▸ If KIO-104, KIO-301, or any of our other product candidates are associated with serious adverse events or undesirable side effects in clinical trials or have characteristics that are unexpected, we may need to abandon· · · · ● 1 ▸ If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.· · · · ● 1 ▸ Under the agreement, TOI is solely and exclusively responsible for all costs and activities related to Phase III clinical trials for KIO-301. TOI may determine, however, that it is commercially reasonable to de-prioritize or· · · · ● 1 ▸ As of December 31, 2025, we had cash and cash equivalents of $8.7 million and short-term investments of $8.4 million for a total of $17.1 million.· · · ● ● 2 rw ▸ Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability.· · · ● ● 2 ▸ We expect to enter into arrangements with third parties to perform consulting, sales, marketing, and distribution services in markets outside the U.S. We may also enter into arrangements with third parties to perform these· · · ● · 1 ▸ We are a clinical-stage company with a limited operating history. Our operations to date have been limited to organizing and staffing our company, acquiring rights to intellectual property, business planning, raising capital,· · ● · · 1 ▸ Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete pre-clinical development and then conduct extensive clinical trials to demonstrate the safety and· ● · · · 1 ▸ We could face delisting from Nasdaq in the event we do not meeting its minimum bid price rules.· ● ● · · 2 ▸ The coronavirus pandemic could adversely impact our business, including clinical trials.● ● · · · 2 ▸ We have identified material weaknesses in our internal controls over financial reporting that, if not properly remediated, could result in material misstatements in our financial statements in future periods.● · · · · 1 ▸ We have received a notice from Nasdaq of non-compliance with its minimum bid price rules.● · · · · 1 ▸ A material amount of our assets represents intangible assets, and our net income would be reduced if our intangible assets become impaired.● ● ● ● ● 5 ▸ Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees, this insurance may not provide adequate coverage against potential liabilities.● ● ● ● ● 5 ▸ Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.● ● ● ● ● 5 ▸ Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.● ● ● ● ● 5 ▸ Foreign currency exchange rate fluctuations may have a negative impact on our financial results.● ● ● ● ● 5 ▸ If KIO-104, KIO-301, or any other product candidate that we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community.● ● ● ● ● 5 rw ▸ If serious adverse or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of such product candidates.● ● ● ● ● 5 ▸ If we are not able to establish additional collaborations, we may have to alter our development and commercialization plans and our business could be adversely affected.● ● ● ● ● 5 ▸ If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in KIO-104, KIO-301, or any other product candidates that we may develop if and when they are approved.● ● ● ● ● 5 rw ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.● ● ● ● ● 5 ▸ If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize KIO-104 and KIO-301, which would materially harm our business.● ● ● ● ● 5 rw ▸ If we experience any of a number of possible unforeseen events in connection with our clinical trials, potential marketing approval or commercialization of our product candidates could be delayed or prevented.● ● ● ● ● 5 ▸ If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.● ● ● ● ● 5 ▸ If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.● ● ● ● ● 5 ▸ If we or our third-party manufacturers fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.● ● ● ● ● 5 rw ▸ Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.● ● ● ● ● 5 ▸ Laws and regulations governing international operations may preclude us from developing, manufacturing, and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs.● ● ● ● ● 5 ▸ Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● ● ● 5 ▸ Our business and operations would suffer in the event of system failures.● ● ● ● ● 5 ▸ Our future success depends on our ability to retain key executives and to attract, retain, and motivate qualified personnel.● ● ● ● ● 5 rw ▸ Our limited operating history may make it difficult for investors to evaluate the success of our business to date and to assess our future viability.● ● ● ● ● 5 rw ▸ Our strategy of obtaining rights to product candidates and approved products through in-licenses and acquisitions may not be successful.● ● ● ● ● 5 ▸ Previously enacted and future legislation may affect our ability to commercialize and the prices we obtain for any products that are approved in the U.S. or foreign jurisdictions.● ● ● ● ● 5 ▸ Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we develop.● ● ● ● ● 5 rw ▸ Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.● ● ● ● ● 5 ▸ group Risks Related to Employee Matters and Managing Growth● ● ● ● ● 5 ▸ group Risks Related to Our Common Stock● ● ● ● ● 5 ▸ group Risks Related to Our Dependence on Third Parties● ● ● ● ● 5 ▸ Risks Related to Our Financial Position and Need for Additional Capital● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters● ● ● ● ● 5 ▸ group Risks Related to the Commercialization of Our Product Candidates● ● ● ● ● 5 ▸ Risks Related to the Discovery and Development of Our Product Candidates● ● ● ● ● 5 ▸ Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.● ● ● ● ● 5 ▸ The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.● ● ● ● ● 5 ▸ The regulatory process can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved.● ● ● ● ● 5 rw ▸ Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.● ● ● ● ● 5 ▸ We are a smaller reporting company and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.● ● ● ● ● 5 ▸ We expect to expand our development capabilities and potentially implement sales, marketing, and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.● ● ● ● ● 5 ▸ We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.● ● ● ● ● 5 ▸ We incur increasing costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.● ● ● ● ● 5 rw ▸ We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.● ● ● ● ● 5 ▸ We may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.● ● ● ● ● 5 ▸ We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming, and unsuccessful.● ● ● ● ● 5 rw ▸ We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.● ● ● ● ● 5 ▸ We may fail to realize any benefits and incur losses related to any acquisition.● ● ● ● ● 5 ▸ We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.● ● ● ● ● 5