ELTX 10-K & 10-Q changes, risk factors and insider trading
Elicio Therapeutics, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1601485 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “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.”
New heading “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.”
New heading “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.”
New heading “We may not be able to obtain PTE under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States and equivalent extension in other countries and, as a result, our product candidates, if approved, may not have patent protection for a sufficient period.”
New heading “Weakening patent laws and enforcement by courts in the United States and foreign countries may impact our ability to protect our markets.”
New heading “Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.”
New heading “The terms of our note arrangement with GKCC, an entity controlled by a member of our board of directors, places certain restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.”
Removed heading “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.”
Removed heading “Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our stock price.”
Largest changes
“While inflation in the United States has reduced recently, during 2021 and 2022, the economy in the United States encountered a material level of inflation. The impact of COVID-19, geopolitical developments such as the Russia-Ukraine and Middle East conflicts, geopolitical tensions with China, and global supply chain disruptions continue to increase uncertainty in the outlook of near-term and long-term economic activity. …”see in full comparison
“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. …”see in full comparison
“Inflation has the potential to negatively impact our liquidity, business, financial condition and results of operations by increasing our overall cost structure. The presence of inflation in the economy has led to, and may continue to lead to, higher interest rates, increased capital costs, supply shortages, and rising labor, manufacturing, shipping and other costs, along with weaker exchange rates and other similar effects. …”see in full comparison
In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm our profitability and reputation. Further, our director and officer liability insurance cost may increase as a result of litigation of this nature and our insurance deductible may be significant before our insurers are required to provide any coverage to us. Additionally, a decrease in our stock price may cause our common stock to no longer satisfy the continued listing standards of Nasdaq. If we are not able to maintain the requirements for listing on Nasdaq, we could be delisted, which could have a materially adverse effect on our ability to raise additional funds as well as the price and liquidity of our common stock.see in full comparison
“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.”see in full comparison
“Any failure to remediate the material weaknesses we identified or any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods. …”see in full comparison
Full comparison: every changed paragraph (208)
•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.
•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 theThe FDA or comparable foreign regulatory authorities may disagree with our regulatory plans and suchwe failuremay fail to obtain regulatory approval of our product candidates would significantly harm our business, results of operations, and prospects.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.
•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.
•OurAny product candidatescandidate we advance into clinical trials may cause undesirableunacceptable sideadverse effects, may not achieve the desired efficacy threshold,events or have other properties or characteristics that couldmay delay or prevent theirour regulatory approval,approval or commercialization or limit theour commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.potential.
•We may form or seek strategic partnerships or collaborations or enter into additional licensing arrangements within thirdthe partiesfuture, and we may not realize the benefits of such transactionsalliances 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.
•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 AMPtechnologies platformare is novelnovel, and any current or future product candidates we develop may be toocomplex complexand difficult to manufacture andon sucha complexitiesclinical or commercial scale. We could leadexperience todelays in satisfying regulatory delaysauthorities or we could experience production problems that couldresult 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.
•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 and patent applications under which we license rights from MITMIT, and if thesuch licensed patent rights lack legal effect or if there is a dispute arises under thesuch license agreement and our licensed rights are narrowed or changesthis license is terminated, that could cause significant impairment to theour scopeability to develop and commercialize certain of the agreement, it could lead to a material adverse effect on our business,product financial condition, results of operations and prospects.candidates.
•Even if we obtainreceive regulatory approval forof our product candidates, we will remain subject to ongoing regulatory requirements.obligations Maintainingand compliance with ongoingcontinued regulatory requirementsreview, which may result in significant additional expense to us, and anywe failuremay to maintain such compliance couldbe subject us to penalties andif causewe our businessfail to suffer.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.
•Healthcare and other legislative reform measures may have a materially negative impact on our business.
•CybersecurityOur internal information technology systems, or those of our vendors, collaborators or other contractors or consultants, may fail or suffer cybersecurity incidents, loss of datadata, and other disruptions, including from cyberattacks,which could result in a material disruption of our product development programs, compromise sensitive information related to our business,business or prevent us from accessing critical informationinformation, orpotentially exposeexposing us to liability,liability whichor couldotherwise adversely affectaffecting our business and our reputation.business.
•Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
•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, accountingcosts and otherdemands expensesupon inmanagement orderas toa complyresult of complying with the laws, rules,rules and regulations associated with being aaffecting public company.companies.
Until such time, if ever, that we can generate sufficient product revenue and achieve profitability, we expect to seek to finance future cash needs through the sale of common stock in public offerings and/or private placements, debt financings, or through other capital sources, including licensing arrangements, partnerships and collaborations with other companies or other strategic transactions. 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 DemandTM 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. To the extent that we raise additional capital through the sale of equity, convertible debt or other securities convertible into equity, the ownership interest of our stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect rights of our stockholders. DebtAdditional 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 current inflationary environment and thepotential imposition of tariffs,new tariffs or increases in additionexisting totariffs and geopolitical instability and tensions, could make the terms of any available financing less attractive to us and more dilutive to our existing stockholders. If we are unable to raise additional capital, we will have to delay, curtail or eliminate one or more of our research and development programs or cease operations. 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.candidates and the advancement of our AMP platform.
We believe that our cash on hand will enable us to fund our operations into the fourththird quarter of 20252026 based on our current plan. This period could be shortened if there are any significant increases in planned or actual spending on development programs or more rapid progress of development programs than anticipated. There is no assurance that financing will be available when needed to allow us to continue as a going concern. If we are unable to obtain additional capital and continue as a going concern, we might have to further scale back our operations or liquidate our assets and cease operations entirely, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. Our lack of capital resources and our conclusion that we may be unable to continue as a going concern may materially adversely affect our share price and our ability to raise new capital or to enter into critical contractual relations with third parties.
Since we are a clinical-stage biotechnology company, our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. Specifically, we have generated net losses each year since our inception, including $51.9$39.6 million and $35.2$51.9 million for the years ended December 31, 20242025 and 2023,2024, 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.candidates and expand the capabilities of our AMP platform. Because of the risks and uncertainties associated with product development, we are unable to predict the extent of any future losses, whether we will ever generate significant revenues or if we will ever achieve or sustain profitability.
We believe that our cash on hand will enable us to fund our operations through the into the fourththird quarter of 20252026 based on our current plan. We are dependent on obtaining, and are continuing to pursue, necessary funding from outside sources, including obtaining additional funding from the issuance of securities in order to continue our operations. Without adequate funding, we may not be able to meet our financial obligations.
Our product candidates will require additional clinical, manufacturing, and non-clinicalnonclinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before they generate any product sales. We cannot guarantee that we will meet our timelines for our development programs, which may be delayed or may not be completed for a number of reasons. Our ability to generate future revenues from product sales depends heavily on our, or our collaborators’, ability to successfully:
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 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. A decline in our value also could cause our stockholders to lose all or part of their investment.
We are a clinical stage biopharmaceutical company with a limited operating history. Our operations to date have been primarily limited to organizing and staffing our company, acquiring, developing and securing our proprietary technology, and preclinical and clinical development of our product candidates. While we endedcompleted study visits for theour 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. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history or commercialized products. Our financial condition has varied significantly in the past and will continue to fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere herein and also include, among other things:
•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,strategies (“REMS”), cause an approved drug to be taken off the market or an inability to establish efficacy needed for approvals;
•our ability to manufacture clinical supplies of required quality to supply our clinical trials;
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 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. GAAP”) technical expertise needed to identify, evaluate and account for complex and non-routine transactions. 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.
We have implemented additional measures to address the remaining material weaknesses identified, however, these material weaknesses will not be considered remediated until the applicable remedial actions operate effectively for a sufficient period of time. As part of these additional measures, we engaged SEC compliance and technical accounting consultants to assist in evaluating transactions for conformity with U.S. GAAP. Also, we hired additional finance and accounting personnel, including a Staff Accountant, to augment accounting staff and to provide more resources for complex accounting matters and financial reporting. We designed additional controls around identification, documentation and application of technical accounting guidance with particular emphasis on complex and non-routine transactions. These controls include an additional review process to ensure that the correct conclusions are reached with respect to complex and non-routine transactions and avoid the potential for a material misstatement of our financial statements. However, we cannot assure you that we will be successful in remediating the material weaknesses we identified or that our internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future.
Any failure to remediate the material weaknesses we identified or any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods. Any failure to remediate the material weaknesses we identified or any failure to implement and maintain effective internal control over financial reporting could also adversely affect the results of management reports and independent registered public accounting firm audits of our internal control over financial reporting that we will eventually be required to include in our periodic reports that will be filed with the SEC. Ineffective disclosure controls and procedures, and internal control over financial reporting could also cause investors to lose confidence in our reported financial and other information, which would likely have a negative effect on the market price of our common stock.
Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our stock price.
We are required, pursuant to Section 404 (“Section 404”) of the Sarbanes-Oxley Act andof 2002, as amended (the related“Sarbanes-Oxley rulesAct”), andto regulationsfurnish ofa thereport SEC require annualby management assessmentson, ofamong 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. If we fail to maintain the adequacy of our internal control over financial reporting, as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act and the related rules and regulations of the SEC. If we cannot favorably assess the effectiveness of our internal control over financial reporting, investor confidence in the reliability of our financial reports may be adversely affected, which could have a material adverse effect on our stock price.
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. GAAP”) technical expertise needed to identify, evaluate and account for complex and non-routine transactions. 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. While the U.S. 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.
Our product candidates are at an early stage of clinical development and may not be successfully developed or commercialized.
In April 2023, we completed enrollment of the AMPLIFY-201 trial for ELI-002,ELI-002 our 2-peptide formulation,2P targeting Kirsten rat sarcoma viral oncogene homolog (“KRAS”) gene mutations, which product candidate also includes ELI-004, our universal AMP-modified CpG adjuvant. In October 2023, we completed enrollment of the AMPLIFY-7P Phase 1 portion of the trial for ELI-002,ELI-002 our 7-peptide formulation,7P and initiated enrollment of the AMPLIFY-7P Phase 2 portion of the trial in January 2024. In NovemberDecember 2024, we completed enrollment in our AMPLIFY-7P Phase 2 portion of the ELI-002 trial.trial and in August 2025, we announced the positive recommendation by the IDMC to continue our AMPLIFY-7P Phase 2 study without modifications to final analysis. We also have an Expanded Access Program for our ELI-002 7P program that is ongoing. All of our other product candidates are in preclinical development and will require substantial further capital expenditures, development, testing, and regulatory approval prior to commercialization. With the limited data on ELI-002, we may not be able to effectively design and execute clinical studies that ultimately support marketing approval. In addition, we have not initiated or submitted for any marketing authorization to any health authorities.
Management's Discussion & Analysis (MD&A)
New heading “At-The-Market Equity Programs”
New heading “Private Placement”
New heading “Public Offerings”
Largest changes
As of the filing date of this Annual Report on Form 10-K, we believe that our cash on hand will enable us to fund our operations into thesee in full comparisonfourththird quarter of20252026 based on our current plan. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the consolidated financial statements, raise substantial doubt about our ability to continue as a going concern.
“Since inception, we have had significant operating losses. Our net loss was $39.6 million and $51.9 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $233.7 million and $18.6 million in cash and cash equivalents. …”see in full comparison
“Our clinical pipeline includes the lymph node targeted cancer immunotherapy ELI-002 7P, currently being evaluated in a Phase 2 study, designed to stimulate an immune response against mKRAS pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The ELI-002 7P formulation is designed to provide broad immune responses targeting seven KRAS mutations that are observed in approximately 88% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for ELI-002 7P beyond PDAC alone. …”see in full comparison
Full comparison: every changed paragraph (64)
We are a clinical-stage biotechnology company pioneeringadvancing the development ofnovel immunotherapies for patients with limitedthe treatment optionsof cancer, including mKRAS-positive pancreatic cancer, CRC, lung cancer and poorother outcomesmKRAS sufferingpositive fromcancers. cancer.We intend to build on recent clinical successes in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Our proprietary Amphiphile (“AMP”) technology is designedaims to generateenhance robustthe anti-tumoreducation, activation and amplification of cancer-specific T lymphocytescells (“Trelative cell”)to responsesconventional byimmunotherapy preferentiallystrategies, targetingwith lymphthe nodes.goal of promoting durable cancer immunosurveillance in patients. Recent advances have identified T cell responses as a key component of effective cancer immunotherapy and we believe our AMP technology can generate a robust T cell responseresponses in patients that can potentially providetranslate to meaningful clinical benefit.
We believe the therapeutic utility of currently approved and development stage cancer immunotherapies areis limited in many cases due to their inability to sufficiently localize to lymph nodes and adequately engage with the critical immune cells responsible for stimulating adaptive immunity. Our AMP technology is specifically intended to localize payloads to lymph nodes leading to the generation of a robust T cell response that we believe is critical to generate an anticancer immune response.
Our lead programs focus on our cancer vaccineimmunotherapy product candidates, which target biologically validated driver tumor mutations using common and well-characterized neoantigens. This strategy results in an “off-the-shelf” therapeutic option allowing patients to receive treatment without delayeddelays due to manufacturing timelines and without the increased costs associated with personalized vaccineimmunotherapy approaches.
Our clinical pipeline includes the lymph node targeted cancer immunotherapy ELI-002 7P, currently being evaluated in a Phase 2 study, designed to stimulate an immune response against mKRAS pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The ELI-002 7P formulation is designed to provide broad immune responses targeting seven KRAS mutations that are observed in approximately 88% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for ELI-002 7P beyond PDAC alone. In August 2025, we announced that following the Independent Data Monitoring Committee’s (“IDMC”) pre-specified interim review of unblinded safety and efficacy data in our Phase 2 AMPLIFY-7P study in mKRAS-driven PDAC, the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P as of such date. We anticipate the final disease-free survival analysis to occur in the first half of 2026. ELI-002 2P (2-peptide formulation) has been studied previously in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy. ELI-002 2P and ELI-002 7P also have been studied in patients with mKRAS-positive CRC in Phase 1 studies. The AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and published in Nature Medicine (Wainberg et al, 2025) and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, we plan to expand ELI-002 7P to other indications including mKRAS positive lung cancer and other mKRAS positive cancers.
Our clinical and preclinical pipeline includes the lymph node targeted therapeutic cancer vaccines ELI-002, currently being evaluated in a Phase 2 study, designed to stimulate an immune response against mutant KRAS cancers,immunotherapies ELI-007, currently being evaluated in preclinical studies for the treatment of mutant b-raf murine sarcoma viral oncogene homolog B1-drivenB1-(“BRAF”) driven cancers, and ELI-008, currently being evaluated in preclinical studies for use in the treatment of mutated tumor protein p53 (“TP53”)- expressing cancers. We believe that each of our immunotherapy product candidates, if approved, has the potential to reduce the risk of recurrence of tumors carrying specific oncogenic driver mutations.
Our operations to date have been financed primarily by aggregate net proceeds of $182.9$219.7 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common stock warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger.Merger with Angion Biomedica Corp. (“Angion”). Since inception, we have had significant annual operating losses. Our net loss was $51.9$39.6 million and $35.2$51.9 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $194.1$233.7 million and $17.6$18.6 million in cash and cash equivalents.
Elicio Operating Company, Inc. (“Former Elicio”) was incorporated in Delaware as Vedantra Pharmaceuticals Inc. in August 2011. In December 2018, Former Elicio formed a wholly owned subsidiary, Elicio Securities Corporation, a Massachusetts corporation.
On January 17, 2023, Former Elicio entered into a definitive merger agreement (the “Merger Agreement”) with Angion Biomedica Corp. (“Angion”) and Arkham Merger Sub, Inc., a wholly owned subsidiary of Angion (“Merger Sub”), pursuant to which Merger Sub merged with and into Former Elicio, with Former Elicio surviving the merger as a wholly owned subsidiary of Angion (the “Merger”).
Elicio Therapeutics, Inc. (“Elicio” or the “Company”) was incorporated in Delaware as Vedantra Pharmaceuticals Inc. in August 2011. In 2023, the Company completed a reverse merger transaction with Angion, a clinical-stage biotechnology company, Arkham Merger Sub, Inc., a wholly owned subsidiary of Angion (“Merger Sub”), and Elicio Operating Company, Inc. (“Former Elicio”), pursuant to which Merger Sub merged with and into Former Elicio, with Former Elicio surviving the merger as a wholly owned subsidiary of Angion (the “Merger”). On June 1, 2023, the Merger wasCompany completed the Merger in accordance with the terms and conditions of the Merger Agreement and Angion changed its name from “Angion Biomedica Corp.” to “Elicio Therapeutics, Inc.” Following the Merger, Former Elicio and Elicio Australia Pty Ltd. (“Elicio Pty”), an Australian subsidiary established in August 2019 for the purpose of qualifying for research credits for studies conducted in Australia, became our wholly owned subsidiaries.
We are currently facing substantial doubt about our ability to continue as a going concern, given our cash position and cash runway. As of the filing date of this Annual Report on Form 10-K, we believe that our cash on hand will enable us to fund our operations into the fourththird quarter of 20252026 based on our current financial operating plan. This period could be shortened or lengthened if there are any significant increases or decreases in planned or actual spending on development programs or more rapid progress of development programs than anticipated. There is no assurance that financing will be available when needed to allow us to continue as a going concern. Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the consolidated financial statements, raise substantial doubt about our ability to continue as a going concern. We expect to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. We plan to address this condition through the sale of our common stock or other securities in public offerings and/or private placements, debt financings, or through other capital sources, including licensing arrangements, partnerships and collaborations with other companies or other strategic transactions, but there is no assurance these plans will be completed successfully or at all. If we are unable to obtain additional capital when and as needed to continue as a going concern, we might have to further reduce or scale back our operations and/or liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.
• advance our lead product candidate, ELI-002,ELI-002 7P, to late-stage clinical trials;
• advance our preclinical programs to clinical trials;
• expand our pipeline of product candidates;
• seek regulatory approval for our investigational medicines;
• maintain, expand, protect and defend our intellectual property portfolio;
• acquire or in-license technology;
• expand our clinical, scientific, management and administrative teams; and
• operate as a public company.
As of the filing date of this Annual Report on Form 10-K, we believe that our cash on hand will enable us to fund our operations into the fourththird quarter of 20252026 based on our current plan. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the consolidated financial statements, raise substantial doubt about our ability to continue as a going concern.
• personnel costs, which include salaries, benefits, and equity-based compensation expense;
• expenses incurred under agreements with consultants and contract organizations that conduct research and development activities on our behalf;
• costs related to sponsored research service agreements;
• costs related to production of preclinical and clinical materials, including fees paid to contract manufacturers;
• laboratory and vendor expenses related to the execution of preclinical studies and planned clinical trials; and
• laboratory supplies and equipment used for internal research and development activities.
Our research and development expenses are not currently tracked on a program-by-program basis. We use our personnel and infrastructure resources across multiple research and development programs directed toward identifying and developing product candidates. Substantially all our research and development costs are incurred on the development of ELI-002 7P and our preclinical candidates.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in conducting clinical trials, manufacturing and otherwise advancing our programs. The process of conducting the clinical research necessary to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and costs of the efforts that will be needed to complete the development of, or the period, if any, in which material net cash inflows may commence from ELI-002 7P or any of our preclinical candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
•the ability to market, commercialize and achieve market acceptance for ELI-002,ELI-002 7P, or any of our preclinical candidates that we or our future collaboration partners may develop in the future.
Any of these variables with respect to the development of ELI-002,ELI-002 7P, or any other of our preclinical candidates that we may develop could result in a significant change in the costs and timing associated with the development of such candidates. For example, if the U.S. Food and Drug Administration (“FDA”) or other regulatory authority were to require us to conduct preclinical and clinical studies beyond those which we currently anticipate will be required for the completion of clinical development or if we experience significant delays in enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of our clinical development programs.
Our general and administrative expenses consist primarily of personnel costs, including equity-based compensation, and other expenses for outside professional services, including marketing, legal, audit and accounting, facility-related costs not otherwise included in research and development expenses, and recruiting. We expect our general and administrative expenses to increase over the next several years to support our continued research and development activities, manufacturing activities, increased costs of expanding our operations and operating as a public company. These increases will likely include increases related to the hiring of additional personnel and legal, regulatory and other fees and services associated with maintaining compliance with the Nasdaq StockMarketplace MarketRules LLCor the Nasdaq Listing Rules and Securities and Exchange Commission (“SEC”) requirements, accounting and audit fees, director and officer insurance costs and investor relations costs associated with being a public company.
Other (Expense) Income
For the years ended December 31, 20242025 and 2023,2024, other income and expense consisted primarily of interest income and expense, foreign exchange transaction gains and losses, gain on sale of equipment, gaingrant on extinguishment of the promissory note payable, andincome, gains and losses related to the re-measurement of our warrant liabilities.liabilities, and a loss on issuance of the July 2024 Pre-Funded Warrants.
Comparison forof the Years Ended December 31, 20242025 and 20232024
Research and development expenses increaseddecreased by $9.8$8.8 million, or 41.1%,26.0%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The net increasedecrease in research and development expenses was primarily due to anlower increase in externalclinical costs associatedas withpatients progressed into the observation phase the Phase 2 study of ELI-002 manufacturing and clinical trials.7P.
General and administrative expenses decreasedincreased by $0.6$1.5 million, or 4.8%,13.1%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The decreaseincrease was primarily due to aan decreaseincrease in externalheadcount costsfor related to the Merger.2025.
Other (expense) IncomeExpense
Other (expense) income for the year ended December 31, 20242025 was $6.9$1.9 million compared to other (expense) income of $0.6$6.9 million for the year ended December 31, 2023.2024. The increasedecrease of $7.5$5.1 million was primarily due to the change in fair value and loss on issuance associated with the pre-fundedoutstanding liability-classified common warrants and commonthe warrants.losses recognized from the March 2024 Offering and the July 2024 Public Offering.
Since inception, we have had significant operating losses. Our net loss was $39.6 million and $51.9 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $233.7 million and $18.6 million in cash and cash equivalents. Our operations through December 31, 2025 have been financed primarily by aggregate net proceeds of $219.7 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger with Angion. Our sources of liquidity for the years ended December 31, 2025 and 2024 are described below.
At-The-Market Equity Programs
In May 2022, we filed a registration statement on Form S-3 (the “Prior Shelf Registration Statement”) with the SEC that registered the offering, issuance, and sale of an amount of common stock, preferred stock, debt securities, and warrants to purchase common stock, preferred stock and/or debt securities, not to exceed an aggregate initial offering price of $100 million. Simultaneously, we entered into an At-the-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated and Virtu Americas LLC, as sales agents, that provided for the issuance and sale of up to $21 million of shares of common stock from time to time in “at-the-market” offerings under the Prior Shelf Registration Statement and related prospectus filed with the Prior Shelf Registration Statement (the “2022 ATM Program"). During the year ended December 31, 2024, we issued and sold a total of 650,179 shares of common stock under the 2022 ATM Program for aggregate net proceeds of $5.4 million after deducting sales commissions. In May 2024, we terminated the 2022 ATM Program.
In June 2024, we filed a registration statement on Form S-3 (the “2024 Registration Statement”) with the SEC that registered the offering, issuance, and sale of an amount of common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock and/or debt securities, and/or units consisting of any combination of such securities, not to exceed an aggregate initial offering price of $200 million. Simultaneously, we entered into the Capital on DemandTM Sales Agreement with JonesTrading Institutional Services, LLC, as agent, to provide for the issuance and sale of up to $40 million of shares of common stock from time to time in “at-the-market” offerings under the 2024 Registration Statement and related prospectus filed with the 2024 Registration Statement (the “2024 ATM Program” and, collectively with the 2022 ATM Program, the “ATM Programs”). During the year ended December 31, 2025, we issued and sold 1,717,507 shares of common stock for net proceeds of $16.2 million under the 2024 ATM Program. During the year ended December 31, 2024, we issued and sold 53,795 shares of common stock for net proceeds of $0.3 million under the 2024 ATM Program.
Private Placement
In March 2024, we entered into a subscription agreement (the “March Subscription Agreement”) with GKCC, LLC (“GKCC”), an entity controlled by a member of Elicio’s board of directors, providing for the issuance and sale by Elicio to GKCC of pre-funded warrants (the “March 2024 Pre-Funded Warrants”) to purchase up to 1,032,702 shares of common stock, at a purchase price per March 2024 Pre-Funded Warrant of $5.81 (the “March 2024 Offering”). Each March 2024 Pre-Funded Warrant issued and sold in the March 2024 Offering is exercisable at an exercise price equal to $0.01 per share, subject to certain adjustments and limitations as provided under the terms of the March 2024 Pre-Funded Warrants. The net proceeds from the March 2024 Offering were $6.0 million. Refer to Note 8 for additional information.
Public Offerings
In July 2024, we closed an underwritten public offering (the “July 2024 Public Offering”), consisting of (i) 500,000 shares of common stock (the “July 2024 Shares”), (ii) pre-funded warrants exercisable for 1,800,000 shares of common stock (the “July 2024 Pre-Funded Warrants”), and (iii) common warrants to purchase up to 2,300,000 shares of common stock, (the “July 2024 Common Warrants”). Each July 2024 Pre-Funded Warrant issued and sold in the July 2024 Public Offering is exercisable at an exercise price equal to $0.01 per share, subject to certain adjustments and limitations as provided under the terms of the July 2024 Pre-Funded Warrants. Each July 2024 Common Warrant is exercisable at an exercise price equal to $5.00 per share, subject to certain adjustments and limitations as provided under the terms of the July 2024 Common Warrants, are immediately exercisable and will expire five years from the issuance date. The net proceeds from the July 2024 Public Offering were $10.9 million after deducting commissions and other transaction costs.
The July 2024 Public Offering consisted of the July 2024 Shares or in lieu thereof, the July 2024 Pre-Funded Warrants, and accompanying July 2024 Common Warrants. Each July 2024 Share and accompanying July 2024 Common Warrant were sold together at a combined offering price of $5.00 per July Share and accompanying July 2024 Common Warrant, and each July 2024 Pre-Funded Warrant and accompanying July 2024 Common Warrant were sold together at a combined offering price of $4.99 per July 2024 Pre-Funded Warrant and accompanying July 2024 Common Warrant, which represented the combined purchase price per July 2024 Pre-Funded Warrant and accompanying July 2024 Common Warrant less the $0.01 per share exercise price for each such July 2024 Pre-Funded Warrant. Refer to Notes 3 and 8 for additional information.
In January 2025, we entered into a securities purchase agreement with certain institutional investors (each an “Investor” and, collectively, the “Investors”), pursuant to which we agreed to issue and sell, in a registered direct offering by Elicio directly to the Investors (the “January 2025 Offering”): (i) an aggregate of 1,261,830 shares of common stock (the “January 2025 Shares”) and (ii) common warrants to purchase up to an aggregate of 1,261,830 shares of common stock (the “January 2025 Common Warrants”). Each January 2025 Share and accompanying January 2025 Common Warrant were sold together at a combined offering price of $7.925. The January 2025 Common Warrants have an exercise price of $7.80 per share, are immediately exercisable and will expire 5 years from the issuance date. The January 2025 Offering resulted in net proceeds of $9.2 million after deducting the placement agent’s fees and related offering expenses.
In August 2024, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with GKCC pursuant to which we issued a 3% Senior Secured Convertible Promissory Note due February 15, 2026 (the “Convertible Note”) in the principal amount of $20.0 million (the “Convertible Note Financing”). Unless earlier converted in accordance with the terms of the Convertible Note, the Convertible Note would mature on February 15, 2026. Interest on the Convertible Note accrued and was payable quarterly in cash on the principal amount equal to 3% per annum, with an initial interest payment date of June 30, 2025. We received net proceeds of approximately $19.7 million from the Convertible Note Financing, after deducting debt issuance costs. In March 2025, Elicio exercised its right under the Convertible Note to require GKCC to convert the full amount of the Convertible Note, including all accrued and unpaid interest, into shares of Elicio’s common stock. In March 2025, we issued 3,500,573 shares of common stock to GKCC in exchange for the principal balance of $20.0 million plus $0.3 million in accrued interest, in satisfaction in full of the Convertible Note. Refer to Note 11 for additional information.
In June 2025, we entered into a note purchase agreement (the “June 2025 Promissory Note Financing”) with GKCC pursuant to which we issued a Senior Secured Promissory Note due June 3, 2028 (the “June 2025 Promissory Note”) in the principal amount of $10.0 million. In connection with the June 2025 Promissory Note Financing, we issued to GKCC a warrant to purchase an aggregate of 103,225 shares of common stock (the “June 2025 Warrant”). The June 2025 Warrant has an exercise price of $7.75 per share, is immediately exercisable, and expires five years from the date of issuance. We received net proceeds of approximately $9.9 million from the June 2025 Promissory Note Financing, after deducting debt issuance costs. Refer to Note 11 for additional information.
Our operations through December 31, 2024 have been financed primarily by aggregate net proceeds of $182.9 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, the exercise of stock options and common stock warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger. Since inception, we have had significant operating losses. Our net loss was $51.9 million and $35.2 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $194.1 million and $17.6 million in cash and cash equivalents. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the consolidated financial statements, raise substantial doubt about our ability to continue as a going concern. We expect to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. The consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K have been prepared on a basis that assumes that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. We plan to address this condition through the sale of our common stock or other securities in public offerings and/or private placements, debt financings, or through other capital sources, including licensing arrangements, partnerships and collaborations with other companies or other strategic transactions. However, there is no assurance that we will be successful in raising additional capital or that such additional funds will be available on acceptable terms, if at all. Should we be unable to raise this amount of capital our operating plans will be limited to the amount of capital that we can access. We may also consider steps to reduce our operating expenses. There can be no assurances that we will be successful in any of the foregoing.
However, there is no assurance that we will be successful in raising additional capital or that such additional funds will be available on acceptable terms, if at all. Should we be unable to raise this amount of capital our operating plans will be limited to the amount of capital that we can access. We may also consider steps to reduce our operating expenses. There can be no assurances that we will be successful in any of the foregoing.
For the year ended December 31, 2024,2025, net cash used in operating activities was $37.1$37.0 million, which primarily consisted of a net loss of $51.9$39.6 million and a change in net operating assets and liabilities of $3.9$3.4 million partially offset by net non-cash charges of $10.9$6.1 million. The change in net operating assets and liabilities of $3.9$3.4 million was the result of a $0.5$1.2 million increasedecrease in the deferred research obligation, a $0.8$1.1 million decrease in prepaid expenses and other current assets, a $2.2$0.2 million decreaseincrease in other long-term prepaid assets, a $0.9 million decrease in the operating lease liability, and a net increasedecrease in accounts payable and accrued expenses of $1.3$2.4 million. The $10.9$6.1 million of net non-cash charges were related to $3.9$1.9 million of change in the fair value of warrant liability,liabilities, $3.5 million loss on the issuance of the pre-funded warrants and common warrants, $1.5$2.7 million of stock-based compensation expense, $0.9$1.1 million related to amortization of the right-of-use (“ROU”) asset, $0.5 million related to issuance costs for the pre-funded warrantsasset and commondebt warrants,discount, $0.3 million of depreciation, $0.2$0.1 million of non-cash interest expense, and $0.1$0.2 million of amortization of debt discount.depreciation.
For the year ended December 31, 2023,2024, net cash used in operating activities was $32.7$37.1 million, which primarily consisted of a net loss of $35.2$51.9 million and a change in net operating assets and liabilities of $0.1$3.9 million partially offset by net non-cash charges of $2.6$10.9 million. The change in net operating assets and liabilities of $0.1$3.9 million was the result of a $0.7$0.5 million decreaseincrease in the deferred research obligation, aan $0.8 million decrease in prepaid assets,expenses and other current assets, a $0.8$2.2 million decrease in other long-term prepaid assets, a $0.9 million decrease in the operating lease liabilityliability, offsetand bya annet increase in accounts payable and accrued expenses of $2.2$1.3 million. The $2.6$10.9 million of net non-cash charges were related to $1.1$3.9 million of interestchange expense related toin the accretionfair value of warrant liabilities, $3.5 million loss on the issuance of the promissorypre-funded notewarrants payable,and $1.2common warrants from the March 2024 Offering and the July 2024 Public Offering, $1.5 million of stock-based compensation expense, $0.8$0.9 million related to amortization of the ROU asset, $0.4$0.5 million related to issuance costs for the pre-funded warrants and common warrants from the March 2024 Offering and the July 2024 Public Offering, $0.3 million of depreciation, $0.1 million loss on disposal of property and equipment partially offset by $0.4 million increase in the fair value of the embedded derivative associated with the promissory notes payable and $0.6$0.2 million of gainnon-cash oninterest theexpense, extinguishmentand $0.1 million of theamortization promissoryof notesdebt payable.discount.
For the year ended December 31, 2025, net cash provided by financing activities was $36.7 million as a result of net cash proceeds of $16.2 million from the issuance of shares of common stock under the 2024 ATM Program, $9.9 million from the June 2025 Promissory Note Financing, $9.2 million from the January 2025 Offering, $1.3 million from the exercise of common warrants, and $0.1 million from the exercise of stock options.
For the year ended December 31, 2024, net cash provided by financing activities was $42.3 million,million comprised of $19.7 million of net proceeds from the issuance of the convertibleConvertible note,Note, $17.5$11.5 million of proceeds from the issuance of common stockwarrants warrants,related andto $5.6the July 2024 Public Offering, $6.0 million of proceeds from the saleissuance of common stock,warrants related to the March 2024 Offering, net cash proceeds of $4.6 million from the issuance of shares of common stock under the ATM Programs, and $1.1 million from the issuance of shares of common stock related to the July 2024 Public Offering, offset by $0.5 million of issuance costs for the pre-funded warrants and common warrants. For the year ended December 31, 2023, net cash provided by financing activities was $38.6 million, comprised of $31.6 million of net proceeds from the Merger and $7.0 million of net proceeds from the sale of common stock.
Based on our current operating plan, as of the filing date of this Annual Report on Form 10-K, we believe our cash and cash equivalents will be sufficient to fund our planned operations into the fourththird quarter of 2025.2026. However, we have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. We are unable to estimate the exact amount of our operating capital requirements. The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:
▪the outcome, costs and timing of seeking andseeking, obtaining and maintaining FDA and any foreign regulatory approvals;
▪the effect of competing technological,technology, market developments and government policy;
▪the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future and the timing and amount of payments thereunder; and
What changed in the latest 10-Q
Risk Factors
New heading “Risks Related to the Development of our Product Candidates”
New heading “Our product candidates are at an early stage of clinical development and may not be successfully developed or commercialized.”
New heading “Our planned Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer may present additional safety risks, and the combination of multiple agents may result in unexpected adverse events or tolerability issues.”
New heading “Our planned combination studies depend on the availability and cost of third-party therapeutic agents, including anti-PD-1 inhibitors and RAS small molecule inhibitors, and we may face challenges in securing adequate supply of such agents on acceptable terms.”
New heading “If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.”
New heading “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.”
Largest changes
“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.”see in full comparison
“Our planned Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer may present additional safety risks, and the combination of multiple agents may result in unexpected adverse events or tolerability issues.”see in full comparison
“Our planned combination studies depend on the availability and cost of third-party therapeutic agents, including anti-PD-1 inhibitors and RAS small molecule inhibitors, and we may face challenges in securing adequate supply of such agents on acceptable terms.”see in full comparison
“If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.”see in full comparison
“Our product candidates are at an early stage of clinical development and may not be successfully developed or commercialized.”see in full comparison
“In June 2026, we reported topline results from our randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven PDAC. AMPLIFY-7P did not meet its pre-specified primary DFS endpoint in the intent-to-treat population; however, DFS analysis at three and six months showed early treatment benefit and a stronger treatment effect in subsets of the patient population. …”see in full comparison
Full comparison: every changed paragraph (30)
Investing in our common stock involves a high degree of risk. You should carefully consider the risk factors, described in the section titled “Risk Factors” in the Form 10-K as well as the other information in this Quarterly Report on Form 10-Q, before deciding whether to invest in shares of our common stock. There have been no material changes in our risk factors from those described in the Form 10-K.10-K, other than as follows.
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.
In June 2026, we reported topline results from our randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven PDAC. AMPLIFY-7P did not meet its pre-specified primary DFS endpoint in the intent-to-treat population; however, DFS analysis at three and six months showed early treatment benefit and a stronger treatment effect in subsets of the patient population. We continue to evaluate pre-specified subgroups, including the R0 resected population, and intend to use such results to further refine our development strategy for a planned Phase 3 study in adjuvant PDAC. In addition, based on preliminary post-study observations suggesting that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition, we announced our intention to initiate a Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer, which we anticipate initiating in the fourth quarter of 2026. Our planned Phase 1 combination study in metastatic PDAC is our near-term priority, while our planned Phase 3 registrational trial in adjuvant PDAC is not expected to commence until we complete an additional capital raise. The pursuit of multiple clinical programs at different stages of development and in different treatment settings – including an early-stage combination study in metastatic disease and a potential late-stage registrational trial in the adjuvant setting – creates distinct risks and uncertainties at each stage. The results from our AMPLIFY-201 and AMPLIFY-7P studies may not be predictive of outcomes in the planned Phase 1 combination study or Phase 3 trial due to, among other things, differences in study design, patient populations, treatment settings, and combination regimens.
In April 2023, we completed enrollment of the AMPLIFY-201 trial for ELI-002 2P targeting Kirsten rat sarcoma viral oncogene homolog (“KRAS”) gene mutations, which product candidate also includes ELI-004, our universal AMP-modified CpG adjuvant. In October 2023, we completed enrollment of the AMPLIFY-7P Phase 1 portion of the trial for ELI-002 7P and initiated enrollment of the AMPLIFY-7P Phase 2 portion of the trial in January 2024. In December 2024, we completed enrollment in our AMPLIFY-7P Phase 2 portion of the ELI-002 7P trial and in August 2025, we announced the positive recommendation by the IDMC to continue our AMPLIFY-7P Phase 2 study without modifications to final analysis. In June 2026, we reported topline results from our randomized Phase 2 AMPLIFY-7P study of ELI-002 7P.
All of our other product candidates are in preclinical development and will require substantial further capital expenditures, development, testing, and regulatory approval prior to commercialization. With the limited data on ELI-002, we may not be able to effectively design and execute clinical studies that ultimately support marketing approval. We may encounter substantial delays in our clinical trials, and our clinical trials may fail to demonstrate the safety and efficacy of our product candidates sufficiently to result in any marketable products. Failure to adequately demonstrate the safety and efficacy of our product candidates in clinical development would significantly impact our ability to obtain regulatory approval and would delay, prevent or limit the scope of any regulatory approval, which would adversely affect our business, financial condition, results of operations and prospects.
If any of our product candidates are found to be unsafe or lack efficacy, we will not be able to obtain regulatory approval for them and our business would be materially harmed. For example, if the results of our ongoing or planned clinical trials of ELI-002 7P do not achieve adequate therapeutic results or demonstrate unacceptable toxicity in patients, our development of ELI-002 7P may be halted or delayed, which would materially harm our business.
Even if our clinical trials are initiated, completed and successful, clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain regulatory approval. There is no assurance that our current and planned clinical studies, including an adequate and well-controlled clinical study, if needed, will yield data that will demonstrate the safety and efficacy of our product candidates to support marketing approval. The timing and successful completion of clinical trials and submission for marketing approval of our product candidates depend on, among other things, the ability to generate positive results in such trials. In addition, even if such trials are successful, we may need to conduct additional studies, which we have not planned for or budgeted, in order to obtain regulatory approval. Our failure to adequately demonstrate the safety and efficacy of our product candidates in clinical development would significantly impact our ability to generate revenue from product sales and would materially harm our business.
The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the costs associated with product manufacturing, formulation, and release, the number of patients that ultimately enroll in clinical trials, the number of clinical sites included in the trials, our ability to enroll a sufficient number of suitable patients for our clinical trials, the efficacy of our product candidates in treating patients, the duration of patient follow-up that is determined to be appropriate in view of the observed clinical response or as may be required by applicable regulatory authorities, protocols, the rate of dropout among clinical trial participants, and evolving standards of treatment from newly approved drugs. Accordingly, even if we are able to obtain the requisite financing to fund our development programs, we cannot assure you that our product candidates will be successfully developed or commercialized. Our failure to develop, manufacture or receive regulatory approval for or successfully commercialize any of our product candidates could result in the failure of our business and a loss of all of our stockholders’ investment.
Our planned Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer may present additional safety risks, and the combination of multiple agents may result in unexpected adverse events or tolerability issues.
We intend to initiate a Phase 1 clinical study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in treatment-naïve and recurrent metastatic mKRAS pancreatic cancer, which we anticipate initiating in the fourth quarter of 2026. This planned study follows preliminary post-study observations, in a small number of patients from our completed Phase 2 AMPLIFY-7P study, suggesting that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition. While we have observed a favorable safety profile for ELI-002 7P as a monotherapy in our AMPLIFY-201 and AMPLIFY-7P studies to date, the safety profile of ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor has not been established in clinical trials. Combination therapies may produce additive or synergistic adverse effects beyond those observed with any single agent alone.
Anti-PD-1 inhibitors carry known risks of immune-related adverse events, including colitis, hepatitis, pneumonitis, endocrinopathies, and dermatologic toxicities, among others. RAS small molecule inhibitors carry their own known toxicities, including hematologic, gastrointestinal, and dermatologic adverse events. The addition of ELI-002 7P, which is designed to stimulate immune responses against mKRAS-mutated cells, to regimens that include these agents may result in novel or unexpected immune-mediated toxicities, exacerbation of known side effects, or unanticipated drug interactions.
If the combination produces unacceptable adverse events or an unfavorable risk-benefit profile, we may need to modify the study design, reduce doses of one or more agents, eliminate a combination arm, or discontinue the combination approach entirely. Regulatory authorities may impose clinical holds or require additional nonclinical or clinical safety data before allowing us to proceed. Any of these events would delay our development timelines, increase our costs, and could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Our planned combination studies depend on the availability and cost of third-party therapeutic agents, including anti-PD-1 inhibitors and RAS small molecule inhibitors, and we may face challenges in securing adequate supply of such agents on acceptable terms.
Our planned Phase 1 combination study in metastatic PDAC requires access to third-party therapeutic agents, including a RAS small molecule inhibitor and/or an anti-PD-1 inhibitor. While certain anti-PD-1 inhibitors are commercially available, the cost of procuring these agents for use in our clinical trials could be significant and may increase our overall development costs. We may need to enter into supply or collaboration agreements with the manufacturers of these agents, and there can be no assurance that such agreements will be available on acceptable terms, or at all. The negotiation of these agreements is often complex, time-consuming, and involves lengthy discussions as well as our management’s time and focus. If we experience significant delays in finalizing these agreements, we may need to delay the start of our planned study.
In addition, certain RAS small molecule inhibitors that we may seek to evaluate in combination with ELI-002 7P are not yet commercially available or have only recently received regulatory approval. For agents that are not yet on the market, we would need to enter into supply agreements with the developers of such agents, and there can be no assurance that such agreements will be available on acceptable terms or will be finalized in a timely manner, if at all. Additionally, the willingness and ability of those third parties to supply their product candidates for use in our studies is uncertain and outside of our control. Even for agents that are commercially available or may become so in the near term, supply may be limited or subject to allocation constraints, particularly for agents in high demand.
If we are unable to secure adequate supply of combination agents on acceptable terms, or if supply is interrupted or discontinued, we may be required to delay initiation of our combination study, modify the study design, substitute alternative agents (which may require additional regulatory submissions and approvals), or discontinue the combination approach. Changes in the regulatory status, market availability, or pricing of combination agents could also affect the feasibility and cost of our planned studies. Any of the foregoing could delay our development programs, increase our costs, and have a material adverse effect on our business, financial condition, and results of operations.
If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of subjects who remain in the trial until its conclusion. We may not be able to initiate or continue conducting clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible subjects to participate in these trials.
The enrollment of patients depends on many factors, including: the patient eligibility criteria defined in the protocol; the size of the patient population required for analysis of the trial’s primary endpoints; the proximity of patients to study sites; the design of the trial; our ability to recruit clinical trial investigators with the appropriate competencies and experience; our ability to obtain and maintain patient consents; the ability to monitor patients adequately during and after treatment; clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies; the risk that patients enrolled in clinical trials will drop out of the trials before completion; and the availability of approved therapeutics effective for the treatment of the relevant disease.
In addition, our ongoing or future clinical trials, including our planned Phase 1 combination study in metastatic PDAC may involve trial designs, treatment settings or therapeutic methodologies with limited precedent in published data to guide our trial design and planning, which could result in the need for additional feedback from, and submissions to, regulatory authorities to obtain authorization for such studies or delays in our current or future study readouts if our planning estimates are incorrect. Our clinical trials also compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors.
Further, our planned Phase 3 registrational trial in adjuvant PDAC is anticipated to target a narrower patient population than the broader KRAS-positive solid tumor populations studied in our earlier trials. The more restrictive eligibility criteria in the adjuvant setting may limit the pool of available patients and slow enrollment. In addition, the extended dosing regimen contemplated for the Phase 3 trial may present patient retention challenges. Patients in the adjuvant setting, who have undergone successful surgical resection and may not have active measurable disease, may be less motivated to enroll in or remain in a clinical trial compared to patients with active metastatic disease. Furthermore, our planned Phase 3 trial will compete for patients with other KRAS-targeting programs in pancreatic cancer, including Phase 3 trials that have completed or are being conducted by well-resourced competitors. These factors, individually or collectively, could result in enrollment delays, increased development costs, or an inability to complete enrollment for our planned Phase 3 trial, which could have a material adverse effect on our business, financial condition, and results of operations.
Because the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which may reduce the number of patients who are available for our clinical trials at such clinical trial sites. Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in any of our future clinical trials. Our inability to enroll a sufficient number of subjects for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Moreover, a significant number of withdrawn subjects would compromise the quality of our data.
Enrollment delays in our clinical trials may result in increased development costs for our product candidates, or the inability to complete development of our product candidates, which could cause our value to decline, limit our ability to obtain additional financing, and materially impair our ability to generate revenues.
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.
The development and commercialization of new therapeutic biologics is highly competitive. Moreover, the immunotherapy field is characterized by rapidly changing technologies, significant competition, and a strong emphasis on intellectual property. We will likely face competition with respect to any product candidates that we may seek to develop or commercialize in the future from numerous pharmaceutical and biotechnology organizations, as well as from academic institutions, government agencies and other public and private research organizations for our current and future product candidates. Our commercial success may be reduced or eliminated and our business, financial condition, results of operations, and prospects may be harmed if our competitors develop products that are safer, more effective or less costly than ours.
A number of well-resourced pharmaceutical and biotechnology companies are developing products to inhibit RAS-mutated cancers. These products, as well as marketing campaigns by competitors and clinical trial results with competitive products, could significantly diminish our ability to market and sell ELI-002 7P for RAS-mutated cancers, if approved. For example, Amgen Inc. (“Amgen”), Bristol Myers Squibb Co. (“Bristol Myers”), and Revolution Medicines, Inc. (“Revolution Medicines”), among others, have developed small molecule therapies for the treatment of KRAS-mutated cancer including G12C, G12D, and pan KRAS inhibitors. Other companies in the immunotherapy and cancer vaccine sector include AstraZeneca Plc, BioNTech SE (“BioNTech”), BridgeBio Oncology Therapeutics, Inc., Boehringer Ingelheim, Bristol Myers, Circio Holding ASA, D3 Bio, Inc., Eli Lilly and Company, Erasca, Inc., Geneos Therapeutics, Inc., Gilead Sciences, Inc., Incyte Corporation, Jacobio Pharmaceuticals Group Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd., Merck & Co., Inc. (“Merck”), Moderna, Inc. (“Moderna”), Roche Holding Ltd./Genentech, Inc. (“Roche/Genentech”), Revolution Medicines, and Verastem, Inc., among others. While many of these programs are in preclinical stages or Phase 1 clinical trials, Amgen and Bristol Myers have products that are approved by the FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, who have received at least one prior systemic therapy. Moderna and Merck are in a combined Phase 3 trial of their personalized cancer vaccine targeting melanoma (mRNA-4157) and BioNTech and Roche/Genentech are in Phase 2 trials of their personalized cancer vaccine targeting pancreatic cancer, colorectal cancer, and bladder cancer (BNT122, RO7198457). In particular, certain competitors pursuing KRAS-targeting therapies in metastatic pancreatic cancer are in late-stage clinical development and may obtain regulatory approval in the near term, potentially before we complete our planned Phase 1 combination study in the metastatic setting or initiate our planned Phase 3 registrational trial in the adjuvant setting. In July 2026, Revolution Medicines announced that its new drug application for its oral RAS(ON) multi-selective inhibitor, daraxonrasib, for pancreatic ductal adenocarcinoma was accepted for review by the FDA for previously treated metastatic PDAC. If one or more competing therapies are approved for metastatic KRAS-mutated PDAC before our product candidates reach the market, the standard of care could shift in ways that may limit the differentiation, commercial potential, and competitive positioning of ELI-002 7P. ELI-002 7P may compete with existing and new therapies that may be approved in the future.
Many of our current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise in research and development, manufacturing, nonclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient enrollment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize product candidates that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than the product candidates we may develop or that would render any of our product candidates obsolete or non-competitive. Our competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for our product candidates, which could result in our competitors establishing a strong market position before we are able to enter the market.
Our commercial opportunity may also be reduced or limited if we or our partners are unable to scale up the manufacture of our product candidates to meet clinical or commercial requirements. ELI-002 7P is comprised of eight APIs, including peptides and nucleotides with a lipid modification. The compositions we seek to develop may exhibit poor pharmaceutical properties; additionally, manufacturing, purification, formulation, and stable storage could be challenging.
In addition, we could face litigation with respect to the validity and/or scope of patents relating to our competitors' products. The availability of competitive products could limit the demand and the price we are able to charge for our products. Further, intellectual property protection for the amphiphile components of our product candidates is dynamic and rapidly evolving. The scope of intellectual property protection for our AMP platform may be limited, and its commercial opportunity may be reduced or limited if our competitors are able to acquire or develop the same or similar technologies.
Management's Discussion & Analysis (MD&A)
New heading “Recent Developments”
New heading “AMPLIFY-7P Phase 2 Topline Results”
New heading “Phase 3 Development Strategy”
New heading “Preliminary Post-Study Observations and Planned Phase 1 Study in Metastatic PDAC”
New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Other Income (Expense)”
Largest changes
“Preliminary Post-Study Observations and Planned Phase 1 Study in Metastatic PDAC”see in full comparison
“In June 2026, we reported that the Phase 2 AMPLIFY-7P trial did not meet its pre-specified primary disease-free survival (“DFS”) endpoint in the intent-to-treat population; however, DFS analysis at three months and six months showed early treatment benefit and a stronger treatment effect in subsets of the patient population, and ELI-002 7P demonstrated a favorable safety profile. …”see in full comparison
Full comparison: every changed paragraph (53)
We are a clinical-stage biotechnology company advancingdeveloping novelnext-generation immunotherapies for the treatment of cancer, including mKRAS-positivemutant Kirsten rat sarcoma viral oncogene homolog (“mKRAS”)-positive pancreatic cancer, colorectal cancer (“CRC”), lung cancer and other mKRAS-positive cancers. We intend to build on recent clinical successes in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Our proprietary Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunotherapy strategies, with the goal of promoting durable cancer immunosurveillance in patients. Recent advances have identified T cell responses as a key component of effective cancer immunotherapy, and we believe our AMP technology can generate robust T cell responses in patients that can potentially translate to meaningful clinical benefit.
Our clinical pipeline includes the lymph node-targeted cancer immunotherapy ELI-002 7P, which we evaluated in a Phase 1/2 study, AMPLIFY-7P, designed to stimulate an immune response against mKRAS pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The ELI-002 7P formulation is designed to provide broad immune responses targeting seven Kirsten rat sarcoma viral oncogene homolog mutations that are observed in approximately 88% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for ELI-002 7P beyond PDAC alone.
In June 2026, we reported that the Phase 2 AMPLIFY-7P trial did not meet its pre-specified primary disease-free survival (“DFS”) endpoint in the intent-to-treat population; however, DFS analysis at three months and six months showed early treatment benefit and a stronger treatment effect in subsets of the patient population, and ELI-002 7P demonstrated a favorable safety profile. We are continuing to evaluate pre-specified subgroups including, the R0 resected population, and intend, based upon such results, to further refine our development strategy for the planned Phase 3 study for ELI-002 7P in adjuvant PDAC. For additional information, see “Recent Developments.”
ELI-002 2P (2-peptide formulation) has been studied previously in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy. ELI-002 2P and ELI-002 7P also have been studied in patients with mKRAS-positive CRC in Phase 1 studies. The AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and published in Nature Medicine (Wainberg et al, 2025) and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population.
In addition, based on preliminary post-study observations suggesting that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition, we intend to initiate a Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in recurrent and treatment-naïve metastatic mKRAS PDAC. We also may seek to expand ELI-002 7P to other indications, including mKRAS-positive lung cancer and other mKRAS-positive cancers, subject to financing.
Our clinical pipeline includes the lymph node targeted cancer immunotherapy ELI-002 7P, currently being evaluated in a Phase 2 study, designed to stimulate an immune response against mKRAS pancreatic ductal adenocarcinoma (“PDAC”), the most common form of pancreatic cancer. The ELI-002 7P formulation is designed to provide broad immune responses targeting seven Kirsten rat sarcoma viral oncogene homolog mutations that are observed in approximately 88% of PDAC patients and 25% of all solid tumors, thereby increasing the potential patient population for ELI-002 7P beyond PDAC alone. In August 2025, we announced that following the Independent Data Monitoring Committee’s (“IDMC”) pre-specified interim review of unblinded safety and efficacy data in our Phase 2 AMPLIFY-7P study in mKRAS-driven PDAC, the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P as of such date. The final disease-free survival analysis is anticipated mid-year 2026. ELI-002 2P (2-peptide formulation) has been studied previously in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy. ELI-002 2P and ELI-002 7P also have been studied in patients with mKRAS-positive CRC in Phase 1 studies. The AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and published in Nature Medicine (Wainberg et al, 2025) and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, we plan to expand ELI-002 7P to other indications including mKRAS positive lung cancer and other mKRAS positive cancers.
Our preclinical pipeline includes the lymph nodenode-targeted targeted immunotherapiesimmunotherapies, ELI-007, currently being evaluated in preclinical studies for the treatment of mutant b-raf murine sarcoma viral oncogene homolog B1-driven cancers, and ELI-008, currently being evaluated in preclinical studies for use in the treatment of mutated tumor protein p53 expressingp53-expressing cancers. We believe that each of our immunotherapy product candidates, if approved, has the potential to decrease tumor burden or reduce the risk of recurrence of tumors carrying specific oncogenic driver mutations.
Recent Developments
AMPLIFY-7P Phase 2 Topline Results
On June 15, 2026, we reported results from our randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven PDAC following completion of standard locoregional therapy. The study enrolled 144 patients across 24 U.S. sites and evaluated ELI-002 7P versus observation in patients with resected Stage I-III mKRAS-driven PDAC who had completed surgery and standard locoregional therapy and were radiographically free of disease at enrollment.
The AMPLIFY-7P study did not meet its pre-specified primary DFS endpoint in the intent-to-treat population. However, DFS analyses showed an approximately 14% absolute DFS benefit during active treatment at both three and six months, with treatment-arm separation persisting through nine months, suggesting early clinical activity.
Although nodal status, the prespecified stratification factor for randomization, was balanced between the treatment arms, a higher proportion of patients with other adverse prognostic factors were included in the ELI-002 7P arm relative to the comparator standard of care arm. Subgroup analyses intended to account for these imbalances showed a significant DFS improvement, helping to inform our Phase 3 strategy. There are currently no approved therapies following locoregional treatment.
The study also demonstrated a strong association between mKRAS-specific immune responses and clinical outcomes (HR 0.22, p<0.0001, n=90), supporting the biological activity of ELI-002 7P, and ELI-002 7P demonstrated a favorable safety profile, with no treatment-related discontinuations or deaths. We continue to evaluate pre-specified subgroups, including the R0 resected population, and intend to further refine our Phase 3 development strategy, which may include stratification and/or exclusion for adverse baseline factors and additional dosing, as described below.
Phase 3 Development Strategy
Insights from AMPLIFY-7P have enabled us to refine our Phase 3 development strategy, focusing on patients with the greatest potential to benefit from treatment and extending treatment duration to enhance the durability of anti-tumor immunity. Accordingly, and subject to financing, we plan to initiate a Phase 3 study with the following key elements:
•Additional dosing beyond the initial ELI-002 7P immunization and booster regimen;
•Potential evaluations of combinations with checkpoint inhibition; and
•A registrational study with a primary endpoint of DFS.
We continue to evaluate pre-specified subgroups from the AMPLIFY-7P trial, including the R0 resected population, and may further refine our Phase 3 development strategy based upon the results of such evaluation.
Preliminary Post-Study Observations and Planned Phase 1 Study in Metastatic PDAC
On June 17, 2026, we reported preliminary clinical observations from three patients who received ELI-002 7P during the Phase 2 AMPLIFY-7P study, experienced disease progression after treatment, and subsequently achieved confirmed complete radiographic and complete metabolic responses after receiving nivolumab-based therapy with concurrent normalization of serum tumor biomarker (CA19-9) levels. Two of the three patients maintained complete responses for at least nine months, with one ongoing complete response at greater than nine months. In addition, all three patients demonstrated persistent mKRAS-specific T cell responses.
All three patients were microsatellite stable/mismatch repair proficient, a population that has historically demonstrated limited responsiveness to immune checkpoint inhibitors. Published studies evaluating chemotherapy-, checkpoint inhibitor-, or RAS inhibitor-based regimens in metastatic pancreatic cancer have reported complete response rates of approximately 0% to 8%, with durable complete responses rarely observed.
We believe these observations provide preliminary clinical support for the hypothesis that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition and support prospective evaluation of combination strategies.
We intend to initiate a Phase 1 study evaluating ELI-002 7P in combination with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor in metastatic mKRAS pancreatic cancer. The planned study is designed to prospectively evaluate whether ELI-002 7P may enhance anti-tumor immunity and improve responsiveness to a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor. We also plan to use the study findings to help inform future development strategies in metastatic PDAC and our planned adjuvant PDAC Phase 3 trial. We anticipate the Phase 1 study to initiate in the fourth quarter of 2026, with potential study readouts anticipated three to six months after study start.
We intend to continue monitoring additional patients who participated in the AMPLIFY-7P study and the Expanded Access Program for ELI-002 7P and are currently following a similar course of treatment.
Our operations tothrough dateJune 30, 2026 have been financed primarily by aggregate net proceeds of $227.5$244.2 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger with Angion. Since inception, we have had significant operating losses. Our net loss was $11.8$20.0 million and $11.2$21.8 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $245.5$253.7 million and cash and cash equivalents of $14.9$23.5 million. In July 2026, the Company entered into a securities purchase agreement with certain institutional investors (each a “July 2026 Investor” and collectively, the “July 2026 Investors”), pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the July 2026 Investors (the “July 2026 Offering”), an aggregate of 4,380,313 shares of common stock (the “July 2026 Shares”). Each July 2026 Share was sold at an offering price of $3.43. The July 2026 Offering resulted in aggregate net proceeds of approximately $13.6 million after deducting the placement agents’ fees and related offering expenses.
We are currently facing substantial doubt about our ability to continue as a going concern, given our cash position and cash runway. As of the filing date of this Quarterly Report on Form 10-Q, we believe that our cash on hand will enable us to fund our operations into the fourthfirst quarter of 20262027 based on our current financial operating plan. This period could be shortened or lengthened if there are any significant increases or decreases in planned or actual spending on development programs or more rapid progress of development programs than anticipated. There is no assurance that financing will be available when needed to allow us to continue as a going concern. Our losses from operations, negative operating cash flows and accumulated deficit, as well as the additional capital needed to fund operations for at least twelve months following the issuance of the condensed consolidated financial statements, raise substantial doubt about our ability to continue as a going concern. We expect to incur substantial expenditures in the foreseeable future for the development of our product candidates and will require additional financing to continue this development. We plan to address this condition through the sale of common stock or other securities in public offerings and/or private placements, debt financings, or through other capital sources, including licensing arrangements, partnerships and collaborations with other companies or other strategic transactions, but there is no assurance these plans will be completed successfully or at all. If we are unable to obtain additional capital when and as needed to continue as a going concern, we might have to further reduce or scale back our operations and/or liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.
•advance our lead product candidate, ELI-002 7P, to early-stage clinical trials in metastatic PDAC and to late-stage clinical trials in adjuvant PDAC;
As of the filing date of this Quarterly Report on Form 10-Q, we believe that our cash on hand will enable us to fund our operations into the fourthfirst quarter of 20262027 based on our current plan. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.
•clinical trials and early-stageearly- or late-stage results;
Other Income (Expense) Income
For the three and six months ended MarchJune 31,30, 2026 and 2025, other income and expense consisted primarily of interest income, foreign exchange transaction gains, interest expense, and the change in fair value of our warrant liabilities.
Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025
Research and development expenses were $6.8 million for the three months ended MarchJune 31,30, 2026, compared to $7.8$7.0 million for the three months ended MarchJune 31,30, 2025. The decrease of $1.0$0.2 million was primarily due to lesslower clinical trial costs as the Phase 2 study of ELI-002 7P continues and the patients moved out of the active dosing phase and into the follow upfollow-up phase of the trial.
General and administrative expenses were $3.8$3.6 million for the three months ended MarchJune 31,30, 2026, compared to $3.0$3.1 million for the three months ended MarchJune 31,30, 2025. The increase of $0.9$0.5 million was primarily due to increased Company headcount resulting in increased personnel costs and a slight increase in professional fees.
Other Income (Expense)
Other expenseincome for the three months ended MarchJune 31,30, 2026 was $1.2$2.2 million compared to an other expense of $0.5 million for the three months ended MarchJune 31,30, 2025. The increase of $0.7$2.7 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrantswarrants, andpartially offset by the interest expense related to the June 2025 Promissory Note.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the periods indicated (in thousands, except percentages):
Research and Development Expenses
Research and development expenses were $13.6 million for the six months ended June 30, 2026, compared to $14.8 million for the six months ended June 30, 2025. The decrease of $1.2 million was primarily due to lower clinical trial costs as the Phase 2 study of ELI-002 7P continues and the patients moved out of the active dosing phase and into the follow-up phase of the trial.
General and Administrative Expenses
General and administrative expenses were $7.5 million for the six months ended June 30, 2026, compared to $6.0 million for the six months ended June 30, 2025. The increase of $1.4 million was primarily due to increased Company headcount resulting in increased personnel costs and a slight increase in professional fees.
Other Income (Expense)
Other income was $1.0 million for the six months ended June 30, 2026, compared to other expense of $0.9 million for the six months ended June 30, 2025. The increase of $1.9 million was primarily due to the change in fair value associated with the outstanding liability-classified common warrants, partially offset by the interest expense related to the June 2025 Promissory Note.
Our operations through MarchJune 31,30, 2026 have been financed primarily by aggregate net proceeds of $227.5$244.2 million from the issuance of common stock, pre-funded warrants, convertible preferred stock, convertible notes, promissory notes, the exercise of stock options and common warrants, the private placement of our securities, at-the-market offerings, and proceeds from the Merger with Angion. Since inception, we have had significant operating losses. Our net loss was $11.8$20.0 million and $11.2$21.8 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $245.5$253.7 million and cash and cash equivalents of $14.9$23.5 million. In July 2026, the Company entered into the July 2026 Offering, pursuant to which the Company agreed to issue and sell directly to the July 2026 Investors the July 2026 Shares. The July 2026 Offering resulted in aggregate net proceeds of approximately $13.6 million after deducting the placement agent’s fees and related offering expenses. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
The following table sets forth a summary of our net cash flow activity for the threesix months ended MarchJune 31,30, 2026 and 2025 (in thousands):
For the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities was $11.6$19.8 million, which consisted of a net loss of $11.8$20.0 million and a decrease in our assets and liabilities of $2.0$0.8 million, partially offset by non-cash charges of $2.2$1.0 million. The non-cash charges wereprimarily related to $1.0 millionconsisted of change in the fair value of warrant liabilities, $0.9$1.8 million of stock-based compensation, $0.2$0.5 million amortization of the ROU asset, and $0.1 million depreciation.of depreciation, and $0.1 million of debt discount amortization, partially offset by a $1.5 million gain from the change in the fair value of warrant liabilities.
For the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities was $10.1$19.1 million, which consisted of a net loss of $11.2$21.8 million and a decrease in our assets and liabilities of $0.3$0.7 million, partially offset by non-cash charges of $1.4$3.4 million. The non-cash charges were primarily related to $0.5$1.4 million of change in the fair value of warrant liabilities, $0.5$1.2 million of stock-based compensation, $0.2$0.5 million amortization of the ROU asset, $0.1$0.2 million of non-cash interest expense, and $0.1 million of depreciation.
For the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities was $8.0$24.5 million as a result of the issuance of $7.9$24.4 million of our common stock under our ATM Programs,Programs net of paidissuance issuanceand offering costs, and $0.1 million from the exercise of stock options.
For the threesix months ended MarchJune 31,30, 2025, net cash provided by financing activities was $10.3$22.3 million, primarily as a result of net proceeds of $9.9 million from the June 2025 Promissory Note Financing, net proceeds of $9.1 million from the January 2025 Offering, the issuance of $0.8$2.9 million of our common stock under our 2024 ATM Program,Program $9.1net millionof fromissuance the January 2025 Offering,costs, and $0.4 million from the exercise of common warrants and stock options.
Based on our current operating plan, as of the filing date of this Quarterly Report on Form 10-Q, we believe our cash and cash equivalents will be sufficient to fund our planned operations into the fourthfirst quarter of 2026.2027. However, we have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. We are unable to estimate the exact amount of our operating capital requirements. The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:
Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in the Form 10-K. There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the threesix months ended MarchJune 31,30, 2026 compared to those disclosed in the Form 10-K.
ELTX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding ELTX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 121,631 | $1.3M | — | Sold out |
| Millennium Management (Israel Englander) | 2026-06-30 | 92,762 | $991.6K | — | Sold out |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 15,978 | $170.8K | — | Sold out |