Press release
Monopar Therapeutics Reports First Quarter 2022 Financial Results and Recent Program Developments
Validive® Phase 2b/3 VOICE Trial Continues Enrolling Patients Toward InterimCamsirubicin Phase 1b Dose-Escalation Trial Clears 3rd Dose Level, Now Enrolling
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Validive® Phase 2b/3 VOICE Trial Continues Enrolling Patients Toward InterimCamsirubicin Phase 1b Dose-Escalation Trial Clears 3rd Dose Level, Now Enrolling 4th WILMETTE, Ill., May 12, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2022 financial results and summarized recent program developments. Recent Program Developments Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting The VOICE trial continues to enroll patients and add additional clinical sites, with the interim analysis anticipated to occur in 2H-2022. Camsirubicin – Phase 1b Dose-Escalation Trial, Actively Recruiting Monopar has cleared the third dose-level and is currently enrolling the fourth dose-level cohort. The fourth dose-level is approximately double the highest dose of camsirubicin ever tested in a prior trial.Early signs of clinical benefit have been observed with camsirubicin in this Phase 1b trial. MNPR-101 Radioimmunotherapeutic (“RIT”) Monopar is currently evaluating pathways to initiate a first-in-human study with the MNPR-101-PCTA radioimmunotherapeutic/radiodiagnostic candidate that Monopar generated with its partner NorthStar Medical Radioisotopes, LLC. MNPR-202 Monopar’s collaborator, the Cancer Science Institute of Singapore at the National University of Singapore, is testing MNPR-202 in preclinical cancer models and the Company is awaiting initial results. Results for the First Quarter Ended March 31, 2022, Compared to the First Quarter Ended March 31, 2021 Cash and Net Loss Cash and cash equivalents as of March 31, 2022 were $17.8 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through at least June 2023. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development through and beyond the ongoing open-label, dose escalation Phase 1b clinical trial. Net loss for the first qu...