2023 Q1 Form 10-K Financial Statement

#000165495423003384 Filed on March 23, 2023

View on sec.gov

Income Statement

Concept 2023 Q1 2022 Q4 2022
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $871.7K $808.7K $2.945M
YoY Change 11.86% 15.79% 11.82%
% of Gross Profit
Research & Development $1.653M $2.103M $7.592M
YoY Change -1.46% 6.07% 16.92%
% of Gross Profit
Depreciation & Amortization
YoY Change
% of Gross Profit
Operating Expenses $2.525M $2.909M $10.54M
YoY Change 2.76% 8.5% 15.44%
Operating Profit -$2.525M -$10.54M
YoY Change 2.76% 15.44%
Interest Expense $90.49K $12.66K $21.24K
YoY Change 19571.74% 2288.68% -11.57%
% of Operating Profit
Other Income/Expense, Net
YoY Change
Pretax Income -$2.435M -$2.896M -$10.52M
YoY Change -0.9% 8.05% 15.52%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$2.435M -$2.896M -$10.52M
YoY Change -0.9% 8.05% 15.52%
Net Earnings / Revenue
Basic Earnings Per Share -$0.19 -$0.83
Diluted Earnings Per Share -$0.19 -$0.22 -$0.83
COMMON SHARES
Basic Shares Outstanding 13.19M shares 12.86M shares 12.72M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $11.68M $13.12M $13.12M
YoY Change -34.47% -35.38% -35.38%
Cash & Equivalents $5.726M $8.186M $8.186M
Short-Term Investments $5.951M $4.934M $4.934M
Other Short-Term Assets $106.8K $45.98K $45.98K
YoY Change -44.84% -78.88% -78.88%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $11.78M $13.17M $13.17M
YoY Change -34.58% -35.84% -35.84%
LONG-TERM ASSETS
Property, Plant & Equipment $49.38K $61.23K $61.23K
YoY Change -8.03%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $49.38K $61.23K $61.22K
YoY Change -8.04%
TOTAL ASSETS
Total Short-Term Assets $11.78M $13.17M $13.17M
Total Long-Term Assets $49.38K $61.23K $61.22K
Total Assets $11.83M $13.23M $13.23M
YoY Change -34.51% -35.55% -35.55%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.888M $3.080M $3.080M
YoY Change 175.51% 94.89% 94.89%
Accrued Expenses $48.58K $48.58K
YoY Change
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $2.888M $3.129M $3.129M
YoY Change 168.85% 97.96% 97.96%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $8.410K $8.410K
YoY Change -100.0%
Total Long-Term Liabilities $0.00 $8.410K $8.410K
YoY Change -100.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.888M $3.129M $3.129M
Total Long-Term Liabilities $0.00 $8.410K $8.410K
Total Liabilities $2.888M $3.137M $3.137M
YoY Change 162.65% 98.5% 98.5%
SHAREHOLDERS EQUITY
Retained Earnings -$54.24M -$51.80M
YoY Change 25.47%
Common Stock $13.22K $12.95K
YoY Change 2.77%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $8.945M $10.09M $10.09M
YoY Change
Total Liabilities & Shareholders Equity $11.83M $13.23M $13.23M
YoY Change -34.51% -35.55% -35.55%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$2.435M -$2.896M -$10.52M
YoY Change -0.9% 8.05% 15.52%
Depreciation, Depletion And Amortization
YoY Change
Cash From Operating Activities -$2.271M -$1.302M -$7.229M
YoY Change -7.96% -35.93% -198.79%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities -$983.4K -$4.919M -$4.919M
YoY Change
Cash From Investing Activities -$983.4K -$4.919M -$4.919M
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $804.8K 138.7K $32.87K
YoY Change -4928.98% -1885.46% -99.7%
NET CHANGE
Cash From Operating Activities -$2.271M -1.302M -$7.229M
Cash From Investing Activities -$983.4K -4.919M -$4.919M
Cash From Financing Activities $804.8K 138.7K $32.87K
Net Change In Cash -$2.461M -6.082M -$12.12M
YoY Change -0.95% 198.17% -166.59%
FREE CASH FLOW
Cash From Operating Activities -$2.271M -$1.302M -$7.229M
Capital Expenditures
Free Cash Flow
YoY Change

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<p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>Note 1 - Nature of Business and Liquidity</strong></p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"> </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em><strong>Nature of Business</strong></em></p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"> </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Monopar Therapeutics Inc. (“Monopar” or the ”Company”) is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve quality of life for cancer patients. Monopar currently has four compounds in development: 1) Validive<sup style="vertical-align:super">®</sup> (clonidine hydrochloride mucobuccal tablet; clonidine HCI MBT), a Phase 2b/3 clinical stage, first-in-class mucoadhesive buccal tablet for the prevention of radiation induced severe oral mucositis (“SOM”) in oropharyngeal cancer patients; 2) camsirubicin (generic name for MNPR-201, GPX-150; 5-imino-13-deoxydoxorubicin), a Phase 1b clinical stage novel analog of doxorubicin engineered specifically to retain anticancer activity while minimizing toxic effects on the heart; 3) MNPR-101 RIT and MNPR-101-Zr, a preclinical stage uPAR-targeted antibody being developed as a radioimmunotherapeutic and companion diagnostic for advanced cancers; and 4) an early stage camsirubicin analog, MNPR-202, for various cancers. </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"> </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em><strong>Liquidity</strong></em></p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"> </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The Company has incurred an accumulated deficit of approximately $51.8 million as of December 31, 2022. To date, the Company has primarily funded its operations with the net proceeds from the Company’s initial public offering of its common stock on Nasdaq, sales of its common stock in the public market through at-the-market sales agreements, private placements of convertible preferred stock and of common stock and cash provided in the camsirubicin asset purchase transaction. Management estimates that currently available cash will provide sufficient funds to enable the Company to meet its obligations at least through March 2024. The Company’s ability to fund its future operations, including the continued clinical development of Validive and camsirubicin, is dependent upon its ability to execute its business strategy, to obtain additional funding and/or to execute collaborative research agreements. There can be no certainty that future financing or collaborative research agreements will occur in the amounts required or at a time needed to maintain operations, if at all.</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"> </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The coronavirus disease (“COVID-19”) continues to affect economies and business around the world. In response to COVID-19 and its effects on clinical trials, in 2020 Monopar modified the original adaptive design Phase 3 clinical trial for its lead product candidate, Validive, to be a Phase 2b/3 clinical trial (“VOICE”) to better fit the types of trials which can enroll sufficient required patients in the current environment. This modification allowed the Company to activate the VOICE clinical trial without requiring near-term financing. To complete the VOICE clinical program, including, if required, completing a second Phase 3 confirmatory clinical trial, Monopar will require additional funding in the millions or tens of millions of dollars (depending on if the Company has consummated a collaboration or partnership or neither for Validive), which it is planning to pursue within the next 12 months. Due to many uncertainties, the Company is unable to estimate COVID-19’s financial impact or duration in light of global vaccine rollouts, treatment options and potential surges of new cases from current or future COVID-19 variants or its potential impact on the Company’s current clinical trials, including COVID-19’s effect on drug candidate manufacturing, shipping, patient recruitment at clinical sites and regulatory agencies around the globe. </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"> </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The Russia-Ukraine war, and resulting sanctions against Russia and Russian entities or allies, have increased fuel costs and may cause shipping delays. The broader economic, trade and financial market consequences are uncertain at this time, which may increase the cost of supplies for the Company’s clinical materials, may delay the manufacture of its clinical materials, may increase costs of other goods and services, or make it more difficult or costly to raise additional financing, any of which could cause an adverse effect on the Company’s clinical programs and on the Company’s financial condition. </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"> </p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Market variables, such as inflation of product costs, higher capital costs, labor rates and fuel, freight and energy costs, as well as geopolitical events could likely cause the Company to suffer significant increases in its operating and administrative expenses.</p>
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<p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and reported amounts of expenses in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. </p>
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