On May 12, 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 first quarter 2022 financial results and summarized recent program developments (Press release, Monopar Therapeutics, MAY 12, 2022, View Source [SID1234614314]).

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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, 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 quarter of 2022 was $2.5 million or $0.19 per share compared to net loss of $1.9 million or $0.16 per share for the first quarter of 2021.

Research and Development (R&D) Expenses

R&D expenses for the three months ended March 31, 2022 were $1,678,000, compared to $1,207,000 for the three months ended March 31, 2021. The increase of $471,000 is attributed to (1) an increase of $244,000 in Validive clinical trial-related and clinical material manufacturing-related expenses, (2) an increase of $193,000 in R&D personnel expenses and (3) a $34,000 net increase of other R&D expenses.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended March 31, 2022 were $779,000, compared to $688,000 for the three months ended March 31, 2021. The increase of $91,000 is primarily attributed to an increase in G&A personnel expenses.