What the changes say
- KALA BIO pivoted its business strategy toward AI-powered life sciences platforms, specifically licensing Researgency and shifting away from clinical biologics development.
What changed since the prior 10-K
New
- NewRisks Related to Our Financial Position and Need for Additional Capital
The Company’s predecessor auditor noted substantial doubt about our ability to continue as a going concern
The company experienced significant liquidity constraints in 2025 under its Oxford Finance debt arrangement and reported an accumulated deficit of $694.9 million.
- NewRisks Related to Our Financial Position and Need for Additional Capital
Because of the new direction of our business strategy, the discontinued clinical trials and the evaluation and development of Researgency, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability
Following discontinued clinical trials and a shift to Researgency, the company cannot predict when or if it will achieve profitability.
- NewRisks Related to Product Development and Monetization of our Biologics Assets
Our ability to monetize our biologics asset portfolio is subject to significant uncertainty, and we may be unable to enter into any licensing, collaboration, sale, or other strategic arrangement with respect to our KPI-012 or KPI-014 product candidates or related intellectual property on acceptable terms, or at all
The company ceased active clinical development of KPI-012 and KPI-014 after the CHASE Phase 2b trial failed to meet endpoints.
- NewRisks Related to Product Development and Monetization of our Biologics Assets
Our increasing focus on and investment in AI and software offerings present risks to our business. We may not be successful in driving the global deployment and customer adoption of an AI platform
The company is devoting significant resources to cloud, edge computing, and AI solutions, facing adoption and regulatory risks.
- NewRisks Related to Our Dependence on Third Parties
The involvement of third-party vendors and partners in developing and delivering our AI platform services introduces risks to quality control that could result in service failures, reputational harm, or liability
A collaboration agreement with Younet for the Researgency platform exposes the company to third-party engineering decisions and quality control risks.
- NewRisks Related to Our AI Platform Business
We are at an early stage of development of our AI platform business and may be unable to successfully develop, commercialize, or generate revenue from Researgency
The company is at an early stage of developing its Researgency on-premises AI infrastructure solution and has not generated revenue from it.
- NewRisks Related to Our AI Platform Business
Our Researgency business depends on an exclusive license for the Researgency platform, and the termination, modification, or invalidity of that license could materially harm our business
The Researgency business depends entirely on an exclusive license that could be terminated, modified, or challenged.
- NewRisks Related to Our AI Platform Business
Issues relating to the use of artificial intelligence and machine learning in our offerings could adversely affect our business and operating results
Incorporating AI and machine learning into drug discovery and operations creates risks of inaccuracy, bias, and intellectual property disputes.
- NewRisks Related to Our AI Platform Business
Regulatory and legislative developments related to the use of AI could adversely affect our use of such technologies in our products, services, and business
Rapidly evolving regulatory frameworks and legislation regarding AI could adversely affect the company's drug discovery platform.
- NewRisks Related to Our AI Platform Business
The market for AI platforms serving the biotechnology and pharmaceutical industries is intensely competitive, rapidly evolving, and may develop in ways that are adverse to our business
The company faces intense competition in the AI platform market from specialized drug discovery companies and large tech firms.
- NewRisks Related to Our AI Platform Business
Our Researgency business model depends on market acceptance of on-premises AI deployment architectures by biotechnology and pharmaceutical companies, and there is no assurance that sufficient market demand will develop
The Researgency business model assumes biotech and pharma companies will prefer on-premises AI deployment over cloud solutions.
- NewRisks Related to Our AI Platform Business
We may not be able to protect our proprietary AI platform technology, and third parties may be able to develop competing products that use similar methods
The legal framework for protecting AI inventions is unsettled, and the company may be unable to protect its proprietary AI technology.
- NewRisks Related to Our AI Platform Business
Our use of artificial intelligence and machine learning in our AI platform business may be subject to methodological and processing limitations that could expose us to regulatory, legal, and reputational risks
- NewRisks Related to Our AI Platform Business
Data security and privacy risks are heightened in our Researgency business given that our platform may process proprietary biological and clinical data of our customers
- NewRisks Related to Our AI Platform Business
Our plans to use our KPI-012 clinical development dataset as a proof-of-concept for Researgency may not generate the commercial benefits we expect, and may expose us to additional risks
- NewRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
Union prior to the date on which the EU Clinical Trials Regulation took effect, the United Kingdom’s legal framework did not benefit from the same revisions as occurred at European Union level
- NewRisks Related to Employee Matters
We have recently undertaken a cost reduction plan and may do so again in the future. The assumptions underlying these activities may prove to be inaccurate, or we may fail to achieve the expected benefits therefrom
- NewRisks Related to Employee Matters
We are substantially dependent on our remaining employees and consultants, along with any other advisors and consultants we may engage, to facilitate pursuit of strategic options and additional financing
- NewRisks Related to Evaluation of Strategic Options and Bankruptcy Proceedings
Our pursuit of strategic options with respect to our biologics asset portfolio and the development of our AI platform business may not be successful, and there can be no assurance that either strategy will generate value for our stockholders
- NewRisks Related to Evaluation of Strategic Options and Bankruptcy Proceedings
Our board of directors may elect to commence bankruptcy or insolvency proceedings
- NewRisks Related to Evaluation of Strategic Options and Bankruptcy Proceedings
We may become involved in securities class action litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages
- NewRisks Related to Our Common Stock
We are a “smaller reporting company,” as defined in Rule 12b-2 under the Exchange Act. We would cease to be a smaller reporting company if we have a public float in excess of $250 million or have annual revenues in excess of $100 million and a public float in excess of $700 million, determined on an annual basis
- NewRisks Related to Our Common Stock
Cybersecurity risks are heightened for our AI platform business, which is designed to be deployed within customer IT environments and may process sensitive biological and clinical data
Dropped
- DroppedRisks Related to Our Financial Position and Need for Additional Capital
expenses will increase substantially if and as we incur commercialization expenses related to product marketing, sales and distribution
- DroppedRisks Related to Product Development
We are substantially dependent on the success of KPI-012 and any other product candidate we may develop in the future. As a result, we intend to devote a substantial portion of our research and development resources and business efforts to the development of KPI-012
Expenses increasing due to commercialization and clinical development of KPI-012.
- DroppedRisks Related to Product Development
obtain regulatory approval of KPI-012 or any other product candidate we develop and the commercialization of KPI-012 or any other product candidate we develop may never occur
- DroppedRisks Related to Product Development
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, and our competitors could bring products to market before we do
- DroppedRisks Related to Product Development
We may not be able to initiate or continue clinical trials for KPI-012 or any other product candidate we may develop if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States
- DroppedRisks Related to Product Development
If serious adverse or unacceptable side effects are identified during the development or commercialization of our product candidates, we may need to abandon or limit our development and/or commercialization efforts for such product candidates
- DroppedRisks Related to Product Development
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
- DroppedRisks Related to Product Development
KPI-012 has been evaluated in a clinical trial outside of the United States and we may in the future conduct clinical trials for product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations
- DroppedRisks Related to Product Development
If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and could delay or permanently halt our development of the applicable product candidates
Substantial dependence on the success of KPI-012.
- DroppedRisks Related to Product Development
burdens of conducting clinical trials under multiple non-U.S. regulatory authority schema; foreign exchange fluctuations; diminished protection of intellectual property in some countries; and interruptions or delays resulting from geopolitical events, such as wars
Uncertainty of obtaining regulatory approval for KPI-012.
- DroppedRisks Related to the Commercialization of our Product Candidates
products from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies
Unforeseen events delaying clinical trials of product candidates.
- DroppedRisks Related to the Commercialization of our Product Candidates
Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved products that we develop would compromise our ability to generate revenues and become profitable
Inability to locate and enroll sufficient patients for clinical trials.
- DroppedRisks Related to the Commercialization of our Product Candidates
Product liability lawsuits against us could divert our resources and could cause us to incur substantial liabilities and limit commercialization of any products that we may develop
Serious adverse side effects requiring abandonment of product candidates.
- DroppedRisks Related to Our Dependence on Third Parties
We have relied, 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
Expending limited resources on less profitable product candidates.
- DroppedRisks Related to Our Dependence on Third Parties
Our current and anticipated future dependence upon others for the manufacture of KPI-012 or any other product candidate we develop may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis
FDA acceptance of clinical trial data from outside the United States.
- DroppedRisks Related to Our Dependence on Third Parties
Our reliance on CIRM funding for KPI-012 adds uncertainty to our research and development efforts, imposes certain compliance obligations on us and imposes requirements that may increase the costs of commercializing KPI-012
Risks associated with conducting international clinical trials.
- DroppedRisks Related to Our Dependence on Third Parties
Additionally, there are significant compliance requirements associated with the CIRM Award, such as reporting, notification, recordkeeping and audit requirements, for which internal and external resources may be needed and which may increase our costs of doing business
Combangio Phase 1b clinical trial of KPI-012 in Mexico.
- DroppedRisks Related to Our Intellectual Property
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours
Third-party payors relying on Medicare coverage policy and lower foreign drug prices.
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
regulatory approval before we are able to obtain approval of KPI-012 for PCED, we could be barred from marketing KPI-012 for PCED in the United States during the seven-year orphan exclusivity period, which would have a severe adverse effect on our business
Inability to obtain coverage and adequate reimbursement rates for approved products.
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
have and may in the future propose self-regulatory standards from time to time. These and other industry standards may legally or contractually apply to us, or we may elect to comply
- DroppedRisks Related to Our Common Stock
Listing Rule 5450(a)(1), or the Bid Price Requirement. We were provided a period of 180 calendar days to regain compliance with the Bid Price Requirement, and in each case, we regained compliance within the cure period, including in the second instance by implementing a reverse stock split of our common stock
- DroppedRisks Related to Our Common Stock
Our largest stockholder may have the ability to exercise significant influence over certain of our business decisions and could influence matters submitted to stockholders for approval
- DroppedRisks Related to Our Common Stock
Baker Brothers holds a significant percentage of our outstanding shares of common stock and could exercise significant influence over matters submitted to our stockholders for approval
- DroppedRisks Related to Our Common Stock
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
Reworded
- 99% rewrittenRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
Although we maintain general liability insurance as well as workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities
Added specific liabilities regarding third-party contract manufacturers failing to comply with environmental, health, and safety laws.
- 88% rewrittenRisks Related to Our Common Stock
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
Disclosed receipt of a Nasdaq deficiency letter on November 10, 2025, for failing the Minimum Market Value of Listed Securities Requirement.
Was: If we fail to comply with the continued listing requirements of Nasdaq, 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. If our common stock is delisted from Nasdaq, we will be in default under our Loan Agreement
- 87% rewrittenRisks Related to Our Common Stock
Certain existing stockholders will experience dilution upon any future conversion of the outstanding shares of our preferred stock into shares of our Common Stock
Updated preferred stock conversion terms to state each Series AA Preferred Stock converts into 55 shares of Common Stock, and added smaller reporting company disclosures.
- 79% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
Minor wording update changing 'common stockholder' to 'Common Stock holder' regarding dilution effects.
- 73% rewrittenRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and if we are found to have improperly promoted such off-label uses, we may become subject to significant liability
Retained standard off-label promotion risk with minor grammatical adjustments.
- 67% rewrittenRisks Related to Employee Matters
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
Replaced former executives Todd Bazemore, Mary Reumuth, and others with Avi Minkowitz as CEO and CFO, and added AI/software staffing dependencies.
- 66% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We have incurred significant losses from operations and negative cash flows from operations since our inception. We expect to incur additional losses and may never achieve or maintain profitability
Updated net losses figure to $27.0 million for 2025 and accumulated deficit to $694.9 million, updating historical funding sources.
- 66% rewrittenRisks Related to Our Common Stock
Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders
Removed specific references to loan and securities purchase agreement dividend restrictions while maintaining the core no-dividend risk.
Was: 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
- 61% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Our limited operating history and our limited experience in developing AI technology or biologics may make it difficult to evaluate the success of our business to date and to assess our future viability
Was: Our limited operating history and our limited experience in developing biologics may make it difficult for you to evaluate the success of our business to date and to assess our future viability
- 57% rewrittenRisks Related to Our Dependence on Third Parties
If we are not able to establish collaborations or strategic partnerships relating to our AI platform, we may have to alter our development and commercialization plans and our business could be adversely affected
Was: If we are not able to establish collaborations, we may have to alter our development and commercialization plans and our business could be adversely affected
- 52% rewrittenRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. We may be subject to additional risks in commercializing any of our product candidates that receive marketing approval in foreign jurisdictions
- 47% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development efforts or cease operations
- 35% rewrittenRisks Related to Our Intellectual Property
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
- 31% rewrittenRisks Related to Our Common Stock
We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices
- 28% rewrittenRisks Related to Our Common Stock
Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition
- 27% rewrittenRisks Related to Our Intellectual Property
Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
- 25% rewrittenRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
Current and future legislation designed to reduce prescription drug costs may affect the prices we and any collaborators may obtain for our product candidates
- 20% rewrittenRisks Related to Our Common Stock
Sales of a substantial number of shares of our Common Stock , or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our Common Stock. As of April 10, 2026, we had outstanding 929,491,578 shares of Common Stock
Was: Sales of a substantial number of shares of our common stock, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. As of March 28, 2025, we had outstanding 6,452,398 shares of common stock
All 66 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Financial Position and Need for Additional Capital
- 01The Company’s predecessor auditor noted substantial doubt about our ability to continue as a going concernNew
- 02We have incurred significant losses from operations and negative cash flows from operations since our inception. We expect to incur additional losses and may never achieve or maintain profitability66% rewritten
- 03Because of the new direction of our business strategy, the discontinued clinical trials and the evaluation and development of Researgency, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitabilityNew
- 04We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development efforts or cease operations47% rewritten
- 05Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates79% rewritten
- 06The milestone consideration we are eligible to receive in connection with the sale of our Commercial Business to Alcon is subject to various risks and uncertainties
- 07If our estimates or judgments relating to our critical accounting policies, or any of our projections, prove to be inaccurate or financial reporting standards or interpretations change, our results of operations could be adversely affected
- 08Our limited operating history and our limited experience in developing AI technology or biologics may make it difficult to evaluate the success of our business to date and to assess our future viability61% rewritten
- 09Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had prior experience developing biological product candidates or a longer operating and commercialization history
Risks Related to Product Development and Monetization of our Biologics Assets
- 10Our ability to monetize our biologics asset portfolio is subject to significant uncertainty, and we may be unable to enter into any licensing, collaboration, sale, or other strategic arrangement with respect to our KPI-012 or KPI-014 product candidates or related intellectual property on acceptable terms, or at allNew
- 11Our increasing focus on and investment in AI and software offerings present risks to our business. We may not be successful in driving the global deployment and customer adoption of an AI platformNew
Risks Related to Our Dependence on Third Parties
- 12The involvement of third-party vendors and partners in developing and delivering our AI platform services introduces risks to quality control that could result in service failures, reputational harm, or liabilityNew
- 13If we continue to pursue development of our MSC-S platform, we may enter into collaborations with third parties for the development or commercialization of our clinical product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates
- 14If we are not able to establish collaborations or strategic partnerships relating to our AI platform, we may have to alter our development and commercialization plans and our business could be adversely affected57% rewritten
Risks Related to Our AI Platform Business
- 15We are at an early stage of development of our AI platform business and may be unable to successfully develop, commercialize, or generate revenue from ReseargencyNew
- 16Our Researgency business depends on an exclusive license for the Researgency platform, and the termination, modification, or invalidity of that license could materially harm our businessNew
- 17Issues relating to the use of artificial intelligence and machine learning in our offerings could adversely affect our business and operating resultsNew
- 18Regulatory and legislative developments related to the use of AI could adversely affect our use of such technologies in our products, services, and businessNew
- 19The market for AI platforms serving the biotechnology and pharmaceutical industries is intensely competitive, rapidly evolving, and may develop in ways that are adverse to our businessNew
- 20Our Researgency business model depends on market acceptance of on-premises AI deployment architectures by biotechnology and pharmaceutical companies, and there is no assurance that sufficient market demand will developNew
- 21We may not be able to protect our proprietary AI platform technology, and third parties may be able to develop competing products that use similar methodsNew
- 22Our use of artificial intelligence and machine learning in our AI platform business may be subject to methodological and processing limitations that could expose us to regulatory, legal, and reputational risksNew
- 23Data security and privacy risks are heightened in our Researgency business given that our platform may process proprietary biological and clinical data of our customersNew
- 24Our plans to use our KPI-012 clinical development dataset as a proof-of-concept for Researgency may not generate the commercial benefits we expect, and may expose us to additional risksNew
Risks Related to Our Intellectual Property
- 25If we are not able to obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for our product candidates, our business may be materially harmed
- 26We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights, which could be expensive, time-consuming and unsuccessful
- 27Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business27% rewritten
- 28Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
- 29If we fail to comply with our obligations under our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business
- 30We may not be able to protect our intellectual property and proprietary rights throughout the world
- 31We 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
- 32Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities
- 33If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed35% rewritten
- 34Patent reform legislation under Leahy-Smith America Invents Act could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
- 35If we experience delays in obtaining approval or if we fail to obtain approval of any product candidate that we develop, the commercial prospects for such product candidate may be harmed and our ability to generate revenues will be materially impaired
- 36Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. We may be subject to additional risks in commercializing any of our product candidates that receive marketing approval in foreign jurisdictions52% rewritten
- 37Union prior to the date on which the EU Clinical Trials Regulation took effect, the United Kingdom’s legal framework did not benefit from the same revisions as occurred at European Union levelNew
- 38Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight
- 39The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and if we are found to have improperly promoted such off-label uses, we may become subject to significant liability73% rewritten
- 40If approved, our products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
- 41Existing and future legislation may affect our ability to commercialize our products, if and when approved, and increase the difficulty and cost for us to obtain reimbursement for our products, if and when approved
- 42Current and future legislation designed to reduce prescription drug costs may affect the prices we and any collaborators may obtain for our product candidates25% rewritten
- 43If we or any third-party manufacturers we engage or may engage in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur significant costs
- 44Although we maintain general liability insurance as well as workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities99% rewritten
- 45We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards
Risks Related to Employee Matters
- 46We have recently undertaken a cost reduction plan and may do so again in the future. The assumptions underlying these activities may prove to be inaccurate, or we may fail to achieve the expected benefits therefromNew
- 47Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel67% rewritten
- 48A partially or fully remote workplace could negatively impact our business
- 49We are substantially dependent on our remaining employees and consultants, along with any other advisors and consultants we may engage, to facilitate pursuit of strategic options and additional financingNew
Risks Related to Evaluation of Strategic Options and Bankruptcy Proceedings
- 50Our pursuit of strategic options with respect to our biologics asset portfolio and the development of our AI platform business may not be successful, and there can be no assurance that either strategy will generate value for our stockholdersNew
- 51Our board of directors may elect to commence bankruptcy or insolvency proceedingsNew
- 52We may become involved in securities class action litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damagesNew
Risks Related to Our Common Stock
- 53If 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 impacted88% rewritten
- 54Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
- 55An active trading market for our Common Stock may not be sustained
- 56The price of our Common Stock is volatile and fluctuates substantially, which could result in substantial losses for purchasers of our Common Stock
- 57Sales of a substantial number of shares of our Common Stock , or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our Common Stock. As of April 10, 2026, we had outstanding 929,491,578 shares of Common Stock20% rewritten
- 58Certain existing stockholders will experience dilution upon any future conversion of the outstanding shares of our preferred stock into shares of our Common Stock87% rewritten
- 59We are a “smaller reporting company,” as defined in Rule 12b-2 under the Exchange Act. We would cease to be a smaller reporting company if we have a public float in excess of $250 million or have annual revenues in excess of $100 million and a public float in excess of $700 million, determined on an annual basisNew
- 60We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices31% rewritten
- 61For as long as we remain a smaller reporting company, we may take advantage of certain exemptions from various reporting requirements as described in the preceding risk factor
- 62Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders66% rewritten
- 63Our Certificate of Incorporation designates the state courts in the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors, officers and employees
- 64Our internal computer systems, or those of our vendors, contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs
- 65Cybersecurity risks are heightened for our AI platform business, which is designed to be deployed within customer IT environments and may process sensitive biological and clinical dataNew
- 66Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition28% rewritten
Other KALA BIO 10-Ks
- FY2024 10-K risk factors68 risks
KALA BIO depends heavily on developing its lead biologic candidate, KPI-012, while facing recurring operating losses, substantial funding requirements, and reliance on third-party manufacturers.
Filed Mar 31, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.