ELTX

Some of the more significant challenges and risks include the following: • We will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed, on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our research and development programs, commercialization efforts or cease operations. • Our recurring losses from operations have raised substantial doubt regarding our ability to continue as a going concern. • We may be unsuccessful in raising the capital necessary to address our going concern issues, or if we are successful, it may be on terms that are highly dilutive to existing stockholders. • We have a history of operating losses that are expected to continue for the foreseeable future, and we are unable to predict the extent of future losses, or whether we will generate significant revenues or achieve or sustain profitability. • We have never generated revenue from product sales and may never become profitable. • We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance. • We are obligated to develop and maintain proper and effective internal control over financial reporting.
In the future, we may not complete our execution of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may result in material misstatements in our consolidated financial statements and may adversely affect investor confidence in our company and, as a result, the value of our common stock. • Our product candidates are at an early stage of development and may not be successfully developed or commercialized. • The FDA or comparable foreign regulatory authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval of our product candidates. • We may not be successful in our efforts to use and expand our discovery engine to build a pipeline of product candidates. • Relative to companies that are more established than we are or that have a larger footprint than we do, we have relatively limited experience as a company in completing preclinical studies to enable the filing of INDs, submitting INDs or commencing, enrolling and conducting clinical trials. • Our ELI-002 clinical trials are designed to require, as part of screening to determine whether patients meet inclusion criteria, the use of an investigational in vitro diagnostic device.
If we are not able to successfully collaborate or partner with a third-party company for the development and authorization of such a device, we may not be able to receive marketing authorization for ELI-002. • 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. • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. • Any product candidate we advance into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent our regulatory approval or commercialization or limit our commercial potential. • We may form or seek strategic partnerships or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements. • We rely on contract manufacturing organizations (“CMOs”) to manufacture our nonclinical and clinical pharmaceutical supplies and expect to continue to rely on CMOs to produce commercial supplies of any approved product candidate, and our dependence on CMOs could adversely impact our business. • We rely on third parties to conduct some of our nonclinical studies and all of our clinical trials.
If these third parties do not meet our deadlines or otherwise conduct the trials as required, our development programs could be delayed or unsuccessful and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all. • We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop. • Our technologies are novel, and any product candidates we develop may be complex and difficult to manufacture on a clinical or commercial scale.
We could experience delays in satisfying regulatory authorities or we could experience production problems that result in delays in our development or commercialization programs, limit the supply of our product candidates we may develop, or otherwise harm our business. • Our success will depend upon intellectual property and proprietary technologies, and we may be unable to protect our intellectual property. • We are substantially dependent on patents and patent applications under which we license rights from MIT, and if such licensed patent rights lack legal effect or if a dispute arises under such license agreement and our licensed rights are narrowed or this license is terminated, that could cause significant impairment to our ability to develop and commercialize certain of our product candidates. • Even if we receive regulatory approval of our product candidates, we will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements. • Health care and other reform legislation may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain. • Our internal information technology systems, or those of our vendors, collaborators or other contractors or consultants, may fail or suffer cybersecurity incidents, loss of data, and other disruptions, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business. • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price. • We will continue to incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies.
During the years ended December 31, 2025 and 2024, we incurred research and development expenses of $24.9 million and $33.7 million, respectively, and net losses of $39.6 million and $51.9 million, respectively.
We currently have no other commitments or agreements relating to any of these types of transactions, other than the Note Purchase Agreement, dated June 3, 2025, between us and GKCC, LLC (“GKCC”) and the related Senior Secured Promissory Note due June 3, 2028 held by GKCC, our Capital on Demand TM Sales Agreement with JonesTrading Institutional Services LLC and obligations related to the exercise of previously issued warrants, and cannot be certain that additional funding will be available to us on acceptable terms, or at all.
Additional debt financing, if available at all, would likely involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, completing acquisitions or declaring or paying dividends.
Furthermore, the impact of macroeconomic factors, including fluctuating inflation, the potential imposition of new tariffs or increases in existing tariffs and geopolitical instability and tensions, could make the terms of any available financing less attractive to us and more dilutive to our existing stockholders.
In addition, securing additional financing would require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates and the advancement of our AMP platform.
Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited consolidated financial statements for the year ended December 31, 2025 included in this Annual Report on Form 10-K.
We believe that our cash on hand will enable us to fund our operations into the third quarter of 2026 based on our current plan.
Specifically, we have generated net losses each year since our inception, including $39.6 million and $51.9 million for the years ended December 31, 2025 and 2024, respectively.
We expect to make substantial expenditures and incur increasing operating costs in the future and our accumulated deficit is expected to increase significantly as we expand development and clinical trial activities for our product candidates and expand the capabilities of our AMP platform.
We believe that our cash on hand will enable us to fund our operations through the into the third quarter of 2026 based on our current plan.
Our product candidates will require additional clinical, manufacturing, and nonclinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before they generate any product sales.
Our failure to become and remain profitable would decrease our value and could impair our ability to raise capital, maintain our research and development efforts, expand our AMP platform and our business or continue our operations.
While we completed our Phase 1 trial of ELI-002 and shared final data in August 2025 and completed enrollment in our AMPLIFY-7P Phase 2 portion of the trial in December 2024, we have not yet successfully completed any other clinical trials for our product candidates, manufactured our product candidates at commercial scale or conducted sales and marketing activities that will be necessary to successfully commercialize our product candidates, if approved.
Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere herein and also include, among other things: • our ability to obtain additional funding to develop our product candidates; • our ability to conduct and complete nonclinical studies and clinical trials; • delays in the commencement, enrollment and timing of clinical trials; • the success of our nonclinical studies and clinical trials through all phases of development; • any delays in regulatory review and approval of product candidates in clinical development; • our ability to obtain and maintain regulatory approval for our product candidates in the United States and foreign jurisdictions; • potential toxicity and/or side effects of our product candidates that could delay or prevent commercialization, limit the indications for any approved products, require the establishment of risk evaluation and mitigation strategies (“REMS”), cause an approved drug to be taken off the market or an inability to establish efficacy needed for approvals; • our ability to establish or maintain partnerships, collaborations, licensing or other arrangements; • market acceptance of our product candidates, if approved; • competition from existing products, new products or new therapeutic approaches that may emerge; • the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for our products; • our ability to leverage our proprietary AMP technology platform to discover and develop additional product candidates; • our ability to manufacture clinical supplies of required quality to supply our clinical trials; • our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business; and • potential product liability claims.
We are obligated to develop and maintain proper and effective internal control over financial reporting.
In the future, we may not complete our execution of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may result in material misstatements in our consolidated financial statements and may adversely affect investor confidence in our company and, as a result, the value of our common stock.
We are required, pursuant to Section 404 (“Section 404”) of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting.
Complying with Section 404 requires a rigorous compliance program as well as adequate time and resources.
We may not be able to complete our internal control evaluation, testing and any required remediation in a timely fashion.
Additionally, if we identify one or more material weaknesses in our internal control over financial reporting, we will not be able to assert that our internal controls are effective.
For example, in our 2024 Form 10-K, we identified material weaknesses in our internal control over financial reporting related to our control environment.
More specifically, we determined that we had not maintained adequate formal accounting policies, processes and controls related to complex transactions as a result of a lack of finance and accounting staff with the appropriate U.S. generally accepted accounting principles (“U.S.
We also determined that we had insufficient financial reporting and close controls to ensure that incurred expenses were accrued at period end.
Even though we remediated these material weaknesses in the year ended December 31, 2025, if other material weaknesses are identified in the future or we are not able to comply with the requirements of Section 404 in a timely manner, our reported financial results could be materially misstated, which could result in investors losing confidence in our reported financial information and may lead to a decline in the stock price.
Failure to comply with Section 404 of the Sarbanes-Oxley Act could potentially subject us to sanctions or investigations by the SEC, the Financial Industry Regulatory Authority or other regulatory authorities, as well as increase the risk of liability arising from litigation based on securities laws.
Significant political, trade, regulatory developments, and other circumstances beyond our control, including as a result of recently announced tariffs, could have a material adverse effect on our financial condition or results of operations.
Changes in United States trade policy, including to existing or potential future tariffs, could have a material adverse impact on our business, financial condition, and results of operations.
The imposition of new tariffs or increases in existing tariffs on goods imported from or expected to be imported from countries where we or our suppliers operate could result in higher costs for and delayed shipments of materials or components essential to our operations.
For example, in April 2025, the United States imposed broad tariffs on imports from virtually all countries, with particularly high tariffs on imports from China.
Supreme Court issued a ruling against the validity of such tariffs in February 2026, the Trump administration has announced the imposition of a new 15% baseline tariff under other legal authority, and there is ongoing uncertainty in connection with tariff policies.
In response to tariffs, some countries have implemented retaliatory tariffs on U.S. goods, while others seek to negotiate agreements regarding U.S.-imposed tariffs.
Historically, tariffs have led to decreased trade and political tensions and, to date, the outcome of the negotiations between the United States and the various countries is not yet clear.
Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets.
Any changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, could have a material adverse effect on our financial condition or results of operations.
Risks Related to the Development of our Product Candidates Our product candidates are at an early stage of clinical development and may not be successfully developed or commercialized.

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Gone since FY2024

Some of the more significant challenges and risks include the following: • We will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed, on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our research and development programs, commercialization efforts or cease operations. • We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.
Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited consolidated financial statements for the year ended December 31, 2024 included in this Annual Report on Form 10-K filed with the SEC. • We have incurred losses since inception, have never generated any revenue from product sales, have a limited operating history on which to assess our business, and anticipate that we will continue to incur significant losses for the foreseeable future. • We have identified material weaknesses in our internal control over financial reporting related to our control environment.
If we do not remediate the material weaknesses in our internal control over financial reporting, or if we fail to establish and maintain effective internal control, we may not be able to accurately report our financial results, which may cause investors to lose confidence in our reported financial information and may lead to a decline in the market price of our stock. • Our product candidates are at an early stage of development and, except for our AMPLIFY-201 and AMPLIFY-7P clinical trials, we have not previously conducted clinical trials with our product candidates.
We may not be able to effectively design and execute a clinical trial that supports marketing approval and may not successfully develop or commercialize our product candidates . • Our clinical trial results may not support approval by the FDA or comparable foreign regulatory authorities and such failure to obtain regulatory approval of our product candidates would significantly harm our business, results of operations, and prospects. • We may be unable to use and expand our discovery engine to build a pipeline of product candidates and progress such product candidates through preclinical or clinical development, which may result in us abandoning our development efforts, or we may not be able to identify, discover, develop, or commercialize additional product candidates, which would have a material adverse effect on our business and could potentially cause us to cease operations. • Due to our limited financial and managerial resources, we may focus on research programs and product candidates we identify for specific indications and may forego or delay other opportunities that may have greater commercial potential. • There are a number of factors that can impact the enrollment of patients in our clinical trials.
If we experience difficulties in enrolling patients, we could experience significant delays and we may need to abandon one or more clinical trials, or we may need to increase development costs for our product candidates which could materially impair our ability to generate revenues. • Our product candidates may cause undesirable side effects, may not achieve the desired efficacy threshold, or have other properties or characteristics that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any. • We may form or seek strategic partnerships or collaborations or enter into additional licensing arrangements with third parties and we may not realize the benefits of such transactions or arrangements. • We rely on contract manufacturing organizations (“CMOs”) to manufacture our product candidates and perform other manufacturing-related services.
If these third parties do not successfully carry out their contractual duties, meet expected timelines, or otherwise conduct the trials as required or perform and comply with regulatory requirements, we may not be able to successfully complete clinical development, obtain regulatory approval or commercialize our product candidates when expected or at all, and our business could be substantially harmed.
We face significant competition, and our competitors may achieve regulatory approval before us or develop safer, more advanced or effective therapies than we might develop. • Our AMP platform is novel and any current or future product candidates may be too complex to manufacture and such complexities could lead to regulatory delays or production problems that could harm our business. • Our success depends on our ability to obtain and maintain our intellectual property for our product candidates and their formulations. • We are substantially dependent on patents we license from MIT and if the licensed patent rights lack legal effect or if there is a dispute under the license agreement or changes to the scope of the agreement, it could lead to a material adverse effect on our business, financial condition, results of operations and prospects. • Even if we obtain regulatory approval for our product candidates, we will remain subject to ongoing regulatory requirements.
Maintaining compliance with ongoing regulatory requirements may result in significant additional expense to us, and any failure to maintain such compliance could subject us to penalties and cause our business to suffer. • Healthcare and other legislative reform measures may have a materially negative impact on our business. • Cybersecurity incidents, loss of data and other disruptions, including from cyberattacks, could compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability, which could adversely affect our business and our reputation. • The instability of the global credit and financial markets may adversely affect our business strategy, including our ability to secure necessary and timely financings, which may impact our financial performance, stock price and development of our product candidates. • We will continue to incur significant legal, accounting and other expenses in order to comply with the laws, rules, and regulations associated with being a public company.
During the years ended December 31, 2024 and 2023, we incurred research and development expenses of $33.7 million and $23.8 million, respectively, and net losses of $51.9 million and $35.2 million, respectively.
We currently have no other commitments or agreements relating to any of these types of transactions, other than our Capital on Demand TM Sales Agreement with JonesTrading Institutional Services LLC and obligations related to the exercise of previously issued warrants, and cannot be certain that additional funding will be available to us on acceptable terms, or at all.
Debt financing, if available at all, would likely involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, completing acquisitions or declaring or paying dividends.
Furthermore, the impact of macroeconomic factors, including the current inflationary environment and the imposition of tariffs, in addition to geopolitical instability and tensions, could make the terms of any available financing less attractive to us and more dilutive to our existing stockholders.
In addition, securing additional financing would require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.
Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited consolidated financial statements for the year ended December 31, 2024 included in this Annual Report on Form 10-K.
We believe that our cash on hand will enable us to fund our operations into the fourth quarter of 2025 based on our current plan.
Specifically, we have generated net losses each year since our inception, including $51.9 million and $35.2 million for the years ended December 31, 2024 and 2023, respectively.
We expect to make substantial expenditures and incur increasing operating costs in the future and our accumulated deficit is expected to increase significantly as we expand development and clinical trial activities for our product candidates.
Our product candidates will require additional clinical, manufacturing, and non-clinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before they generate any product sales.
Our failure to become and remain profitable would decrease our value and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.
While we ended study visits for the Phase 1 trial of ELI-002 in August 2024, we have not yet successfully completed any other clinical trials for our product candidates, manufactured our product candidates at commercial scale or conducted sales and marketing activities that will be necessary to successfully commercialize our product candidates, if approved.
Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere herein and also include, among other things: • our ability to obtain additional funding to develop our product candidates; • our ability to conduct and complete nonclinical studies and clinical trials; • delays in the commencement, enrollment and timing of clinical trials; • the success of our nonclinical studies and clinical trials through all phases of development; • any delays in regulatory review and approval of product candidates in clinical development; • our ability to obtain and maintain regulatory approval for our product candidates in the United States and foreign jurisdictions; • potential toxicity and/or side effects of our product candidates that could delay or prevent commercialization, limit the indications for any approved products, require the establishment of risk evaluation and mitigation strategies, cause an approved drug to be taken off the market or an inability to establish efficacy needed for approvals; • our ability to establish or maintain partnerships, collaborations, licensing or other arrangements; • market acceptance of our product candidates, if approved; • competition from existing products, new products or new therapeutic approaches that may emerge; • the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for our products; • our ability to leverage our proprietary AMP technology platform to discover and develop additional product candidates; • our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business; and • potential product liability claims.
We have identified material weaknesses in our internal control over financial reporting related to our control environment.
If we do not remediate the material weaknesses in our internal control over financial reporting, or if we fail to establish and maintain effective internal control, we may not be able to accurately report our financial results, which may cause investors to lose confidence in our reported financial information and may lead to a decline in the market price of our stock.
As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls.
Pursuant to Section 404 (“Section 404”) of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), we are required to furnish a report by our management on our internal control over financial reporting in our periodic reports filed with the SEC.
However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.
In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404.
If we identify additional material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented, or detected and corrected on a timely basis.
In our 2023 Form 10-K, we identified material weaknesses in our internal control over financial reporting related to our control environment.
More specifically, we determined that we had not ensured calculations used in financial reporting were properly reviewed, including earnings per share (“EPS”) and weighted average shares outstanding (“WASO”) calculations as a result of a lack of finance and accounting staff with the appropriate U.S.
GAAP technical expertise needed to identify, evaluate, and review such calculations.
This material weakness was remediated as of December 31, 2024.
Additionally, in our 2023 Form 10-K, we determined that we had not maintained adequate formal accounting policies, processes and controls related to complex transactions as a result of a lack of finance and accounting staff with the appropriate U.S. generally accepted accounting principles (“U.S.
We also determined that we had insufficient financial reporting and close controls to ensure that incurred expenses are accrued at period end.
Although we initiated efforts to remediate these material weaknesses, the material weaknesses have not been fully remediated as of December 31, 2024.
Our remediation efforts are intended to address the identified material weaknesses.
However, these material weaknesses will not be considered remediated until the applicable remedial actions operate effectively for a sufficient period of time.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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