Forward-Looking Statements
The following section of this Annual Report on Form 10-K entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations" contains statements that are not statements of historical fact and are forward-looking statements within the meaning of federal securities laws. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Factors that may cause our actual results to differ materially from those in the forward-looking statements include those factors described in "Item 1A. Risk Factors" beginning on page 22 of this Annual Report on Form 10-K. You should carefully review all of these factors, as well as the comprehensive discussion of forward-looking statements on page 1 of this Annual Report on Form 10-K. Business Overview We are a clinical-stage specialty pharmaceutical company developing and commercializing products for the treatment of ophthalmic diseases. We were formed as aDelaware corporation onDecember 26, 2004 under the name ofEyeGate Pharmaceuticals, Inc. , and changed our name toKiora Pharmaceuticals, Inc. effectiveNovember 8, 2021 . We were originally incorporated in 1998 under the name ofOptis France S.A. inParis, France . At that time, the name of the French corporation was changed to EyeGate Pharma S.A.S. and became a subsidiary ofEyeGate Pharmaceuticals, Inc. EyeGate Pharma S.A.S. was dissolved effectiveDecember 30, 2020 . We have four wholly-owned subsidiaries:Jade Therapeutics, Inc. ,Kiora Pharmaceuticals, GmbH (formerly known as Panoptes Pharma Ges.m.b.H.),Bayon Therapeutics, Inc. , andKiora Pharmaceuticals Pty Ltd (formerly known asBayon Therapeutics Pty Ltd ). Our lead product is KIO-301 with an initial focus on patients with later stages of disease progression due to Retinitis Pigmentosa (any and all sub-forms). KIO-301 is a potential vision-restoring small molecule that acts as a "photoswitch" specifically designed to restore vision in patients with inherited and age-related degenerative retinal diseases. The molecule is specifically designed to restore the eyes' ability to perceive and interpret light in visually impaired patients. It selectively enters viable downstream retinal ganglion cells (no longer receiving electrical input due to degenerated rods and cones) and is intended to turn them into light sensing cells, capable of signaling the brain as to the presence or absence of light. We expect to initiate a Phase 1b clinical trial in third quarter of 2022. OnMarch 17, 2022 , we were granted Orphan Drug Designation by theU.S. FDA for the API in KIO-301. KIO-301 (formerly known as B-203) was acquired through the Bayon transaction which closedOctober 21, 2021 . KIO-101 is a product that focuses on patients with OPRA. KIO-101 is a next-generation, non-steroidal, immuno-modulatory and small-molecule inhibitor of Dihydroorotate Dehydrogenase ("DHODH") with what we believe to be best-in-class picomolar potency and a validated immune modulating mechanism designed to overcome the off-target side effects and safety issues associated with commercially available DHODH inhibitors. In the fourth quarter of 2021, we reported top-line safety and tolerability data from a phase 1b proof-of-concept ("POC") study evaluating KIO-101 in patients with ocular surface inflammation. We expect to initiate a Phase 2 clinical trial in the second half of 2022. KIO-101 (formerly known as PP-001) was acquired through the acquisition of Panoptes Pharma Ges.m.b.H "Panoptes" in the fourth quarter of 2020. In addition, we are developing KIO-201, for patients undergoing PRK surgery for corneal wound repair after refractive surgery. KIO-201 is a modified form of the natural polymer hyaluronic acid, designed to protect the ocular surface to permit re-epithelialization of the cornea and improve and maintain ocular surface integrity. KIO-201 has unique properties that help hydrate and protect the ocular surface. InMay 2020 , we were granted a loan (the "Loan") fromSilicon Valley Bank in the amount of$0.278 million pursuant to the Paycheck Protection Program (the "PPP") under Division A, Title I of the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act"), which was enacted inMarch 2020 . The Loan could have been prepaid by us at any time prior to maturity with no prepayment penalties. Funds from the Loan were only permitted to be used for payroll costs, costs used to continue group health care benefits, mortgage payments, rent, utilities, and interest on other debt obligations incurred beforeFebruary 15, 2020 ("Qualifying Expenses"). We used the entire Loan amount for Qualifying Expenses. Under the terms of the PPP, certain amounts of the Loan could be forgiven if they are used for Qualifying Expenses as described in the CARES Act. InApril 2021 , we were notified by theSmall Business Administration ("SBA") that this Loan was forgiven in full. Throughout our history, we have not generated significant revenue. We have never been profitable, and from inception throughDecember 31, 2021 , our losses from operations have aggregated$124.734 million . Our Net Loss was approximately
$16.395 million 51 Table of Contents
and$8.092 million for the twelve months endedDecember 31, 2021 and 2020, respectively. We expect to incur significant expenses and increasing operating losses for the foreseeable future as we continue the development and clinical trials of and seek regulatory approval for our KIO-101, KIO-201 and KIO-301 product candidates, and any other product candidates we advance to clinical development. If we obtain regulatory approval for KIO-101, KIO-201 and KIO-301, we expect to incur significant expenses to create an infrastructure to support the commercialization of KIO-101, KIO-201 and KIO-301 including sales, marketing and distribution functions. The continued spread of the COVID-19 pandemic could adversely impact our clinical studies. In addition, COVID-19 has resulted in significant governmental measures being implemented to control the spread of the virus, including quarantines, travel restrictions, and business shutdowns. COVID-19 has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which could negatively affect our ability to raise additional capital on attractive terms or at all. See "Item 1A. Risk Factors" above. The extent to which COVID-19 may impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the emergence of new variants, and the effectiveness of actions to contain and treat COVID-19. We cannot presently predict the scope and severity of any potential disruptions to our business, including to our ongoing and planned clinical studies. Any such shutdowns or other business interruptions could result in material and negative effects to our ability to conduct our business in the manner and on the timelines presently planned, which could have a material adverse impact on our business, results of operation, and financial condition. As of the date of this report, there have been no material adverse effects to our ongoing business operations from COVID-19. We will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings, license and development agreements, or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. These conditions raise substantial doubt about our ability to continue as a going concern. We will need to generate significant revenue to achieve profitability, and we may never do so.
Financial Overview
Revenues
To date, we have recognized collaboration revenue fromU.S. and foreign government grants made to Jade and Panoptes, as well as from license agreements as performance obligations toward milestones were met. See Note 2 to our financial statements, "Summary of Significant Accounting Policies". We expect to continue to incur significant operating losses as we fund research and clinical trial activities relating to our therapeutic assets, consisting of our photoswitch, DHODH and modified HA-based products, or any other product candidate that we may develop. There can be no guarantee that the losses incurred to fund these activities will succeed in generating revenue.
Research and Development Expenses
We expense all research and development expenses as they are incurred. Research and development expenses primarily include:
? non-clinical development, preclinical research, and clinical trial and
regulatory-related costs;
? expenses incurred under agreements with sites and consultants that conduct our
clinical trials;
? expenses related to generating, filing, and maintaining intellectual property;
and
? employee-related expenses, including salaries, bonuses, benefits, travel, and
stock-based compensation expense.
Substantially all of our research and development expenses to date have been incurred in connection with KIO-201 and our former legacy products. We expect our research and development expenses to increase for the near future as we advance KIO-101, KIO-201, KIO-301, and any other product candidate through clinical development, including the conduct of our planned clinical trials. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We are unable to estimate with any certainty the costs we will incur in the continued development of our KIO-101, KIO-201, KIO-301, and any other product candidate that we may develop. Clinical development timelines, the probability of success and development costs can differ materially from expectations. 52
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We may never succeed in achieving marketing approval for our product candidate.
The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:
? per patient trial costs;
? the number of sites included in the trials;
? the countries in which the trials are conducted;
? the length of time required to enroll eligible patients;
? the number of patients that participate in the trials;
? the number of doses that patients receive;
? the cost of comparative agents used in trials;
? the drop-out or discontinuation rates of patients;
? potential additional safety monitoring or other studies requested by regulatory
agencies;
? the duration of patient follow-up; and
? the efficacy and safety profile of the product candidate.
We do not expect our product candidates to be commercially available, if at all, for the next several years.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation. Our general and administrative expenses consisted primarily of payroll expenses for our full-time employees. Other general and administrative expenses include professional fees for auditing, tax, patent costs and legal services. We expect that general and administrative expenses will remain consistent for the near future until commercialization of our photoswitch, DHODH and modified HA-based products, which could lead to an increase in these expenses.
Total Other Income (Expense)
Total other income (expense) consists primarily of interest income we earn on interest-bearing accounts, and interest expense incurred on our outstanding financing arrangements.
Critical Accounting Policies and Significant Judgments and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with accounting principles generally accepted inthe United States , orU.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ materially from these estimates under different assumptions or conditions. 53
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While our significant accounting policies are more fully described in Note 2 to our financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.
Business Combinations
We applied the provisions of Accounting Standards Codification ("ASC") Topic 805, "Business Combinations," in the accounting for our acquisitions of Bayon and Panoptes. It required us to recognize the assets acquired and the liabilities assumed at their acquisition date fair values, which were determined using market, income, and cost approaches, or a combination.Goodwill as of the respective acquisition date was measured as the excess of consideration transferred over the net of the acquisition date fair value of the assets acquired and the liabilities assumed.Goodwill is generally the result of expected synergies of the combined company or an assembled workforce. Indefinite-lived intangible assets acquired were in-process research and development. The fair value for these intangible assets was determined using the income approach. Under the income approach, fair value reflects the present value of the projected cash flows that are expected to be generated by the products incorporating the in-process research and development, if successful.
Goodwill represents the excess of the purchase price over the estimated fair value of the identifiable assets acquired and liabilities assumed in a business combination. The Company evaluates goodwill for impairment annually or when a triggering event occurs that could indicate a potential impairment. The evaluation for impairment includes assessing qualitative factors or performing a quantitative analysis to determine whether it is more-likely-than-not that the fair value of net assets is below the carrying amount. The goodwill was related to the 2021 acquisition of Bayon and 2020 acquisition of Pantones, which represents the excess of the purchase price over the estimated fair value of the net assets acquired. For the year endedDecember 31, 2021 , we have a$4.5 million impairment loss related to goodwill. Intangible assets acquired in a business combination are recognized separately from goodwill and are initially recognized at fair value at the acquisition date. The Company tests intangible assets for impairment as ofDecember 31 of each year or more frequently if indicators of impairment are present. The authoritative accounting guidance provides an optional qualitative assessment for any indicators that indefinite-lived intangible assets are impaired. If it is determined that it is more likely than not that the indefinite-lived intangible assets are impaired, the fair value of the indefinite-lived intangible assets is compared with the carrying amount and impairment is recorded for any excess of the carrying amount over the fair value of the indefinite-lived intangible assets. During the fourth quarter endedDecember 31, 2021 , the Company performed the annual evaluation of its intangible assets for impairment. The Company considered the development timelines for its program and noted no qualitative factors that would indicate potential impairment of its intangible assets. The Company also performed a quantitative analysis for impairment analysis and based on this analysis, the fair value of these products was greater than their carrying value as ofDecember 31, 2021 . As a result of this analysis, an impairment charge of$1.8 million was taken on the intangible assets. The impairment loss is for KIO-201 and is due to the fact the asset is regulated as a drug and not a device which is extending development time.
As part of the process of preparing financial statements, we are required to estimate and accrue research and development expenses. This process involves the following:
communicating with our applicable personnel to identify services that have been
? performed on our behalf and estimating the level of service performed and the
associated cost incurred for the service when we have not yet been invoiced or
otherwise notified of actual cost;
? estimating and accruing expenses in our financial statements as of each balance
sheet date based on facts and circumstances known to us at the time; and
? periodically confirming the accuracy of our estimates with selected service
providers and making adjustments, if necessary.
Examples of estimated research and development expenses that we accrue include:
? fees paid to contract research organizations and investigative sites in
connection with clinical studies;
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fees paid to contract manufacturing organizations in connection with
? non-clinical development, preclinical research, and the production of clinical
study materials; and
? professional service fees for consulting and related services.
We base our expense accruals related to non-clinical development, preclinical studies, and clinical trials on our estimates of the services received and efforts expended pursuant to contracts with organizations/consultants that conduct and manage clinical studies on our behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts may depend on many factors, such as the successful enrollment of patients, site initiation and the completion of clinical study milestones. Our service providers invoice us as milestones are achieved and monthly in arrears for services performed. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates. To date, we have not experienced significant changes in our estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical studies and other research activities.
Stock-Based Compensation
We have issued options to purchase our common stock and restricted stock. Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service/vesting period. Determining the appropriate fair value model and calculating the fair value of stock-based payment awards require the use of highly subjective assumptions, including the expected life of the stock-based payment awards and stock price volatility. We estimate the grant date fair value of stock options and the related compensation expense, using the Black-Scholes option valuation model. This option valuation model requires the input of subjective assumptions including: (1) expected life (estimated period of time outstanding) of the options granted, (2) volatility, (3) risk-free rate and (4) dividends. In general, the assumptions used in calculating the fair value of stock-based payment awards represent management's best estimates, but the estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our stock-based compensation expense could be materially different in the future.
Recent Accounting Pronouncements
InJune 2016 , the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU No. 2016-13 replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The new guidance is effective for smaller reporting companies in fiscal years beginning afterDecember 15, 2022 , including interim periods within those fiscal years. We do not expect the adoption of this standard to have a material effect on our Condensed Consolidated Financial Statements and related disclosures.
Other Information
Net Operating Loss Carryforwards
As ofDecember 31, 2021 , we have federal and state income tax net operating loss ("NOL") carryovers of approximately$72.370 million and$51.930 million , respectively. Federal NOL carryovers as ofDecember 31, 2017 totaling$46.055 million and state NOL carryovers as ofDecember 31, 2021 totaling$49.894 million will expire at various dates through 2041 and state NOL carryovers as ofDecember 31, 2021 of$2.037 million can be carried forward indefinitely but limited to offset 80% of taxable income. Federal NOL carryovers generated during the years endedDecember 31, 2018 and forward totaling$26.316 million will be carried forward indefinitely, but their utilization will be limited to 80% of taxable income. The Company has foreign net operating loss carryforwards of$9.405 million as ofDecember 31, 2021 , which can be carried forward indefinitely. As ofDecember 31, 2021 we also have federal and state research and development tax credit carryforwards of approximately$2.456 million and$0.503 million , respectively, to offset future income taxes, which expire at various times through 2041. 55 Table of Contents
Utilization of these net operating loss and tax credit carryforwards may be subject to a substantial limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, and comparable provisions of state, local and foreign tax laws due to changes in ownership of our company that have occurred previously or that could occur in the future. Under Section 382 of the Code and comparable provisions of state, local and foreign tax laws, if a corporation undergoes an "ownership change," generally defined as a greater than 50% change by value in its equity ownership over a three-year period, the corporation's ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research and development tax credits, to reduce its post-change income may be limited. We have not completed a study to determine whether our initial public offering, our registered direct offering, our follow-on public offerings, and other transactions that have occurred over the past three years may have triggered an ownership change limitation. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership. As a result, if we generate taxable income, our ability to use our pre-change net operating loss and tax credits carryforwards to reduceU.S. federal and state taxable income may be subject to limitations, which could result in increased future tax liability to us. In addition, the TCJA enacted onDecember 22, 2017 limits the amount of NOLs that we are permitted to deduct in any taxable year to 80% of our taxable income in such year. The TCJA also eliminates the ability to carry back NOLs to prior years but allows NOLs generated after 2017 to be carried forward indefinitely. As such, there is a risk that due to such items, our existing NOLs could expire or be unavailable to offset future income.
JOBS Act
Effective
Results of Operations
Comparison of Years Ended
The following table summarizes the results of our operations for the years endedDecember 31, 2021 and 2020: Year Ended December 31, 2021 2020 Change Collaboration Revenue $ -$ 12,059 $ (12,059) Operating Expenses: Research and Development (5,350,264) (3,566,045) 1,784,219 General and Administrative (5,323,649) (4,658,769) 664,880 Goodwill Impairment Loss (4,498,234) - 4,498,234
Intangible Asset Impairment Loss (1,770,314)
- 1,770,314 Total Operating Expenses (16,942,461) (8,212,755) 8,705,588 Other Income, Net 242,761 132,870 109,891
Loss Before Income Tax Benefit (Expense) (16,699,700) (8,079,885) 8,815,479 Income Tax Benefit (Expense) 304,781
(12,055) (316,836) Net Loss$ (16,394,919) $ (8,091,940) $ 8,498,643 Collaboration Revenue. There was no Collaboration Revenue for the year endedDecember 31, 2021 , compared to$0.012 million for the year endedDecember 31, 2020 . The revenue recognized for the year endedDecember 31, 2020 related to the Panoptes acquisition and the accompanying revenue generated from government funds from the date of its acquisition. Research and Development Expenses. Research and Development Expenses increased by$1.784 million or 50% due to development costs for KIO-101, KIO-201 and KIO-301, as well as personnel related costs from the Panoptes acquisition. These increases were partially offset by a decrease in costs related to KIO-201, as well as costs related to the expiration of a prepaid agreement with a research vendor in the first quarter of 2020.
General and Administrative Expenses. General and Administrative Expenses
increased by
Goodwill Impairment Loss. Goodwill Impairment Loss increased by
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Intangible Asset Impairment Loss. Intangible Asset Impairment Loss increased by$1.770 million due to the write-down of IPR&D. The intangible asset impairment loss relates to KIO-201 and is due to the fact the asset is regulated as a drug and not a device which is extending development time. Other Income, Net. Other Income, Net increased by$0.110 million or 82% due to recording a gain of$0.278 million as a result of the full forgiveness of the Loan under the PPP, as well as contingent consideration expense of$0.030 million as a result of the change in fair value during 2021. These net gains were partially offset by a gain of$0.114 million recorded in 2020 as a result of the disposition of a foreign subsidiary. Income Tax Benefit (Expense). Income Tax Benefit (Expense) was$0.304 million for the year endedDecember 31, 2021 , compared to$(0.012) million for the year endedDecember 31, 2020 . The 2021 tax benefit was mainly due to the release of valuation allowance as a result of the Bayon acquisition. The 2020 tax expense was a result of an increase in the state blended tax rate, which was applied to the deferred tax liability balance.
Liquidity and Capital Resources
Since becoming a public company in 2015, we have financed our operations from several registered offerings and private placements of our securities, payments from license agreements, andU.S. and foreign government grants. From inception throughApril 13, 2022 , we have raised a total of approximately$118.6 million from such sales of our equity and debt securities, both as a public company and prior to our IPO, as well as approximately$14.9 million in payments received under our license agreements and government grants and$0.278 million received pursuant to the Loan under the PPP, which was fully forgiven in April of 2021.
On
OnJanuary 6, 2021 , we completed a private placement of 1,531,101 shares of Common Stock and warrants to purchase up to 1,531,101 shares of Common Stock to an affiliate ofArmistice Capital, LLC , with a combined purchase price per share and warrant of$5.225 . The total net proceeds from the private placement were approximately$8.0 million . The warrants have an exercise price of$5.225 per share, subject to adjustments as provided under the terms of the warrants, and will be exercisable on the six-month anniversary of their issuance date. The warrants are exercisable for five years from the issuance date. OnAugust 11, 2021 , we completed a registered direct offering for 4,668,844 shares of Common Stock with a purchase price of$2.3025 per share. We also completed a concurrent private placement of unregistered warrants to purchase up to an aggregate of 2,334,422 shares of Common Stock at an exercise price of$2.24 per share that are exercisable immediately upon issuance and will expire five and one-half years following the date of issuance. The total net proceeds to us from the offering were approximately$9.8 million .
At
The following table sets forth the primary sources and uses of cash for
the years ended
Year EndedDecember 31, 2021 2020
(157,020)
(244,438)
Net Cash Provided by Financing Activities
Comparison of Years Ended
Operating Activities. During the year endedDecember 31, 2021 , we recorded a net loss of$16.394 million , which includes a goodwill impairment loss of$4.498 million , an intangible asset impairment loss of$1.770 million , an increase in tax credits receivable of$0.441 million , a decrease in accounts payable and accrued expense of$0.270 million , an increase in deferred taxes of$0.252 million , a decrease in contingent consideration of$0.212 million , and an increase in prepaid expense of$0.157 million , which was partially offset by non-cash expense for stock-based compensation in the amount of$0.842 million . During the year endedDecember 31, 2020 , we recorded a net loss of$8.092 million which was partially offset by non-cash expense for stock-based compensation in the amount of$0.724 million . 57
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Investing Activities. During the year endedDecember 31, 2021 , net cash used related to the acquisition of Bayon, as well as the purchase of office furniture and fixtures. During the year endedDecember 31, 2020 , net cash used mainly related to acquisition of Panoptes and the dissolution of EyeGate Pharma S.A.S. Financing Activities. During the year endedDecember 31, 2021 , we received net proceeds of$9.756 million from the completion of a registered direct offering, as well as net proceeds of$7.989 million from the completion of a private placement. These proceeds were partially offset by full forgiveness of the Loan under the PPP in the amount of$0.278 million . During the year endedDecember 31, 2020 we received net proceeds of$4.501 million from the completion of a registered direct stock offering,$0.278 million of Loan funds from the PPP and$0.218 million from the exercise of warrants.
Funding Requirements and Other Liquidity Matters
Our KIO-101, KIO-201 and KIO-301 product pipeline is still in various stages of clinical development. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
? seek marketing approval for our KIO-101, KIO-201 or KIO-301 products or any
other products that we successfully develop;
? establish a sales and marketing infrastructure to commercialize our KIO-101,
KIO-201 or KIO-301 products in
add operational, financial and management information systems and personnel,
? including personnel to support our product development and future
commercialization efforts.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our Stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a Common Stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, including our KIO-301, KIO-101 and KIO-201 products, on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market KIO-101, KIO-201 and KIO-301 products, or any other products that we would otherwise prefer to develop and market ourselves. Based on our cash on hand atDecember 31, 2021 , we believe we will have sufficient cash to fund planned operations intoJuly 2022 . However, the acceleration or reduction of cash outflows by management can significantly impact the timing needed for raising additional capital to complete development of its products. To continue development, we will need to raise additional capital through debt and/or equity financing, or access additional funding through grants. Although we successfully completed our IPO and several subsequent registered offerings and private placements of our securities, additional capital may not be available on terms favorable to us, if at all. OnMay 13, 2019 , theSEC declared effective our registration statement on Form S-3, registering a total of$50,000,000 of our securities for sale to the public from time to time in what is known as a "shelf offering". We do not know if our future offerings, including offerings pursuant to our shelf registration statement, will succeed. Accordingly, no assurances can be given that management will be successful in these endeavors. Our recurring losses from operations have caused management to determine there is substantial doubt about our ability to continue as a going concern. Our Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should we be unable to continue as a going concern.
Off-Balance Sheet Arrangements
We had no material off-balance sheet arrangements at
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