Q2 2024 BioAtla Inc Earnings Call

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Operator: Ma'am, please stand by. Your program is about to begin. If you need assistance during your conference today, please press star zero. Good day, everyone, and welcome to today's Bioatla second quarter 2024 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star one on your telephone keypad. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Bruce Mackle of Lifesci Advisors. Thank you, operator, and good afternoon, everyone. 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 in a short Q&A. Earlier this afternoon, Bioatla released financial results and a business update for the second quarter ended June 30, 2024. A copy of the press release and corporate presentation are available on the company's website. 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, achievement of milestones, results, conduct, progress, and timing of its research and development programs and clinical trials, 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, the potential regulatory approval path for its product candidates, expectations about the sufficiency of its cash and cash equivalents to fund operations, and expectations regarding R&D expense and cash burn.

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Speaker Change: Please stand by, your program is about to begin. If you need assistance during your conference today, please press star zero.

Operator: If you need assistance during your conference call today, please press star zero. Good day, everyone, and welcome to today's Bioatla 2nd Quarter 2024 earnings call.

Operator: At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer sessions. You may register to ask a question at any time by pressing star 1 on your telephone keypad. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Bruce Mackle of Lifesci Advisors.

Bruce Mackle: Thank you, operator, and good afternoon, everyone. With me today on the phone from Bioatla are our 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 in a short Q&A. Earlier this afternoon, Bioatla released financial results and a business update for the second quarter ended June 30, 2024. A copy of the press release and corporate presentation is available on the company's website.

Richard Waldron: And Richard Waldron, Chief Financial Officer.

Speaker Change: Following today's call Dr. Eric Sievers, Chief Medical Officer, and Sherry Lilac, Chief Commercial officer will join Jay and Rick and a short Q&A.

Speaker Change: Earlier this afternoon, <unk> released financial results and a business update for the second quarter ended June 32024.

Speaker Change: 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 BioAtlas business plans and prospects and whether its clinical trials will support registration, as well as plans to form collaborations and other strategic partnerships for selected assets.

Speaker Change: 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 stay.

Speaker Change: Statements regarding bio Atlas business plans and prospects and whether its clinical trials will support registration.

Speaker Change: Plans to form collaborations and other strategic partnerships for selected assets.

Bruce Mackle: Achievement of Milestones, Results Conduct Progress, and Timing of its research and development programs in clinical trials, and 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. The Potential Regulatory Approval Path for its Product Candidates Expectations about the sufficiency of its cash and cash equivalents to fund operations, and Expectations regarding R&D expense and cash per share. 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 quarterly report on Form 10Q.

Speaker Change: Achievement of milestones.

Speaker Change: Results conduct progress and timing of its research and development programs and clinical trials.

Speaker Change: Expectations with respect to enrollment and dosing in its clinical trials.

Speaker Change: Plans and expectations regarding future data updates clinical trials regulatory meetings and regulatory submissions.

Speaker Change: The potential regulatory approval path for its product candidates.

Speaker Change: The expectations about the sufficiency of its cash and cash equivalents to fund operations and expectations regarding R&D expense and cash burn.

Operator: 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 quarterly report on Form 10-Q.

Speaker Change: These statements are subject to various risks assumptions and uncertainties that can cause actual results to differ materially.

Speaker Change: Are described in the filings made with the SEC, including the most recent quarterly report on Form 10-Q.

Operator: You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 8, 2024, and Bioatlet describes any obligation to update such statements to reflect future information, events, or circumstances, except as required by law.

Bruce Mackle: You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 8, 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 Dr. Jay Short.

Speaker Change: You are cautioned not to place undue reliance on these forward looking statements, which speak only as of today August eight 2024, and bio outlet disclaims any obligation to update such statements to reflect future information.

Speaker Change: Vince or circumstances, except as required by law.

Bruce Mackle: With that, I'd like to turn the call over to Dr. Jay Short. Jay?

Speaker Change: With that I'd like to turn the call over to Dr. Jay short Jay.

Jay Short: Thank you, Bruce, and thanks to everyone for joining us for our second quarter of 2024 Bioatlet earnings call. Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on their website. Also, the presentation and webcast of our R&D Day held two weeks ago featuring three renowned KOLs are also available on our website. We continue to make considerable progress across all of our ongoing clinical programs. Beginning with our CAB or 280COs and RISTA-MAB Bedotent being evaluated as a monotherapy and highly treatment refractory head net cancer patients with a median of three prior lines of treatment, we shared last quarter that among the 29 available patients, 11 responses were documented at the combined 2Q3W and Q2W dose regimens, with six responses now confirmed.

Jay: Thank you Bruce and thanks to everyone for joining us for our second quarter 2024 earnings call.

Jay Short: Additional details related to what we will share today are available in today's press release, and our updated company presentation, which are available on our website.

Speaker Change: Also the presentation a webcast of our R&D day held two weeks ago, featuring three Renault Kols.

Speaker Change: Also available on our website.

Speaker Change: Yeah.

Jay Short: We continue to make considerable progress across all of our ongoing clinical trials. Beginning with our CAVOR2-ADCO Zoristamab-Bidotin being evaluated as a monotherapy in highly treatment-refractory head and neck cancer patients with a median of three prior lines of treatment, we shared last quarter that among the 29 evaluable patients, 11 responses were documented at the combined 2Q3W and Q2W dose regimens, with six We have had an abstract accepted for a poster presentation at the upcoming Osmo Conference and look forward to sharing the updated data in September.

Speaker Change: We continue to make considerable progress across all of our ongoing clinical programs.

Speaker Change: Beginning with our cab or two ADC as a risk the mab the doses being evaluated as a monotherapy in highly treatment refractory head and neck cancer patients with a median of three prior lines of treatment. We shared last quarter that among the 29 Evaluable patients 11 responses were documented at the combined two Q3 W.

Speaker Change: In Q2 W dose regimens with six responses now confirmed.

Jay Short: We have an abstract accepted as a poster presentation at the upcoming Osmo Conference and look forward to sharing the updated data in September. Additionally, we continue to see a manageable safety profile, with no new safety signals to date. Given the strength of the data, we recently received a fast track designation from the FDA, which represents an important recognition of the potential of Osmo RISTA-MAB Bedotent to potentially fill a significant unmet need in refractory head net cancer. The encouraging clinical profile supports rapidly advancing into a potentially registration trial, evaluating monotherapy treatment versus investigator's choice in the second line and beyond settings.

Speaker Change: We have an abstract accepted as a poster presentation at the upcoming ESMO conference and look forward to sharing the updated data in September. Additionally.

Jay Short: Additionally, we continue to see a manageable safety profile with known new safety signals to date. Given the strength of the data, we recently received a fast track designation from the FDA, which represents an important recognition of the potential of a zoristum ad that doesn't. Thus, potentially, a significant, unmet need and refractory head of the neck kit.

Speaker Change: Additionally, we continue to see a manageable safety profile with no new safety signals to date.

Speaker Change: Given the strength of the data. We recently received fast track designation from the FDA, which represents an important recognition of the potential of the Arista mab for them to potentially still a significant unmet need in refractory head and neck cancer.

Jay Short: The encouraging clinical profile supports rapidly advancing into a potentially registration trial, evaluating monetary treatment versus investigators' choice in the second line and beyond setting, and we are on track to meet with the FDA later this year to discuss further. Moving now to our CAP C2A4 antibody, Dev Prasad, Doug, As presented during our R&D day, we have treated 40 patients across multiple doses of Avastatug, and we continue to observe a low incidence and severity of immune-related adverse events in the combined safety from our Phase I and Phase II studies.

Speaker Change: The encouraging clinical profile supports rapidly advancing into a potentially registrational trial evaluating monotherapy treatment versus investigator's choice in the second line and beyond setting and we are on track to meet with the FDA later this year to discuss further.

Jay Short: And we are on track to meet with the FDA later this year to discuss further. Moving now to our CAPC-4 antibody, Ivalsta Tug, as presented during our R&D Day, we have treated 40 patients across multiple doses of Ivalsta Tug, and we continue to observe low incidence and severity of immune-related adverse events in the combined safety from our Phase 1 and Phase 2 studies. Specifically, a relatively low rate of grade 3 of immune-related adverse events was observed in only 4 out of 40 patients, with no grade 4 or 5 related treatment-emergent adverse events. The incidence and severity of immune-related AEs were consistent across both Phase 1 and Phase 2 studies.

Speaker Change: Moving now to our capsid totally for antibody advanced attacks.

Jay Short: Specifically, a relatively low rate of grade 3 immune-related adverse events was observed in only 4 out of 40 patients with no grade 4 or 5 related treatment emergent adverse events. The incidence and severity of immune-related AEs were consistent across both Phase 1 and Phase 2 studies. With regard to efficacy from our Phase One study, we previously reported confirmed responses for three of eight treatment refractory patients using the 350 milligram dose in combination with a PD1 antibody, including one complete response with one additional partial response at according to the attending physicians should know evidence of disease and may eventually be ruled as such a complete response.

Speaker Change: As presented during our R&D day, we have treated 40 patients across multiple doses of the vast attack and we continued to observe low incidence and severity of immune related adverse events and the combined safety from our phase one and phase two studies.

Speaker Change: Specifically, a relatively low rate of grade three of immune related adverse events were observed and only four out of 40 patients with no grade four or five related treatment emergent adverse events.

Speaker Change: The incidence and severity of the immune related aes were consistent across both phase one and phase two studies.

Jay Short: With regards to efficacy from our phase 1 study, we previously reported confirmed responses for 3 of 8 treatment refractory patients using the 350-mg dose in combination with a PD-1 antibody, including one complete response, with one additional partial response that, according to the attending physician, showed no evidence of disease and may eventually be ruled as such a complete response. No dose interruptions occurred in patients treated with greater than or equal to 350 milligrams of Ivalsta Tug, and multiple patients have remained on therapy for more than one year without progression. These data are consistent with the anticipated benefits of our conditionally binding technology.

Speaker Change: With regards to efficacy from our phase one study we previously reported confirm responses for three of eight treatment refractory patients using the 350 milligram dose in combination with a PD one antibody, including one complete response with one additional partial response that according to.

Speaker Change: The attending physician showed no evidence of disease and May eventually they rule is such a complete response.

Jay Short: No dose interruptions occurred in patients treated with greater than or equal to 350 mg of Oustatug, and multiple patients have remained on therapy for more than one year without progression. These data are consistent with the anticipated benefits of our conditionally binding technology.

Speaker Change: No dose interruptions occurred in patients treated with greater than or equal to 350 milligrams of <unk>.

Speaker Change: And multiple patients have remained on therapy for more than one year without progression.

Speaker Change: These data are consistent with the anticipated benefits of our conditionally binding technology.

Jay Short: Initial data from our Phase II monotherapy study across 14 different treatment-refractory solid tumor types at 350 mg or 700 mg showed 10 patients with stable disease, and multiple patients experienced prolonged progression-free survival for greater than 10 months. We look forward to presenting the data at several upcoming medical conferences, including an oral presentation at the Society for Melanoma Research Congress in October and a poster presentation at the Society for Immunotherapy of Cancer in November.

Jay Short: Initial data from our phase 2 monotherapy study across 14 different treatment refractory solid tumor types at 350 milligrams or 700 milligrams showed 10 patients with stable disease, and multiple patients experienced prolonged progression-free survival for greater than 10 months.

Speaker Change: Initial data from our phase two monotherapy study across 14 different treatment refractory solid tumor types at 350 milligrams or 700 milligrams showed 10 patients with stable disease at multiple patients experienced prolonged progression free survival for greater than 10 months.

Jay Short: We look forward to presenting the data as several upcoming medical conferences, including an oral presentation at the Society for Melanoma Research Congress in October, and a poster presentation at the Society for Immunotherapy of Cancer in November. We continue to enroll in the phase 2 first line melanoma study, followed by mutated non-small cell lung cancer, using a combination of Ivalsta Tug and PD-1 antibody. We are on track for an initial data readout in Malinoma later this year. Thanks for our evolving data. We continue to believe Ivalsta Tug has the potential to be the best in class CTA-4 antibody that holds the promise to be used as often as a PD-1 antibody and potentially expand the indications where combined immune checkpoint inhibition can be effective.

Speaker Change: We look forward to presenting the data at several upcoming medical conferences, including an oral presentation at the society for melanoma Research Congress in October and the poster presentation at the society for immunotherapy of cancer in November.

Jay Short: We continue to enroll in the Phase 2 first-line melanoma study, followed by mutated non-small cell lung cancer using a combination of Valsatug and PD-1 antibody. We are on track for an initial data readout in melanoma later this year. Revolving data, we continue to believe, I'll also tell you, it has the potential to be the best in class C2A4 antibody that holds the promise to be used as often as a PD1 antibody and potentially expand the indications where combined immune checkpoint inhibition can be effective.

Speaker Change: We continue to enroll in the phase two first line melanoma study followed by mutated non small cell lung cancer using a combination of that is also targeting PD. One antibody. We are on track for an initial data readout in melanoma later this year.

Speaker Change: Based on our evolving data we continue to believe that Boston has the potential to be the best in class utility for antibody that holds the promise to be used as often as a PD, one antibody and potentially expand the indications where combined immune checkpoint inhibition can be effective.

Jay Short: We are now designing a blind and randomized pivotal trial employing a Valsa Tug plus PD-1 antibody for newly diagnosed, metastatic, or unresectable melanoma patients and anticipate FDA guidance in the second half of this year.

Speaker Change: We are now designing a blinded randomized pivotal trial employing about <unk> plus PD, one antibody for newly diagnosed metastatic or unresectable melanoma patients.

Jay Short: We are now designing a blinded, randomized pivotal trial employing Valsatud plus PD-1 antibody for newly diagnosed metastatic or unresectable melanoma patients and anticipate FDA guidance in the second half of this year. Now on to our cab, actual ADCS, which makes motormaps the boat.

Speaker Change: And anticipate F D. A guidance of the second half of this year.

Jay Short: Now onto our CAB-AXO-ADCF-MACBOTIMAP to donate. As part of our phase 2 trial, patients with non-small cell lung cancer have completed an additional expansion cohort of 33 patients to evaluate actual expression, dose, subtype, and safety. In our subgroup analysis, we observed that actual expression greater than or equal to 1% is correlated with clinical benefit and heavily pre-treated patients with a median of three prior lines of therapy. We further evaluated the genotype status in this heavily pre-treated patient population with tumors expressing multiple K-RAS mutation variants, including G12A, G12C, and G12D. In addition, we have a patient with a complete response that has been maintained now for over two years, demonstrating encouraging clinical benefit in this emerging opportunity in patients with mutated K-RAS variants.

Speaker Change: Now onto our cab axle ADC asset.

Speaker Change: Bo to map that out.

Jay Short: As part of our Phase 2 trial on patients with non-small cell lung cancer, we have completed an additional expansion cohort of 33 patients to evaluate actual expression, dose, subtype, and safety. In our subgroup analysis, we observed that actual expression of greater than or equal to 1% is correlated with clinical benefit in heavily pre-treated patients with a median of three prior lines of therapy. We further evaluated the genotype status in this heavily-pre-treated patient population with tumors expressing multiple KLS mutation variants, including G12A, G12C, and G12D.

Speaker Change: As part of our phase II trial in patients with non small cell lung cancer.

Speaker Change: We have completed additional expansion cohort of 33 patients to evaluate actual expression dose subtype and safety.

Speaker Change: Subgroup analysis, we observed that actual expression of greater than or equal to 1% is correlated with clinical benefit in heavily pretreated patients with a median of three prior lines of therapy.

Speaker Change: We further evaluated the genotype status in this heavily pretreated patient population with tumors expressing multiple K Ras mutation variants, including G. 12 day G 12 C N G 12 Z.

Jay Short: Among the 18 valuable patients with known K-Rass mutations, we observed five responders, including one responder whose tumor expressed the mutated K-Rass G12C variant and its prior failure of soda rapset. In addition, we have a patient with a complete response that has been maintained now for over two years, demonstrating encouraging clinical benefit in this emerging opportunity in patients with mutated K-RAS. Importantly, our initial findings support a trend for improved overall survival among patients with tumors expressing mutated K-RAS variants compared to the K-RAS wild-type genotype. Furthermore, the Imensible Safety Profile continues with known new safety signals identified in the space of population.

Speaker Change: Among the 18 evaluable patients with known K Ras mutations, we observed five responders, including one responder, whose tumor expressed the mutated K Ras G 12 C variant and has experienced prior failure of soda ratchet.

Speaker Change: In addition, we have a patient with a complete response that has been maintained now for over two years.

Speaker Change: Demonstrating encouraging clinical benefit in this emerging opportunity in patients with mutated K Ras various.

Jay Short: Importantly, our initial findings support a trend for improved overall survival among patients with tumors expressing mutated K-RAS variants compared to the K-RAS wild-type genotype. Furthermore, a manageable safety profile continues, with no new safety signals identified in this patient population. We continue to assess K-RAS expression across the phase two data set and look forward to providing an update and additional details regarding a potential path forward later this year.

Speaker Change: Importantly, our initial funding support a trend for improved overall survival among patients with tumors expressing mutated K Ras variance compared to the K Ras Wild type genotype.

Speaker Change: Furthermore, it manageable safety profile continues with no new safety signals identified in this patient population.

Jay Short: We continue to assess KRAS expression across the Phase 2 data set and look forward to providing an update and additional details regarding a potential path forward later this year. Regarding our Phase 2 Potentially Registrational Trial in Undifferentiated Pleomorphic Sarcoma, UPS, we are evaluating the initial 20 patient data set and will provide an update on the remaining portion of the registrational trial later this year. Now in our Phase 1-2 Dose Escalation Study for CAB-EPCAM-CAB-CD3-T cell engager, the study is progressing and ongoing.

Speaker Change: We continue to assess K Ras expression across the phase two dataset and look forward to providing an update and additional details regarding a potential path forward later this year.

Jay Short: Regarding our phase two potentially registration trial in undifferentiated pleomorphic sarcoma (UPS), we are evaluating the initial 20 patient data set and will provide an update on the remaining portion of the registration trial later this year. Now, in our phase one-two dose estimation study, for KAB Epkin, KAB CD3 T-cell engager, the study is progressing and ongoing. We remain on track for a phase one data readout in the second half of this year. The T-cell engager space offers tremendous opportunities for more effective therapies. In particular, our KAB-enabled Epkin T-cell Engager has potential to treat patients with a wide range of metastatic tumors, including cancers of colon, lung, breast, pancreas, prostate, among others.

Speaker Change: Regarding our phase two potentially registrational trial, and undifferentiated pleomorphic sarcoma U P S.

Speaker Change: We are evaluating the initial 20 patient dataset and we'll provide an update on the remaining portion of the Registrational trial later this year.

Speaker Change: Now in our phase one two dose escalation study for CAD Cam cab CD three T cell engagement.

Speaker Change: The study is progressing and ongoing.

Jay Short: We remain on track for a phase one data readout in the second half of this year. The T-Cell Engager space offers tremendous opportunity for more effective therapies, and in particular, our CAB-enabled Epcan 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. Finally, we are in meaningful discussions regarding potential strategic partnerships with multiple companies evaluating selected preclinical and clinical assets.

Speaker Change: We remain on track for our phase one data readout in the second half of this year.

Speaker Change: The T cell engagements things offers tremendous opportunity for more effective therapies and in particular, our cab enabled F. Chem 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.

Jay Short: Finally, we are in meaningful discussions regarding potential strategic partnerships with multiple companies evaluating selected pre-clinical and clinical assets. The current stage of these discussions supports our beliefs that we remain on track for establishing one or more collaborations this year, including for one of our phase two clinical assets.

Speaker Change: Finally, we are in meaningful discussions regarding potential strategic partnerships with multiple companies evaluating selected preclinical and clinical assets. The current stage of these discussions support our belief that we remain on track for establishing one or more collaborations this year, including for.

Jay Short: The current stage of these discussions supports our belief that we remain on track to establish one or more collaborations this year, including for one of our phase two clinical assets. With that, I would now like to turn the call over to Rick to review the second quarter 2024 financials. Rick.

Speaker Change: One of our phase two clinical assets.

Richard Waldron: With that, I would now like to turn the call over to Rick to review the second quarter of 2024 financials.

Rick Waldron: Research and development expenses were $16.2 million for the quarter ended June 30, 2024, compared to $31 million for the same quarter in 2023. The decrease of $14.8 million was primarily due to completion of preclinical development for our Nectin-4 ADC, which received IND clearance in May 2024, and the impact of prioritization of our clinical programs in 2023, resulting in less expense for our preclinical programs in 2024. Our Clinical Program Expense decrees due to completion of Phase 2 Enrollment for ongoing ADC trials for a photo map video and also written ad video.

Speaker Change: With that I would now like to turn the call over to Rick to review the second quarter 'twenty 'twenty four financials Rick.

Richard Waldron: Rick? Thank you, Jay. Research and development expenses were $16.2 million for the quarter ended June 30, 2024, compared to $31 million for the same quarter in 2023. The decrease of $14.8 million was primarily due to completion of pre-clinical development for our Nectin 4 ADC, which received IND clearance in May 2024.

Rick: Thank you Jay.

Rick: Research and development expenses were $16 $2 million for the quarter ended June 32024, compared to $31 million.

Rick: At the same quarter in 2023, a decrease of $14 $8 million, primarily due to completion of preclinical development for our next 10 core ADC, which received <unk> clearance in May 2024, and the impact of prioritization of our clinical.

Richard Waldron: In the impact of prioritization of our clinical program in 2023, resulting in less expense for our pre-clinical programs in 2024. Our clinical program expense decreased due to completion of Phase 2 enrollment for our ongoing ADC trials for McBodamad-Vadotin and Ozer-Ryftamad-Vadotin. We expect our R&D expenses to continue to decrease in the near term as we complete our planned Phase 2 clinical trial and meet with the FDA to discuss potentially-registerational trials for our Phase 2 programs. General and administrative expenses were $5.8 million for the quarter-ended June 30, 2024, compared to $6.2 million for the same quarter in 2023.

Rick: Program in 2023, resulting in less expense for our preclinical programs in 2024.

Rick: Our clinical program expense decreased due to completion of phase two enrollment for our ongoing ADC trial, Paul Nick both of mine.

Rick: And always the risks in that window.

Rick Waldron: We expect our R&D expenses to continue to decrease in the near term as we complete our planned phase two clinical trial and meet with the FDA to discuss potentially organizational trials for our phase two program. General and administrative expenses were $5.8 million for the quarter ended June 30, 2024 compared to $6.2 million for the same quarter in 2023. The.5 million-dollar decrease was primarily due to lower stock-based compensation expense.

Rick: We expect our R&D expenses to continue to decrease in the near term as we complete our planned phase two clinical trial and meet with the FDA to discuss potentially registrational trials.

Jay Short: Thank you, Bruce, and thanks to everyone for joining us for our second quarter 2020 Forward Bioatla earnings call. Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on our website. Also, the presentation of the Webcast of our R&D Day, held two weeks ago featuring three renowned KOLs, is also available on our website.

Rick: These two programs.

Rick: General and administrative expenses were $5 $8 million for the quarter ended June 32024, compared to $6 $2 million for the same quarter in 2023.

Richard Waldron: The $0.5 million decrease was primarily due to lower stock-based compensation expense. Net loss for the quarter ended June 30, 2024, was $21.1 million compared to a net loss of $35.8 million for the same quarter in 2023. Net cash used in operating activities for the six months in the June 30, 2024, was $50 million compared to net cash used in operating activities of $46.7 million for the same period in 2023. Our cash used for the quarter ended June 30, 2024, was $19 million compared to $30.8 million during the quarter ended March 31, 2024. In line with our operating plan, we expect a further reduction in overall cash utilization in the third quarter of 2024.

Rick: The point $5 million decrease is primarily due to lower stock based compensation expense.

Rick Waldron: The net loss for the quarter ended June 30, 2024 was $21.1 million compared to a net loss of $35.8 million for the same quarter in 2023. Net cash used in operating activities for the six months ending June 30, 2024 was $50 million compared to net cash used in operating activities of $46.7 million for the same period in 2023. Our cash use for the quarter ended June 30, 2024, was $19 million compared to $30.8 million during the quarter ended March 31, 2024.

Rick: Net loss for the quarter ended June 32024 was $21.1 million compared to a net loss of $35.8 million.

Rick: But at the same quarter in 2023.

Rick: Net cash used in operating activities for the six months ended June 32020, Utah was $15 million compared to net cash used in operating activity.

Rick: $46.7 million.

Rick: Same period in 2023.

Rick: Our cash use for the quarter ended June 32024 was $19 million compared.

Rick: Compared to $38 million during the quarter ended March 31, 'twenty 'twenty four.

Rick Waldron: In line with our operating plan, we expect a further reduction in overall cash utilization in the third quarter of 2024. Cash and cash equivalents as of June 30, 2024 were $61.7 million compared to $111.5 million as of December 31, 2023. We expect current cash and cash equivalents will be sufficient to fund planned operations, including our prioritized cab programs through the third quarter of 2025, which is sufficient to deliver clinical readouts in multiple indications, position our programs for one or more potentially registration trials, and enhance our position in advancing strategic collaboration discussions. And now, back to Jay.

Rick: In line with our operating plan, we expect a further reduction in overall cash utilization in the third quarter of 2020 call.

Richard Waldron: Cash and cash equivalence as of June 30, 2024, was $61.7 million compared to $111.5 million as of December 31, 2023.

Rick: Cash and cash equivalents as of June 32024.

Rick: $61 $7 million compared to $111.5 million as of December 31, 2023.

Richard Waldron: We expect current cash and cash equivalence will be sufficient to fund planned operations, including our prioritized CAD programs through the third quarter of 2025, which is sufficient to deliver clinical readouts in multiple indications, position our programs for one or more potentially registration trials, and enhance opposition in advancing strategic collaboration discussions.

Rick: We expect current cash and cash equivalents will be sufficient to fund planned operations.

Speaker Change: Clothing prioritize cab programs.

Rick: Through the third quarter of 2025.

Rick: It is sufficient to deliver clinical readouts in multiple indications.

Rick: <unk> programs for one or more potentially registration trials and enhance our position in advancing strategic collaboration discussions.

Jay Short: And now, act to J. Thank you, Rick. We are pleased with the considerable progress we have made to date and our cumulative results across our CAD pipeline targeting solid tumors. We continue to focus on finalizing the data readouts and reports for our CAD board to and to absolutely for assets. And look forward to presenting work to and see to lay for data at upcoming medical meetings, as well as keeping you updated on our business activities.

Rick: And now back to Jay.

Jay Short: Thank you Rick.

Jay Short: We are pleased with the considerable progress we have made to date and our cumulative results across our cap pipeline targeting solid tumors. We continue to focus on finalizing the data readouts and reports for our cab axle, cab war two, and cab seat delay for assets. And look forward to presenting war two and seat delay for data upcoming medical meetings, as well as keeping you updated on our business. With that, we will turn it back to the operator to take your questions.

Speaker Change: We are pleased with the considerable progress we have made to date and our cumulative results across our cat pipeline targeting solid tumors. We continue to focus on finalizing the data Readouts of reports for our cab Axel Gab War, two and caps. He told you for assets and look forward to presenting word to as easily afford data at upcoming medical meetings.

Rick: As well as keeping you updated on our business activities.

Operator: 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 star one on your telephone. You may remove yourself from the queue at any time by pressing star two. Once again, that is star 1 to ask a question. We will pause for a moment to allow questions to queue.

Speaker Change: With that we will turn it back to the operator to take your questions.

Operator: At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star one to ask a question. We will pause for a moment to allow questions to die. Our first question comes from Brian Chang with J.P. Morgan. Please go ahead.

Speaker Change: At this time, if you would like to ask a question. Please press star one on your telephone keypad.

Speaker Change: You may remove yourself from the queue at any time by pressing star two.

Speaker Change: Once again that is star one to ask a question.

Speaker Change: We will pause for a moment to allow questions to queue.

Speaker Change: Okay.

Speaker Change: Okay.

Brian Chang: Our first question comes from Brian Chang with JP Morgan. Please go ahead. Hi guys, good afternoon. Thanks for taking out questions.

Speaker Change: Our first question comes from Brian Cheng with J P. Morgan. Please go ahead.

Brian Chan: Hey guys, good afternoon, thanks for taking out the questions. Maybe just first on Axel and UPS, can you confirm if you have met with the FDA on the remaining portion of the registrational study? If so, what is the initial feedback from the agency? And, furthermore, can you give us a bit more color on the patient compliance and safety profile that you saw in the initial communication? We would like a quick follow-up, thank you.

Brian Cheng: Hey, guys. Good afternoon, thanks for taking our question.

Eric Sievers: Maybe just first on Axel in UPS. Can you confirm if you have met with the FDA on the remaining portion for in the registration study? What is the initial feedback of the agency? And just furthermore, can you give us a bit more color on the patient compliance and save the profile that you saw in the initial presentation and a quick call. Thank you.

Brian Cheng: Maybe just first on actual new P. S can you confirm that.

Speaker Change: The FDA on our remaining Washington part in a Registrational study.

Speaker Change: L. A what is the initial feedback from the agency.

Speaker Change: And just back Tomorrow can you give us a bit more color on.

Speaker Change: Patient compliance and safety profile that you sign an initial implementation.

Speaker Change: Oh, thank you.

Eric Sievers: Eric, just some sounds like it's for you. Great. Thanks, Brian.

Jay Short: Eric, this one sounds like it's for you.

Speaker Change: Eric just sort of it sounds like for you.

Eric Sievers: Great. Thanks, Brian.

Speaker Change: Great. Thanks, Brian So as we previously disclosed we had a conversation with the FDA about Nick bow to map the doting in undifferentiated pleomorphic sarcoma.

Eric Sievers: So, as we previously disclosed, we had a conversation with the FDA about Mick Bodomev, the Doton in undifferentiated pre-amorphic sarcoma. And we discussed Project Optimist requirements. We discussed treating at two different dose levels. We discussed the potential bar for accelerated approval with a single-arm trial data set. We have not met with the agency yet with regard to our recent enrollment of the additional patients. And we would plan to review our data and then update on this later in the second half of the year.

Eric Sievers: So, as we've previously disclosed, we had a conversation with the FDA about mcBodumab-Vidotin in undifferentiated preamorphic sarcoma, and we discussed Project Optimist requirements. We discussed treating at two different dose levels. We discussed the potential bar for accelerated approval with a single-arm trial data set. We have not met with the agency yet with regard to our recent enrollment of additional patients, and we would plan to review our data and then update on this later in the second half of the year. Brian, I think you had a dish and admissions about who for us.

Speaker Change: And we discussed project Optimus requirements, we discussed.

Speaker Change: Treating at two different dose levels, we discussed that.

Speaker Change: The potential bar for accelerated approval with a single arm trial datasets.

Speaker Change: We have not met with the agency yet with regard to our recent enrollment of additional patients and we would plan to.

Speaker Change: To review our data and then update on this later in the second half of the year.

Eric Sievers: And Brian, I think you had additional questions about overall safety. Is that right? Yeah. And I guess just from the initial 20 patients. I think you can provide any color. The patient compliance and any initial read on efficacy and safety. They'll be very helpful. Sure. So, on the efficacy, we're not able to update publicly on that. But on the safety, I think in general, Eric, at a high level, you certainly can update that. Yeah. I'm happy to do so. Certainly, no new safety findings have been identified with the ADC. And we, we did decide that giving the drug every on the three, two, four regimen was.

Speaker Change: And Brian I think you had additional questions about overall safety is that right.

Brian Chan: Yeah, and I guess just from the initial 20 patients, I think, you know, you can use it as a variety of color. Thank you for your time, and any initial reading on efficacy and safety that will be very helpful.

Brian Cheng: And I guess just fine.

Brian Cheng: So plenty of patients.

Speaker Change: Hello.

Speaker Change: Yes.

Speaker Change: And any initial read on efficacy and safety.

Speaker Change: Very helpful.

Eric Sievers: Sure, but I think of the, so on the efficacy, you know, it had to not be able to, I'm just gonna say on the efficacy, we're not, because it's part of the potential registration, we're not able to update publicly on that. But on the safety, I think, in general, Eric, at a high level, you certainly get up there at that.

Speaker Change: Sure well I think so.

Speaker Change: Go ahead, you are not able to I was just going to say on the efficacy we're not because it's part of the potentially registrational trial were not able to update publicly on that.

Speaker Change: But on the safety I think in general Eric at a high level, you certainly can update that.

Eric Sievers: Yeah, I'm happy to do so. Certainly, no new safety findings have been identified with the ADC, and we did decide that giving the drug every day on the 324 regimen was, we didn't see much patient compliance with that coming in so frequently to clinic, so we really focused on the days one and eight regimen of the three weeks cycle.

Eric Sievers: Yeah, and I'm happy to do so certainly no new safety findings have been identified with the ADC.

Speaker Change: And we.

Speaker Change: We we did decide that giving the drug every on the three Q4 regimen was.

Eric Sievers: We didn't see much patient compliance with that, coming in so frequently to clinics. So we really focused on the days one and eight regimen of a three-week cycle. Okay.

Speaker Change: We didn't see much patient compliance with that coming in so frequently to clinic. So we believe focused on days, one and eight regimen of a three week cycle.

Jay Short: Okay. Maybe just lastly, just on the partnership or BD from, can you just talk about your level of confidence, whether you'll be able to lock in the potential field in the back half of this year. And, you know, as you think about the potential partnerships that are on the table, which potential assets will make the most sense to partner off based on the current data. Thank you.

Speaker Change: Okay, and maybe just maybe just lastly, just on that partnership IBD fight.

Speaker Change: Can you just talk about your level of confidence whether you know you won't be able to lock in that potential in the back half of this year and you know when you think about that.

Jay Short: I think that's a good example of confidence whether, you know, you'll be able to lock in the potential deal in the back half of this year. And, you know, when, as you think about, you know, the potential partners that they're on table, which potential assets do you think would make the most sense to partner off based on the current data. Thank you. So I'm fairly confident that we're going to be successful in establishing partnerships one or more in this remaining portion of the year. I think we, as I mentioned in the script, we also may see a partnership, you know, as part of that in the preclinical assets.

Speaker Change: Potential partnership that unstable wish potential assets do you think what mercantile exchange to partner.

Speaker Change: On the current data thank you.

Speaker Change:

Jay Short: I'm fairly confident that we're going to be successful in establishing partnerships one or more in this remaining portion of the year. Thanks. I think we, as I mentioned in the script, we also may see partnerships as part of that in the preclinical asset. When it comes to the 80s, or certainly getting the most line light in discussions, and so I think it's a little difficult to predict for sure which one would partner first, but I'd say both are potential candidates, so we like them both. And we feel we remain on track for that, as best we can forecast. And the discussions are clearly at a meaningful level, and so we're very encouraged.

Speaker Change: So I'm fairly confident that we're going to be successful in establishing partnerships with one or more are in this remaining portion of the year.

Speaker Change: I think we are as I mentioned in the script. We've also may see a partnership you know as part of that and the preclinical assets.

Jay Short: When it comes to the, I think the ADCs are certainly getting the most limelight in discussions, and so I think it's a little difficult to predict for sure which one would partner first. But I'd say both are potential candidates. We like them both, so I think we remain on track for that as best one can forecast. And the discussions are clearly at a meaningful level. And so we're very encouraged.

Speaker Change: When it comes to the I think the Abcs are certainly getting the most limelight.

Speaker Change: Discussions and so I think it's a little difficult to predict for sure, which one would partner first but I'd say both are potential candidates. So we like them. Both so I think we remain on we feel we remain on track for that as best one can forecast and the discussions are clearly.

Speaker Change: At a meaningful level and so we're very encouraged by it.

Speaker Change: Okay.

Tony Butler: We'll go next to Tony Butler with Rodman and Renshaw. Please go ahead.

Operator: We'll go next to Tony Butler with Rodman and Renchall. Please go ahead.

Speaker Change: We'll go next to Tony Butler with Rodman and Renshaw. Please go ahead.

Speaker Change: Yeah.

Eric Sievers: Hi, this is Tasha, the son of Tony. The question is about the actual ADC. I think we'll recall that the patient with the complete response received the combinations now as it potentially the combination. I wonder if you can characterize what you see since the last day that day when it comes to, let's say, seeing a potential deepening of response or patients who are not quite there when it comes to having a response. And getting close to that negative 30% mark over time.

Toshita: Hi, this is Toshita, it's on for Tony. The question is about the actual ADC. I simply call that the patient with the complete response to receive the combination. Now, as it pertains to the combination, I wonder if you can characterize what you see. Since the last data update, when it comes to, let's say, seeing a potential deepening of response to patients who are not quite there when it comes to having a response, getting close to that negative 30% mark.

Speaker Change: Hi, This is Josh it is done on for Tony.

Speaker Change:

Speaker Change: It's about the axle ADC.

Speaker Change: I seem to recall that the patient with complete response received the combination now.

Speaker Change: Potentially the combination.

Speaker Change: If you can characterize what you see.

Speaker Change: The last day that date.

Speaker Change: When it comes to let's say seeing eight.

Speaker Change: Potential deepening of responses.

Speaker Change: Patients who are not quite there when it comes to having a response getting close to that negative 30% model over time.

Eric Sievers: You will know it's Eric Sievers again, and so if I can clarify, I think you're asking about our relatively mature data set now with McBodamavododen and non-small cell lung cancer, and you commented on the CR patient that we've reported previously, and then I think the second part of your question was asking about whether we've seen deepening of some of these responses over time. I think I'd probably best to refer everyone to slide 45 in our updated corporate deck, where we are characterizing the confirmed responses across the KRAS mutation variants.

Eric Sievers: So it's Eric Sievers again. And so if I can clarify, I think you're asking about our relatively mature data set now with both of them have the doden in non-small cell lung cancer and you commented on the CR patient that we've reported previously. And then I think the second part of your question was asking about whether we've seen deepening of some of these responses over time.

Speaker Change: You will know, it's Eric Sievers again and.

Speaker Change: So if I can clarify I think you were asking about are relatively mature data set now with.

Speaker Change: <unk> in non small cell lung cancer and you commented on that.

Speaker Change: CR patient that we've reported previously and then I think the second part of your question was asking about weather.

Speaker Change: Weather, we've seen deepening of some of these.

Speaker Change: Responses over time.

Eric Sievers: I think I probably best to refer everyone to slide 45 and our updated corporate deck where we are characterizing the confirm responses across the K-RAS mutation variants. Interestingly, one of our responses is a CR patient. And then also direct folks to slide 46, which is a preliminary analysis suggesting a difference in outcome amongst patients expressing the mutated K-RAS versus wild type K-RAS genotype. So we are continuing to witness the data evolving over time. This is our current data set that we've made public and look forward to continuing to evolve to evaluate the evolving K-RAS story.

Speaker Change: I think I'd, probably best to refer everyone to slide 45, and our updated our corporate deck.

Speaker Change: Where we are characterizing the confirmed responses across the K Ras mutation variants into.

Eric Sievers: Interestingly, one of our responses is from a CR patient and then also directs folks to slide 46, which is a preliminary analysis suggesting a difference in outcome amongst patients expressing the mutated KRAS versus the wild-type KRAS genotype. So, we're continuing to witness the data evolving over time. This is our current data set that we've made public, and we look forward to continuing to evaluate the evolving KRAS story. I want to indicate that 21 of the patients still have a pending genotype, and we're categorizing them as either wild-type or mutant so we can further this preliminary finding.

Speaker Change: Interestingly.

Speaker Change: One of our responses as our CR patient and.

Speaker Change: And then also direct folks to slide 46, which.

Speaker Change: Which is a preliminary analysis, suggesting a difference in outcome amongst patients expressing the mutated K Ras versus wild type K Ras genotype.

Speaker Change: So we're continuing to witness the data evolving over time.

Speaker Change: This is our current data set that we've made public can look forward to continuing to evolve to evaluate the evolving <unk> story.

Eric Sievers: I want to indicate that 21 of the patients still have a pending genotype, and we're categorizing them as either wild type or mutant so we can further this preliminary finding. I understand and thank you for that. Furthermore.

Speaker Change: I want to indicate that 'twenty one of the patients still have the pending genotype and were categorizing them as either wild type or mutant.

Speaker Change: We can further this preliminary finding.

Toshita: Furthermore... No, how much you can't cry? Breast Bancers and our clinical activity, that they disease control, duration longer than, and fewer than 16 weeks. With this, with the combination of Mifotumab, Vidotin, and Nivolumab in patients whose spurious mutation status is either unknown or, or wild.

Speaker Change: I understand and thank you for that further more.

Eric Sievers: No, how would you characterize responses and or clinical activity that the disease control duration longer than and fewer than 16 weeks with this with the combination of mid-closum, unknown or wild. So looking at slide 45, we're seeing a duration of response of 4.8 months for those with the mutated K-RAS. I think that the survival curves give a suggestion of a somewhat lower PFS amongst the patients with a wild type K-RAS, and we've not performed a formal analysis of the 21 individuals that are unknown.

Speaker Change: No how would you characterize.

Speaker Change: Responses and clinical activity.

Speaker Change: Thank you need control.

Speaker Change: Duration Longbow.

Speaker Change: Fewer than 16 week with this with the combination of my close enough and.

Napoleon: Napoleon up in patients, whose terrorists mutation status.

Speaker Change: Or or wild type.

Eric Sievers: So, looking at slide 45, we're seeing a duration of response of 4.8 months for those with the mutated K-RAS. I think that the survival curves give a suggestion of a somewhat lower PFS amongst the patients with a wild-type K-RAS, and we've not performed a formal analysis of the 21 individuals that are unknown. So, I look forward to a future data presentation and medical congress where that will be disclosed. I do think it's fairly competitive.

Speaker Change: So I'm looking at slide 45, we are seeing a duration of response at four eight months for those with the M. A.

Speaker Change: The mutated K Ras.

Speaker Change: I think that the survival curves give a suggestion of a somewhat lower.

Speaker Change: PFS amongst the patients with a wild type K Ras and we've not performed a formal analysis of the 21 individuals.

Speaker Change: That are unknown.

Eric Sievers: So I look forward to a future data presentation of the medical congress where that will be disclosed. I do think it's a fairly competitive profile given the fact this is effectively a fourth line median fourth line set of patients.

Speaker Change: So I look forward to a future data presentation at the medical Congress, where that will be disclosed.

Speaker Change: I think it's a fairly competitive profile given the fact this is effectively a fourth line median fourth line set of patients.

Eric Sievers: I do think it's a fairly competitive profile given the fact this is effectively a fourth line. Media and Fourth Line South patience.

Speaker Change: Thank you.

Speaker Change: Okay.

Arthur He: As a reminder, if you'd like to ask a question today, please press *1. We'll go next to Arthur He with HCWing, right? Hey, good afternoon, guys. Thanks for taking my question. So I had a couple of quick ones. So for the EXO program regarding the UPS studies, if I understand correct, so you have the additional 20 patients' data and as of now, he's just going to be waiting for the data to take to the FDA. In the meantime, are you still your orientation in the program? We're not knowing patients at the moment. We're waiting for the three total scans and evaluating the data's comes in, and then we'll proceed from there.

Operator: I have a reminder, if you'd like to ask a question today, please press star 1. We'll go next to Arthur He with H.C. Wayne Wright

Speaker Change: As a reminder, if you'd like to ask a question today. Please press star one.

Arthur He: We'll go next to Arthur he with H C Wainwright.

Arthur He: Hey, good afternoon guys. Thanks for taking my questions. So, for the actual program, regarding the UPS study, if I understand correctly, you have the additional 20 patient data, and as of now, he's just going to pick what you for the data to pick for FDA. And in the meantime, are you still your role as a patient in the program?

Arthur He: Hey, good afternoon guys.

Arthur He: Thanks for taking my question, So I had.

Arthur He: Couple of quick one so for the XL program regarding the <unk> study.

Speaker Change: Understand quite so you have the additional 20 patient data and now you're just going to pick waiting for the data to take to the FDA.

Speaker Change: Meantime, you.

Speaker Change: Still you wrote in patients in the program.

Jay Short: We are not enrolling patients at the moment. We're waiting for the three total scans and evaluating the data as it comes in, and then we'll proceed from there.

Speaker Change: We are not enrolling patients at the moment, we're waiting for the three total scans of evaluating the data as it comes in and then.

Speaker Change: We will proceed from there.

Arthur He: I see.

Jay Short: I see. Thanks, Jay. And for the non-small-cell lung cancer study in the future, my take is you're probably going to take the K-Ras status, as well as the Exo status, together to select a position, or you might go for either one.

Arthur He: I see thanks, Jay and for the.

Eric Sievers: Thanks, check. And for the announce Musao lung cancer study in the future, my take is you probably going to take the K-RAS status as well as the EXO status together to select the patient or you might go for either one. I think, you know, I think it could be the other one, but I think right now we see a nice correlation on MK-RAS. It just happens to be that actual highly correlated with that. So it's not necessarily required that you have that actual expression. We clearly see benefit with our drug with actual expression. So when we get, when we finish the next 21 patients' analysis, obviously, we'll be comparing that and coming forward with how we think it best be carried out.

Speaker Change: Non small cell lung cancer study in the future My take is you're probably going to taking the K Ras status as well as the XO standards together to some expectation or you might go for either one.

Arthur He: I see.

Jay Short: You know, I think it could be either one, but I think right now we see a nice correlation on M.K.R.S. It just happens to be that actually highly correlated with that, so it's not. Although necessarily requiring that you have that axle expression, we clearly see the benefit with our drug with axle expressions. So when we finish the next 21 patients' analysis, obviously, we'll be comparing that and coming forward with how we think it best should be carried out.

Speaker Change: I think it could be either one but I think right now we see we see a nice correlation on M. K Ras it just happens to be that axle is highly correlated with that so it's not.

Arthur He: Necessarily require that you have that axle expression, we clearly see benefit with our drug with oxo expression. So when we get when we finish the next 21 patients analysis.

Arthur He: Obviously, we'll be comparing that and coming forward with how we think it best be carried out.

Eric Sievers: You got to.

Eric Sievers: You've got to. Can I add to that, too? Because, Arthur, I think that it's a great question, and as Jay said, these are evolving data. We're looking at the 21 patients to see how they sort out between mutated and wild type. But it's conceivable that if the KRAS findings are further supported with additional data, given that that's a standard assessment, the genotype of lung cancer patients is very standard for defining the appropriate treatment options, this would enable a pretty straightforward approach for defining a population experiencing pronounced clinical benefit. Again, illustrated in slide 46, with the difference in survival that we're seeing. Now, that could be biological differences between those two subgroups of patients. It could also be due to the drug.

Speaker Change: Gotcha, and I add to that too because Arthur I think it's a great question and as Jay said these are evolving data. We're looking at the 21 patients to see how they.

Eric Sievers: And I add to that, too, because Arthur, I think that it's a great question. And as Jay said, these are evolving data. We're looking at the 21 patients to see how they sort out between mutated and wild type. But it's conceivable that if the K-RAS findings are further supported with additional data, that given that that's a standard assessment, the genotype of lung cancer patients is very standard for defining the appropriate treatment options, that this would enable a pretty straightforward approach for defining a population experiencing pronounced clinical benefit. Again, illustrated in slide 46 with the difference of survival that we're seeing.

Speaker Change: Sort out between mutated in wild type.

Arthur He: But it's conceivable that the K Ras findings.

Arthur He: Our further supported with additional data that.

Speaker Change: Given that Thats, a standard assessment the gene the type of lung cancer patients is very standard.

Arthur He: For defining the appropriate treatment options.

Arthur He: That this would enable a pretty straightforward approach for defining a population experiencing pronounced clinical benefit again illustrated in slide 46, with a different set of survival that were seeing now that could be biologic differences between those two subgroups of patients at all.

Eric Sievers: Now, that could be viologic differences between those two subgroups of patients. It also could be due to the drug. Thanks for the color, Eric.

Arthur He: So it could be due to the drug.

Eric Sievers: Thanks for the color, Eric. And I had another one for the secular studies. Just curious, do you guys still plan to enroll more patients for the monotherapy at the 700-minute grant level? Or that's pretty much the 19th patient, I guess the 19th patient is for the, is every patient you plan for the monotherapy study.

Speaker Change: Hi, Thanks, Thanks for the color Eric.

Eric Sievers: And I had another one for the CTOF4 study. Just curious, do you guys still plan to enroll more patients at for the monotherapy at the 700-minigran dose level, or that's pretty much the 19, I guess the 19 patient is every patient that you plan for the monotherapy study? I'm happy to take that. So we do not plan to further characterize monotherapy safety. I want to emphasize that the phase two monotherapy approach was a way to very efficiently and rapidly confirm our hypothesis that we were seeing a lower rate of immune-related adverse events compared with marketed CTOF4 antibodies.

Speaker Change: And I had another one for the <unk> four study just curious do you guys still playing to enroll.

Speaker Change: More patients for the mono therapy at the.

Speaker Change: Milligram dose level or.

Speaker Change: That's pretty much the the 19th.

Speaker Change: 19 patients is the for the it is every patient that you plan for the monotherapy study.

Eric Sievers: I'm happy to take that. So we do not plan to further characterize monotherapy safety. I want to emphasize that the phase two monotherapy approach was a way to very efficiently and rapidly confirm our hypothesis that we were seeing a lower rate of immune-related adverse events compared with marketed CTLA4 antibodies. We believe that we are indeed seeing a substantially lower rate of immune-related adverse events. And so our focus is now combining it with PD1 antibody approaches and further evaluating drug activity and safety in newly diagnosed metastatic or unresectable melanoma as well as patients with lung cancer with specified mutations. Thanks for the invention questions.

Speaker Change: I'm happy to take that.

Speaker Change: We do not plan to further characterize monotherapy safety.

Speaker Change: I want to emphasize that the phase two monotherapy approach.

Speaker Change: It was a way to very efficiently and rapidly confirm our hypothesis.

Speaker Change: We were seeing a lower rate of immune related adverse events compared with marketed <unk> four antibodies we.

Eric Sievers: We believe that we are indeed seeing a substantially lower rate of immune-mediated adverse events. And so our focus is now combining with PD1 antibody approaches and further evaluating drug activity and safety in newly diagnosed metastatic or unresectable melanoma, as well as patients with lung cancer with specified mutations. Gotcha. Thanks for listening to my question. Talk soon. Thank you.

Speaker Change: We believe that we are indeed, seeing a substantially lower rate of immune mediated adverse events.

Speaker Change: And so our focus is now combining with PD one antibody approaches.

Speaker Change: And further evaluating drug activity and safety in.

Speaker Change: <unk> newly diagnosed.

Speaker Change: Metastatic or unresectable melanoma, as well as patients with lung cancer.

Operator: Ma'am, please stand by your program is about to begin if you need assistance during your conference today please press star zero, good day everyone and welcome to today's Bioatla second quarter 2024 earnings call at this time all participants are in a listen only mode later you will have the opportunity to ask questions during the question and answer session you may register to ask a question at any time by pressing star one on your telephone keypad I will be standing by if you should need any assistance it is now my pleasure to turn the conference over to Bruce Mackle of Lifesci Advisors thank you operator and good afternoon everyone with me today on the phone from Bioatla or 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 in a short Q&A earlier this afternoon Bioatla released financial results and a business update for the second quarter ended June 30 2024 a copy of the press release and corporate presentation are available on the company's website 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, achievement of milestones, results, conduct, progress, and timing of its research and development programs and clinical trials, 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, the potential regulatory approval path for its product candidates, expectations about the sufficiency of its cash and cash equivalence to fund operations, and expectations regarding R&D expense and cash burn. 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 quarterly report on form 10Q.

Speaker Change: With specified mutations.

Eric Sievers: Thanks for the in-depth questions. Talk soon. Thank you.

Speaker Change: Got you thanks for taking my question.

Speaker Change: Yes.

Speaker Change: Thank you.

Operator: As a reminder, if you'd like to ask a question today, please press star one. I'm showing no further questions at this time.

Operator: As a reminder, if you'd like to ask a question today, please press star 1. I'm showing no further questions at this time. I will now turn the program back over to Jay Short for closing remarks.

Speaker Change: As a reminder, if you'd like to ask a question today. Please press star one.

Jay Short: I'm showing no further questions at this time I will now turn the program back over to Jay short for closing remarks.

Jay Short: I will now turn the program back over to J-Short for closing remarks. Thanks everyone for attending today, and we look forward to seeing everyone it has most September, as well as our additional conferences coming up in their future. Thank you, and we'll also intend to report out on our business developments as they occur. Thank you.

Jay Short: Thanks, everyone, for attending today, and we look forward to seeing everyone at ESMO in September, as well as at our additional conferences coming up in the near future. Thank you, and we'll also intend to report out on our business developments as they occur.

Jay Short: Thanks to everyone for attending today, and we look forward to seeing everyone at ESMO in September as well as some of our additional conferences coming up in the near future.

Jay Short: Thank you and we'll also intend to report out of our business developments.

Jay Short: As they occur thank you.

Jay Short: Yes.

Jay Short: Yeah.

Operator: This does conclude today's program. Thank you for your participation. You may disconnect at any time. Thank you very much.

Operator: This does conclude today's program. Thank you for your participation. You may disconnect at any time.

Jay Short: This does conclude today's program.

Speaker Change: Thank you for your participation you may disconnect at any time.

Operator: [music]

Speaker Change: [music].

Operator: You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 8, 2024, and Bioatlet describes 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 Dr. Jay Short. Jay?

Jay Short: Thank you, Bruce, and thanks to everyone for joining us for our second quarter of 2024 Bioatlet earnings call.

Jay Short: Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on their website. Also, the presentation and webcast of our R&D day held two weeks ago featuring three renowned KOLs are also available on our website. We continue to make considerable progress across all of our ongoing clinical programs. Beginning with our CAB or 280COs and RISTA-MAB Bedotent being evaluated as a monotherapy and highly treatment refractory head net cancer patients with a median of three prior lines of treatment, we shared last quarter that among the 29 available patients 11 responses were documented at the combined 2Q3W and Q2W dose regimens with six responses now confirmed.

Jay Short: We have an abstract accepted as a poster presentation at the upcoming Osmo conference and look forward to sharing the updated data in September. Additionally, we continue to see a manageable safety profile with no new safety signals to date. Given the strength of the data, we recently received a fast track designation from the FDA, which represents an important recognition of the potential of Osmo RISTA-MAB Bedotent to potentially fill a significant unmet need in refractory head net cancer.

Jay Short: The encouraging clinical profile supports rapidly advancing into a potentially registration trial, evaluating monotherapy treatment versus investigators choice in the second line and beyond settings. And we are on track to meet with the FDA later this year to discuss further. Moving now to our CAPC-4 antibody, Ivalsta Tug, as presented during our R&D day, we have treated 40 patients across multiple doses of Ivalsta Tug, and we continue to observe low incidence and severity of immune-related adverse events in the combined safety from our phase 1 and phase 2 studies.

Jay Short: Specifically, a relatively low rate of grade 3 of immune-related adverse events were observed in only 4 out of 40 patients with no grade 4 or 5 related treatment emergent adverse events. The incidence and severity of immune-related AEs were consistent across both phase 1 and phase 2 studies. With regards to efficacy from our phase 1 study, we previously reported confirmed responses for 3 of 8 treatment refractory patients using the 350-mg dose in combination with a PD-1 antibody, including one complete response with one additional partial response that according to the attending physician showed no evidence of disease and may eventually be ruled as such a complete response.

Jay Short: No dose interruptions occurred in patients treated with greater than or equal to 350 milligrams of Ivalsta Tug, and multiple patients have remained on therapy for more than one year without progression. These data are consistent with the anticipated benefits of our conditionally binding technology. Initial data from our phase 2 monotherapy study across 14 different treatment refractory solid tumor types at 350 milligrams or 700 milligrams showed 10 patients with stable disease and multiple patients experienced prolonged progression-free survival for greater than 10 months.

Jay Short: We look forward to presenting the data as several upcoming medical conferences, including an oral presentation at the Society for Malinoma Research Congress in October, and a poster presentation at the Society for Immunotherapy of Cancer in November. We continue to enroll in the phase 2 first line melanoma study, followed by mutated non-small cell lung cancer, using a combination of Ivalsta Tug and PD-1 antibody. We are on track for an initial data readout in Malinoma later this year.

Jay Short: Thanks for our evolving data. We continue to believe Ivalsta Tug has the potential to be the best in class CTA-4 antibody that holds the promise to be used as often as a PD-1 antibody and potentially expand the indications where combined immune checkpoint inhibition can be effective.

Jay Short: We are now designing a blind and randomized pivotal trial employing a Valsa Tug plus PD-1 antibody for newly diagnosed, metastatic, or unresectable melanoma patients and anticipate FDA guidance in the second half of this year.

Jay Short: Now onto our CAB-AXO-ADCF-MACBOTIMAP to donate. As part of our phase 2 trial patients with non-small cell lung cancer, we have completed an additional expansion cohort of 33 patients to evaluate actual expression, dose, subtype, and safety. In our subgroup analysis, we observed that actual expression greater than or equal to 1% is correlated with clinical benefit and heavily pre-treated patients with a median of three prior lines of therapy. We further evaluated the genotype status in this heavily pre-treated patient population with tumors expressing multiple K-RAS mutation variants, including G12A, G12C, and G12D.

Jay Short: In addition, we have a patient with a complete response that has been maintained now for over two years, demonstrating encouraging clinical benefit in this emerging opportunity in patients with mutated K-RAS variants. Importantly, our initial findings support a trend for improved overall survival, among patients with tumors expressing mutated K-RAS variants compared to the K-RAS wild-type genotype. Furthermore, a manageable safety profile continues with no new safety signals identified in this patient population. We continue to assess K-RAS expression across the phase two data set and look forward to providing an update and additional details regarding a potential path forward later this year.

Jay Short: Regarding our phase two potentially registration trial in undifferentiated Pleiomorphic Sarcoma UPS, we are evaluating the initial 20 patient data set and will provide an update on the remaining portion of the registration trial later this year.

Jay Short: Now, in our phase one-two dose estimation study, for KAB Epkin, KAB CD3 T-cell Engager, the study is progressing and ongoing. We remain on track for a phase one data readout in the second half of this year.

Jay Short: The T-cell Engager Space offers tremendous opportunities for more effective therapies. In particular, our KAB enabled Epkin T-cell Engager has potential to treat patients with a wide range of metastatic tumors, including cancers of colon, lung, breast, pancreas, prostate, among others.

Jay Short: Finally, we are in meaningful discussions regarding potential strategic partnerships with multiple companies evaluating selected pre-clinical and clinical assets.

Jay Short: The current stage of these discussions support our beliefs that we remain on track for establishing one or more collaborations this year, including for one of our phase two clinical assets.

Richard Waldron: With that, I would now like to turn the call over to Rick to review the second quarter of 2024 financials. Rick? Thank you, Jay. Research and development expenses were $16.2 million for the quarter ended June 30, 2024, compared to $31 million for the same quarter in 2023. The decrease of $14.8 million was primarily due to completion of pre-clinical development for our Nectin 4 ADC, which received IND clearance in May 2024. In the impact of prioritization of our clinical program in 2023, resulting in less expense for our pre-clinical programs in 2024.

Richard Waldron: Our clinical program expense decreased due to completion of Phase 2 enrollment for our ongoing ADC trials for McBodamad-Vadotin and Ozer-Ryftamad-Vadotin. We expect our R&D expenses to continue to decrease in the near term as we complete our planned Phase 2 clinical trial and meet with the FDA to discuss potentially-registerational trials for our Phase 2 programs. General and administrative expenses were $5.8 million for the quarter-ended June 30, 2024, compared to $6.2 million for the same quarter in 2023.

Richard Waldron: The $0.5 million decrease was primarily due to lower stock-based compensation expense. Net loss for the quarter-ended June 30, 2024 was $21.1 million compared to a net loss of $35.8 million for the same quarter in 2023. Net cash used in operating activities for the six months in the June 30, 2024 was $50 million compared to net cash used in operating activities of $46.7 million for the same period in 2023. Our cash used for the quarter-ended June 30, 2024 was $19 million compared to $30.8 million during the quarter-ended March 31, 2024.

Richard Waldron: In line with our operating plan, we expect a further reduction in overall cash utilization in the third quarter of 2024. Cash and cash equivalence as of June 30, 2024 was $61.7 million compared to $111.5 million as of December 31, 2023. We expect current cash and cash equivalence will be sufficient to fund planned operations, including our prioritized CAD programs through the third quarter of 2025, which is sufficient to deliver clinical readouts in multiple indications, position our programs for one or more potentially registration trials, and enhance opposition in advancing strategic collaboration discussions.

Jay Short: And now, act to J. Thank you, Rick. We are pleased with the considerable progress we have made to date and our cumulative results across our CAD pipeline targeting solid tumors. We continue to focus on finalizing the data readouts and reports for our CAD board to and to absolutely for assets. And look forward to presenting work to and see to lay for data at upcoming medical meetings as well as keeping you updated on our business activities.

Operator: 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 star one on your telephone You may remove yourself from the queue at any time by pressing star 2. Once again, that is star 1 to ask a question. We will pause for a moment to allow questions to queue.

Eric Sievers: Our first question comes from Brian Chang with JP Morgan. Please go ahead. Hey guys, good afternoon. Thanks for taking out questions. Maybe just for us on actual in UPS. Can you confirm if you have met with the FDA on the remaining portion for in the registrational study? If so, what is the initial feedback from the agency? And just furthermore, can you give us a bit more color on the patient compliance and safety profile that you saw in the initial communication? And have a quick thought. Thank you. Eric just sounds like for you. Great. Thanks, Brian.

Eric Sievers: So,[inaudible] We have met with regard to our recent enrollment of the additional patients. And we would plan to review our data and then update on this later in the second half of the year. And Brian, I think you had additional questions about overall safety. Is that right? [inaudible] I'm fairly confident that we're going to be successful in establishing partnerships one or more in this remaining portion of the year. I think we, as I mentioned in the script, we also may see a partnership as part of that in the preclinical assets.

Eric Sievers: When it comes to the, I think the ADCs are certainly getting the most limelight in discussions and so I think it's a little difficult to predict for sure which one would partner first but I'd say both are potential candidates. We like them both so I think we remain on track for that as best one can forecast. And the discussions are clearly at a meaningful level. And so we're very encouraged.

Eric Sievers: We'll go next to Tony Butler with Rodman and Renshaw. Please go ahead. Hi, this is Tasha, the son on for Tony. The question is about the actual ADC. I think we'll recall that the patient with the complete response received the combinations now as it potentially the combination. I wonder if you can characterize what you see since the last day that day when it comes to let's say seeing a potential deepening of response or patients who are not quite there when it comes to having a response.

Eric Sievers: And getting close to that negative 30% mark over time. So it's Eric Sievers again. And so if I can clarify, I think you're asking about our relatively mature data set now with both of them have the doden in non small cell lung cancer and you commented on the CR patient that we've reported previously. And then I think the second part of your question was asking about whether we've seen deepening of some of these responses over time.

Eric Sievers: I think I probably best to refer everyone to slide 45 and are updated corporate deck where we are characterizing the confirm responses across the K-RAS mutation variants. Interestingly, one of our responses is a CR patient. And then also direct folks to slide 46, which is a preliminary analysis suggesting a difference in outcome amongst patients expressing the mutated K-RAS versus wild type K-RAS genotype. So we are continuing to witness the data evolving over time.

Eric Sievers: This is our current data set that we've made public and look forward to continuing to evolve to evaluate the evolving K-RAS story. I want to indicate that 21 of the patients still have a pending genotype and we're categorizing them as either wild type or mutant so we can further this preliminary finding. I understand and thank you for that furthermore. No, how would you characterize responses and or clinical activity that the disease control duration longer than and fewer than 16 weeks with this with the combination of mid-closum, unknown or wild.

Eric Sievers: So looking at slide 45, we're seeing a duration of response of 4.8 months for those with the mutated K-RAS. I think that the survival curves give a suggestion of a somewhat lower PFS amongst the patients with a wild type K-RAS and we've not performed a formal analysis of the 21 individuals that are unknown. So I look forward to a future data presentation of the medical congress where that will be disclosed. I do think it's a fairly competitive profile given the fact this is effectively a fourth line median fourth line set of patients. As a reminder, if you'd like to ask a question today, please press star 1.

Eric Sievers: We'll go next to Arthur He with HCWing, right? Hey, good afternoon guys. Thanks for taking my question. So I had a couple of quick ones. So for the EXO program regarding the UPS studies, if I understand correct, so you have the additional 20 patients data and as of now, he's just going to be waiting for the data to take to the FDA. In the meantime, are you still your orientation in the program? We're not knowing patients at the moment. We're waiting for the three total scans and evaluating the data's comes in and then we'll proceed from there.

Eric Sievers: I see. Thanks, check. And for the announce Musao lung cancer study in the future, my take is you probably going to take the K-RAS status as well as the EXO status together to select the patient or you might go for either one. I think, you know, I think it could be the other one, but I think right now we see a nice correlation on MK-RAS. It just happens to be that actual highly correlated with that.

Eric Sievers: So it's not necessarily required that you have that actual expression. We clearly see benefit with our drug with actual expression. So when we get, when we finish the next 21 patients analysis, obviously, we'll be comparing that and coming forward with how we think it best be carried out.

Eric Sievers: You got to. And I add to that, too, because Arthur, I think that it's a great question. And as Jay said, these are evolving data. We're looking at the 21 patients to see how they sort out between mutated and wild type. But it's conceivable that if the K-RAS findings are further supported with additional data that given that that's a standard assessment, the genotype of lung cancer patients is very standard for defining the appropriate treatment options that this would enable a pretty straightforward approach for defining a population experiencing pronounced clinical benefit.

Eric Sievers: Again, illustrated in slide 46 with the difference of survival that we're seeing. Now, that could be viologic differences between those two subgroups of patients. It also could be due to the drug. Thanks for the color, Eric.

Unknown Executive: And I had another one for the CTOF4 study. Just curious, do you guys still plan to enroll more patients at for the monotherapy at the 700-minigran dose level, or that's pretty much the 19, I guess the 19 patient is every patient that you plan for the monotherapy study? I'm happy to take that.

Unknown Executive: So we do not plan to further characterize monotherapy safety. I want to emphasize that the phase two monotherapy approach was a way to very efficiently and rapidly confirm our hypothesis that we were seeing a lower rate of immune-related adverse events compared with marketed CTOF4 antibodies. We believe that we are indeed seeing a substantially lower rate of immune media that adverse events. And so our focus is now combining with PD1 antibody approaches and further evaluating drug activity and safety in newly diagnosed metastatic or unrestectable melanoma as well as patients with lung cancer with specified mutations. Gotcha. Thanks for listening to my question. Talk soon. Thank you. As a reminder, if you'd like to ask a question today, please press star one. I'm showing no further questions at this time.

Jay Short: I will now turn the program back over to J-Short for closing remarks. Thanks everyone for attending today and we look forward to seeing everyone it has most September as well as our additional conferences coming up in their future. Thank you and we'll also intend to report out on our business developments as they occur.

Unknown Executive: Thank you.

Operator: This does conclude today's program. Thank you for your participation. You may disconnect at any time.

Unknown Executive: Thank you very much.