On August 11, 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 second quarter 2022 financial results and summarized recent program developments (Press release, Monopar Therapeutics, AUG 11, 2022, View Source [SID1234618156]).
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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 in the U.S. and Europe (now at 58 active sites). Based on findings extracted from public reporting of recently completed severe oral mucositis (SOM) trials that led to subsequent enhancements being made to Monopar’s interim analysis, the Company anticipates the interim analysis to occur in Q1 2023.
Camsirubicin – Phase 1b Dose-Escalation Clinical Trial, Actively Recruiting
Monopar has cleared the third dose-level and is currently dosing 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
Monopar is actively 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, tested MNPR-202 in preclinical cancer models with promising results and is currently conducting additional preclinical studies. The aim is to submit an abstract of the results to one or more scientific/medical conferences within the coming months.
Results for the Second Quarter Ended June 30, 2022, Compared to the Second Quarter Ended June 30, 2021
Cash and Net Loss
Cash and cash equivalents as of June 30, 2022 were $16.5 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 September 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 second quarter of 2022 was $2.8 million or $0.22 per share compared to net loss of $2.1 million or $0.17 per share for the second quarter of 2021.
Research and Development (R&D) Expenses
R&D expenses for the three months ended June 30, 2022 were $2,078,000, compared to $1,476,000 for the three months ended June 30, 2021. The increase of $602,000 is attributed to (1) an increase of $473,000 in camsirubicin clinical trial expenses including patient dosing and manufacturing-related expenses, (2) an increase of $302,000 in Validive clinical trial-related and clinical material manufacturing-related expenses, and (3) a $9,000 net increase in other R&D expenses (4) offset by a decrease of $182,000 in R&D personnel costs.
General and Administrative (G&A) Expenses
G&A expenses for the three months ended June 30, 2022 were $685,000, compared to $616,000 for the three months ended June 30, 2021. The increase of $69,000 is primarily the result of an increase in G&A personnel expenses.