On November 12, 2020 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported third quarter 2020 financial results and business update (Press release, Monopar Therapeutics, NOV 12, 2020, View Source [SID1234570745]).

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Third Quarter Business Update

Lead Product Candidate Validive

Monopar’s Phase 2b/3 clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy for oropharyngeal cancer (OPC) is on track to commence before year-end. There currently is no FDA-approved prevention or treatment for radiation-induced SOM.
The U.S. Patent and Trademark Office allowed patent claims for Monopar’s lead product candidate, Validive, covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." The recently issued patents would provide protection should Monopar determine in the future to conduct additional Validive development and commercialization activities related to adverse side effects of chemotherapy beyond OPC.
Camsirubicin

The Phase 2 clinical trial of camsirubicin is anticipated to begin at the end of 2020 or in early 2021. Monopar has partnered with Grupo Español de Investigación en Sarcomas (GEIS), which will lead the multi-country, randomized, open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against standard-of-care doxorubicin in patients with advanced soft tissue sarcoma (ASTS).
The trial will begin with a dose escalation "run-in" prior to the randomization portion of the trial. The primary endpoint of the trial will be progression-free survival, with secondary endpoints including overall survival, response rate, and incidence of treatment-emergent adverse events.
MNPR-101

Forward progress was made on the Monopar/NorthStar collaboration focused on developing a novel treatment for severe COVID-19 by partnering with 1) IsoTherapeutics Group, LLC to develop and manufacture radioimmunotherapeutics targeting uPAR (uPRITs), 2) Aragen Bioscience, Inc. to perform studies aimed at selecting a lead candidate uPRIT to advance into IND-enabling development, and 3) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies through the TLII and to participate in the clinical development of uPRITs.
Third Quarter Summary Financial Results

Results for the Third Quarter Ended September 30, 2020 Compared to the Third Quarter Ended September 30, 2019

Cash and Net Loss

Cash and cash equivalents as of September 30, 2020 were $18.0 million, which includes $6.7 million of net proceeds raised in the third quarter of 2020 under the Company’s Capital on Demand Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $9.66. Monopar anticipates that its current cash and cash equivalents will fund the Company’s planned operations through 2021, including the initiation and completion of the Phase 2b portion of its Validive clinical trial and the initiation of the Phase 3 portion, the funding of the initiation of the GEIS Phase 2 camsirubicin clinical trial, and continuation of the development of the COVID-19 uPRIT program. The Company will need to raise funds or engage a partner to complete the Validive Phase 3 clinical trial. Net loss for the third quarter of 2020 was $1.6 million or $0.15 per share compared to net loss of $0.7 million or $0.08 per share for the third quarter of 2019.

Research and Development (R&D) Expenses

R&D expenses for the third quarter of 2020 were $1.2 million, compared to $0.2 million, for the third quarter of 2019. This increase of $1.0 million is primarily attributed to increases in expenses for the planning of the camsirubicin Phase 2 clinical trial and manufacturing expenses of $0.4 million, increases in the Validive clinical trial planning and manufacturing expenses of $0.3 million, and increases in R&D personnel salaries and benefits, including equity grants and salaries and benefits for three new R&D personnel of $0.3 million.

General and Administrative (G&A) Expenses

G&A expenses for the third quarter of 2020 were $0.4 million, compared to $0.5 million, for the third quarter of 2019.