A Phase 2b Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults With Newly-Diagnosed Acute Myeloid Leukemia (AML), Not Eligible for Standard Induction Therapy

• Adult ≥18 years of age

• AML according to the 2016 revision to the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: ≥20% blasts in peripheral blood or marrow

∙ de-novo AML or

‣ AML secondary to MDS or

‣ AML secondary to exposure to potentially leukemogenic therapies or agents (e.g. radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years

• Not eligible for standard induction chemotherapy;

∙ Age ≥75 years or

‣ Age ≥18 years with at least one of the following comorbidities:

• i. Clinically significant heart or lung comorbidities, as reflected by at least one of:

⁃ Left ventricular ejection fraction (LVEF) ≤50%

⁃ Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected

⁃ Forced expiratory volume in 1 second (FEV1) ≤65% of expected ii. Chronic stable angina or congestive heart failure controlled with medication iii. Other contraindication(s) to anthracycline therapy (must be documented) iv. Other comorbidity that the Investigator judges as incompatible with intensive remission induction chemotherapy, which must be documented

• Creatinine clearance (estimated by the Cockroft-Gault (C-G) or measured by 24 hours urine collection) ≥45 mL/min

• Liver enzymes (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 times the upper limits of normal (ULN)

• Total bilirubin ≤1.5 x ULN unless due to known history of Gilbert's disease

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening

• Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study

• Women of reproductive potential must have a negative serum pregnancy test within 48 hours of the first day of any BST-236 treatment course

⁃ Women or men of reproductive potential must use (or have his/her partner use) two forms of effective birth control methods starting from 1 month prior to screening and until 3 months following the last BST-236 administration day (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, partner's vasectomy, or double-barrier method condom or diaphragm with spermicide)

⁃ Patient must voluntarily sign and date an ICF, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures

⁃ Patient must be able to adhere to the study visit schedule and other protocol requirements