On November 12, 2021 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 2021 financial results and summarized recent clinical developments (Press release, Monopar Therapeutics, NOV 12, 2021, View Source [SID1234595449]).

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Recent Clinical Developments

Validive

Monopar received clearance in multiple European countries to conduct its Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer.
Monopar continues to actively initiate additional clinical sites in both the U.S. and the EU for the Phase 2b clinical trial, which is on track to reach the interim in the first half of 2022.
There remains no FDA-approved prevention or treatment for CRT-induced SOM.
Camsirubicin

Camsirubicin, a propriety doxorubicin analog, has been engineered specifically to retain the anticancer activity of doxorubicin while minimizing the toxic effects on the heart.
In August 2021, Monopar received clearance from the U.S. Food and Drug Administration to proceed under an Investigational New Drug (IND) application with an open-label Phase 1b dose-escalation clinical trial evaluating camsirubicin plus growth factor support (pegfilgrastim/G-CSF) in patients with advanced soft tissue sarcoma.
In September 2021, Monopar initiated the Phase 1b clinical trial, and in October 2021, dosed the first patients.
Monopar continues to work on activating additional clinical sites in the U.S. for the Phase 1b clinical trial.
Results for the Third Quarter Ended September 30, 2021, Compared to the Third Quarter Ended September 30, 2020

Cash and Net Loss

Cash and cash equivalents as of September 30, 2021, were $22.3 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 December 2022. 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 beyond the Phase 1b clinical trial.

Net loss for the third quarter of 2021 was $2.5 million or $0.20 per share compared to net loss of $1.6 million or $0.15 per share for the third quarter of 2020.

Research and Development (R&D) Expenses

R&D expenses for the third quarter of 2021 were $1.8 million compared to $1.2 million for the third quarter of 2020. This increase of $0.6 million was primarily due to increases of $0.5 million for VOICE clinical trial expenses and $0.2 million for R&D personnel expenses offset by a decrease of $0.1 million for Phase 1b camsirubicin clinical trial expenses.

General and Administrative (G&A) Expenses

G&A expenses for the third quarter of 2021 were $0.6 million, compared to $0.4 million for the third quarter of 2020. This increase of $0.2 million was primarily due to an increase in G&A personnel expenses.