On March 27, 2020 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 fourth quarter and full-year 2019 financial results and business updates (Press release, Monopar Therapeutics, MAR 27, 2020, View Source [SID1234555944]).
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Fourth Quarter and Recent Highlights
Initial Public Offering
In December 2019, the Company completed its initial public offering of 1,277,778 shares of common stock, including the underwriters’ exercise of their over-allotment option, at a public offering price of $8.00 per share before underwriting discounts and commissions.
The shares began trading on the Nasdaq Capital Market on December 19, 2019 under the symbol "MNPR."
Orphan Drug Designation
On February 18, 2020, the Company announced that the European Commission has granted Orphan Drug Designation for the Company’s Phase 2 clinical-stage drug candidate, camsirubicin, for the treatment of soft tissue sarcomas. Camsirubicin is being developed under a clinical trial partnership with Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcoma cancers. The approximately 170-patient GEIS-sponsored camsirubicin Phase 2 clinical trial for the treatment of advanced soft tissue sarcoma is anticipated to begin in the second half of 2020.
European Orphan Drug Designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of market exclusivity. Designated orphan medicines are also eligible for conditional marketing authorization. Camsirubicin has already received Orphan Drug Designation in the U.S. by the Food and Drug Administration (FDA), which provides for similar benefits such as fee reductions and 7 years of market exclusivity.
Fourth Quarter and Full Year Summary Financial Results
Results for the Quarter and Year Ended December 31, 2019 Compared to the Quarter and Year Ended December 31, 2018
Cash and cash equivalents as of December 31, 2019 were approximately $13.2 million, compared to approximately $6.9 million as of December 31, 2018. The increase in cash and cash equivalents was driven primarily by the approximately $9.4 million net cash proceeds from the Company’s initial public offering offset by approximately $3.0 million of cash used in operating activities.
Research and Development (R&D) Expenses
R&D expenses for the quarter ended December 31, 2019 were approximately $0.6 million, compared to approximately $0.5 million for the quarter ended December 31, 2018, an increase of approximately $0.1 million.
R&D expenses for the year ended December 31, 2019 were approximately $2.0 million, compared to approximately $1.8 million for the year ended December 31, 2018, an increase of approximately $0.2 million.
General and Administrative (G&A) Expenses
G&A expenses for the quarter ended December 31, 2019 were approximately $0.6 million, compared to approximately $0.4 million for the quarter ended December 31, 2018, an increase of approximately $0.2 million.
G&A expenses for the year ended December 31, 2019 were approximately $2.4 million, compared to approximately $1.6 million for the year ended December 31, 2018, an increase of approximately $0.8 million.
Net loss was $0.13 per share for the fourth quarter of 2019, compared to $0.10 per share in the comparable period in 2018. For the year ended December 31, 2019, net loss was $0.45 per share compared to $0.35 per share in the same period in 2018.