenses were $22 $7 million for the quarter ended December 31st 2023, compared to 21.9 million for the same quarter in 2022.
Jay M. Short: Our Phase 1-2 Dose Escalation Study continues to progress and is on track. We anticipate completion of the Phase 1 study with a full data readout in the second half of this year, with potential initiation of a phase 2 study also in the second half of this year. If shown to be safe and effective among cancer patients enrolled, our CAB-enabled T-cell engager has the potential to treat patients with a wide range of metastatic tumors, including cancers of the colon, lung, breast, pancreas, and prostate, among others. As we have previously discussed, ADCs are a promising treatment modality with broad applicability across multiple tumor types. To further reduce the potential risk associated with neutropenia from off-target toxicity, we developed a novel next-gen carbohydrate linker system with superior serum stability, solubility, and tumor-specific payload release, yielding our first glycoconjugate CAD Nectin for ADC, BA3361.
Rick: The increase the point $8 million was due to clinical development expenses, primarily related to the launch of all P. A 30 11 U P S potentially registrational trial in 2023, and overall accelerated enrollment across our clinical.
Rick: Trials in 2023.
Rick: Offset by a decrease in expense dropped preclinical programs and selected clinical indications due to our program prioritization in 'twenty two 'twenty three.
Rick: We expect our R&D expenses to decrease overall in the first half of 2024.
Rick: Due to recently completed enrollment.
Rick: In clinical trials for datasets expected to enable potentially registrational trials for our ADC programs be a 30 21 and be a 30 11.
Rick: General and administrative expenses were $5 $9 million for the quarter ended December 31, 2023, compared to $6 7 million for the same quarter in 2022.
Richard A. Waldron: At the upcoming AACR meeting in April, efficacy data will be presented demonstrating complete tumor regression and xenograft models, including superior efficacy compared to an infortimab to dentin analog in the patient-derived pancreatic cancer model. We will also present both PK and toxicology data in non-human primates, as well as the influence of our linker technology in specific cancer models. These data indicate that our next-gen CAB Nectin 480C petition is a more effective treatment with reduced toxicity. We plan to submit the IND in April. And finally, I am pleased to report our progress with the medical and scientific communities and important ongoing communications with numerous publications and presentations, including at conferences such as Asthma, Sarcoma, and Rare Cancers, CITSE Spring, and the AACR Annual Meeting in April, which can be found on our website. With that, I would now like to turn the call over to Rick to review the fourth quarter and full year 2023 financials. Rick, Thank you, Jay. Research and development expenses were $22.7 million for the quarter ended December 31, 2023, compared to $21.9 million for the same quarter in 2022.
Rick: Point $8 million decrease was primarily due to a lowest stock based compensation and D&O insurance premiums.
Rick: Net loss for the quarter ended December 31st 2023 was $26 $9 million compared to a net loss of $27.6 million for the same quarter in 2022.
Rick: Yeah.
Rick: Net cash used in operating activities for the full year ended December 31, 2023 was $104 million compared to net cash used in operating activities of $94 million for the same period in 2022.
Rick: Our cash use for the quarter ended December 31st 2023 was $29.8 million.
Rick: Cash and cash equivalents as of December 31, 2023 were $111.5 million compared to $215 $5 million as of December 31, 2022.
Rick: We expect our cash utilization to decrease in the first half of 'twenty 'twenty four, allowing our current cash and cash equivalents to fund operations into the second half of 2025.
Richard A. Waldron: The increase of $0.8 million was due to clinical development expenses primarily related to the launch of our VA 3011 UPS potentially registrational trial in 2023 and overall accelerated enrollment across our clinical trials in 2023, offset by a decrease in expense for our preclinical programs and selected clinical indications due to our program prioritization in 2023. We expect our R&D expenses to decrease overall in the first half of 2024 due to recently completed enrollment in clinical trials for datasets, expected to enable potentially registrational trials for our ADC programs BA3021 and BA3011. General and administrative expenses were $5.9 million for the quarter ended December 31, 2023, compared to $6.7 million for the same quarter in 2022. The $0.8 million decrease was primarily due to lower stock-based compensation and D&O insurance premiums.
Rick: And now back to Jay.
Jay M. Short: Thank you Rick.
Jay M. Short: I'll also made considerable progress in 2023 across all ongoing clinical trials targeting various tumor types and we look forward to the multiple important milestones in the second quarter of this year, including an initial data readout from our phase to see till a for Io antibody.
Jay M. Short: Phase two in both melanoma and head and neck cancer.
Valuations of clinical benefit and axle agnostic patients in our phase two non small cell lung cancer studies.
Jay M. Short: We are encouraged by the compelling clinical efficacy and safety that continues to emerge highlighting our differentiated cab technology across multiple therapeutic targets.
Speaker Change: With that we will turn it back to the operator to take your questions.
Speaker Change: Thank you.
Speaker Change: We will now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
Speaker Change: A confirmation tone will indicate that your line is in the question queue.
Speaker Change: And you May press star two if you'd like to remove your question from the queue.
Speaker Change: For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
One moment, please pull for questions.
Speaker Change: Uh huh.
Speaker Change: Thank you. Our first question comes from the line of Kelly <unk> with Jefferies. Please proceed with your question.
Richard A. Waldron: The net loss for the quarter ended December 31st, 2023 was $26.9 million, which appeared to a net loss of $27.6 million for the same quarter in 2022. Net cash used in operating activities for the full year ended December 31, 2023 was $104 million compared to net cash used in operating activities of $90.4 million for the same period in 2022. Our cash use for the quarter ended December 31st, 2023 was $29.8 million. Cash and cash equivalents as of December 31, 2023 were $111.5 million compared to $215.5 million as of December 31, 2022. We expect our cash utilization to decrease in the first half of 2024, allowing our current cash and cash equivalents to fund operations into the second half of 2025.
Kelly: Hi, This is Dave on Florida Caliche.
Kelly: Question, one on excuse me it'll one one in U P. S. Maybe if you can talk about your expectation and what do you anticipate from the meeting from.
Dave: From the FDA meeting that you plan in second half also be you'll be discussing additional indication or will it be only for U B S.
Sherry do you want to take that one again.
Sheri Lydick: Sure. Thank you for the question.
Sherry Lilac: Thanks.
Sheri Lydick: In terms of the second I'll take the second part of your question. So the meeting would be focused on Upi finish this is our appetite.
Sheri Lydick: Actually a registrational trial so.
Speaker Change: I'll leave it up to discuss.
Speaker Change: They are the fact that we had generated in the first 20 patients.
In terms of efficacy and Tolerability and I think I would pass.
Speaker Change: First part of your question over to Eric Sorry, industrial economy.
Eric L. Sievers: Sure I'm happy to take that thank you Sherry so our goals with the FDA meeting are really to plot.
Eric L. Sievers: Plot out together, an agreeable registration path and I think we've guided previously that that would be based on an overall response rate with a certain durability.
Richard A. Waldron: Thank you, Rick. Bioatla made considerable progress in 2023 across our ongoing clinical trials targeting various tumor types. And we look forward to the multiple important milestones in the second quarter of this year, including initial data readout from our phase 2 CTLA-4-IO antibody, Phase II in both melanoma and head and neck cancer, and evaluation of clinical benefit in axonal agnostic patients in our Phase II non-small cell lung cancer. We are encouraged by the compelling clinical efficacy and safety that continues to emerge, highlighting our differentiated CAD technology across multiple therapeutic targets. With that, we will turn it back to the operator to take your questions. Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue.
I'll also be talking with the agency about project optimists, and whether that be multiple different dosing regimens that we've explored in U P. S are sufficient to achieve.
Eric L. Sievers: Achieved the project Optimus guidelines.
Eric L. Sievers: And we then hope to be able to provide a guidance.
Eric L. Sievers: On our path forward after that meeting.
Speaker Change: Great. Thank you for taking our question. Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Caveri Polman with B T. I G. Please proceed with your question.
Kaveri Pohlman: Oh, yeah. Good evening, congrats on the progress and thanks for taking my questions first do you feel like or any additional color you can provide on the first line melanoma and non small cell lung cancer trials are these going to be single arm trials and how many patients do you plan to enroll.
Kaveri Pohlman: Eric do you want to start with that one.
Eric L. Sievers: Sure. Thank you Caveri.
Eric L. Sievers: So we would expect to enroll about 15 to 20 patients in each of our first line melanoma cohort and the first line targeted non small cell lung cancer by the end of the second half of 2024.
Operator: And you may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we pull for questions. Thank you. Our first question comes from the line of Kelly Shi with Jeffries. Please proceed with your question. Hi, this is Dev on behalf of Kailishi. I have a couple of questions. One on 3011 in UPS.
Eric L. Sievers: We hope that this dataset both in melanoma and non small cell lung cancer will help guide next steps for us.
Eric L. Sievers: And I also want to emphasize as Jay did that we've.
Eric L. Sievers: Pass the 700 milligram dose.
Which is equivalent to a 10 per kilo dosing and are now evaluating one gram. So we're really up the belief that a higher dose levels will be very important and extending survival as other studies have shown.
Unknown Executive: Maybe if you can talk about your expectations and what you anticipate from the meeting, from the FDA meeting that you plan for the second half. Also, will you be discussing additional indications, or will it be only for UPS? Sheri, do you want to take that one again?
Speaker Change: And I think I would just add I think our goal here is from these studies is to inform us.
Speaker Change: Allow the positioning for a registrational trial.
Speaker Change: In that case would be randomized studies.
Speaker Change: Got it that's helpful and I have for.
Sheri Lydick: Sure, thank you for the question Dave. In terms of the second part, I'll take the second part of your question. So the meeting would be focused on UPS, and this is our potentially registrational trial, so we would look to discuss the data set that we have generated with the first 20 patients in terms of efficacy and tolerability. And I think I would pass the first part of your question over to Eric for additional comment. Sure, I'm happy to take that. Thank you, Sheri.
Speaker Change: For <unk> three by specific trial.
Speaker Change: I understand it it's for multiple solid tumors, but are you enriching or have you seen enrichment for patients with kidney tumor type and can you set some expectations for what we will be seeing in second half and what would good data look like.
Speaker Change: Okay.
I'd say, obviously adenocarcinoma, but I think we're seeing some colorectal patients. So that we would expect to see a continuation along those lines as we go through the different dose layers.
Eric L. Sievers: So our goals with the FDA meeting are really to plot out an agreeable registration path, and I think we've discussed previously that that would be based on an overall response rate with a certain durability. We'll also be talking with the agency about Project Optimus and whether the multiple different dosing regimens that we've explored in UPS are sufficient to achieve the Project Optimus guidelines. And we then hope to be able to provide guidance on our path forward after that meeting. Great
Speaker Change: To the.
Speaker Change: Ultimate dose selection level and what our goal is to report out on those with a multiple scans. It's very much similar to what we did was see till it for in December.
Speaker Change: With that read out as we position for our phase two studies, Eric do you want to add anything to that.
Eric L. Sievers: I think I'd covers more than 70% of tumors are adenocarcinoma is so where we think we have plenty of coverage with this approach and compare it to your question, we're not needing to specifically pick patients based on target expression.
Operator: Thank you for taking our question. Thank you. Thank you. Our next question comes from the line of Kaveri Pohlman with BTIG.
Speaker Change: Cameras, so robustly expressed by tumors that are.
Unknown Executive: Please proceed with your question. Yeah, good evening. Congratulations on the progress and thanks for taking my questions. For CCLA, for any additional color you can provide on the first line melanoma and non-small cell lung cancer trials, are these going to be single-arm trials, and how many patients do you plan to enroll? Eric, do you want to start with that one?
We think that just using that the adenocarcinoma approach.
Speaker Change: We'll be getting patients likely to benefit.
Speaker Change: Got it thanks for taking my question.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: Thank you, ladies and gentlemen, as a reminder, if you would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: Our next question comes from the line of Arthur He with H C. Wainwright. Please proceed with your question.
Arthur He: Hey, good afternoon know Jay and team Thanks for taking my question.
Eric L. Sievers: Sure. Thank you, Kaveri. So, we would expect to enroll about 15 to 20 patients in each of our first-line melanoma cohorts and the first-line targeted non-small cell lung cancer by the end of the second half of 2024. We hope that this data set, both in melanoma and non-small cell lung cancer, will help guide next steps for us. And I also want to emphasize, as Jay did, that we've passed the 700 milligram dose, which is equivalent to a 10 per kilo dose and are now evaluating one gram. So, we're really of the belief that higher dose levels will be very important in extending survival, as other studies have shown. And I think the, I'll just add, I think our goal here from these studies is to inform us and allow the positioning for registrational trials, which in that case would be randomized studies. That's helpful. And for EPCAM CD3 by specific trial, I understand it's for multiple solid tumors, but are you enriching, or have you seen enrichment for patients with certain tumor types? And can you set some expectations for what we will be seeing in the second half and what good data would look like?
Arthur He: So I just want to get into your.
Arthur He: Is.
Arthur He: For the $33 71, and there 30 21 update is that gonna be altogether at the our first quarter earnings call.
Speaker Change: No it would be our expectation is 30 21, well, we will be giving you a top line update then.
Speaker Change: Yes, Dave for 30, 71, well there could be an update on the dose escalation.
Dave: We won't know for sure until we get a few weeks a further down the road here since we're enrolling at the one gram level right now, but the first part that is a possibility there, but we'll see as we got closer to time I think for the readout of the monotherapy phase II study with approximately 20 patients where we look.
Dave: So a majority have been recruited at 350 milligram flat dose.
Dave: And just a few remaining patients at the 700 milligram dose a that'll be sometime in June and the latter part of June I'm estimate because we wanted to get as much a scan data. If you remember back on 30 71, you definitely want to see two scans because you are initiating the immune system so well.
That really wasn't going to give us just a little more time, but all of them pretty not very far away quite frankly coming quickly.
Speaker Change: Gotcha Gotcha, thanks for that and.
Speaker Change: My second question is.
Speaker Change: So regarding the next candidate I, just curious to try to pick a brain is y.
Speaker Change: Another a D C are not.
Jay M. Short: OK. I think, obviously, adenocarcinoma, but I think we're seeing some colorectal patients, and we would expect to see a continuation along those lines as we go through the different dose layers to the ultimate dose selection level. And our goal is to report out on those with multiple scans, very much similar to what we did with C24 in December with that readout, as we prepare for Phase 2 studies. Eric, do you want to add anything to that? I think that covers it. More than 70% of tumors are adenocarcinomas.
Speaker Change: C T cell engagement.
Speaker Change: That's one and the second question of why <unk> four as a target.
Speaker Change: For that.
Speaker Change: Well I think two things we have both we have a an ADC a that just happened to be ready first and then we also have a bi specific which I believe we've reported on in previous conferences.
But I think that there are a couple of reasons.
Speaker Change: Why neck and for number one there is and associated toxicity with the current marketed that therefore that limits its.
Speaker Change: Applicability.
Speaker Change: Secondly, as we're going to report on and April at ACR, We're seeing efficacy in tumors that were not addressable with the current marketed drug and so we see an opportunity to move expand indications and also improve on existing indications.
Operator: So we think we have plenty of coverage with this approach. And Kaveri, to your question, we don't need to specifically pick patients based on target expression. EPCAM is so robustly expressed by tumors that we think that just using the adenocarcinoma approach will get patients likely to benefit.
Speaker Change: And that's driven of course by a novel Nextgen, a carbohydrate linker, which reduces our off target levels of off target toxicity that is a result of the payload coming off our prior to entering the cancer cell it and so on.
Operator: Got it. Thanks for taking my question. Thank you. Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from the line of Arthur He with H.C. Wainwright. Please proceed with your question. Hey Grapheneau, JN team.
Speaker Change: In general we see both of these assets.
Speaker Change: Important opportunity for a validated target.
Speaker Change: And in general.
Speaker Change: So I'll quickly I mean, you could ask the same question I see today for you know here's a here's a drug with incredible opportunity, but the toxicity that has been very difficult to manage.
Arthur He: Thanks for taking my question. So I just want to gather your thoughts on the 3071 and the 3021 update. Is that going to be all together at the first quarter earnings call? No, our expectation is 30-21.
Speaker Change: And has been used in very limited extent relative to what its potential is and I think we can make that argument across several different targets. When we acquire a cab technology, which improves that selectivity between for the cancer cell and protects the normal cell.
Jay M. Short: We will be giving a top line update then. The key update for 30-71, well, there could be an update on the dose escalation. We won't know for sure until we get a few weeks further down the road here since we're rolling at the one gram level right now, but that is a possibility there, but we'll see as we get closer to time. I think for the readout of the monotherapy phase two study with approximately 20 patients where the majority have been recruited at 350 milligrams flat dose and just a few remaining patients at the 700 milligram dose. That'll be sometime in June and the latter part of June, I'm estimating because we want to get as much scan data as we can.
Speaker Change: I think thanks for the additional color. So if I may can I squeeze in one more.
Speaker Change: Just curious I just quickly noticed the ACR.
Fantasia: Fantasia you got it.
Speaker Change: You're going to be doing at the.
Fantasia: April.
Fantasia:
Fantasia: Could you tell us more on the tetravalent T cell engage the B I believe that would be the 783 target.
Fantasia: Oh, what's the what's the special of these design or just curious.
Speaker Change: Well I think it's.
Speaker Change: What we referred to as kind of a butterfly design in other words, we have to.
Speaker Change: Arms of the antibody that both combined to the tumor cells. So that's the tumor cell engage her and then we also have two arms.
Jay M. Short: If you remember back on 30-71, you definitely want to see two scans because you're initiating the immune system, so we're going to give it just a little more time, but all pretty not very far away, quite frankly, coming quickly. Gotcha, gotcha. Thanks for that. My second question is, regarding the next candidate, I'm just curious to try to pick your brain about why another ADC, not a T-cell engager, that's one, and the second question is, why the next four as a target? Thanks for that. Well, I think of two things. We have both.
Speaker Change: Come off the light chains that combine to the C. D. Three receptor now we've since at least in terms of the F. Chem drug no doubt were binding to a single C. D. Three arm at a time, whereas we can still buying too.
Speaker Change: Two different antigens on the tumor cells, so, but this increases your ability to.
Speaker Change: Kris was the potency of the drug to have this tetravalent structure, even in the case, where one arm combined and I told them I can see the three of them suddenly you're going to get not only affinity, but also as entity and tumor targeting portion so.
Speaker Change: It's a.
Speaker Change: A very nice designing from that perspective, but secondly, because there's.
Speaker Change: There's only one form of this antibody that can be generated and dairy manufacturing simplifies manufacturing and.
Jay M. Short: We have an ADC that just happened to be ready first, and then we also have a bispecific, which I believe we've reported on in previous conferences. But I think that there are a couple reasons why Nectin-4. Number one, there is an associated toxicity with the current marketed Nectin-4 that limits its applicability. Secondly, as we're going to report on in April at AACR, we're seeing efficacy in tumors that were not addressable with the current marketed drug. And so we see an opportunity to move, find indications, and also improve on existing indications. And that's driven, of course, by our novel Nectin Carbohydrate Linker, which reduces off-target levels of off-target toxicity that is a result of the payload coming off prior to entering the cancer cell area.
Speaker Change: Reduces cost of goods, which is also an advantage.
Speaker Change: Gotcha. Thanks.
Speaker Change:
Speaker Change: Okay.
Speaker Change: Thank you. Our next question comes from the line of Ren Benjamin with citizens JMP. Please proceed with your question.
Reni John Benjamin: Hey, good afternoon, guys. Thanks for taking the questions.
Reni John Benjamin: Hum.
Reni John Benjamin: As I think about 30 71 I guess one question is you know now you're looking at the one gram dose level at at.
Reni John Benjamin: At what point do you kind of stopped dosing higher or can you just continue to go higher until you.
Reach a DLT and then I guess the second question is what I'm thinking about the melanoma non small cell combination with Pembroke cohorts for which we'll have data or data read out in the second half of this year can you talk you know.
Jay M. Short: And an important opportunity for a validated target. And in general, philosophically, I mean, you could ask the same question about C-Til-A-4, you know, here's a drug with incredible opportunity, but the toxicity has been very difficult to manage and has been used to a very limited extent relative to what its potential is, and I think we can make that argument across several different targets when we apply our CAB technology, which improves that selectivity for the cancer cell and protects the normal I say thanks for the addition, Carter. So, if I may, could I squeeze one more? Just curious, I just quickly noticed the ACR presentation you're going to be doing in April. Could you tell us more about the Tetravalent T7 Engage, I believe the B7H3 target, what's special about these designs? I'm just curious.
Reni John Benjamin: Awfully kind of metrics that you might need to to meet like for example in melanoma should I be thinking about you know you guys, beating or trying to beat Knievel plus your boy from both an efficacy and safety perspective or are you more concerned about the safety aspect and the same kind of question for non small.
Reni John Benjamin: Yes.
Reni John Benjamin: Eric.
Speaker Change: Start on this one.
Eric L. Sievers: Sure I think I'll take a start and then hand to Sherry you had a really interesting question about really how high to go.
Eric L. Sievers: With <unk> four inhibition, it's really striking to look back at our earlier randomized trials of them. If you remember at <unk> 10 per kilo versus three per kilo.
Sheri Lydick: And the survival benefits are really quite striking at multiple years of follow up.
Sheri Lydick: However, it would be 10 per kilo was associated with considerable toxicity.
Speaker Change: So most sponsors that are pursuing Cta for antibody really wanted to push the dose a two to achieve high exposures and then we.
Jay M. Short: Well, I think it's what we refer to as kind of a butterfly design. In other words, we have two arms of the antibody that both can bind to the tumor cell. So that's the tumor cell engager. And then we also have two arms that come off the light chains that can bind to the CD3 receptor.
Speaker Change: We also want a good high.
Speaker Change:
Speaker Change: Concentration trough in our pharmacokinetics, so that <unk> four blockade lingers for the full three weeks between doses.
Jay M. Short: Now, we've since, at least in terms of the EPCAM drug, known that we're binding to a single CD3 arm at a time, whereas we can still bind to two different antigens on the tumor cell. But this increases your ability to...increases the potency of the drug to have this tetravalent structure, even in the case where one arm can bind at a time, like in the CD3 arm And you're going to get not only affinity but also avidity in the tumor targeting portion. So it's a very nice design from that perspective, but secondly, because there's only one form of this antibody that can be generated during manufacturing. It simplifies manufacturing and reduces the cost of goods, which is also an advantage.
Speaker Change: So.
Our current plan is to treat the patients had one gram every three weeks and we.
Speaker Change: We don't plan to go higher we felt that that represents 14.2 milligrams per kilogram, if you compared it to the MP dosing and I think I think we can use that and.
Speaker Change: Just have a broad goal of giving as much see Chile four blockade as early in a cancer patient's treatment as possible.
Speaker Change: And make this something that.
Speaker Change: Based on Tolerability and its efficacy would be reach for US often is a PD one inhibitor.
Speaker Change: Sherri do you want to address the questions of.
Sherri: Regarding what we would see them in the context of melanoma and non small cell lung cancer.
Sherri: Sure sure. Thank you Eric and thank you Ron for your question I think basically what we would like it to be meaningfully better.
Arthur He: Gotcha. Thanks. Thanks, Jay.
Operator: Thank you. Our next question comes from the line of Ren Benjamin with Citizens JMP. Please proceed with your question. Hey, good afternoon, guys.
Sherri: Yeah, the current market and a standard of care.
Speaker Change: So what that means is meaningfully better not only in terms of efficacy, but also tolerability, so providing a regimen that well.
Reni John Benjamin: Thanks for taking the question. As I think about 3071, I guess one question is, you know, now you're looking at the one gram dose. At what point do you kind of stop dosing higher? I continue to go higher.
Speaker Change: We will allow no.
Speaker Change: Patient to really experience the full benefit.
Speaker Change: On the therapy.
Speaker Change: So in the context of melanoma.
Operator: And then, I guess the second question is, when I'm thinking about the melanoma non-small cell combination with Pembro-CoA, who will have a data readout this year, can you talk about the roughly kind of metrics that you might need to meet? And for Melanoma, should I be thinking about... Hugo, plus Yervoy from both an efficacy and safety perspective. Safety Aspect
Speaker Change: Whether that means being meaningfully better than.
Speaker Change: Do lag in terms of efficacy.
Speaker Change: Were meaningfully better than you know a fever. Nevertheless.
Speaker Change: We aim to be meaningfully better than those regimens currently provide.
Speaker Change: Got it and then.
Speaker Change: And what about for non small cell.
Speaker Change: Hi.
Speaker Change: Yeah, I'll just add him jump in here for a second as you noticed we mentioned that we're doing any targeted a population with significant large population, but with a subset of all non small cell lung cancer patients and we're going to.
Eric L. Sievers: Eric, do you want to start on this one? Sure. I think I'll take a start and then hand it to Sheri. You had a really interesting question about really how high to go with CTLA-4 inhibition. It's really striking to look back at earlier randomized trials of ipilimumab 10 per kilo versus 3 per kilo, and the survival benefits are really quite striking at multiple years of follow-up. However, IP10 per kilo was associated with considerable toxicity.
Speaker Change: Talk a bit more about that in a future conference I got at the moment, we're just simply.
Speaker Change: Keeping that at a high level at this point.
Speaker Change: Got it Okay, and just maybe just going back to Eric's answer just in regards to the $14 two makes per keg.
Speaker Change: Difficultly higher than what's been evaluated you know prior do we have a sense as to kind of the PK P. D. It at this point and how much sort of receptor occupancy or blocking where we're already getting.
Sheri Lydick: So, most sponsors that are pursuing CTLA-4 antibody really want to push the dose to achieve high exposures, and then we also want a good high concentration trough in our pharmacokinetics so that CTLA-4 blockade lingers for the full three weeks between doses. So, our current plan is to treat the patients at one gram every three weeks, and we don't plan to go higher. We felt that that represents 14.2 milligrams per kilogram if you compared it to the IPI doses, and I think we can use that and just have a broad goal of giving as much CTLA-4 blockade as early in a cancer patient's treatment as possible and make this something that, based on tolerability and its efficacy, would be reached for as often as a PD-1 inhibitor.
Speaker Change: Any any sort of color there would be helpful.
Speaker Change: Eric I'll just jump in for a moment you know I think that Oh, a lot of the studies that were done prior with aluminum and have shown that you do continue get it advantage up to 10 Megs per Kid.
Speaker Change: We don't have the data at $14 two mix per kg, but we'll definitely be comparing our the 10 to the 14 point too.
Speaker Change: And our belief is where we may not quite a saturated it yet.
Speaker Change: At the time, but the data is pretty clear when you compare one going one three and up to 10 Megs per kit that you continue to get benefit. So I think so your point is reasonable its a reasonable question, though at what point does that effort start to become saturated I think certainly is.
Sheri Lydick: Sheri, do you want to address the questions regarding what we would see in the context of melanoma and non-small cell lung cancer? Sure, sure. Thank you, Eric, and thank you, Ren, for your questions. I think basically what we would like is to be meaningfully better than, you know, the current marketed standard of care. So what that means is meaningfully better, not only in terms of efficacy but also tolerability, so providing a regimen that will allow, you know, a patient to really experience the full benefit of the therapy.
Speaker Change: Plenty of the incentive to check out the one gram level.
Speaker Change: But we will hope to report out on that in the future.
Speaker Change: And then maybe I'll jump in here with your question about the PK. So.
Speaker Change: As these are conditionally binding antibodies, we would need to do tumor biopsies to explore a receptor occupancy.
Speaker Change: Because the antibody was designed to explicitly not bind in.
Speaker Change: In the periphery. So it turns out to be a more challenging question to answer and one that we we haven't done those biopsies in humans.
Jay M. Short: So in the context of melanoma, whether that means being meaningfully better than a doulag in terms of efficacy or meaningfully better than, you know, Abhivo Yirrboy, we aim to be meaningfully better than what those regimens currently provide. I got it. And then, and I, and what about for non-small cell lung cancer? I'll just add in, jump in here for a second. As you notice, we mentioned that we're doing a targeted population, which is significant, a large population, but it's a subset of all non-small cell lung cancer patients, and we're going to talk a bit more about that at a future conference, but at the moment, we I got it.
Characterized receptor occupancy.
Speaker Change: And then your question about Teekay is that it is really behaving.
Speaker Change: And a pretty standard.
Speaker Change: Manor, there are really no PK surprises to date.
Speaker Change: Excellent thanks, guys for taking the questions. Thank.
Speaker Change: Thank you.
Speaker Change: Yep.
Speaker Change: Yeah.
Speaker Change: Thank you there are no further questions at this time I would like to turn the floor back over to Jay short for any closing comments.
Jay M. Short: Thanks, everyone for your attention and we're looking forward to a very exciting second quarter. We're talking to you soon thank you.
This concludes today's teleconference. You may disconnect your lines at this time.
Jay M. Short: Okay. And maybe just going back to, [inaudible] In regards to the... for Mix4Cake, higher than what's been evaluated, you know, prior. Do we have a sense as to kind of the at this point and how much sort of receptor occupancy or blocking we're already getting? Eric, I'll just jump in for a moment. You know, I think that a lot of the studies that were done prior with ipilimumab have shown that you do continue to get an advantage up to 10 mg per kg. We don't have data on 14.2 mg per kg, but we'll definitely be comparing the 10 to the 14.2, and our belief is we may not quite have saturated it yet at the 10, but the data is pretty clear when you compare 1 going 1, 3, and up to 10 mg per kg that you continue to get benefits.
Speaker Change: Thank you for your participation.
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Jay M. Short: So I think, though, your point is reasonable. It's a reasonable question, though: At what point does that effort start to become saturated?
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Eric L. Sievers: And I think certainly there's plenty of incentive to check out this one gram level, and we'll hope to report on that in the future. And Ren, maybe I'll jump in here with your question about the PK. So as these are conditionally binding antibodies, we would need to do tumor biopsies to explore receptor occupancy because the antibody was designed to explicitly not bind in the periphery. So it turns out to be a more challenging question to answer and one that we haven't done those biopsies in humans to characterize receptor occupancy.
Speaker Change: Yeah.
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Eric L. Sievers: And then your question about PK is that it is really behaving in a pretty standard manner. There are really no PK surprises to date. Excellent, thanks guys for taking the questions. Thank you.
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Jay M. Short: Thank you. There are no further questions at this time. I would like to turn the floor back over to Jay Short for any closing comments. Thanks everyone for your attention and we're looking forward to a very exciting second quarter. We'll be talking to you soon. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. [inaudible] ?? ?? ?? [inaudible] ??
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