Monopar Therapeutics(MNPR) - 2022 Q4 - Annual Report

Financial Position - As of December 31, 2022, the company's cash, cash equivalents, and investments totaled $13.1 million, expected to fund ongoing clinical trials through the end of 2023[335]. - The company incurred a net loss of $10,516,000 for the year ended December 31, 2022, compared to a net loss of $9,103,000 in 2021, reflecting an increase of $1,413,000[358]. - As of December 31, 2022, the company had an accumulated deficit of approximately $51.8 million and anticipates continued losses in the foreseeable future[362]. - The net cash used in operating activities for the year ended December 31, 2022, was $7,228,000, a slight decrease from $7,317,000 in 2021[366]. - The company experienced a net cash outflow of $12,118,000 in 2022, compared to a net cash inflow of $3,567,000 in 2021, representing a decrease of $15,685,000[366]. Funding and Capital Requirements - The company anticipates requiring additional funding in the millions or tens of millions of dollars to complete the VOICE clinical program for Validive[337]. - The company plans to seek additional capital within the next 12 months through equity offerings, debt financings, and strategic collaborations to fund future operations[363]. - Future funding requirements will depend on various factors, including the costs associated with clinical development and regulatory approvals for drug product candidates[375]. - The company anticipates significant increases in expenses as it advances clinical development and seeks regulatory approvals for its drug product candidates, including Validive and camsirubicin[376]. - The company expects expenditures to increase in 2023 and beyond, requiring additional funding in the millions or tens of millions of dollars for the VOICE clinical program and other drug product candidates[378]. - The company plans to finance future cash needs primarily through equity offerings, debt financings, strategic collaborations, and grant funding, which may dilute current stockholders' ownership[379]. Clinical Trials and Drug Development - In the Phase 2 clinical trial of Validive, the absolute incidence of severe oral mucositis (SOM) in oropharyngeal cancer patients was reduced by 26.3%, with a 15.5-day decrease in the duration of disease for those who developed SOM[346]. - Camsirubicin demonstrated clinical benefit in 52.6% of patients evaluable for tumor progression in a single-arm Phase 2 study, with higher cumulative doses showing consistent results[346]. - The ongoing Phase 1b clinical trial of camsirubicin is currently enrolling patients at a fifth dose level, which is over twice the highest dose administered in prior trials[338]. - The company plans to initiate a first-in-human imaging study with MNPR-101-Zr as early as the end of this year, based on promising preclinical imaging results[341]. - The company aims to expand its drug development pipeline through in-licensing and acquisition of oncology product candidates, particularly those that leverage existing scientific data[346]. Expenses and Financial Performance - Research and development (R&D) expenses for the year ended December 31, 2022, were $7,592,000, an increase of $1,099,000 from $6,493,000 in 2021, primarily due to increased clinical trial costs[359]. - General and administrative (G&A) expenses for the year ended December 31, 2022, were $2,945,000, up by $311,000 from $2,634,000 in 2021, mainly due to higher personnel costs[360]. Licensing and Agreements - The company has a licensing agreement with Onxeo S.A. that includes potential milestones up to $108 million and escalating royalties from 5% to 10% on net sales of Validive[382]. - The company incurred $0.3 million in expenses under the GEIS agreement for the development of camsirubicin in patients with advanced soft tissue sarcoma[385]. - The company has a non-exclusive license agreement with XOMA Ltd. for MNPR-101, with potential milestones reaching up to $14.925 million, but no milestones have been achieved as of March 10, 2023[386]. Management and Operations - The management team has extensive experience, having achieved four drug approvals and three diagnostic imaging device approvals in the U.S. and EU[343]. - The company is focused on developing proprietary therapeutics to improve the quality of life for cancer patients, leveraging scientific and clinical experience to reduce risks in drug development[334]. - The company is currently leasing office space for $4,238 per month through February 2024, with plans to lease additional space as personnel increases[389]. - The company has not been involved in any adverse material legal proceedings to date[390]. - The company has indemnification obligations to its officers and non-employee directors, with no claims made to date[392].