Full Press Release Details
Kala Pharmaceuticals, Inc. ( we , us or our ) is filing information for the purpose of updating and superseding the risk factor disclosure contained in its prior public filings, including those previously set forth in Part II, Item IA, Risk Factors of its Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on April 2, 2018, its Quarterly Report on Form 10-Q for the period ended March 31, 2018, filed with the SEC on May 10, 2018, and its Quarterly Report on Form 10-Q for the period ended June 30, 2018, filed with the SEC August 9, 2018.
You should carefully consider the following risk factors, in addition to other information included in our other filings with the Securities and Exchange Commission, in evaluating us and our business. The following risk factors should be carefully considered. The risks and uncertainties described below are not the only ones we face. Additional risks that are currently unknown to us or that are currently considered to be immaterial may also impair our business or adversely affect our financial condition or results of operations. If any of the following risks occur, our business prospects, operating results, financial condition and future growth prospects could be materially and adversely affected.
Risks 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 losses over the next several years and may never achieve or maintain profitability.
Since inception, we have incurred significant losses from operations and negative cash flows from operations. Our net losses were $25.9 million for the six months ended June 30, 2018, $42.2 million for the year ended December 31, 2017, $33.2 million for the year ended December 31, 2016 and $16.7 million for the year ended December 31, 2015. As of June 30, 2018, we had an accumulated deficit of $160.3 million. We have not generated any revenues to date from product sales and have financed our operations primarily through our initial public offering, or IPO, private placements of our preferred stock, convertible debt financings and borrowings under credit facilities. We have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical trials and engaging in activities to prepare to commercially launch our first FDA approved product, INVELTYSTM (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. Although we expect to generate revenue from sales of INVELTYS, there can be no assurance that we will generate any such revenue or as to the timing of any such revenue, and we expect to continue to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.
We anticipate that our expenses will increase substantially as compared to prior periods as we commercially launch INVELTYS in the United States and engage in activities to prepare for commercialization of our product candidates, as a result of increased headcount, including management personnel to support our clinical, manufacturing and commercialization activities, expanded infrastructure, increased legal, compliance, accounting and investor and public relations expenses associated with being a public company and increased insurance premiums, among other factors. Our license agreement with The Johns Hopkins University, or JHU, under which we license certain of our patent rights and a significant portion of the technology for INVELTYS and KPI-121 0.25%, imposes royalty and other financial obligations on us, and we may enter into additional licensing and funding arrangements with third parties that may impose milestone payment, royalty, insurance and other obligations on us.
Our expenses will also increase if and as we:
commercially launch INVELTYS in the United States and seek regulatory approval for INVELTYS in the European Union;
continue to grow our sales, marketing and distribution capabilities to commercialize INVELTYS and any product candidates for which we may submit for and obtain marketing approval;
continue development of KPI-121 0.25%, including conducting our ongoing Phase 3 clinical trial, and/or seek marketing approvals for KPI-121 0.25% and any other product candidates;
pursue the clinical development of KPI-121 for the treatment of other additional indications or for use in other patient populations or seek to broaden the label of INVELTYS or, if approved, KPI-121 0.25%;
pursue the preclinical and clinical development of product candidates derived from our topically applied MPP receptor Tyrosine Kinase Inhibitor program, or rTKI program, for use in the treatment of retinal diseases;
expand our sales, marketing and distribution capabilities for our other product candidates, prior to or upon receiving marketing approval;
continue to scale up our manufacturing processes and capabilities to support commercialization of INVELTYS, and any of our product candidates, including KPI-121 0.25%, for which we seek and/or obtain marketing approval;
leverage our proprietary MPP technology to advance additional potential high-value therapeutics into preclinical and clinical development;
in-license or acquire the rights to other products, product candidates or technologies;
maintain, expand and protect our intellectual property portfolio;
hire additional clinical, quality control, scientific, manufacturing, commercial and management personnel;
expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company; and
increase our product liability insurance coverage as we initiate and expand our commercialization efforts.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Our expenses will increase from what we anticipate if:
we elect to or are required by the FDA or non-U.S. regulatory agencies to perform clinical trials or studies in addition to those expected;
there are any delays in enrollment of patients in or completing our clinical trials or the development of our product candidates; or
there are any third-party challenges to our intellectual property portfolio, or the need arises to defend against intellectual property-related claims or enforce our intellectual property rights.
Our ability to become and remain profitable depends on our ability to generate revenue. While we expect to begin to generate revenue from the sales of INVELTYS in 2019, there can be no assurance that we will generate any such revenue or as to the timing of any such revenue, and we may not achieve profitability for several years, if at all. Achieving and maintaining profitability will require us to be successful in a range of challenging activities, including:
successfully completing the commercial launch of INVELTYS, including by further developing our sales force, marketing and distribution capabilities;
obtaining marketing approval for KPI-121 0.25% or any other product candidates;
manufacturing at commercial scale, marketing, selling and distributing INVELTYS or any product candidates for which we obtain marketing approval, including KPI-121 0.25%;
maintaining regulatory and marketing approvals for INVELTYS and for any other product candidates for which we obtain approval;
hiring and building a full commercial organization required for the marketing, selling and distributing for those products which we obtain marketing approval;
achieving an adequate level of market acceptance of and obtaining and maintaining coverage and adequate reimbursement from third-party payors for INVELTYS and any other products we commercialize; and
obtaining, maintaining and protecting our intellectual property rights.
INVELTYS is our only product that has been approved for sale and it has only been approved in the United States for the treatment of inflammation and pain following ocular surgery. Our ability to generate revenue from operations will depend, in part, on the timing and success of commercial sales of INVELTYS, which we plan to commercially launch in the United States in early 2019. However, the successful commercialization of INVELTYS in the United States is subject to many risks. We are currently undertaking our first commercial launch with INVELTYS, and we may not be able to do so successfully or on the currently expected timeline or at all. There are numerous examples of unsuccessful product launches and failures to meet expectations of market potential, including by pharmaceutical companies with more experience and resources than us. We do not anticipate our revenue from sales of INVELTYS alone will be sufficient for us to become profitable for several years, if at all.
We may never succeed in these activities and may never generate revenue that is sufficient to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.
Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
We are an early-stage company. Our operations to date have been limited to organizing and staffing our company, acquiring rights to intellectual property, business planning, raising capital and developing INVELTYS and our product candidates, including KPI-121 0.25%, and engaging in activities to prepare for the commercial launch of INVELTYS. Although we are preparing for the launch and commercialization of INVELTYS, we have no history of commercializing products, are still in the process of preparing for the commercial launch of INVELTYS and, to date, have not generated revenue from the sale of INVELTYS. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.
In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We are in the early stages of the process of transitioning from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition.
We expect our financial condition and operating results to fluctuate significantly from quarter-to-quarter and year-to-year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance.
We may 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 programs or commercialization efforts.
We expect to devote substantial financial resources to our ongoing and planned activities, particularly as we commercialize INVELTYS, seek marketing approval for KPI-121 0.25%, and continue the development of and potentially seek marketing approval for other product candidates. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we commercialize INVELTYS and advance our preclinical activities and clinical trials for our product candidates. In addition, our expenses will further increase as we conduct our third Phase 3 trial for KPI-121 0.25% and if we elect to or are required to conduct any further trials. We also expect to devote additional financial resources to conducting research and development, initiating clinical trials of, and potentially seeking regulatory approval for, other potential product candidates, including product candidates that we may develop using our rTKI program.
We have begun to incur commercialization expenses related to INVELTYS, including beginning to build a commercial infrastructure, and increasing marketing, distribution and manufacturing capabilities. If we obtain marketing approval for KPI-121 0.25% or any other product candidate that we develop, we expect to incur significant additional commercialization expenses for such product candidate. Furthermore, we will incur additional costs associated with operating as a public company, hiring additional personnel and expanding our facilities. Accordingly, we may need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.
Our future capital requirements will depend on many factors, including:
our ability to successfully commercialize and sell INVELTYS in the United States;
the cost and our ability to establish and maintain the commercial infrastructure and manufacturing capabilities required to support the commercialization of INVELTYS and any other products for which we receive marketing approval, including product sales, medical affairs, marketing, manufacturing and distribution;
the progress, costs and results of our additional Phase 3 trials for KPI-121 0.25%, STRIDE 3 (STRIDE - Short Term Relief In Dry Eye), and whether we determine, or are required, to conduct any additional clinical trials or other activities for KPI-121 0.25%;
the costs, timing and outcome of regulatory review of KPI-121 0.25%, including whether any additional clinical trials or other activities are required for approval or label expansion;
the progress, costs and results of any clinical activities for regulatory review of INVELTYS and KPI-121 0.25% outside of the United States;
the costs and timing of process development and manufacturing scale-up activities associated with INVELTYS and KPI-121 0.25%;
the costs of commercialization activities for KPI-121 0.25% if we receive marketing approval and pre-commercialization costs for KPI-121 0.25% incurred prior to receiving any such marketing approval, including the costs and timing of establishing product sales, marketing, distribution and outsourced manufacturing capabilities;
the amount of revenue received from commercial sales of INVELTYS and, assuming receipt of marketing approval, KPI-121 0.25% or any other product candidates;
our ability to establish and maintain strategic collaborations, licensing or other agreements and the financial terms of such agreements;
the scope, progress, results and costs of any product candidates that we may derive from any other product candidates that we may develop;
the extent to which we in-license or acquire rights to other products, product candidates or technologies; and
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims.
We believe that our existing cash on hand as of June 30, 2018, together with borrowings under the Term A Loan under the Athyrium Credit Facility, will enable us to fund our planned operating expenses, debt service obligations and capital expenditure requirements through early 2020. We have based these estimates on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. As a result, we could deplete our available capital resources sooner than we currently expect.
Conducting preclinical testing and clinical trials, seeking market approvals and commercializing products are time-consuming, expensive and uncertain processes that take years to complete. Although we expect to commercially launch INVELTYS in early 2019, we do not anticipate that our revenue from product sales of INVELTYS will be sufficient for us to become profitable for several years, if at all. Additionally, while we are planning to submit a new drug application, or an NDA, to the FDA for KPI-121 0.25% during the second half of 2018, the FDA may decide not to accept the NDA for filing, or, if accepted, we may not receive approval to commercialize KPI-121 0.25%. Based upon the recommendation of the FDA, we also initiated an additional Phase 3 clinical trial, STRIDE 3, in the third quarter of 2018 evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. We may determine to conduct additional Phase 3 trials prior to or following submission of the NDA for KPI-121 0.25% or to potentially expand the label of KPI-121 0.25% if we receive marketing approval for a narrower indication than we are targeting. In addition, we may never generate the necessary data or results required to obtain regulatory approval of KPI-121 0.25% or of any other product candidates. We will need to obtain substantial additional financing to achieve our business objectives. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. Adequate additional financing may not be available to us on acceptable terms, or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for one or more of our product candidates or delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize INVELTYS or any other product candidates for which we obtain approval.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, royalty agreements, and marketing and distribution arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. The lenders under our Athyrium Credit Facility are currently entitled to exercise warrants for up to 184,660 shares of common stock. If we draw down on the remaining $35.0 million of potentially available borrowings under our Athyrium Credit Facility, the lenders thereunder will be entitled to exercise warrants for up to an additional 86,175 shares of our common stock. Your ownership interest will be diluted to the extent any such warrants are exercised. Debt financing and preferred equity financing, if available, may involve agreements that include pledging of assets as collateral, covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our pledge of our assets as collateral
to secure our obligations under our Athyrium Credit Facility may limit our ability to obtain additional debt financing. Under our Athyrium Credit Facility, we are also restricted from paying dividends on our common stock without the lender s consent
If we raise additional funds through collaborations, strategic alliances, licensing arrangements, royalty agreements, or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses 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 current or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Our substantial indebtedness may limit cash flow available to invest in the ongoing needs of our business.
We have a significant amount of indebtedness. As of June 30, 2018, we had $20.0 million of outstanding borrowings under our venture debt facility, or the 2014 Debt Facility. In October 2018 we entered into the Athyrium Credit Facility and repaid the 2014 Debt Facility in full. We currently have $75.0 million of outstanding borrowings under the Athyrium Credit Facility and have the ability to draw an additional $35.0 million prior to June 30, 2020 upon either FDA approval of KPI-121 0.25% for a dry eye indication or reaching net product revenues of INVELTYS of at least $25.0 million for the two fiscal quarter period then most recently ended. Amounts outstanding under the Athyrium Credit Facility bear interest at a rate of 9.875% per annum. The Athyrium Credit Facility provides for quarterly interest-only payments for 48 months. Beginning on September 30, 2022, we will be required to make principal and interest payments through October 1, 2024. Our obligations under the Athyrium Credit Facility are secured by substantially all of our assets. We could in the future incur additional indebtedness beyond our borrowings under our Athyrium Credit Facility.
Our debt combined with our other financial obligations and contractual commitments could have significant adverse consequences, including:
requiring us to dedicate a substantial portion of cash flow from operations or cash on hand to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes;
increasing our vulnerability to adverse changes in general economic, industry and market conditions;
subjecting us to restrictive covenants that may reduce our ability to take certain corporate actions or obtain further debt or equity financing;
limiting our flexibility in planning for, or reacting to, changes in our business and our industry; and
placing us at a competitive disadvantage compared to our competitors that have less debt or better debt servicing options.
We intend to satisfy our current and future debt service obligations with our existing cash and anticipated product revenue from INVELTYS. Nonetheless, we may not have sufficient funds or may be unable to arrange for additional financing to pay the amounts due under our existing debt and funds from external sources may not be available on acceptable terms, if at all. In addition, a failure to comply with the covenants under our Athyrium Credit Facility could result in an event of default and acceleration of amounts due. If an event of default occurs and the lender accelerates the amounts due under our Athyrium Credit Facility, we may not be able to make accelerated payments, and the lender could seek to enforce security interests in the collateral securing such indebtedness.
Risks Related to Product Development
We are dependent on the success of INVELTYS and our lead product candidate, KPI-121 0.25%. If we are unable to successfully commercialize INVELTYS or obtain marketing approval for KPI-121 0.25%, or
experience significant delays in doing so, or if, after obtaining marketing approval for KPI-121 0.25%, we fail to successfully commercialize KPI-121 0.25%, our business will be materially harmed.
We have devoted a significant portion of our financial resources and business efforts to the development of INVELTYS for the post-operative treatment of inflammation and pain following ocular surgery and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. There is a significant risk that we will fail to successfully commercialize INVELTYS and to successfully obtain marketing approval for and commercialize KPI-121 0.25%. In January 2018, we announced that we had completed two Phase 3 clinical trials evaluating KPI-121 0.25%, STRIDE 1 and STRIDE 2, evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with dry eye disease. In STRIDE 1, statistical significance was achieved for both primary endpoints. However, in STRIDE 2 we did not achieve statistical significance for the primary symptom endpoint of ocular discomfort severity. While we are planning to submit an NDA to the FDA for KPI-121 0.25% during the second half of 2018, the FDA may decide not to accept the NDA for filing, or, if accepted, we may not receive approval to commercialize KPI-121 0.25%. Based upon the recommendation of the FDA, we initiated an additional Phase 3 clinical trial, STRIDE 3, in the third quarter of 2018 evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. We may also determine to conduct additional Phase 3 trials prior to or following submission of the NDA for KPI-121 0.25% or to potentially expand the label of KPI-121 0.25% if we receive marketing approval for a narrower indication than we are targeting. We cannot accurately predict when or if KPI-121 0.25% will receive marketing approval. Our ability to generate product revenues will depend on our successful commercialization of INVELTYS and our obtaining marketing approval for, and successfully commercializing, KPI-121 0.25%.
The success of our product INVELTYS, our lead product candidate, KPI-121 0.25%, and any other product candidates will depend on many factors, including the following:
successful commercialization of INVELTYS in the United States, including establishing sales, marketing and distribution capabilities for INVELTYS;
successfully developing and applying for and receiving marketing approvals from applicable regulatory authorities for KPI-121 0.25% and other product candidates;
receiving regulatory approval of our manufacturing processes and our third-party manufacturers facilities from applicable regulatory authorities;
expanding and maintaining a workforce of experienced scientists and others with experience in MPP technology to continue to develop our product candidates;
establishing sales, marketing and distribution capabilities for KPI-121 0.25% and successfully launching commercial sales of any other product candidates for which we obtain marketing approval, whether alone or in collaboration with others;
acceptance of INVELTYS and, if and when approved, KPI-121 0.25% and our other product candidates by patients, the medical community and third-party payors;
effectively competing with other therapies;
maintaining an acceptable safety profile of our products following approval;
obtaining and maintaining coverage, adequate pricing, and adequate reimbursement from third-party payors, including government payors, for our product candidates;
obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;
protecting our rights in our intellectual property portfolio; and
not infringing on others intellectual property rights.
Successful development of KPI-121 0.25% for additional indications, if any, or for use in broader patient populations and our ability, if it is approved, to broaden the label for KPI-121 0.25% will depend on similar factors.
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 INVELTYS or our product candidates, including KPI-121 0.25%, which would materially harm our business.
If clinical trials of KPI-121 0.25% or any other product candidate that we develop fail to demonstrate safety and efficacy to the satisfaction of the FDA or other regulatory authorities or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidate.
Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later stage clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their product candidates. Furthermore, the failure of any product candidates to demonstrate safety and efficacy in any clinical trial could negatively impact the perception of our other product candidates and/or cause the FDA or other regulatory authorities to require additional testing before approving any of our product candidates. For example, we previously conducted a Phase 2 clinical trial of KPI-121 0.25% for the treatment of meibomian gland dysfunction which did not achieve its primary endpoint. The failure of this trial may have an adverse impact on the perceived safety or efficacy of KPI-121 0.25% in treating dry eye disease or other indications or of INVELTYS.
In January 2018, we announced that we had completed two Phase 3 clinical trials evaluating KPI-121 0.25%, STRIDE 1 and STRIDE 2, evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with dry eye disease. In STRIDE 1, statistical significance was achieved for both primary endpoints. However, in STRIDE 2 we did not achieve statistical significance for the primary symptom endpoint of ocular discomfort severity. While we are planning to submit an NDA to the FDA for KPI-121 0.25% during the second half of 2018, the FDA may decide not to accept the NDA for filing, or, if accepted, we may not receive approval to commercialize KPI-121 0.25%. Based upon the recommendation of the FDA, we initiated an additional Phase 3 clinical trial, STRIDE 3, in the third quarter of 2018 evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. We may also determine to conduct additional Phase 3 trials prior to or following submission of the NDA for KPI-121 0.25% or to potentially expand the label of KPI-121 0.25% if we receive marketing approval for a narrower indication than we are targeting. If the FDA determines that we have not sufficiently demonstrated efficacy for both signs and symptoms of dry eye, we may need to conduct additional clinical trials to support approval of KPI-121 0.25% for temporary relief of signs and symptoms of dry eye disease. If we conduct additional clinical trials of KPI-121 0.25%, our expenses will significantly increase and could delay or halt our ability to obtain marketing approval. Regulatory authorities outside the United States, in particular in the European Union, have not issued guidance on the requirements for approval of a dry eye drug. Our Phase 3 clinical trials of KPI-121 0.25% may not be sufficient to support an application for marketing approval outside the United States. Further, if regulatory authorities outside the United States do not accept the data from any trial we conduct in the United States, in particular if the European Union does not allow us to utilize the results from our Phase 3 clinical trials of KPI-121 0.25% pursuant to the Article 10(3) submission pathway or otherwise, we will likely need to conduct additional trials to obtain marketing approval in such jurisdiction, which would be costly and time-consuming and could delay or permanently halt our ability to commercialize the applicable product candidates in the applicable jurisdictions.
We performed additional analyses on a post-hoc basis on the results of our completed Phase 2 clinical trial for KPI-121 0.25% for the purpose of designing our STRIDE 1 and STRIDE 2 clinical trials for KPI-121 0.25%. Following completion of these Phase 3 trials we conducted additional analyses on a post-hoc basis of the data from both these Phase 3 trials and the Phase 2 clinical trial to support our planned NDA submission and to inform the design of our STRIDE 3 clinical trial and our development plan. We may also conduct additional post-hoc analyses on the results of clinical trials in the future. Post-hoc analyses performed after unmasking trial results can result in the introduction of bias, may not be predictive of success in any future clinical trials and are given less weight by regulatory authorities than pre-specified analyses.
If we are required to conduct additional clinical trials or other testing of KPI-121 0.25% or any other product candidate that we develop beyond those that we currently expect, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:
be delayed in obtaining marketing approval for our product candidates;
not obtain marketing approval at all;
obtain approval for indications or patient populations that are not as broad as intended or desired;
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;
be subject to additional post-marketing testing requirements; or
have the product removed from the market after obtaining marketing approval.
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.