AB8939 / AB Science - LARVOL DELTA

AB Science announces today the successful completion of capital increases of a total gross amount of EUR 14.2 million (GlobeNewswire) - "Use of proceeds..The Company intends to use the net proceeds from the Private Placement to fund its research and development programs, with primary focus on: AB8939 development in acute myeloid leukemia; Masitinib development in amyotrophic lateral sclerosis; and Nearer-term value-creation projects that are expected to be finalized and disclosed in September....This transaction strengthens the Company’s cash position and enables it to cover its financing needs beyond the next 12 months."

Financing • Acute Myelogenous Leukemia • Amyotrophic Lateral Sclerosis

AB Science provides an update on its clinical program, suspending some non-priority clinical trials to focus on two clinical programs (Yahoo Finance) - "AB Science...to focus on two clinical programs, the AB8939 program for acute myeloid leukemia and the masitinib program for amyotrophic lateral sclerosis....three clinical studies—which the company currently considers non-priority and for which patient enrollment had been suspended—are being discontinued, namely: Phase 2 study (AB20006) of masitinib in mast cell activation syndrome; Phase 3 study (AB15003) of masitinib in mastocytosis; Phase 3 study (AB20009) of masitinib in progressive forms of multiple sclerosis....The discontinuation of these studies is not related to any safety concerns regarding masitinib. The company intends to complete these clinical studies in accordance with applicable regulations...The next step is to seek authorization from health authorities—based on a preliminary favorable opinion from the study's Independent Data Monitoring Committee (IDMC)—to initiate Phase 4 of the study, which will evaluate the triple combination of AB8939..."

New P4 trial • Trial suspension • Acute Myelogenous Leukemia • Amyotrophic Lateral Sclerosis • Hematological Malignancies • Immunology • Multiple Sclerosis

AB Science announces the successful completion of a EUR 2.3 million private placement (GlobeNewswire) - "The Company intends to use the net proceeds of the Private Placement to finance research and development programs of the Company, the priority being the AB8939 program in acute myeloid leukemia....This transaction strengthens the Company’s cash position and enables it to cover its financing needs beyond the next 12 months."

Financing • Acute Myelogenous Leukemia

AB Science…today provides an update on the Phase 1 study of the molecule AB8939 and the completion of Step 3, evaluating the combination of AB8939 + venetoclax in patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile (The Manila Times) - "The combination of AB8939 with venetoclax generated a 67% overall response rate (ORR) and a 100% disease control rate (DCR), with no dose-limiting toxicities (DLT) observed, in a poor-prognosis population with adverse genetics treated in the second- to fourth-line relapsed or refractory setting...With Step 3 completed, the next step is Step 4, evaluating the triple combination of AB8939 + venetoclax + azacitidine."

P1 data • Trial status • Acute Myelogenous Leukemia

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: AB Science | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

AB Science announces the successful completion of a EUR 3.2 million private placement (The Manila Times) - "The Company intends to use the net proceeds of the Private Placement to finance its ongoing activities, with a focus on the clinical development of the AB8939 program."

Financing • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

AB Science SA...announces today that a final agreement has been reached with its financial creditors for the 24-month deferral of repayment of its bank debt (for a total amount of approximately €3.7 million) and the 12-month deferral of repayment of a loan subscribed with the EIB (for a total principal amount of €12 million, initially repayable in January and December 2028). (Yahoo Finance UK) - "AB Science has reached a final agreement with its financial creditors; This agreement provides for a two-year deferral of repayment of the State-Guaranteed Loans and a 12-month deferral of the repayment date of the EIB Covid credit; The savings over the period will be invested in R&D...'Having secured insurance for its Phase III clinical trial, AB Science is honored to receive the confidence of its banking partners, who are extending the maturity of their loans. AB Science will now focus on its Phase III study in amyotrophic lateral sclerosis and its AB8939 program.'"

Financing • Acute Myelogenous Leukemia • Amyotrophic Lateral Sclerosis • Myelodysplastic Syndrome

Voluntary temporary halt of clinical trials in Europe (Yahoo Finance) - "The recruitment of new patients in AB Science studies has been voluntarily halted while AB Science was negotiating with the insurer and was having on-going exchanges with European health authorities...AB Science submitted detailed responses to the agencies and is reviewing its strategic priorities, namely:To deprioritize development in mastocytosis and mast cell activation program...To pursue the phase 3 clinical development in multiple sclerosis and Alzheimer’s disease through partnerships...To prioritize AB Science clinical development program on the masitinib phase 3 in amyotrophic Lateral Sclerosis (ALS) and AB8939 phase 1 in acute myeloid leukemia (AML)."

Discontinued • New P3 trial • Trial status • Trial suspension • Acute Myelogenous Leukemia • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Multiple Sclerosis • Rare Diseases

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Active, not recruiting | Sponsor: AB Science | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia (GlobeNewswire) - "The combination treatment was well-tolerated, with no hematological toxicity and no dose limiting toxicity. The fourth patient had a complex karyotype including a monosomy of chromosome 5 and TP53 mutation, and was in the third-line of treatment. He had a near complete response after 14 days of treatment with AB8939 at 21 mg/m2 plus venetoclax. This is the fourth patient responding to the combination from a total of 4 patients treated. The partial response rate is 100% (4/4), including one patient in complete remission, one near complete response and 2 partial responses."

P1 data • Acute Myelogenous Leukemia

AB SCIENCE RELEASES INITIAL DATA ON THE COMBINATION OF AB8939 WITH VENETOCLAX FOR THE TREATMENT OF REFRACTORY OR RELAPSED ACUTE MYELOID LEUKEMIA (AML): THE FIRST THREE PATIENTS, ALL OF WHOM HAVE AML WITH VERY UNFAVORABLE GENETIC PROFILES, ARE RESPONDING TO TREATMENT (GlobeNewswire) - "The combination treatment is well-tolerated, with no hematological toxicity; The disease control rate is 100% (3/3); The partial response rate is 100% (3/3), including one patient in complete remission....Phase 1 continues with a new stage that will evaluate a higher dose of AB8939, still in combination with venetoclax."

P1 data • Trial status • Acute Myelogenous Leukemia

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: AB Science | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Aug 2026

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

AB Science announces the successful completion of a EUR 1.925 million private placement (GlobeNewswire) - "AB Science S.A...announces today the successful completion of a capital increase of a total gross amount of EUR 1.925 million subscribed by a limited number of investors (the 'Private Placement')....The Company intends to use the net proceeds of the Private Placement to finance its ongoing activities, with a focus on the clinical development of the AB8939 program."

Financing • Oncology

AB Science announces issuance of a Canadian patent protecting the composition of matter of AB8939, including its use in the treatment of acute myeloid leukemia, with protection until 2036 (GlobeNewswire) - "AB Science SA...announced that the patent office of Canada has granted a patent (CA 2975644) protecting the composition of matter of AB8939, and closely related compounds, until 2036. This patent also covers the use of AB8939 in the treatment of hematological disorders and/or proliferative disorders and provides a strong overall protection for the AB8939 clinical development program, including the treatment of acute myeloid leukemia (AML)....A separate secondary medical use patent application was filed to protect the use of AB8939 for the treatment of AML with certain chromosomal abnormalities, which if granted, would extend AB8939 protection until 2044 in these sub-populations of AML patients."

Patent • Acute Myelogenous Leukemia

AB Science announces the settlement delivery of its latest capital increase for €1.8 million (GlobeNewswire) - "This transaction strengthens the Company's cash position and enables it to cover its financing needs in 2025 and beyond the next 12 months, taking into account the explanations set out in section 5.2.1.5 (note 2) of the 2024 financial report."

Commercial • Acute Myelogenous Leukemia • Alzheimer's Disease • Chronic Obstructive Pulmonary Disease • Immunology • Melanoma • Myelodysplastic Syndrome • Oncology • Parkinson's Disease • Rheumatoid Arthritis

Update on the AB8939 microtubule program and in particular on the ability of AB8939 to generate a response on MECOM rearrangement (GlobeNewswire) - "The intellectual property rights of AB8939 in AML are guaranteed until 2036 through a ‘composition of matter’ patent and potentially until 2044 in AML with chromosomal abnormalities, including the MECOM gene, through a ‘second medical use’ patent."

Patent • Acute Myelogenous Leukemia

AB Science announces that EMA granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (GlobeNewswire) - "AB Science SA...announces today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (AML)."

Orphan drug • Acute Myelogenous Leukemia

AB Science provides a summary of the webcast held on December 16, 2024 (GlobeNewswire) - "The objective of the phase 1 is to determine the maximum tolerated dose (MTD) for three different cycles of AB8939. The first step of the phase 1 has been completed with 28 patients enrolled...The second step of the phase 1 is close to completion and enrolled 10 patients...Preliminary activity in MECOM...AB8939 is a stem cell ALDH targeted therapy with potential use in AML with MECOM. ALDH gene expression is a marker of survival prognosis in AML. The higher the expression, the worse the prognosis; MECOM is associated with the worst prognosis in AML; The expression of ALDH1A1 is regulated by EVI1 and has an outstanding role in the formation and transformation of hematopoietic cells and in particular leukemia stem cells...AB8939 has shown activity on MECOM rearrangement, based on non-clinical data and early clinical data in relapsing/refractory line of treatment, with 50% response rate observed."

Clinical • Trial status • Acute Myelogenous Leukemia

AB Science provides a summary of the webcast held on December 16, 2024 (GlobeNewswire) - "AB Science SA...today provides an update on its AB8939 program in acute myeloid leukemia (AML)...AB8939 blocks proliferating leukemia cells through microtubules...AB8939 targets leukemia cancer stem cells though inhibition of ALDH...Non clinical pharmacology...i) AB8939 is active against chemotherapy naive or chemotherapy refractory/relapsing patient’s AML cancers cells ex vivo; ii) AB8939 eradicates blasts in Blood and Bone Marrow in 5-AraC-resistant (Cytarabine) PDX; iii) AB8939 increases survival and has an additive effect in combination with reference treatment Azacitidine and Venetoclax; iv) ALDHs expression is a hallmark of cancer stem cells (CSCs) and AB8939 is an inhibitor of ALDH1/2. Therefore, AB8939 is a targeted therapy for leukemia cancer stem cells; v) AB8939 eradicates Leukemia Cancer Stem Cells in a human PDX AML model."

Preclinical • Acute Myelogenous Leukemia

AB Science announces a capital increase of 5.0 million euros [Google translation] (GlobeNewswire) - "AB Science SA...announces today a capital increase of €5.0 million...through the issuance of 5,368,725 new ordinary shares, each of which is subject to share subscription warrants. This capital increase was subscribed by European qualified investors...'his fundraising is primarily intended to finance the phase 2 clinical development of the microtubule program (AB8939).'...The proceeds of the Capital Increase will provide AB Science with the additional resources needed to finance its activities over the next twelve months, including the clinical development of masitinib in amyotrophic lateral sclerosis and other orphan diseases, as well as the development of AB Science's microtubule destabilizer platform."

Financing • Amyotrophic Lateral Sclerosis • CNS Disorders • Oncology

AB Science provides an update on the microtubule program AB8939 and in particular the ability of AB8939 to generate response on MECOM rearrangement (GlobeNewswire) - P1/2 | N=78 | NCT05211570 | Sponsor: AB Science | "The phase 1 clinical trial of AB8939 completed its first step, consisting in determining the maximum tolerated dose following 3 consecutive days of AB8939 treatment, and was authorized to proceed with the next step, consisting in determining the maximum tolerated dose following 14 consecutive days of AB8939 treatment...In the phase 1 trial, 4 patients bore the MECOM rearrangement and 50% responded to AB8939 when used as a single agent. In phase 1, so far, AB8939 does not appear to be toxic to bone marrow, avoiding severe neutropenia and suggesting the possibility to use the drug for long-term treatment. A phase 2 with a limited sample size...would probably be convincing enough for an accelerated approval. This will be discussed with FDA in future regulatory milestone. This study could be implemented in 2025."

P1/2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: AB Science | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2024

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

AB Science reports a first complete bone marrow response in a relapsed refractory acute myeloid leukemia patient from the very low dose arm of its AB8939 Phase I/II clinical trial (AB18001) (Market Screener) - P1/2 | N=78 | NCT05211570 | Sponsor: AB Science | "AB Science SA...announces a case report from the initial stage of its Phase I/II study (AB18001) evaluating AB8939, a microtubule destabilizer, in patients with refractory and relapsed acute myeloid leukemia (AML)....One month after the first treatment cycle (i.e., three consecutive days of AB8939 treatment) there was a drastic reduction in bone marrow blast cells (i.e., leukemia cells), from a pretreatment level of 55% to 5% (i.e., a morphologic leukemia free state). Remarkably, this response was achieved at a very low dose of AB8939, corresponding to the second step of dose increment (out of 13 potential steps) in phase I. The patient also showed excellent tolerance to AB8939, having experienced no treatment-related toxicities....AB Science will host a live webcast on Thursday March 16, 2023, from 6pm to 7pm CET, to present in further detail the synthetic microtubule destabilizers platform and the on-going phase 1/2 with AB8939."

P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: AB Science | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Not yet recruiting | Sponsor: AB Science | Initiation date: Mar 2022 ➔ Jun 2022

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology