MTX-005 / Memo Therap - LARVOL DELTA

SAFE KIDNEY II: Safety, Tolerability and Efficacy of AntiBKV As Treatment of BKV Infection in Kidney Transplant Recipients (clinicaltrials.gov) - P2/3 | N=180 | Active, not recruiting | Sponsor: Memo Therapeutics AG | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Nov 2024 ➔ Mar 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Transplantation

Memo Therapeutics AG Raises CHF 25 Million Series C Financing to Complete Phase II Clinical Development of AntiBKV for BKV Infection in Renal Transplant Patients (Businesswire) - "Memo Therapeutics AG...announced today the closing of a CHF25 million Series C financing led by Pureos Bioventures....MTx will use the proceeds to complete U.S. Phase II clinical development of its best- and first-in-class antibody, AntiBKV, intended to neutralize BK polyomavirus ('BKV') infection in kidney transplant recipients....With Phase II clinical data anticipated in 2024...we will also scale up CMC manufacturing of AntiBKV to ensure we have product ready for further clinical evaluation and in anticipation of a potential launch in 2025..."

Financing • Launch • P2 data • Infectious Disease

SAFE KIDNEY I: Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers. (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Memo Therapeutics AG | Active, not recruiting ➔ Completed

Trial completion • Renal Disease

Memo Therapeutics AG Receives FDA Fast Track Designation for AntiBKV as Treatment of BKV Infection in Renal Transplant Patients (Businesswire) - "Memo Therapeutics AG...announced today that the U.S. Food and Drug Administration ('FDA') has granted Fast Track designation to AntiBKV, MTx’s lead antibody therapeutic that targets BK polyomavirus ('BKV') infection commonly seen in renal transplant patients. AntiBKV has successfully completed a phase I clinical study and following FDA clearance has started actively recruiting patients for a pivotal phase II/III clinical trial....'We have recently started recruitment into a pivotal phase II/III clinical trial in the U.S. and plan for a subsequent BLA submission in 2024. We hope then to be able to offer patients a much needed therapeutic option by 2025 at the latest.'"

BLA • Fast track designation • New P2/3 trial • Infectious Disease

SAFE KIDNEY II: Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: Memo Therapeutics AG | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Transplantation

SAFE KIDNEY II: Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients (clinicaltrials.gov) - P2/3 | N=180 | Not yet recruiting | Sponsor: Memo Therapeutics AG

New P2/3 trial • Infectious Disease • Transplantation

SAFE KIDNEY I: Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers. (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Memo Therapeutics AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Renal Disease

SAFE KIDNEY I: Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers. (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Memo Therapeutics AG | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Aug 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Renal Disease

SAFE KIDNEY I: Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers. (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Memo Therapeutics AG | Not yet recruiting ➔ Recruiting

Enrollment open • Renal Disease

SAFE KIDNEY I: Phase 1, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers. (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Memo Therapeutics AG

New P1 trial • Renal Disease