Rani Therapeutics Holdings Inc

Item 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 may not be available on acceptable terms. If 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 of cash since our inception. We are in early clinical development with certain product candidates 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. In addition, we are developing 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 with respect to the 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, and any delay resulting from such further or repeat studies or trials could also result in the need for additional financing.

As of March 31June 30, 2025, our cash, cash equivalents and marketable securities totaled $15.90.2 million. Based on our available cash resources and current operating plan, 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. 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 the United States Bankruptcy Code. Our existing capital resources will not be sufficient to enable us to initiate any pivotal clinical trials. We will need to raise substantial additional funds in the future in order to complete the development of the RaniPill platform, to complete the clinical development of our product candidates, including RT-114, and seek regulatory approval thereof, to expand our manufacturing capabilities, and to commercialize any of our product candidates.

Based on our current planned operations, and in the absence of additional sources of liquidity, management anticipates that our existing cash and cash equivalents and anticipated cash flows from operations, will not be sufficient to meet our operating and liquidity needs beyond early Augustlate 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 which those assets are carried on our audited financial statements, and investors may lose all or a part of their investment.

We may not be able to obtain additional funding on acceptable terms, or at all. As a result of geopolitical events, including the conflicts in Ukraine a, Gaza and GazaIran, 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 thisour 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 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 of our research or development programs, the development of our oral delivery technology, including the RaniPill HC, the commercialization of any product candidates or cease operations altogether;

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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 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 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 any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, 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 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 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, and results of our research pipeline;

the progress and costs of development of the RaniPill HC device and other improvements or advancements to our delivery technologies;

the willingness of the FDA or other regulatory authorities 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 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;

our ability to manufacture sufficient quantities of the RaniPill capsule;

our need to expand our research and development activities;

the costs associated with manufacturing, and obtaining drug supply for, our product candidates, including for clinical and commercial supplies;

the costs associated with securing and establishing commercial infrastructure, including establishing sales, marketing, and distribution capabilities;

the costs of acquiring, licensing, or investing in businesses, product candidates, and technologies;

our ability to maintain, expand, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense, and enforcement 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 to establish strategic collaborations or enter into strategic transactions;

our need to implement additional internal systems and infrastructure, including financial and reporting systems;

security breaches, data losses or other disruptions affecting our information systems;

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our ability to realize savings from any restructuring plans and cost-containment measures we propose to implement;

the economic and other terms, timing of and success of any collaboration, licensing, or other arrangements which we may enter in the future; 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 fail to meet the requirements for continued listing on The Nasdaq Global Market, trading in our common stock could be suspended and our common stock delisted from Nasdaq, which would have a negative effect on the price of our common stock and our ability to raise additional capital.

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 marbid 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 May 1June 20, 2025, we received written notice from the Listing Qualifications Department (Staff) of The Nasdaq Stock Market LLC (Nasdaq) notifying us that we were not in , based on the closing bid price of our Class A compliance wmon stock, par value $0.0001 per share for the prior 30 consecutive business days we no longer comply with the MVLS inimum Bid Price Requirement (the Notice). In accordance with thefor continued listing on The Nasdaq Global Market (the Bid Price Notice). Nasdaq Listing Rules, we were granted 180 calendar days, or u 5450(a)(1) requires listed securities to maintain a minimum bid price of $1.00 per share. Under Nasdaq Listing Rule 5810(c)(3)(A), we are entil Octotled to a 180-day period, ending on December 2817, 2025, to regain compliance with the MVLS Requirementctify the deficiency. In order to do so, we must achieve and maintain an MVLS  minimum bid price of at least $50,000,000 1 per share or more for a minimum of 10 consecutive business days. If we do not regain compliance with the MVLS Requirement by Octobby December 2817, 2025, the Bid Price Notice states that we will receive written notification that our securities are subject to delisting. At that timelternatively, we may appeal the delisting determinabe eligible for an addition to a Nasdaq hearings panel. Alternatively, al 180-calendar day compliance period if we may apply for a elect to transfer of tto The listing of its securitiesNasdaq Capital Market to The Nasdaq Capittake advantage of the additional Market, provided compliance period offered on that market. To qualify, we then will be required to meet the continued listing requirements on The Nasdaq Capit for market value of publicly held shares and all other initial Market. We are considering actlisting standards, with the exception of the Minimum Bid Price Requirement, and will need to provide written notice of our intentions that we may take in response to the Notice to  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 continued listing requirements, but nmpliance period(s), including any extensions that may be granted by Nasdaq, then the common stock will be subject to decisions about a resplisting. We intend to monitor the closing bid price of our common stock and conse have been made atider our available options to resolve the noncompliance with this timee Minimum Bid Price Requirement. There can be no assurance that we will be able to regain compliance with tThe MVLS requirement or will otherwise be in compliance with other NasdaqNasdaq Global Markets continued listing criteria. Frequirements or example,that Nasdaq Listing Rule 5450(a)(1) requires listed securitieswill grant us a further extension of time to mregaintain a minimum bid price of $1.00 per share (t compliance, if applicable.

On May 1, 2025, we received written notice from the Minimum Bid Price Staff notifying us that we were not in compliance with the MVLS Requirement) and  (the MVLS Notice). In accordance with the Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price s, we were granted 180 calendar days, or until October 28, 2025, to regain compliance with the MVLS Requirement exists if the deficiency continues . In order to do so, we must achieve and maintain an MVLS of at least $50,000,000 or more for a periodminimum of 310 consecutive tradingbusiness days. The per share price of If we do not regain compliance with the MVLS Requirement by October 28, 2025, the MLVS Notice states that we will receive written notification that our common stock has fluctuated significantly and has traded below $1.00 per share forsecurities 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 of the past 5 conslisting of its secutive trading days. Our stockrities to The Nasdaq Capital Market, price may not close at or above $1.00 per share and ifovided that we then meet the continued listing requirements on The Nasdaq Capital Market. We are considering actions the price remains below $1.00 per share for a period of 30 at we may take in response to the Notice to regain compliance with the consecutive tradtinued listing dayrequirements, our stock could become subject to delisting because of the failure but no decisions about a response have been made at this time. There can be no assurance that we will be able to satisfy thregain compliance with the Minimum Bid Price Requirement.VLS requirement or will otherwise be in compliance with other Nasdaq listing criteria. 

The delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm 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 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 the OTC Markets system, which could make it more difficult to dispose of, or obtain accurate quotations for the price of, our common stock, and may lead to a reduction in coverage by securities analysts and the news media, which could cause the price of our common stock to decline further.

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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.

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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 . 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 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.

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