Ite m 1A. Risk Factors Other than described below, management believes that there have been no significant changes to the risk factors associated with our business as compared to those disclosed in Part 1, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. There is substantial doubt regarding our ability to continue as a going concern and holders of our common stock could suffer a total loss of their investment. We will need to raise additional funding, which Our collaboration with Chugai may not be available on acceptable terms. If successful, and we are unable to raise additional capital when needed, we may be forced to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. Our operations have consumed substantial amounts not realize the anticipated benefits of cash since our inception. We are in early clinical development with certain product candidates the Collaboration and have conducted or are in preclinical development with other product candidates. To advance our product candidates into initial and later stages of clinical development requires significant capital. License Agreement. In addition, October 2025, we are developing entered into the RaniPill HC. If the FDA or any comparable foreign regulatory authorities, such as the European Medicines Agency, require that we perform studies or trials in addition to those that we currently anticipate Collaboration and License Agreement with respect Chugai to develop, manufacture, seek regulatory approvals for and, if approved, commercialize the Product combining Chugais Compound, which is in development of our product candidates or any of our future product candidates, or repeat studies or trials, our expenses would further increase beyond what we currently expect, for hemophilia, and any delay resulting from such further or repeat studies or trials could also result in the need Device for additional financing. As of June 30, 2025, our cash, cash equivalents use in humans. Under the Collaboration and marketable securities totaled $10.2 million. Based on our available cash resources and current operating plan, there is substantial doubt regarding our ability License Agreement, we are entitled to continue as a going concern and holders receive an upfront payment of our common stock could suffer a total loss $10.0 million within 30 days of their investment. Our Board of Directors had initiated a review of alternatives, including potential strategic options, and of our financing strategy. Any failure or delay to obtain additional funding could force us to delay, limit or terminate our operations, make reductions in our workforce, liquidate all or a portion of our assets and/or seek protection under Chapter 7 or 11 of Chugai receiving an invoice for the United States Bankruptcy Code. Our existing capital resources will not be sufficient to enable us to initiate any pivotal clinical trials. upfront payment after closing. We will need are eligible to raise substantial additional funds receive up to $18.0 million in the future in order technology transfer milestones, up to complete the $57.0 million in development of the RaniPill platform, milestones, up to complete $100.0 million in sales-based milestones, contingent upon approval and the clinical development commercial success of our product candidates, including RT-114, the product, and seek regulatory single-digit royalties on net sales, contingent on approval thereof, to expand our manufacturing capabilities, and to commercialize any commercialization of our product candidates. Based on our current planned operations, and in the absence Product. The success of additional sources of liquidity, management anticipates that our existing cash and cash equivalents and anticipated cash flows from operations, will not be sufficient this collaboration is subject to meet our operating numerous risks and liquidity needs beyond late September 2025. If we are unable to raise additional funds and continue as a going concern, we may have to cease operations and liquidate our assets. We may receive less than the value at uncertainties, many of which those assets are carried on our audited financial statements, and investors may lose all or a part outside of their investment. We may not be able our control. Our ability to obtain additional funding on acceptable terms, receive milestone or at all. As a result royalty payments depends on the achievement of geopolitical specified technology transfer, development, regulatory, and commercial events, including the conflicts in Ukraine, Gaza many of which depend on both parties' efforts and Iran, inflation, rising interest rates and other conditions, the global credit and financial markets have experienced volatility and disruptions. In addition, the report from our independent registered public accounting firm issued in connection with our Annual Report on Form 10-K contains statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future ultimate performance, approval and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all. If we are unable to obtain funding on a timely basis, or to generate sufficient revenues, if at all, from collaboration arrangements, we may be required to: significantly curtail, delay or discontinue one or more commercialization of our research or development programs, the development of our oral delivery technology, Product including the RaniPill HC, Compound and the commercialization of any product candidates or cease operations altogether; 34 seek collaborators for one or more of our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; relinquish or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves; forego expansion of our operations or refrain from pursuing business opportunities; or file Device. As a voluntary petition for relief under the United States Bankruptcy Code in order to implement a restructuring plan or liquidation. Our efforts to raise additional funding result, we may divert our management from their day-to-day activities, which may adversely affect our ability to develop the RaniPill platform, to progress development of our product candidates or to automate our manufacturing processes. Moreover, the terms of not receive any financing may adversely affect the holdings or the rights all of our stockholders and the issuance of additional securities, whether equity potential milestone or debt, royalty payments contemplated by us, or the possibility of such issuance, may cause the market price of our Class A common stock to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants and other operating restrictions that could adversely impact our ability to conduct our business. The Lender already Agreement. Chugai has a security interest in substantially all of our assets, including our intellectual property, which may prevent or limit our ability to incur additional indebtedness. Our funding requirements and the timing of our need primary responsibility for additional capital are subject to change based on a number of factors, including: the progress, costs, trial design, results and timing of our preclinical studies and clinical trials; the progress, costs, development, regulatory filings, and results commercialization of our research pipeline; the progress and costs of Product, while we are responsible for development of the RaniPill HC device and other improvements or advancements for certain manufacturing and supply activities. If Chugai fails to our delivery technologies; devote sufficient resources to the willingness of the FDA collaboration or other regulatory authorities otherwise determines to accept data from our clinical trials, as well as data from our completed and planned preclinical studies and clinical trials and other work, as the basis for review and approval reprioritize or discontinue development of our product candidates; the outcome, costs, and timing of seeking and obtaining FDA, and any other, regulatory approvals; the number and characteristics of product candidates that we pursue; Product, our ability to manufacture sufficient quantities of advance the RaniPill capsule; our need to expand our research program would be materially and adversely affected. Moreover, the development activities; of the costs associated with manufacturing, Product is subject to significant scientific, regulatory, and obtaining commercial risks inherent in drug supply for, our and combination product candidates, including for development. There can be no assurance that the Product will successfully complete preclinical or clinical and studies, obtain regulatory approval, or achieve commercial supplies; the costs associated with securing success, if approved. In addition, Chugai holds certain options and establishing commercial infrastructure, rights under the Agreement, including establishing sales, marketing, and distribution capabilities; a one-time right to replace the costs compound, a right of acquiring, licensing, or investing in businesses, product candidates, first refusal for certain additional drug targets, and technologies; our ability options to maintain, expand, and defend extend its rights to additional drug targets. The exercise of these rights could alter the scope or economics of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, collaboration, or that we may receive, in connection with not occur at all, which could affect the licensing, filing, prosecution, defense, and enforcement potential value of any patents or other intellectual property rights; our need and ability to retain key management and hire scientific, technical, business, and engineering personnel; the effect of competing drugs and product candidates and other market developments; the timing, receipt, and amount of sales from our potential products, if approved; our ability arrangement to establish strategic collaborations us. If the collaboration is significantly delayed or enter into strategic transactions; our need terminates early, whether due to implement additional internal systems and infrastructure, including financial and reporting systems; security breaches, data losses breach, convenience, or other disruptions affecting our information systems; 35 our ability to realize savings from any restructuring plans and cost-containment measures circumstances, we propose may be unable to implement; continue development of the economic and other terms, timing Product. Any of these events could materially harm our business, financial condition, and success results of any collaboration, licensing, or other arrangements which we may enter operations. We have in the future; past and the effects of disruptions to and volatility in the credit and financial markets in the United States and worldwide from geopolitical conflicts or other such disruptions. In the event we determine that additional sources of liquidity will not be available to us or will not allow us to meet our obligations as they become due, we may need to file a voluntary petition for relief under the United States Bankruptcy Code in order to implement a restructuring plan or liquidation. We do not currently meet the requirements for continued listing on The Nasdaq Global Market. If we future fail to continue to meet the requirements for continued listing on The Nasdaq Global Market, trading in our common stock could be suspended standards of Nasdaq, and as a result our common stock delisted from Nasdaq, may be delisted, which would could have a negative material adverse effect on the price liquidity of our common stock and our ability to raise additional capital. stock. Our Class A common stock is currently listed on The Nasdaq Global Market. We are required to meet specified requirements to maintain our listing on The Nasdaq Global Market, including, among others, a minimum bid price of $1.00 per share of our class A common stock under Nasdaq Listing Rule 5450(a)(1) (Minimum Bid Price Requirement) and a minimum market value of listed securities (MVLS), of $50,000,000 under Nasdaq Listing Rule 5450(b)(2)(A) (the MVLS Requirement). On June 20, 2025, we received written notice a letter from the Listing Qualifications Department (Staff) Staff of The Nasdaq Stock Market LLC (Nasdaq) (Nasdaq Staff) notifying us that, based on that for the closing last 30 consecutive business days, the bid price of our Class A common stock, par value $0.0001 stock had closed below $1.00 per share for the prior 30 consecutive business days we no longer comply share, and was not in compliance with the Minimum Bid Price Requirement for continued Requirement. The notification received had no immediate effect on the listing of our 36 common stock on The the Nasdaq. In accordance with Nasdaq Global Market (the Bid Price Notice). Nasdaq Listing Rule 5450(a)(1) requires listed securities Rules, we had 180 calendar days to maintain a regain compliance with the minimum bid price requirement by having shares of $1.00 per share. Under Nasdaq Listing Rule 5810(c)(3)(A), we are entitled to a 180-day period, ending on December 17, 2025, to rectify the deficiency. In order to do so, we must achieve and our common stock maintain a minimum closing bid price of at least $1 $1.00 per share or more for a minimum of 10 consecutive business days. If we do not regain compliance by December 17, 2025, the Bid Price Notice states that we will receive written notification that our securities are subject to delisting. Alternatively, we may be eligible for an additional 180-calendar day compliance period if we elect to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, we will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the Minimum Bid Price Requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary. If we do not regain compliance within the compliance period(s), including any extensions that may be granted by Nasdaq, then the common stock will be subject to delisting. We intend to monitor the closing bid price of our common stock and consider our available options to resolve the noncompliance with the Minimum Bid Price Requirement. There can be no assurance that we will be able to regain compliance with The Nasdaq Global Markets continued listing requirements or that Nasdaq will grant us a further extension of time to regain compliance, if applicable. On May 1, 2025, we received written notice a letter from the Nasdaq Staff notifying us that we were not in compliance with the MVLS Requirement (the MVLS Notice). The notification received had no immediate effect on the listing of our common stock on the Nasdaq. In accordance with the Nasdaq Listing Rules, we were granted 180 calendar days, or until October 28, 2025, days to regain compliance with the MVLS Requirement. In order to do so, we must achieve and maintain an MVLS of at least $50,000,000 or more for a minimum of 10 consecutive business days. If On November 4, 2025, we do not regain compliance with received two letters from the MVLS Requirement by October 28, 2025, Nasdaq Staff. The first letter from the MLVS Notice states Nasdaq Staff indicated that we will receive written notification that our securities are subject to delisting. At that time, we may appeal the delisting determination to a Nasdaq hearings panel. Alternatively, we may apply for a transfer closing bid price of our Class A common stock had been at $1.00 per share or greater for the listing of its securities last 10 consecutive business days, from October 21, 2025, to The Nasdaq Capital Market, provided that November 3, 2025, and accordingly, we then meet the continued listing requirements on have regained compliance with Nasdaq Listing Rules 5450(a)(1). The second letter from the Nasdaq Capital Market. We are considering actions Staff indicated that we may take in response to the Notice MVLS of our Class A common stock had been at a value of at least $50,000,000 for the last 10 consecutive business days, from October 17, 2025, to regain October 30, 2025, and accordingly, we had regained compliance with the continued listing requirements, but no decisions about a response have been made at this time. Nasdaq Listing Rules 5450(b)(2)(A). There can be no assurance that we will be able continue to regain compliance with meet the Minimum Bid Price Requirement, MVLS requirement requirement, or will otherwise be any other Nasdaq requirements in compliance with the future. In addition, we may be unable to meet other applicable Nasdaq listing criteria. The delisting requirements, including maintaining minimum levels of our common stock from Nasdaq could materially reduce the liquidity stockholders equity or market values of our common stock and result stock, in a corresponding material reduction in the price of which case our common stock. In addition, delisting stock could harm be delisted. If our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and would also make it more difficult for our stockholders to sell or purchase our common stock when they wish were to do so. If delisted from The Nasdaq Global Market, and not able to transfer to The Nasdaq Capital Market, we will likely trade on be delisted, the OTC Markets system, which could make it more difficult to dispose of, or obtain accurate quotations for the price of, liquidity of our common stock, stock would be adversely affected, and may lead to a reduction in coverage by securities analysts and the news media, which could cause the market price of our common stock to decline further. 36 could decrease. International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects. We operate in a global economy, which includes utilizing third-party suppliers in several countries outside the United States, including suppliers of drug substance for our pipeline programs and suppliers of certain raw materials for the manufacture of the RaniPill capsule. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty. The U.S. government has recently announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the pharmaceutical industry. In response, certain foreign governments have announced or implemented retaliatory tariffs and other protectionist measures. These developments have created a dynamic and unpredictable trade landscape, which may adversely impact our business, results of operations, financial condition and prospects. We manufacture the RaniPill capsule in the United States. We are vertically integrated and manufacture many of the components used in the RaniPill capsule. We source raw materials for our components and manufacturing from a variety of suppliers. Currently, nearly all of the principal suppliers of our raw materials and externally-sourced components used to support our manufacturing come from suppliers located in the United States. The current principal supplier of one raw material is located in China. We obtain supply of the drug substances used for our pipeline programs from third parties. The drug substance for our RT-114 (bispecific GLP-1/GLP-2 receptor agonist) program is manufactured in Korea and China, and the drug substances for our RT-111 (ustekinumab biosimilar) and RT-105 (adalimumab biosimilar) programs are manufactured in Korea. The drug substance for our RT-102 (parathyroid hormone) and RT-110 programs is manufactured in the United States. Current or future tariffs will result in increased research and development and manufacturing expenses, including with respect to increased costs associated with drug substances, raw materials, laboratory equipment and research materials and components . components. In addition, such tariffs will increase our supply chain complexity and could also potentially disrupt our existing supply chain. Trade restrictions affecting the import of materials necessary for clinical trials could result in delays to our development timelines. Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence, negatively impacting our ability to secure additional financing or collaborations on favorable terms or at all. In addition, as we advance toward commercialization in the future, tariffs and trade restrictions could hinder our ability to establish cost-effective production capabilities, negatively impacting our growth prospects. The complexity of announced or future tariffs may also increase the risk that we or our collaborators or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to 37 engage with, purchase from or invest in U.S. entities, which may limit our ability to compete internationally and attract non-U.S. investment, employees, collaborators and suppliers. Foreign governments may also take other retaliatory actions against U.S. entities, such as decreased intellectual property protection, increased enforcement actions, or delays in regulatory approvals, which may result in heightened international legal and operational risks. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business. Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects. In addition, tariffs and other trade developments have heightened and may continue to heighten the risks related to the other risk factors described in our Annual Report for the fiscal year ended December 31, 2024. 37