BP1002 / Bio-Path - LARVOL DELTA

BP1002-102-AML: A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Bio-Path Holdings, Inc. | Trial completion date: Sep 2024 ➔ Sep 2027 | Trial primary completion date: Mar 2024 ➔ Mar 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

BP1002-101-Lymph: A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Bio-Path Holdings, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Apr 2025 | Trial primary completion date: Sep 2024 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma • Waldenstrom Macroglobulinemia

Bio-Path Holdings Provides Update from Phase 1/1b Clinical Trial of BP1002 for Treatment of Refractory/Relapsed Acute Myeloid Leukemia (GlobeNewswire) - "Bio-Path Holdings...provides an update from the Company’s ongoing Phase 1/1b clinical trial evaluating BP1002 for the treatment of refractory/relapsed acute myeloid leukemia (AML), including venetoclax-resistant patients. The Company announced a meaningful patient response to treatment and the clinical trial has progressed to the fourth, higher dose cohort of 90 mg/m2....'The third dosing cohort completed enrollment faster than expected, which we believe reflects the urgent need for additional treatment options. We look forward to quickly advancing this study through the fourth dosing cohort and into the combination therapy segment of this Phase 1/1b study with increased levels of BP1002 for the treatment of these vulnerable patients'."

Trial status • Acute Myelogenous Leukemia

Bio-Path Holdings Reports Third Quarter 2024 Financial Results (GlobeNewswire) - "In October, Bio-Path announced completion of enrollment for the third dosing cohort of the Company’s Phase 1/1b trial of BP1002 in venetoclax-resistant AML patients....Research and development expense for the three months ended September 30, 2024 decreased to $1.3 million, compared to $2.3 million for the three months ended September 30, 2023 primarily due to decreased manufacturing expenses related to drug product releases as well as a decrease in expense related to our clinical trial for BP1001 in AML due to timing of patient enrollment during the quarter."

Commercial • Enrollment status • Acute Myelogenous Leukemia

Completion of Enrollment for Third Dosing Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed AML Patients (GlobeNewswire) - "After the U.S. Food and Drug Administration (FDA) completed its review of data from the first two dosing cohorts in the Phase 1/1b clinical trial in refractory/relapsed AML patients, Bio-Path initiated enrollment for the third, higher-dosing cohort of 60 mg/m2. Enrollment was completed faster than projected within six weeks, which underscores the continuing need for new treatment options."

Enrollment status • FDA event • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Bio-Path Holdings Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "Research and development expense for the three months ended June 30, 2024 decreased to $1.9 million, compared to $3.1 million for the three months ended June 30, 2023 primarily due to decreased manufacturing expenses related to drug product releases partially offset by an increase in expense related to our clinical trial for BP1002 in lymphoma due to increased patient enrollment in 2024."

Commercial • Hematological Malignancies • Lymphoma • Oncology

Bio-Path Holdings Provides Clinical Update and Expansion Plans (GlobeNewswire) - "Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML...Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024....Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL)...Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end."

PK/PD data • Trial status • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

Bio-Path Holdings Reports First Quarter 2024 Financial Results (GlobeNewswire) - "Research and development expense for the three months ended March 31, 2024 decreased to $2.3 million, compared to $4.0 million for the three months ended March 31, 2023 primarily due to decreased manufacturing expenses related to drug product releases partially offset by an increase in expense related to our clinical trial for BP1002 in lymphoma due to increased patient enrollment in the first quarter of 2024."

Commercial • Hematological Malignancies • Lymphoma • Oncology

Bio-Path Holdings Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients (GlobeNewswire) - "Bio-Path Holdings...announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients....Initially, the dose escalation portion of the clinical plan calls for a total of six evaluable patients to be treated with BP1002 monotherapy over two dose levels in a standard 3+3 design, with a starting dose of 20 mg/m2 and the second dose of 40 mg/m2....The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients."

Trial status • Acute Myelogenous Leukemia

Bio-Path Holdings Provides 2024 Clinical and Operational Update (GlobeNewswire) - "Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL)...Enrollment is now open for patients for the second BP1002 dose cohort of 40 mg/m2....Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer)."

Enrollment status • New P1 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Bio-Path Holdings, Inc. | Trial completion date: Jan 2025 ➔ Jan 2026

Metastases • Trial completion date • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma • Waldenstrom Macroglobulinemia

Bio-Path Holdings Announces Completion of First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients (GlobeNewswire) - "Bio-Path Holdings, Inc...announced completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle antisense, for the treatment of refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients."

Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Bio-Path Holdings Successfully Completes First Dose Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia - P1 | N=48 | (NCT05190471) | Sponsor: Bio-Path Holdings, Inc. | "The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients. Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial...Gary Schiller...are each serving as principal investigators."

P1 data

Bio-Path Holdings Successfully Completes First Dose Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (GlobeNewswire) - "Bio-Path Holdings...announced completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients including venetoclax-resistant patients....A total of three evaluable patients per dosing cohort are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients tested....The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients."

Trial status • Acute Myelogenous Leukemia

A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Bio-Path Holdings, Inc. | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Sep 2023 ➔ Sep 2024

IO biomarker • Metastases • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma • Waldenstrom Macroglobulinemia • BCL2

Bio-Path Holdings Reports First Quarter 2023 Financial Results (GlobeNewswire) - "Important Near-Term Clinical Milestones - BP1001-A Phase 1/1b Clinical Trial in Solid Tumors: Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout currently expected mid-year. BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML: Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected mid-year."

P1 data • Trial status • Acute Myelogenous Leukemia • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Bio-Path Holdings Reports Full Year 2022 Financial Results (GlobeNewswire) - "Important Near-Term Clinical Milestones - BP1001-A Phase 1/1b Clinical Trial in Solid Tumors: Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout expected before mid-year. BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML: Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected in the second quarter of 2023."

P1 data • Trial status • Acute Lymphocytic Leukemia • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Uterine Cancer

Bio-Path Holdings Provides Clinical and Operational Update (GlobeNewswire) - "BP1001-A Phase 1/1b Clinical Trial in Solid Tumors: Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout expected before mid-year. BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML: Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected in the second quarter of 2023. Prexigebersen (BP1001) Phase 2 Clinical Trial in AML...Assess safety and efficacy of each cohort treatment combination therapy with potential to qualify for expedited program status after cohort’s initial interim analysis, which are expected to commence by cohort in the second quarter of 2023."

P1 data • Trial status • Acute Myelogenous Leukemia • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Uterine Cancer

Bio-Path Holdings Announces First Patient Dosed in Phase 1/1b Study of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia Patients (GlobeNewswire) - "Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial. Dr. Roboz...Gary Schiller, M.D...are each serving as principal investigators."

Bio-Path Holdings Announces First Patient Dosed in Phase 1/1b Study of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia Patients (GlobeNewswire) - "Bio-Path Holdings, Inc...announced the enrollment and dosing of the first patient in a Phase 1/1b clinical trial evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients....Initially, a total of six evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Bio-Path Holdings, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2

Bio-Path Holdings Reports Second Quarter 2022 Financial Results (GlobeNewswire) - "...'We look forward to initiating our Phase 1 studies of BP1001-A, a drug product modification of prexigebersen, for the treatment of solid tumors and of BP1002 to treat relapsed/refractory acute myeloid leukemia (AML), including venetoclax resistant patients, in the coming weeks'..."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Bio-Path Holdings, Inc. | Initiation date: Apr 2022 ➔ Jul 2022

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2

A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Bio-Path Holdings, Inc. | Trial completion date: Aug 2022 ➔ Jan 2024 | Trial primary completion date: Feb 2022 ➔ Sep 2023

IO biomarker • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma • Waldenstrom Macroglobulinemia • BCL2

A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Bio-Path Holdings, Inc. | Initiation date: Jan 2022 ➔ Apr 2022

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2