Slide 1: TX45 Phase 1b (Part B) PH-HFrEF Data Release
TX45 Phase 1b (Part B) PH-HFrEF Data Release Single Dose Hemodynamic Trial October 2025
Slide 2: Disclaimer
2 DISCLAIMER Statements contained in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “pot
Slide 3: Positive Results in TX45 Single Dose Study in PH-HFrEF Patients
3 Positive Results in TX45 Single Dose Study in PH-HFrEF Patients Trial Goal • Assess safety and tolerability of TX45 in patients with PH-HFrEF • Observe trends in hemodynamic effects similar to Phase 1b (Part A) PH-HFpEF study (Topline data reported January 2025) Results • TX45 was observed to be w
Slide 4: Rationale for Exploring TX45 in PH-HFrEF, Enriched for CpcPH
4 Rationale for Exploring TX45 in PH-HFrEF, Enriched for CpcPH (Combined post- and pre-Capillary Pulmonary Hypertension) • Pulmonary and systemic vasodilator resulting in decreased right ventricle (RV) and Mechanism Appears left ventricle (LV) afterload Ideal to Address • Cardiac relaxation during d
Slide 5: Different LV Pathology but Similar Pulmonary Vascular and RV Consequences
5 Different LV Pathology but Similar Pulmonary Vascular and RV Consequences Thickened, Normal Weakened less distensible heart heart muscle heart muscle Characteristics HFrEF HFpEF (Heart Failure with Reduced Ejection Fraction) (Heart Failure with Preserved Ejection Fraction) Ejection Fraction % ≤40%
Slide 6: Phase 1b (Part B) Trial Design
6 Phase 1b (Part B) Trial Design A Single Dose, Open-Label, Acute Hemodynamic Trial in PH-HFrEF (n = 14) TX45 IV n = 1 @ 0.3 mg/kg n = 1 @ 1 mg/kg n = 12 @ 3 mg/kg Days 2, 15, 29: ECHO Right Heart Catheter (RHC) is inserted Days 8, 43: Safety Screening and hemodynamic measurements are Follow-ups Adm
Slide 7: Key Hemodynamic Measures
7 Key Hemodynamic Measures Goal: Treatment for PH due to heart failure needs to both increase LV function and improve pulmonary vascular and right ventricular component of the disease Hemodynamic Definition Significance PCWP • Measure of left atrial pressure • Key marker of left ventricular (LV) fun
Slide 8: Baseline Characteristics and Concomitant Medications
8 Baseline Characteristics and Concomitant Medications Consistent with HFrEF Population; Enriched for CpcPH Baseline Characteristics All Subjects PVR < 2WU 2 WU ≤ PVR < 3WU PVR ≥3 WU Age [mean (SD)] 66.9 (7.9) n=2 n=5 n=7 Females [n (%)] 7 (50%) LVEF (%); [mean (SD)]* 34.1 (6.6) Key Concomitant Medi
Slide 9: Baseline Hemodynamics are Consistent with PH-HFrEF
9 Baseline Hemodynamics are Consistent with PH-HFrEF Generally Accepted All Patients Baseline Value Parameter Normal Ranges Mean (SD) (At Rest) Systolic Blood Pressure (mm Hg) 136 (14.1) 90-120 Diastolic Blood Pressure (mm Hg) 78 (11.3) 60-80 Pulmonary Capillary Wedge Pressure (mm Hg) 21.1 (5.2) 4-1
Slide 10: TX45 was Well-Tolerated in PH-HFrEF After a Single Dose
10 TX45 was Well-Tolerated in PH-HFrEF After a Single Dose • No serious or severe adverse events, Treatment-emergent adverse events (TEAE) discontinuations, infusion related reactions or drug related adverse 0.3 mg/kg 1 mg/kg 3 mg/kg Total events Preferred Term (n = 1) (n = 1) (n = 12) (n = 14) • Al
Slide 11: TX45 Improved Left Heart Function and Pulmonary Hemodynamics in PH-HFrEF Patients
11 TX45 Improved Left Heart Function and Pulmonary Hemodynamics in PH-HFrEF Patients CFB* % CFB* Hemodynamic Endpoints Mean [95% CI] Mean [95% CI] Key Hemodynamic Endpoints (n = 14) PCWP in all participants -6.4 [-8.6 to -4.2] mm Hg -29.2% [-36.0% to -22.4%] PVR in CpcPH (PVR ≥ 3 WU) (n = 7) -1.
Slide 12: Echo Results at Day 29 Demonstrated Sustained Improvement in Markers of LV and RV Function
12 Echo Results at Day 29 Demonstrated Sustained Improvement in Markers of LV and RV Function, and Pulmonary Hemodynamics Data Presented as Mean ± SD for All Subjects (n = 14) LVEF TAPSE/SPAP RVFAC CFB Mean [95% CI] +6.2 [+2.7 to +9.7] +0.10 [+0.03 to +0.17] +5.1 [-0.11 to +10.3] % CFB Mean [95% CI]
Slide 13: Summary: TX45 Improves Cardiac and Pulmonary Hemodynamics in PH-HFrEF and PH-HFpEF Patients
13 Summary: TX45 Improves Cardiac and Pulmonary Hemodynamics in PH-HFrEF and PH-HFpEF Patients • TX45 was well-tolerated in both patient populations • TX45 demonstrated hemodynamic improvements in both left heart function and in the pulmonary vasculature in PH-HFrEF, consistent with effects in PH-HF