On November 10, 2022 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, reported third quarter 2022 financial results and summarized recent program developments (Press release, Monopar Therapeutics, NOV 10, 2022, View Source [SID1234623658]).

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Recent Program Developments

Validive – International Phase 2b/3 Trial, Interim Go/No-go Analysis on Track for Q1 2023

The VOICE trial continues to enroll patients and add additional clinical sites (now at 73 active sites and over 130 patients dosed across the U.S. and Europe).

Enrollment for the Phase 2b portion of the trial has been completed. The trial recently expanded to include sites in Germany and Poland, and enrollment for the Phase 3 portion of the trial has commenced.

The blinded interim analysis of clinical data from the Phase 2b patient cohort of the trial, to be performed by an independent data monitoring board, will be used to guide the Company as to whether or not to continue enrolling the Phase 3 portion of the trial. This analysis should be completed and reported out in Q1 2023.

Camsirubicin – Phase 1b Dose-Escalation Trial, Data to be Presented Next Week at CTOS 2022

Monopar is currently dosing the fourth dose-level cohort, which is approximately double the highest dose of camsirubicin ever tested in a prior trial.

Early results from the open-label camsirubicin Phase 1b clinical trial will be presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting Conference being held on November 16-19, 2022 in Vancouver, BC.

MNPR-101 Radioimmunotherapeutic – Preclinical Studies Being Conducted to Support FIH Study

Monopar is actively conducting preclinical studies to support a submission for a first-in-human (FIH) study with an MNPR-101-based radioimmunotherapeutic/radiodiagnostic that the Company has generated with its partner NorthStar Medical Radioisotopes, LLC.

MNPR-202: Preclinical Data to be Presented at ASH (Free ASH Whitepaper) 2022 in December

Monopar’s collaborator, the Cancer Science Institute of Singapore at the National University of Singapore, has been testing MNPR-202 in preclinical cancer models with promising results.

Monopar and Cancer Science Institute of Singapore will present a poster of MNPR-202 preclinical data at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting being held on December 10-13, 2022, in New Orleans, LA. The poster abstract can be found at the following link: View Source

Results for the Third Quarter Ended September 30, 2022, Compared to the Third Quarter Ended September 30, 2021

Cash and Net Loss

Cash and cash equivalents as of September 30, 2022, were $14.3 million. Monopar anticipates that its current cash and cash equivalents will fund: the completion of 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 November 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 third quarter of 2022 was $2.4 million or $0.19 per share compared to net loss of $2.5 million or $0.20 per share for the third quarter of 2021.

Research and Development (R&D) Expenses

R&D expenses for the three months ended September 30, 2022, were $1,732,000, compared to $1,827,000 for the three months ended September 30, 2021. The decrease of $95,000 is attributed to (1) a decrease of $272,000 in R&D personnel expenses and (2) a $60,000 net decrease of other R&D expenses, partially offset by an increase of $237,000 in Validive clinical trial-related and clinical material manufacturing-related expenses.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended September 30, 2022, were $675,000, compared to $632,000 for the three months ended September 30, 2021. The increase of $43,000 was primarily the result of an increase in G&A personnel expenses.