2020 Q4 Form 10-Q Financial Statement

#000143774920023676 Filed on November 12, 2020

View on sec.gov

Income Statement

Concept 2020 Q4 2020 Q3 2019 Q3
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.480M $2.110M $1.290M
YoY Change 16.54% 63.57% -18.87%
% of Gross Profit
Research & Development $2.580M $3.138M $1.743M
YoY Change 55.42% 79.96% 49.04%
% of Gross Profit
Depreciation & Amortization $20.00K $30.00K $20.00K
YoY Change -33.33% 50.0% -33.33%
% of Gross Profit
Operating Expenses $4.090M $3.138M $1.743M
YoY Change 38.18% 79.96% 49.04%
Operating Profit -$5.274M -$3.052M
YoY Change 72.81% -56.23%
Interest Expense $30.00K $29.23K $21.99K
YoY Change 0.0% 32.93% -42.1%
% of Operating Profit
Other Income/Expense, Net
YoY Change
Pretax Income -$4.060M -$5.245M -$3.030M
YoY Change 38.57% 73.1% -56.3%
Income Tax $0.00 -$805.7K -$226.0K
% Of Pretax Income
Net Earnings -$4.060M -$4.439M -$2.804M
YoY Change 8.27% 58.31% -58.27%
Net Earnings / Revenue
Basic Earnings Per Share -$0.07 -$0.60
Diluted Earnings Per Share -$62.77K $64.01M $4.693M
COMMON SHARES
Basic Shares Outstanding 64.02M 64.00M 4.693M
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q4 2020 Q3 2019 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $18.52M $21.91M $6.140M
YoY Change 30.61% 256.84% -44.28%
Cash & Equivalents $18.52M $21.91M $6.140M
Short-Term Investments
Other Short-Term Assets $260.0K $770.0K $580.0K
YoY Change -44.68% 32.76% 5.45%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $18.78M $22.68M $6.718M
YoY Change 28.17% 237.54% -41.93%
LONG-TERM ASSETS
Property, Plant & Equipment $149.2K $174.1K $279.4K
YoY Change -40.88% -37.69% -26.31%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $15.77K $252.1K $290.7K
YoY Change -95.11% -13.29% 10.32%
Total Long-Term Assets $8.953M $9.240M $9.479M
YoY Change -5.37% -2.52% -21.17%
TOTAL ASSETS
Total Short-Term Assets $18.78M $22.68M $6.718M
Total Long-Term Assets $8.953M $9.240M $9.479M
Total Assets $27.73M $31.92M $16.20M
YoY Change 15.01% 97.05% -31.35%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $545.8K $1.412M $502.5K
YoY Change -56.38% 180.95% 289.34%
Accrued Expenses $1.890M $1.280M $720.0K
YoY Change 302.13% 77.78% -12.2%
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 $2.436M $2.687M $1.218M
YoY Change 41.5% 120.52% 28.85%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $40.00K $60.00K $160.0K
YoY Change -71.43% -62.5%
Total Long-Term Liabilities $40.00K $60.00K $160.0K
YoY Change -71.43% -62.5%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.436M $2.687M $1.218M
Total Long-Term Liabilities $40.00K $60.00K $160.0K
Total Liabilities $2.915M $3.193M $2.678M
YoY Change -26.68% 19.2% -0.32%
SHAREHOLDERS EQUITY
Retained Earnings -$105.9M -$101.8M -$87.97M
YoY Change 15.47% 15.77% 18.32%
Common Stock $130.7M $130.6M $101.5M
YoY Change 16.87% 28.65% 6.54%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $24.81M $28.72M $13.52M
YoY Change
Total Liabilities & Shareholders Equity $27.73M $31.92M $16.20M
YoY Change 15.01% 97.05% -31.35%

Cashflow Statement

Concept 2020 Q4 2020 Q3 2019 Q3
OPERATING ACTIVITIES
Net Income -$4.060M -$4.439M -$2.804M
YoY Change 8.27% 58.31% -58.27%
Depreciation, Depletion And Amortization $20.00K $30.00K $20.00K
YoY Change -33.33% 50.0% -33.33%
Cash From Operating Activities -$3.390M -$3.510M -$2.150M
YoY Change 38.93% 63.26% 11.98%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities
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 0.000 -140.0K -80.00K
YoY Change -100.0% 75.0%
NET CHANGE
Cash From Operating Activities -3.390M -3.510M -2.150M
Cash From Investing Activities
Cash From Financing Activities 0.000 -140.0K -80.00K
Net Change In Cash -3.390M -3.650M -2.230M
YoY Change -142.22% 63.68% 16.15%
FREE CASH FLOW
Cash From Operating Activities -$3.390M -$3.510M -$2.150M
Capital Expenditures
Free Cash Flow
YoY Change

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<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 45pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font: inherit;">1.</div></div></div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;"><div style="display: inline; text-decoration: underline;">Organization and Description of Business</div></div></div> </td> </tr> </table> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;text-indent:9pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt 7.2pt;text-align:justify;text-indent:36pt;">Diffusion Pharmaceuticals Inc., a Delaware corporation, is an innovative biopharmaceutical company developing novel therapies that enhance the body's ability to deliver oxygen to the areas where it is needed most.&nbsp; The Company's lead product candidate, TSC, is being developed to enhance the diffusion&nbsp;of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine's most intractable and difficult-to-treat conditions.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt 7.2pt;text-align:justify;text-indent:36pt;">TSC was designed to enhance the level of organization among water molecules by increasing the amount of hydrogen bonding.&nbsp; This creates a less dense matrix of water molecules, which facilitates the diffusion of oxygen molecules from areas of high to low oxygen concentrations, such as from oxygenated red blood cells into tissues where the oxygen is used to power the cells. In animal models, this diffusion-enhancing mechanism of action has been observed to affect hypoxic tissue preferentially while avoiding excessive oxygen-related tissue toxicity, also known as hyperoxia.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt 7.2pt;text-align:justify;text-indent:36pt;">TSC previously has been demonstrated safe&nbsp;and tolerable&nbsp;in over <div style="display: inline; font-style: italic; font: inherit;">160</div> subjects included in the Company's clinical program across a variety of medical conditions often complicated by hypoxia, including the Company's clinical studies conducted in patients afflicted with GBM, peripheral artery disease with intermittent claudication, and stroke, as well as its ongoing <div style="display: inline; font-style: italic; font: inherit;">100</div>-<div style="display: inline; font-style: italic; font: inherit;">303</div> COVID Trial.&nbsp; In each of these conditions and many others, hypoxia is a significant contributor to morbidity and mortality, and a considerable treatment obstacle for medical providers.</div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt 7.2pt;text-align:justify;text-indent:36pt;">In <div style="display: inline; font-style: italic; font: inherit;"> September 2020, </div>the Company initiated the <div style="display: inline; font-style: italic; font: inherit;">100</div>-<div style="display: inline; font-style: italic; font: inherit;">303</div> COVID Trial, its ongoing Phase <div style="display: inline; font-style: italic; font: inherit;">1b</div> clinical trial evaluating TSC in hospitalized COVID-<div style="display: inline; font-style: italic; font: inherit;">19</div> patients and, on <div style="display: inline; font-style: italic; font: inherit;"> September 10, 2020, </div>the Company announced the dosing of the <div style="display: inline; font-style: italic; font: inherit;">first</div> <div style="display: inline; font-style: italic; font: inherit;">two</div> patients in the trial. As of the date of this Quarterly Report, patient enrollment continues and <div style="display: inline; font-style: italic; font: inherit;">no</div> dose-limiting toxicities have been observed. However, given the complex design&nbsp;of the <div style="display: inline; font-style: italic; font: inherit;">100</div>-<div style="display: inline; font-style: italic; font: inherit;">303</div> COVID Trial, the sequential nature of patient enrollment thereunder, and the resulting challenges to expediting the trial when ordinary course delays are encountered, protocol&nbsp;the&nbsp;Company now expects the <div style="display: inline; font-style: italic; font: inherit;">100</div>-<div style="display: inline; font-style: italic; font: inherit;">303</div> COVID Trial to be completed with topline data available by the end of <div style="display: inline; font-style: italic; font: inherit;">first</div> quarter of <div style="display: inline; font-style: italic; font: inherit;">2021.</div></div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</div> <div style=" font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt 7.2pt; text-align: justify; text-indent: 36pt;">In addition to TSC, the Company's product candidate DFN-<div style="display: inline; font-style: italic; font: inherit;">529,</div> a novel, allosteric <div style="display: inline; font-style: italic; font: inherit;">PI3K/Akt/mTOR</div> pathway inhibitor, is in early-stage development.&nbsp; The Company previously completed <div style="display: inline; font-style: italic; font: inherit;">two</div> Phase <div style="display: inline; font-style: italic; font: inherit;">1</div> clinical trials evaluating DFN-<div style="display: inline; font-style: italic; font: inherit;">529</div> in age-related macular degeneration, and DFN-<div style="display: inline; font-style: italic; font: inherit;">529</div> was also previously in preclinical development in oncology, specifically GBM.</div></div>
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