Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS

Key Inclusion Criteria:

1. Participant must be ≥18 years of age

2. Participant must have confirmed diagnosis as follows: R/R AML and has not achieved adequate response to, cannot tolerate, or refused allapproved therapies known to be active for treatment of their disease OR R/R MDS withover 10% blasts in the bone marrow and has not achieved an adequate response to atleast 4 cycles of a hypomethylating agent (HMA)- containing regimen or othertreatment known to be active for their disease OR R/R AML or R/R MDS that hasrelapsed after a hematopoietic stem cell transplant (HSCT)

3. Participant must be willing and able to comply with scheduled study visits andtreatment plans.

4. Participant must be willing to undergo all study procedures unless contraindicateddue to medical risk.

5. Participant must have an Eastern Cooperative Oncology Group (ECOG) performancestatus (PS) of ≤2

6. Participant must have adequate hepatic function

7. Participant must have adequate renal function

8. Participant must have adequate cardiovascular function

9. Participant must have a white blood cell (WBC) count ≤20 × 10⁹/L (with stablehydroxyurea use allowed)

10. Participant must meet timing requirements with respect to prior therapy and surgery

11. Participant must agree to use effective contraception during the study and for therequired post-treatment period: Males: Use condoms (even if vasectomized) during thestudy and for 90 days post-treatment. Females of childbearing potential: Use acombination of 1 highly effective and 1 effective method of contraception during thestudy and for 180 days post-treatment.

Key Exclusion Criteria:

1. Participant is unable to provide informed consent and/or to follow protocolrequirements.

2. Participant has undergone chimeric antigen receptor T cell therapy or HSCT within 60days of the first dose of study treatment or has active clinically significantgraft-versus-host disease (GVHD)

3. Participant has another malignancy that may interfere with diagnosis and treatmentof R/R AML or R/R MDS.

4. Participant has an active severe infection that requires anti-infective therapy orhas an unexplained temperature of >38.5°C during screening visits or on their firstday of study treatment.

5. Participant has a known sensitivity to AUTX-703 or any of its components.

6. Participant is taking systemic strong CYP3A4 inhibitors or inducers within 14 daysof the first dose of study treatment.

7. Participant who are taking proton pump inhibitors should be switched to anotheracid-reducing agent such as an antacid or H2 blocker

8. Participant is taking P-gp and breast cancer resistance protein (BCRP) inhibitors orinducers within 14 days of first dose of study treatment.

9. Participant has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infectionswith detectable viral load

10. Participant has experienced AIDS related illness within the past 6 months or havedetectable HIV viral load.

11. Participant has an uncontrolled intercurrent illness

12. Participant has active Class III or IV cardiovascular disease within 6 months priorto the start of study treatment

13. Participant is unable to tolerate the administration of oral medication or has GIdysfunction that would preclude adequate absorption, distribution, metabolism, orexcretion of an oral medication

14. Participant is pregnant or breastfeeding or is planning to become pregnant within 1year of the start of study treatment