$IKT
Inhibikase Therapeutics, Inc.

2022 Q2 Form 10-Q Financial Statement

#000095017022010085 Filed on May 16, 2022

View on sec.gov

Income Statement

Concept 2022 Q2 2022 Q1 2021 Q1
Revenue $6.552K $46.03K $1.407M
YoY Change -99.52% -96.73% 419.66%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.664M $1.670M $1.601M
YoY Change 3.44% 4.31% 203.32%
% of Gross Profit
Research & Development $2.982M $3.017M $2.432M
YoY Change 25.17% 24.06% 758.97%
% of Gross Profit
Depreciation & Amortization $0.00 $0.00
YoY Change
% of Gross Profit
Operating Expenses $4.646M $4.687M $4.032M
YoY Change 16.41% 16.22% 397.34%
Operating Profit -$4.640M -$4.641M -$2.625M
YoY Change 76.53% 76.77% 386.15%
Interest Expense $5.00 $11.80K
YoY Change -99.96% 58.88%
% of Operating Profit
Other Income/Expense, Net
YoY Change
Pretax Income -$4.640M -$4.641M -$2.640M
YoY Change 76.01% 75.78% 380.0%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$4.640M -$4.641M -$2.637M
YoY Change 76.01% 75.98% 381.71%
Net Earnings / Revenue -70817.14% -10081.47% -187.4%
Basic Earnings Per Share -$0.18 -$0.18
Diluted Earnings Per Share -$0.18 -$184.1K -$262.7K
COMMON SHARES
Basic Shares Outstanding 25.23M 25.23M
Diluted Shares Outstanding 25.23M 25.21M

Balance Sheet

Concept 2022 Q2 2022 Q1 2021 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $32.21M $36.61M $9.610M
YoY Change -31.22% 280.97% 96000.0%
Cash & Equivalents $32.21M $36.61M $9.610M
Short-Term Investments
Other Short-Term Assets $1.731M $1.730M $1.930M
YoY Change -3.47% -10.34% 19200.0%
Inventory
Prepaid Expenses $919.1K $565.3K $712.7K
Receivables $6.550K $47.98K
Other Receivables $0.00 $0.00
Total Short-Term Assets $33.95M $38.39M $11.87M
YoY Change -31.02% 223.38% 39470.84%
LONG-TERM ASSETS
Property, Plant & Equipment $43.09K
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $0.00
YoY Change -100.0%
Total Long-Term Assets $43.09K -$4.00 $2.783K
YoY Change -4309000.0% -100.14% -72.17%
TOTAL ASSETS
Total Short-Term Assets $33.95M $38.39M $11.87M
Total Long-Term Assets $43.09K -$4.00 $2.783K
Total Assets $33.99M $38.39M $11.87M
YoY Change -30.93% 223.31% 29585.09%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $860.4K $806.2K $715.0K
YoY Change -4.1% 12.75% -4.66%
Accrued Expenses $3.630M $3.574M $627.4K
YoY Change 315.9% 469.65% -66.27%
Deferred Revenue $1.251M
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00 $0.00 $990.0K
YoY Change -100.0% 191.18%
Total Short-Term Liabilities $4.490M $4.380M $3.589M
YoY Change 134.77% 22.06% -18.99%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $250.0K
YoY Change -100.0% -100.0% -19.35%
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $0.00 $0.00 $250.0K
YoY Change -100.0% -100.0% -19.35%
TOTAL LIABILITIES
Total Short-Term Liabilities $4.490M $4.380M $3.589M
Total Long-Term Liabilities $0.00 $0.00 $250.0K
Total Liabilities $4.490M $4.380M $3.837M
YoY Change 107.74% 14.14% -19.04%
SHAREHOLDERS EQUITY
Retained Earnings -$39.10M -$34.46M -$17.67M
YoY Change 92.56% 95.02%
Common Stock $68.60M $68.47M $25.71M
YoY Change 1.84% 166.36%
Preferred Stock
YoY Change
Treasury Stock (at cost) $314.2K $385.9K
YoY Change -59.32%
Treasury Stock Shares
Shareholders Equity $29.50M $34.01M $8.037M
YoY Change
Total Liabilities & Shareholders Equity $33.99M $38.39M $11.87M
YoY Change -30.93% 223.31% 29585.09%

Cashflow Statement

Concept 2022 Q2 2022 Q1 2021 Q1
OPERATING ACTIVITIES
Net Income -$4.640M -$4.641M -$2.637M
YoY Change 76.01% 75.98% 381.71%
Depreciation, Depletion And Amortization $0.00 $0.00
YoY Change
Cash From Operating Activities -$4.356M -$3.934M -$3.934M
YoY Change 2.47% 0.0% 1440.22%
INVESTING ACTIVITIES
Capital Expenditures -$43.09K
YoY Change
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$43.09K $0.00
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 -204.8K -409.7K
YoY Change -100.0% -50.02% -263.79%
NET CHANGE
Cash From Operating Activities -4.356M -3.934M -3.934M
Cash From Investing Activities -43.09K 0.000
Cash From Financing Activities 0.000 -204.8K -409.7K
Net Change In Cash -4.399M -4.139M -4.344M
YoY Change -111.82% -4.72% 81674.89%
FREE CASH FLOW
Cash From Operating Activities -$4.356M -$3.934M -$3.934M
Capital Expenditures -$43.09K
Free Cash Flow -$4.313M
YoY Change

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<div style="text-indent:0.0%;display:flex;margin-top:12.0pt;line-height:1.15;justify-content:flex-start;align-items:baseline;margin-bottom:0.0pt;min-width:3.333%;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;text-indent:0;display:inline-flex;font-size:10.0pt;font-family:Times New Roman;justify-content:flex-start;min-width:3.333%;">1.</span><div style="display:inline;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">Nature of Business </span></div></div><p style="text-indent:3.733%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">Inhibikase Therapeutics, Inc. (the “Company,” “we” or “our”) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s Disease, or PD, and related disorders that arise inside and outside of the brain. In 2021, we commenced clinical development of IkT-148009, a small molecule Abelson Tyrosine Kinase inhibitor we believe can modify the course of Parkinson’s disease including its manifestation in the gastrointestinal tract, or GI. Results to date of our ongoing Phase 1 Single and Multiple Ascending Dose escalation study (SAD and MAD, respectively) in older and elderly healthy volunteers have revealed important insights into the safety, tolerability and pharmacokinetics of IkT-148009 in human subjects. We enrolled 88 subjects in the Phase 1 study. Results from the Phase 1 study have shown that IkT-148009 has a half-life of greater than 24 hours and just a 25 mg once-daily oral dose in older and elderly healthy subjects in our Phase 1 study reached exposures that are consistent with the exposure to the drug that resulted in therapeutic efficacy in animal models of progressive Parkinson’s disease. In July 2021, the U.S. Food and Drug Administration, or FDA, agreed with the Company’s plan to initiate its Phase 1b study in Parkinson’s patients which commenced dosing October 19, 2021, and one cohort of 8 patients have completed the Phase 1b study to date. The Company anticipates initiating Phase 2 studies of IkT-148009 in Parkinson’s disease in the second quarter of 2022, subject to agreements with the FDA. Clinical development of IkT-148009 for the GI complications in PD patients will cross-reference the Phase 1 study of IkT-148009 for the treatment of PD. Our efforts in Parkinson’s disease are being extended into other Parkinson’s-related indications, such as the Orphan Disease Multiple Systems Atrophy, or MSA. Depending on the outcome of animal model studies of MSA, the Company may initiate Phase 2 studies of IkT-148009 in MSA in the fourth quarter of 2022 following regulatory submissions in the U.S. and European Union, or EU. Clinical development of the Company’s oncology asset, IkT-001Pro, is anticipated to begin shortly after submission of the Company’s Investigational New Drug application, or IND, for IkT-001Pro; submission of the IND is anticipated to occur in the second quarter of 2022.</span></p><p style="text-indent:3.733%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">Our advancement of the pre-clinical and clinical development program for MSA was benefited by a grant received from the National Institute of Neurological Diseases and Stroke, or NINDS, an Institute of the National Institutes of Health, for $</span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">385,888</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> to fund animal model studies of IkT-148009 as a therapy for MSA. These animal studies are now underway. At the same time, we are preparing regulatory submissions to the European Medicines Agency, or EMA, and to the FDA to enable a Phase 2a safety and tolerability study in MSA patients in up to 19 sites in the EU, and up to 6 sites in the U.S. involving 60 patients. The proposed clinical Phase 2a study will have primary endpoints in safety and tolerability and exploratory endpoints in MSA efficacy parameters with 3 month daily dosing at two different doses. While we complete the set-up of the Phase 2a study in MSA, we will complete at least one animal model study to support advancing IkT-148009 into patients in the fourth quarter of 2022. Dosing of patients with MSA will depend on a positive outcome in animal model studies; if IkT-148009 is not a successful therapy in MSA model studies, the Phase 2a clinical study will not proceed. In this circumstance, the regulatory effort for IkT-148009 in the EU would be applied to future studies of Parkinson’s disease efficacy in the EU. The Company plans to pursue orphan drug designation for IkT-148009 to treat Multiple System Atrophy with regulators in the U.S. and Europe.</span></p><p style="text-indent:3.733%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">We have also advanced clinical batch manufacturing and pill formulation for our platform prodrug technology involving IkT-001Pro. Clinical batch manufacturing was completed in the fourth quarter of 2021 and an IND is planned to be filed in the second quarter of 2022, to include the production of the data package for the final pill formulation.</span></p><p style="text-indent:3.733%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">In the ensuing 12 months, the Company anticipates reporting the full outcomes of its completed Phase 1 study of IkT-148009 in older and elderly healthy subjects, reporting the outcomes of the completed chronic toxicology studies in rats and monkeys for IkT-148009 to enable chronic drug administration in Parkinson’s patients, completing a Phase 1b extension study of IkT-148009 in Parkinson’s patients and initiating its Phase 2a efficacy study in Parkinson’s patients. Advancement of the Company’s Phase 2a program in PD with IkT-148009 is subject to review and agreements with the FDA. We further anticipate initiating the Phase 2a clinical study in MSA in the U.S. and EU, subject to a successful model study outcome and agreements with regulatory agencies in the U.S. and EU. Finally, we intend to advance IkT-001Pro through IND filing and initiate clinical development, possibly completing clinical development in 2022.</span></p><p style="text-indent:3.733%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">Our </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">programs utilize small molecule, oral protein kinase inhibitors to treat PD and its GI complications. We have shown in animal models of progressive PD that our lead clinical candidate, IkT-148009, is a brain penetrant Abelson tyrosine kinase, or c-Abl inhibitor, that halts disease progression and reverses functional loss in the brain and reverses neurological dysfunction in the GI tract. We have not yet observed reversal of functional loss in humans. The ability to halt progression and restore function was shown in animal models of progressive disease that mimic the rate of disease progression and the extent of functional loss in the brain and/or the GI tract as found in patients with PD. We believe our therapeutic approach is disease-modifying. Our understanding of how and why PD progresses has led us to believe that functional loss in Parkinson’s patients may be at least partially reversed. Based on the measurements in animal models, we believe patients treated with IkT-148009 may have their disease progression slowed or halted, we may see a progressive reduction in the need for symptomatic or supportive therapy and/or we may ultimately eliminate the need for</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">symptomatic </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">therapy. However, as of the date of this Quarterly Report on Form 10-Q ("Report"), it is unknown whether the disease modification seen in the animal models will occur in patients following treatment with IkT-148009.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
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<p style="text-indent:0.0%;font-size:10.0pt;margin-top:12.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Use of Estimates</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:3.733%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">The preparation of the Company’s financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company utilizes certain estimates in the determination of the fair value of its stock options and warrants, deferred tax valuation allowances and revenue recognition, to record expenses relating to research and development contracts and accrued expenses. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
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<p style="text-indent:0.0%;font-size:10.0pt;margin-top:12.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Concentrations of Credit Risk</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:3.733%;font-size:10.0pt;margin-top:9.0pt;line-height:1.15;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">For the three months ended March 31, 2022 and 2021</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">, the Company derived more than </span><span style="font-size:10.0pt;font-family:Times New Roman;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">90</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:Times New Roman;min-width:fit-content;">% of its total revenue from a single source, the United States Government, in the form of federal research grants.</span></p>
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254047
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2077932

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