UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 8.01 – Other Events
BioAtla, Inc. (the “Company”) provided supplemental clinical program updates for mecbotamab vedotin (BA3011) in non-small cell lung cancer (NSCLC) and sarcoma in a corporate presentation, which presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K. The Company may use such presentation from time to time in conversations with investors and analysts.
Item 9.01 - Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit | Description | |
| 99.1 | Corporate Presentation | |
| 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: November 4, 2022 | BIOATLA, INC. | |||||
| By: | /s/ Jay M. Short | |||||
| Name: | Jay M. Short | |||||
| Title: | Chief Executive Officer | |||||
Exhibit 99.1 BA3011 Supplemental NSCLC and Sarcoma Data 10/2022 1
AXL BA3011-002 (Phase 2 Part 1) - Disposition as of October 2022 24 patients enrolled 6 patients on-going with 0 scan (3 combo) Preliminary Data 2 patients not dosed yet 2 withdrawal of consent early, before the first scan 14 efficacy-evaluable patients* ORR: 5/14 (36%) 12 Non-Sq patients 2 Sq patients ORR: 5/12 (42%) ORR: 0/2 (0%) ORR: 4/8 (50%) ORR: 1/4 (25%) 8 monotherapy 1 Combo 1 Mono 4 combo SD PD 1 CR 4 PRs 2 SD 2 SD 2 PD 1 PD *Average prior lines of therapy = 3 All patients were PD-1 failure with the exception of 1 NSQ patient who failed EGFR treatment Interim data- Data cut-off of Oct 28, 2022 2 confidential
Phase 2 part 1 BA3011 NSCLC – response rate 60 57% 50% # Patients 50 42% Enrolled 24 40 36% Dosed / 0 scan 6 (3 combo) 30 Not yet dosed 2 25% W/D consent 2 20 Efficacy evaluable 14 10 0/2 5/14 5/12 4*/7 4*/8 1**/4 0 NSQ+SQ All NSQ NSQ NSQ NSQ BA3011 + SQ monotherapy monotherapy nivolumab PD-1 Failure W/D – withdrew; NSQ – non-squamous; SQ – squamous Responses include 4 partial responses (*) and one complete response (**) Interim data- Data cut-off of Oct 28, 2022 3 ORR (%)
BA3011: Best Response in Phase 2 Non-Squamous Patients Non-Squamous patients - Phase 2 only 1.8mg/kg Q2W 100 Preliminary Data 80 60 40 PD PD SD PD SD SD SD PR* PR PR CR PR* EGFR Failure 20 0 -20 -40 -60 ---Monotherapy ---Combination -80 nd *2 scan pending TmPS range 1% - 100% -100 Average prior lines of therapy = 3 All patients were PD-1 failure with the exception of 1 NSQ patient who failed EGFR treatment Interim data- Data cut-off of Oct 28, 2022 4 confidential %Change in Sum of Target Lesions
BA3011 NSCLC: Safety and tolerability profile Phase 2 at the RP2D 1.8 mg/kg Q2W BA3011 + Opdivo Characteristic BA3011 (N=13) (N=9) Any Adverse Events (AEs) 11 (85%) 6 (67%) 1 Related AEs with CTCAE Grade 3 or 4 (31%) 2 (22%) ▪ No treatment-related deaths 2 4 2 Any related serious AEs 2 (15%)* 2 (22%)^ ▪ Few treatment-related SAEs 2 Related AEs leading to death 0 0 ▪ Few AEs leading to treatment discontinuation Related AEs leading to treatment § 1 (8%) 0 2 discontinuation ▪ No clinically meaningful on-target toxicity Grade 1-2 (9%) observed over background Constipation Grade 3-4 (0%) ▪ Differentiated profile due to avoiding on-target off-tumor toxicity All Grade 1-2 (4.5%) Peripheral Neuropathy Grade 3-4 (0%) Grade 1-2 (14%) Diarrhea Grade 3-4 (0%) Low-grade constipation observed is consistent with baseline levels seen in advanced cancer patients Company material – confidential Interim data- Data cut-off of Oct 25, 2022 1 Note: CTCAE: Common Terminology Criteria for Adverse Events. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which is utilized for Adverse Event (AE) 2 reporting. A grading (severity) scale is provided for each AE term. As assessed by the investigator. Missing responses are counted as related. *Hyperglycemia & infusion reaction ^creatinine § increase & Acute kidney injury; Infusion reaction 5
Phase 2 Part 1 Topline Interim Analysis Results following BA3011 in refractory sarcoma subtypes Advance Phase 2 Part 1 Interim Results P2 Part 2 Leiomyosarcoma Leiomyosarcoma; Evaluating (n=18)* PFS rate 12W 32% STS Synovial sarcoma Synovial Go – Label Pendi (n=5)* PFS rate 12W 54% Expansion ng Liposarcoma Liposarcoma Go – Label BA3011 Monotherapy (n=6)* PFS rate 12W 67% Expansion Interim results satisfied pre- (n=105) defined ‘Go’ criteria into part 2 of Other Soft Tissue / UPS UPS Go – Initial § (n=19 / 8 )* PR = 2 / 6 Indication the Phase 2 BA3011 study in multiple sarcoma subtypes: Go – Label Osteosarcoma Osteosarcoma; Bone • UPS – clear guidance from Expansion (n=6)* PFS rate 12W 67% FDA, moving in phase 2, part 2 Ewing sarcoma Ewing sarcoma as initial indication (n=4)* Pending • Osteosarcoma, liposarcoma Others (chondro/chordo) Others (chondro/chordo) and synovial – pursue Pending (n=11 [6/ 3])* registration post UPS approval Combination with PD-1 CD20 Combo w/ PD-1; PR = 1 / 1 (UPS)** & CD 20 Positive Evaluating (n=20) (BA3011 + Opdivo) PFS rate 12W (combo overall) 32% (n=14)* CD 20 Negative Combo w/ PD-1, 1 PR (LMS); Evaluating (n=12)* PFS rate 12W 31% Cohorts in gray – continue to interim read-out Pre-defined criteria for each subgroup up to 10 patients: ‘No Go’ if 0 CR/PR and PFS rate at 3 months <40%; ‘Go’ if ≥1 CR/PR or PFS rate at 3 months ≥40%. * As of data cut-off Oct 17, 2022; Cohorts in gray continuing enrollment until sufficient sample size is achieved. **Included in UPS cohort. BA3011 dose 1.8 mg/kg Q2W. PFS, progression-free survival; PR, partial response; UPS, § undifferentiated pleomorphic sarcoma. Of 8 enrolled, 6 efficacy evaluable; 2 on-going with 1 scan. 6
Undifferentiated Pleomorphic Sarcoma (UPS): Phase 1 & 2 (1.8mg/kg; n=10) BioAtla Page 1 of 1 Protocol: BA3011-001 Figure 1.3.2.1.1 Progression-free Survival per Investigator Assessment for UPS Patients with TmPS or TcPS >= 70 in Change Target Lesion From Baseline (%) Progression-free Survival Phase 1&2 1.0 Events Median(mos) PFS 12WK Events Median (mos) PFS 3mo n(%) (95% CI) %(95% CI) All Patients 7 ( 70.0) 6.8 (1.4-NE) 50.0 (18.4, 75.3) 100 n(%) (95% CI) % (95%CI) 0.8 80 All 7(70.0) 6.8 (1.4 – NE) 50.0 (18.4, 75.3) 60 Patients 40 0.6 20 0 c c 0.4 -20 Combo -40 0.2 -60 -80 0.0 -100 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Number at Risk Months from First Dose Months from First Dose 10 10 8 4 4 4 4 3 3 3 3 2 2 2 2 1 1 1 1 1 1 1 1 0 All Patients Number at Risk Program name: FPFS_UPS.sas, Data Extraction Date: 17OCT2022, Run date: 20OCT2022 All Patients 10 10 8 4 4 4 4 3 3 3 3 2 2 2 2 1 1 1 1 1 1 1 1 0 ▪ Combined Phase 1 & 2: enrolled = 10; efficacy evaluable = 8; on-going with 1 scan = 2 ― 4 / 8 patients achieved PRs, with an ORR of 50% and PFS rate at 3 months of 50% ― Responses to BA3011 treatment are durable, with partial responders remaining on treatment for extended periods of time ▪ Interim results satisfied the pre-defined Go criteria of UPS cohort into part 2 of the Phase 2 study Interim data- Data cut-off of Oct 17, 2022 7 Progress-Free Survival Probability
Osteosarcoma: Phase 2 Change in Target Lesion and Progression Free Survival (1.8mg/kg; n=6) BioAtla Page 1 of 1 Protocol: BA3011-001 Figure 1.3.1.9.1 Progression-free Survival per Investigator Assessment for Patients with BA3011 alone & in Combination with Nivolumab - Bone(Osterosarcoma) in Phase 2 1.0 Events Median(mos) PFS 12WK Events Median (mos) PFS 3mo n(%) (95% CI) %(95% CI) All Patients 6 (100.0) 4.2 (1.2-NE) 66.7 (19.5, 90.4) n(%) (95% CI) % (95%CI) 0.8 6(100.0) 4.2 (1.2 – NE) All Patients 66.7 (19.5, 90.4) 0.6 c 0.4 0.2 0.0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Number at Risk Months from First Dose 6 6 4 4 3 2 1 1 1 1 1 1 0 All Patients Program name: FPFS_OSTERO.sas, Data Extraction Date: 17OCT2022, Run date: 19OCT2022 ▪ Of 6 patients enrolled, PFS rate at 3 months was 66.7% ▪ Interim results satisfied the pre-defined Go criteria of osteosarcoma cohort into part 2 of the Phase 2 study Interim data- Data cut-off of Oct 17, 2022 Recent independent phase 2 study demonstrated placebo PFS rate at 2 months for 1st and 2nd line metastatic osteosarcoma of ~0% (www.thelancet.com/oncology Vol 20 January 2019) 8 Progress-Free Survival Probability Progression Free Survival Probability
Liposarcoma and Synovial sarcoma Phase 2 Progression Free Survival Synovial Sarcoma BioAtla Page 1 of 1 Liposarcoma Change Target Lesion From Baseline (%) Protocol: BA3011-001 BioAtla Page 1 of 1 BA3011 1.8mg/kg Q2W BA3011 1.8mg/kg Q2W Figure 1.3.1.6.1 Progression -Free Survival by AXL for Patients with BA3011 alone - STS (Synovial) Protocol: BA3011-001 Figure 1.3.1.5.2 Progression-free Survival per Investigator Assessment for STS Patients with BA3011 alone & in As-treated Sarc n=5 oma Subjects in Phase 2 n=6 Combination with Nivolumab - STS(Liposarcomas) in Phase 2 1.0 Events Median(mos) PFS 12WK Events Median (mos) PFS 3mo 1.0 Events Median(mos) PFS 12WK n(%) (95% CI) %(95% CI) Events Median (mos) PFS 3mo n(%) TmPS or(9 TcP 5 S% >= C 70 I ) 3( 60.0) 3.5(1.1-4.7) % 50( .09 (55 ..8%C , 84.5I) ) n(%) (95% CI) %(95% CI) All Patients 4 ( 66.7) 4.6 (0.2-NE) 66.7 (19.5, 90.4) TmPS ≥ 70 n(%) (95% CI) % (95%CI) 4(80.0) 4.4 (1.1 – NE) TmPS>=70 53.3 (6.8, 86.3) 0.8 4 (66.7) 4.6 (0.2 – NE) 0.8 TmPS>=70 66.7 (19.5, 90.4) 0.6 0.6 c c 0.4 0.4 0.2 0.2 0.0 0.0 Months from First Dose 0 1 2 3 4 5 6 0 1 2 3 4 5 6 7 8 Number at Risk Months from First Dose Number at Risk 5 4 3 1 1 0 Months from First Dose TmPS or TcPS >= 70 BA3011 All Patients 6 5 4 3 3 1 1 0 Program name: fpfs_13161.sas, Data Extraction Date: 25Jul2022, Run date: 07AUG2022 Program name: FPFS_LIPO.sas, Data Extraction Date: 17OCT2022, Run date: 19OCT2022 ▪ Interim results satisfied the pre-defined Go criteria of liposarcoma and synovial sarcoma cohorts into part 2 of the Phase 2 study. Interim data- Data cut-off of Oct 17, 2022 9 Progress-Free Survival Probability Progress-Free Survival Probability
BA3011 Sarcoma: Safety and Tolerability Profile Phase 2 at the RP2D 1.8 mg/kg Q2W Overview Mecbo– BA3011 ▪ AEs consistent with MMAE-based toxicity, including: o Reversible myelosuppression Grade 1-2 (19%) o Transient liver enzyme elevation Constipation Grade 3-4 (1%) o Metabolic disturbances ▪ Few related SAEs Peripheral Neuropathy All Grade 1-2 (19%) ▪ Few related AEs leading to treatment discontinuation Grade 1-2 (19%) Diarrhea Grade 3-4 (0%) CAB AXL-ADC Mecbo– BA3011 Dosing 1.8mg/kg Q2W Constipation is believed to be an on-target mediated effect (safety population Phase 2) Low-grade constipation observed is consistent with baseline levels seen in advanced cancer patients BA3011 + Nivo BA3011 Characteristic (N=63) (n=26) 60 ( 95%) 24 (92%) Any Adverse Events (AEs)• No clinically meaningful on-target toxicity observed • Differentiated profile due to advantageous 1 Related AEs with CTCAE Grade 17 ( 27%) 8 (30%) pharmacokinetic characteristics of CAB ADCs 2 3 or 4 2 Any related serious AEs 5 ( 8%) 4 (15%) 2 0 0 Related AEs leading to death Related AEs leading to § ^ 3 (5%) 1 (3.8%) 2 treatment discontinuation Note: 1CTCAE: Common Terminology Criteria for Adverse Events. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which is utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. 2As assessed by the § investigator. Missing responses are counted as related. Grade 2 peripheral neuropathy; pancreatitis; ^grade 2 Ileus Data cut-off of Oct 17 2022 10
UPS – Part 2 of the Phase 2 study (potentially registrational) • Written feedback received from the FDA to the proposed part 2 of the Phase 2 study design, including selection of primary endpoint (ORR) and size of the study (n=80) • FDA supportive of including a more intensive dosing arm • Protocol being finalized post FDA written feedback • Anticipate study enrollment commencement by year-end 11