RANI 10-K & 10-Q changes, risk factors and insider trading
Rani Therapeutics Holdings, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1856725 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Our collaboration with Chugai may not be successful, and we may not realize the anticipated benefits of the Chugai Collaboration and License Agreement.”
New heading “We have in the past and may in the future fail to continue to meet the listing standards of Nasdaq, and as a result our common stock may be delisted, which could have a material adverse effect on the liquidity of our common stock.”
New heading “We have identified a material weakness in our internal control over financial reporting and may identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, which may result in material misstatements of our consolidated financial statements or cause us to fail to meet our periodic reporting obligations.”
New heading “International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.”
Removed heading “There is substantial doubt regarding our ability to continue as a going concern. 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.”
Removed heading “Our existing indebtedness contains restrictions that limit our flexibility in operating our business. In addition, we may be required to make a prepayment or repay our outstanding indebtedness earlier than we expect.”
Removed heading “Any restructuring actions that we undertake may not deliver the expected results and these actions may adversely affect our business operations.”
Removed heading “The Tax Receivable Agreement with certain of the Continuing LLC Owners requires us to make cash payments to them in respect of certain benefits to which we may become entitled. In certain circumstances, payments under the Tax Receivable Agreement may be accelerated and/or significantly exceed the actual tax benefits we realize.”
Removed heading “We are controlled by certain of the Continuing LLC Owners, whose interests may differ from those of our public stockholders.”
Removed heading “The multi-class structure of our common stock has the effect of concentrating voting control which will limit your ability to influence the outcome of important transactions, including a change in control.”
Removed heading “We do not know whether an active, liquid and orderly trading market will develop for our common stock.”
Removed heading “We are a “controlled company” within the meaning of the Nasdaq rules and, as a result, qualify for, and may rely on, exemptions and relief from certain corporate governance requirements. If we rely on these exemptions, our stockholders will not have the same protections afforded to stockholders of companies that are subject to such requirements.”
Removed heading “Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our Class A common stock.”
Largest changes
“A breach of any of these covenants could result in an event of default under the Loan Agreement. An event of default will also occur if, among other things, a material adverse effect in our business, operations, or condition occurs, which could potentially include a material impairment of the prospect of our repayment of any portion of the amounts we owe under the Loan Agreement. …”see in full comparison
“We have in the past and may in the future fail to continue to meet the listing standards of Nasdaq, and as a result our common stock may be delisted, which could have a material adverse effect on the liquidity of our common stock.”see in full comparison
“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 and Gaza, 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 this Annual Report on Form 10-K contains statements expressing substantial doubt about our ability to continue as a going concern. …”see in full comparison
“International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.”see in full comparison
“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. …”see in full comparison
“We have identified a material weakness in our internal control over financial reporting and may identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, which may result in material misstatements of our consolidated financial statements or cause us to fail to meet our periodic reporting obligations.”see in full comparison
Full comparison: every changed paragraph (148)
There is substantial doubt regarding our ability to continue as a going concern. 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. We intend to advance our product candidates into initial and later stages of clinical development, which requires significant capital. In addition, we are developing the RaniPill HC. If the FDA or any comparable foreign regulatory authorities, such as the EMA, 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 December 31, 2024, our cash, cash equivalents and marketable securities totaled $27.6 million. Based on our available cash resources and current operating plan, there is substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that our financial statements for the year ended December 31, 2024 are issued. Our existing capital resources, including the net proceeds from our IPO, the October Offering and July Offering, and term loans we received under a loan and security agreement and related supplement (the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P (the “Lender”), 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 and seek regulatory approval thereof, to expand our manufacturing capabilities, to further develop the RaniPill HC device and to commercialize any of our product candidates.
If we are unable to 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 and Gaza, 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 this 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;
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; or forego expansion of our operations or refrain from pursuing business opportunities.
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, including the RaniPill HC, 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;
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;
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.
We may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.
We may seek additional funding through a combination of equity offerings, debt financings, collaborations and/or licensing arrangements. Additional funding may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, current stockholders’ interestinterests will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of existing stockholders. The incurrence of indebtedness and/or the issuance of certain equity securities could result in fixed payment obligations and could also result in certain additional restrictive covenants, such as limitations on our ability to incur debt and/or issue additional equity, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. In addition, the issuance of additional equity securities by us, or the possibility of such issuance, may cause the market price of our Class A common stock to decline. In the event that we enter into collaborations and/or licensing arrangements in order to raise capital, we may be required to accept unfavorable terms, including relinquishing or licensing to a third party on unfavorable terms our rights to the RaniPill capsule, the RaniPill HC or our product candidates that we otherwise would seek to develop or commercialize ourselves or potentially reserve for future potential arrangements when we might be able to achieve more favorable terms.
Our existing indebtedness contains restrictions that limit our flexibility in operating our business. In addition, we may be required to make a prepayment or repay our outstanding indebtedness earlier than we expect.
In August 2022, we entered into the Loan Agreement with the Lender for term loans (the “Loans”) in an aggregate principal amount up to $45.0 million. A Loan of $30.0 million was committed at closing, with $15.0 million funded immediately and $15.0 million available to be drawn between October 1, 2022 and December 31, 2022, which was drawn in December 2022. The remaining $15.0 million of Loans was uncommitted and subject to certain conditions and is no longer available under the Loan Agreement. The Loan Agreement contains various covenants that limit our ability to engage in specified types of transactions. These covenants limit our ability to, among other things:
incur or assume certain debt;
merge or consolidate or acquire all or substantially all of the capital stock or property of another entity;
enter into any transaction or series of related transactions that would be deemed to result in a change in control of us under the terms of the agreement;
change the nature of our business;
change our organizational structure or type;
license, transfer, or dispose of certain assets;
grant certain types of liens on our assets;
make certain investments;
pay cash dividends; and enter into material transactions with affiliates.
The restrictive covenants in the Loan Agreement could prevent us from pursuing business opportunities that we or our stockholders may consider beneficial.
A breach of any of these covenants could result in an event of default under the Loan Agreement. An event of default will also occur if, among other things, a material adverse effect in our business, operations, or condition occurs, which could potentially include a material impairment of the prospect of our repayment of any portion of the amounts we owe under the Loan Agreement. In the case of a continuing event of default under the Loan Agreement, the Lender could elect to declare all amounts outstanding to be immediately due and payable, proceed against the collateral in which we granted the Lender a security interest under the Loan Agreement, or otherwise exercise the rights of a secured creditor. Amounts outstanding under the Loan Agreement are secured by substantially all of our existing and future assets, including intellectual property.
We may not have enough available cash or be able to raise additional funds on satisfactory terms, if at all, through equity or debt financings to repay or refinance our indebtedness at the time any such repayment is required. In such an event, we may be required to delay, limit, reduce, or terminate our product development or commercialization efforts. Our business, financial condition, and results of operations could be materially adversely affected as a result.
Any restructuring actions that we undertake may not deliver the expected results and these actions may adversely affect our business operations.
We may undertake various restructuring activities in an effort to better align our resources, organizational structure and costs with our strategic priorities, including streamlining of business operations and development program priorities and reduction in force. The estimates of costs that we may expect to incur in connection with the restructuring and the timing thereof are subject to a number of assumptions and actual results may differ materially from estimates. We may also incur other charges or cash expenditures not contemplated in connection with a restructuring due to unanticipated events that may occur, including in connection with the implementation of a restructuring. In connection with such activities, we may experience a disruption in our ability to perform functions critical to our strategy or business objectives. While we strive to reduce the negative impact of restructuring actions, such actions could result in significant disruptions to our operations, including adversely affecting our clinical program development, technology platform development, the successful implementation and completion of our strategic objectives and the results of our operations. We expect to continue to actively manage our costs. However, if we do not fully realize or maintain the anticipated benefits of our restructuring plans and cost reduction initiatives, our business could be adversely affected. Restructuring activities may also yield unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond our intended reduction-in-force, a reduction in morale among our remaining employees, and the risk that we may not achieve the anticipated benefits, all of which may have an adverse effect on our results of operations or financial condition.
We are in the early stages of our development efforts and have only a limited number of product candidates in early clinical development. Other product candidates are still in preclinical stage. We will need to progress our product candidates through Investigational New Drug (IND)-enabling studies and submit INDs to the FDA or equivalent regulatory filings to foreign regulatory authorities prior to initiating their clinical development. None of our product candidates havehas advanced into a pivotal study.
Our business and future profitability isare substantially dependent on our ability to successfully develop, obtain regulatory approval for and then successfully commercialize our product candidates. Our approach presents a novel method of delivering biologics directly into the intestinal wall, and we are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA or any comparable foreign regulatory authorities. The pathway for obtaining regulatory approval for our approach has not been definitively established, and we may never receive such regulatory approval for any of our product candidates. Further, the regulatory pathway for our product candidates is dependent on the molecule being delivered. As such, the regulatory pathway may vary for each of our product candidates, which may impact our ability to rely on prior interactions with FDA for current or future product candidates. The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of regulatory authorities. Approval policies, regulations and the types and amount of clinical and manufacturing data necessary to gain approval may change during the course of clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate and it is possible that none of our existing product candidates or any product candidates we have in development or may seek to develop in the future will ever obtain regulatory approval.
We are early in our development efforts for our product candidates, and we will need to successfully complete later-stage and pivotal clinical trials in order to obtain FDA or comparable foreign regulatory approval to market our current or any future product candidates. Carrying out later-stage clinical trials and the submission of a successful BLA or NDA is a complicated process. As an organization, we have conducted Phase 1 clinical trials in Australia. We have not previously conducted any later stage or pivotal clinical trials, have limited experience as a company in preparing, submitting and prosecuting regulatory filings and have not previously submitted a BLA, NDA or other comparable foreign regulatory submission for any product candidate. We also plan to conduct a number of clinical trials for multiple product candidates in parallel over the next several years. This may be a difficult process to manage with our limited resources and may divert the attention of management. In addition, we have had limited interactions with the FDA, and we have never filed an IND. We cannot be certain about the regulatory pathway for each of our product candidates, which may vary depending on the molecule being delivered, how many clinical trials of our product candidates will be required or how such trials will have to be designed. For example, we anticipate relying on data developed on the RaniPill platform to enable shortened or more efficient development for subsequent product candidates, but this may not be the case and the FDA or other regulatory authorities may require us to perform a full suite of studies for each of our product candidates. Consequently, we may be unable to successfully and efficiently commence, execute and complete necessary clinical trials in a way that leads to regulatory submission and approval of any of our product candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in submitting BLAs or NDAs for and commercializing our product candidates.
Because we have limited financial and managerial resources, we focus on specific product candidates, indications and development programs. We also plan to conduct several clinical trials for our product candidates in parallel over the next several years, which may make our decision as to which product candidates to focus on more difficult. As a result, we may forgo or delay pursuit of opportunities with other product candidates or other indications that could have had greater commercial potential or likelihood of success. In addition, we are focused on developing the RaniPill capsule in addition to the drug formulations for use in the RaniPill capsule. While we intend to focus on well-characterized molecules with attractive commercial characteristics, focusing both on drug delivery and formulation will require substantial resourceresources and attention. In addition, we are developing a device with a payload capacity up to 20 mg,the RaniPill HC, and in the future we may seek to develop other variations of the RaniPill capsule. In such cases, we need to redesign and conduct additional preclinical and clinical studies of any new design of the RaniPill capsule. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through future collaborations, licenses and other similar arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.
Designation as a breakthrough therapy is at the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a breakthrough therapy designation for a drug may not result in a faster development process, review, or approval compared to drugs considered for approval under conventional FDA procedures and it would not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that the product candidates no longer meetsmeet the conditions for qualification, or it may decide that the time period for FDA review or approval will not be shortened.
The availability and extent of reimbursement by governmental and private payors isare essential for most patients to be able to afford medications and therapies. Sales of any of our product candidates that receive marketing approval will depend substantially, both in the United States and internationally, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain adequate pricing that will allow us to realize a sufficient return on our investment.
There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about reimbursement for new products are typically made by CMS,the Centers for Medicare and Medicaid Services, an agency within the United States Department of Health and Human Services.Services ("CMS"). CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare. Private payors tend to follow CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for novel products such as ours since there is no body of established practices and precedents for these new products. Reimbursement agencies in Europe may be more conservative than CMS.
Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada and other countries may cause us to price our product candidates on less favorable terms thatthan we currently anticipate. In many countries, particularly the countries of the European Union, the prices of medical products are subject to varying price control mechanisms as part of national health systems. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidates to other available therapies. In general, the prices of products under such systems are substantially lower than in the United States. Certain other countries allow companies to fix their own prices for products, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.
Moreover, increasing efforts by governmental and third-party payors, in the United States and internationally, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for our product candidates. For example, the U.S. Department of Health and Human Services (“HHS”) imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. HHS has also been empowered to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products into the healthcare market.
We face competition from current and future (generic and biosimilars) manufacturers of subcutaneous and IV injectable versions of our product candidates, such as AbbVie Inc., Eli Lilly and Company, Janssen Biotech, Inc., as well as obesity treatments from Eli Lilly and Company, Novo Nordisk,Nordisk A/S, ProGen and others. We may also face competition from companies that develop oral small molecule therapeutics to the same biological targets as the biologics incorporated into our RaniPill capsule, as well as device-based technologies such as the SOMA and LUMI from the Novo Nordisk-MIT collaboration and devices being developed by Biograil ApS andApS, Biora Therapeutics, Inc. and Alma Therapeutics. In December 2024, Biora announced that it is undertakingundertook a Chapter 11 sale process. After the sale process concluded in May 2025, the bankruptcy case converted from Chapter 11 to Chapter 7, indicating a liquidation of Biora’s remaining assets. Additionally, we face competition from companies that are pursuing the development and manufacture of oral biologics, includingincluding, for example, Oramed Pharmaceuticals, Inc., Entera Bio Ltd., Protagonist Therapeutics, Inc., Chiesi Farmaceutici SpA, i2O Therapeutics, Intract Pharma, and Novo Nordisk A/S.S, and Eli Lily and Company. We also face competition from implantable device companies, such as Vivani Medical Inc., and gene and cell therapy companies. Further, our product candidates aim to treat chronic diseases. As a result, we also compete with curative therapies on the basis that they cure the chronic disease we are intending to treat. We believe that our ability to successfully compete will depend on, among other things:
Management's Discussion & Analysis (MD&A)
New heading “Financial Update”
New heading “Exclusive License Agreement”
Removed heading “60-Day GLP Study”
Removed heading “Reduction in Force”
Largest changes
In August 2022, we entered into the Loan Agreement with the Lender. The Loan Agreementsee in full comparisonprovidesprovided for term loans (the “Loans”) in an aggregate principal amount up to $45.0 million. A Loan of $30.0 million was committed at closing, with $15.0 million funded immediately and $15.0 million available to be drawn between October 1, 2022 and December 31, 2022, which was drawn in December 2022. The remaining $15.0 million of Loans was uncommitted and subject to certain conditions andiswas no longer available under the Loan Agreement. The Loan Agreement alsocontainscontained various covenants and restrictive provisions. There have been no material adverse events in connection with the LoanAgreement and the substantial doubt regarding our ability to continue as a going concern does not currently constitute a material adverse event under the terms of the LoanAgreement. The Loan principaliswas repayable in equal monthly installments which began in September 2024.As of December 31, 2024, we were in compliance with all applicable debt covenants under the Loan Agreement.
We have incurred recurring losses and negative cash flows from operations since inception, including net loss ofsee in full comparison$56.6$41.0 million for the year ended December 31,2024.2025. As of December 31,2024,2025, we had an accumulated deficit of$102.9$132.6 million and for the year ended December 31,2024,2025, had negative cash flows from operations of$35.5$18.7 million. As of December 31,2024,2025, our cash, cash equivalents and marketable securities totaled$27.6$49.7 million. We expect to continue to incur losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.Our existing capital resources, including the net proceeds from our IPO and term loans we received under the Loan Agreement and the Offerings, will not be sufficient to enable us to initiate any pivotal clinical trials. Based on our available cash resources and current operating plan, there is substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that our financial statements for the year ended December 31, 2024 are issued. If we are unable to 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.
“As of December 31, 2024, we had cash and cash equivalents and marketable securities of $27.6 million, compared to $48.5 million as of December 31, 2023. Based on our available cash resources and current operating plan, there is substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that our financial statements for the year ended December 31, 2024 are issued. …”see in full comparison
If we raise additional capital through debt financing, we may be subject to covenants that restrict our operations including limitations on our ability to incur liens or additional debt, pay dividends, make certain investments, and engage in certain merger, consolidation, or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us. If we raise funds through collaborations, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials or delay investments in our manufacturing scale-up and automation. In addition, our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets.see in full comparisonFurthermore, this 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.
“In October 2025, we entered into the Chugai Collaboration and License Agreement with Chugai to develop, manufacture, seek regulatory approvals for and, if approved, commercialize the Chugai Product combining Chugai’s Compound, which is in development for hemophilia, and the RaniPill HC oral delivery device for use in humans. In accordance with a development plan, the parties have allocated responsibility for the development of the Chugai Product worldwide, with Chugai leading and having sole responsibility for clinical, regulatory, and commercial activities. …”see in full comparison
Full comparison: every changed paragraph (76)
Our technology comprises a drug-agnostic oral delivery platform, the RaniPill capsule, which is designed to deliver a wide variety of drug substances, including antibodies, proteins, peptides, and oligonucleotides. We have two configurations of the platform – the RaniPill GO and the RaniPill HC. The RaniPill GO is designed to deliver up to a 3 mg dose of drug in microtablet form with high bioavailability. We have completed three Phase 1 clinical trials using the RaniPill GO. We are also developing a high-capacity version of the RaniPill capsule known as the RaniPill HC, which is intended to enable delivery of drug payloads up to 200µL in liquid form with high bioavailability. We have tested preclinically the RaniPill HC with multiple therapeutics, including multiple different antibodies and peptides. In December 2025, we initiated a peptide.Phase We intend to initiate1 clinical testingtrial ofwith theRT-114, a RaniPill HC incapsule mid-2025.containing a GLP-1/GLP-2 dual agonist (PG-102), for the treatment of obesity.
Financial Update
In October 2025, we entered into a Private Placement pursuant to which we sold (i) 42,633,337 shares of our Class A Common Stock, (ii) warrants to purchase up to an aggregate of 125,000,004 shares of Class A Common Stock or pre-funded warrants (the “Common Warrants”) and (iii) pre-funded warrants to purchase up to an aggregate of 82,366,667 shares of Class A Common Stock (the “Pre-Funded Warrants”), for the aggregate purchase price of approximately $60.3 million (including conversion of the Loan amount of $6.0 million described below). In connection with the Private Placement, we implemented certain governance changes, including amendments to our organizational documents and the termination of certain existing agreements. See “Business Update – Financing” in the Business section above for more information.
In October 2025, we entered into the LSA Amendment with the Lender, pursuant to which the Lender, among other things, converted $6.0 million of outstanding Loans into 12,500,000 shares of Class A Common Stock (or Pre-Funded Warrants in lieu thereof) and Common Warrants to purchase up to 12,500,000 shares of our Class A Common Stock (or Pre-Funded Warrants in lieu thereof), on the same terms as other investors in the Private Placement. In January 2026, the Lender exercised 2,099,844 shares of Pre-Funded Warrants, resulting in 80,266,823 shares of Pre-Funded Warrants outstanding. In September 2025, we modified the exercise price of the warrants to purchase 76,336 shares of our Class A common stock we initially issued to the Lender in August 2022 from $11.79 to $0.50 per share, in consideration for a deferral of a principal repayment due in October 2025. On the modification date, we remeasured the warrants and recognized an additional $15 thousand to interest expense on the our consolidated statement of operations. In December 2025, we repaid all outstanding amounts under the Loan Agreement, including the remaining principal balance of $6.2 million, accrued interest, a final payment of $1.7 million, and a prepayment fee of $0.1 million. We recognized a loss on the extinguishment of the debt of $0.6 million. Upon repayment of these amounts, all obligations under the Loan Agreement were fully satisfied. We no longer have any outstanding debt obligations as of December 31, 2025.
In October 2025, we entered into the Chugai Collaboration and License Agreement with Chugai to develop, manufacture, seek regulatory approvals for and, if approved, commercialize the Product combining Chugai’s Compound, which is in development for hemophilia, and the RaniPill HC oral delivery device for use in humans. Under the Chugai Collaboration and License Agreement, we received a $10.0 million upfront payment and we are eligible to receive up to $18.0 million in technology transfer milestones, up to $57.0 million in development milestones, up to $100.0 million in a series of sales-based milestones, contingent upon approval and the commercial success of the Product, and single digit royalties on net sales, contingent on approval and commercialization of the Product. Of the $10.0 million upfront payment, $8.0 million was received in cash and $2.0 million remains in accounts receivable relates to tax withheld by the Japanese tax authorities, which is expected to be refunded to us upon submission and acceptance of the required residency certificate. See “Business Update – Collaboration” in the Business section above for more information.
In July 2025, we entered into the July 2025 Securities Purchase Agreement with an institutional investor, relating to the issuance and sale of 4,354,000 shares of Class A common stock and pre-funded warrants to purchase 3,146,000 shares of Class A common stock (the "Offering"). The pre-funded warrants are exercisable immediately following the closing date of the Offering and have an unlimited term and an exercise price of $0.0001 per share. The Offering price was $0.40 per share of Class A common stock and $0.3999 per pre-funded warrant for total gross proceeds of $3.0 million. After closing of the Offering, the institutional investor fully exercised all pre-funded warrants.
In May 2025, we entered into the Letter Agreement with an existing institutional investor (the “Equity Investor”) pursuant to which the Equity Investor exercised for cash all outstanding Series B and Series C warrants at a reduced exercise price of $0.65 per share in consideration for the issuance of Series D Warrant to purchase an aggregate of 13,160,172 shares of Class A common stock with the exercise price of $0.65 per share. In October 2025, the Equity Investor exercised 6,967,150 shares of Series D Warrants, resulting in 6,193,022 shares of Series D Warrants remained outstanding. We received cash proceeds of $4.5 million as a result of the exercise.
As of December 31, 2024, our cash, cash equivalents and marketable securities totaled $27.6 million. In October 2024, we entered into a securities purchase agreement (the “October Securities Purchase Agreement”) with an institutional investor relating to the issuance and sale of: (i) 3,000,000 shares of our Class A common stock, (ii) pre-funded warrants to purchase 333,333 shares of Class A common stock, and (iii) Series C common warrants, which accompany the Class A common stock and pre-funded warrants, to purchase an aggregate of 3,333,333 shares of Class A common stock (the “October Offering” and collectively with the July Offering, the “Offerings”). The aggregate net proceeds from the October Offering totaled $9.4 million, after deducting placement agent fees and other offering expenses payable by us, and excluding potential proceeds, if any, from the exercise of the pre-funded warrants and Series C common warrants issued in the October Offering. In October 2024, the pre-funded warrants were fully exercised for de minimis proceeds.
In July 2024, we entered into a securities purchase agreement (the “July Securities Purchase Agreement”) with an institutional investor relating to the issuance and sale of: (i) 2,800,000 shares of its Class A common stock, (ii) pre-funded warrants to purchase 446,753 shares of Class A common stock, (iii) Series A common warrants, which accompany the Class A common stock and pre-funded warrants, to purchase an aggregate of 3,246,753 shares of Class A common stock (the “Series A Warrants”) and (iv) Series B common warrants, which accompany the Class A common stock and pre-funded warrants, to purchase an aggregate of 3,246,753 shares of Class A common stock (the “July Offering”). Pursuant to the October Securities Purchase Agreement, the Series A Warrants were cancelled. The aggregate net proceeds from the July Offering totaled $8.9 million, after deducting placement agent fees and other offering expenses, and excluding potential proceeds, if any, from the exercise of the Series B common warrants issued in the July Offering. In August 2024, the pre-funded warrants were fully exercised for de minimis proceeds.
As of December 31, 2025, our cash, cash equivalents and marketable securities totaled $49.7 million. We expect to continue to incur losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities. Our existing capital resources, including the net proceeds from the Offerings, our initial public offering in 2021 (“IPO”) and term loans we received under a loan and security agreement and related supplement (the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P (the “Lender”), 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 and seek regulatory approval thereof, to expand our manufacturing capabilities, to further develop the RaniPill HC device and to commercialize any of our product candidates. We may seek to raise capital through equity offerings or debt financings, collaboration agreements, or other arrangements with other companies, or through other sources of financing.
In JuneOctober 2024,2025, we entered into athe Chugai Collaboration Agreementand (the “ProGen CollaborationLicense Agreement”) with ProGen Co., Ltd. (“ProGen”). Under the ProGen Collaboration Agreement, the parties will collaborateChugai to develop, manufacture, develop, seek regulatory approvals for and, if approved, commercialize athe productChugai Product (RT-114RT-117) combining ProGen’sChugai’s GLP-1/GLP-2Compound, dualwhich agonistis compound,in PG-102,development for hemophilia, and the RaniPill HC oral delivery device (thefor “Device”)use in the field of weight management (including without limitation obesity, weight reduction and weight maintenance) in humans (the “ProGen Collaboration”).humans.
Under the ProGen Collaboration Agreement, development costs, as well as operating profits and losses from the commercialization of the Product, will be equally shared by us and ProGen. We and ProGen each granted to the other party an exclusive right and license (except with respect to the other party’s affiliates and sublicensees) to certain intellectual property to develop RT-114 for weight management and an exclusive right and license to seek regulatory approval for, and to use, sell, offer to sell, import and commercialize RT-114 in their assigned territories. The parties share responsibility for the development of RT-114 worldwide, with Rani leading such development for preclinical activities through Phase 1 clinical trials. After initiation of the first Phase 2 clinical trial, we will lead development and commercialization of RT-114 in the United States, Canada, Europe (including the United Kingdom) and Australia, and ProGen will lead development and commercialization in all other countries. See “License and Evaluation Agreements – ProGen Co., Ltd.” in the Business section above.
Data Update
In March 2025, we announced preclinical data demonstrating bioequivalence of RT-114, PG-102 delivered orally via the RaniPill capsule, to subcutaneously administered PG-102. RT-114 yielded a relative bioavailability of 111% compared to PG-102 delivered subcutaneously with comparable pharmacokinetic profiles. RT-114 was well tolerated with no changes in drug-related safety profile compared to delivery and was excreted without sequelae in all subjects. Average peak weight loss was the same in both groups with greater variability with subcutaneous dosing (6.7% ± 0.5% for RT-114 and 6.7% ± 2.2% for subcutaneous PG-102).
In February 2025, we announced preclinical data demonstrating successful oral delivery of the glucagon-like peptide-1 receptor (“GLP-1”) agonist semaglutide via the RaniPill HC (“RT-116”). In the study, RT-116 demonstrated comparable bioavailability, pharmacokinetics and weight loss to subcutaneous (“SC”) administration of semaglutide. Further, RT-116 was well tolerated with no serious adverse events.
In October 2024, we announced new pharmacokinetic data from a preclinical study evaluating a GLP-1, GIP and glucagon receptors incretin triagonist with a delivery method mimicking the RaniPill route of administration. The preclinical study evaluated the pharmacokinetic (“PK”) and pharmacodynamic (“PD”) profiles of an incretin triagonist (GLP-1, GIP, glucagon receptors) when delivered via an endoscope-guided transenteric administration to mimic the RaniPill route of administration, versus the traditional administration route of subcutaneous injection. The study was conducted in canines separated into two groups. In Group 1 (N=3), 0.12 mg/kg of drug was administered via transenteric delivery by endoscope. In Group 2 (N=5), 0.12 mg/kg of drug was administered by SC injection. Blood samples were collected over 2 weeks for analysis of serum drug concentrations and various PD and safety biomarkers.
A single dose of drug delivered via either transenteric or SC routes elicited rapid decreases in body weight and serum lipids. Weight loss observed following transenteric delivery was 9.7 ± 2.5 % versus 6.9 ± 2.1 % following SC injection and is believed to be due to early satiety leading to reduced caloric intake. Additionally, the bioavailability of drug delivered via the transenteric route was comparable to that of drug delivered via the SC route at the same dose. The drug was well tolerated in both groups with no serious adverse events (SAEs) observed or changes in safety markers examined.
Transenteric delivery yielded 80% relative bioavailability versus SC and differences between PK parameters (AUC, Cmax, Tmax) were not statistically significant.
RaniPill HC
We continue to develop the RaniPill HC, a high-capacity RaniPill capsule designed to deliver drug payloads up to 200µL.
In March 2025, we announced preclinical data demonstrating bioequivalence of RT-114, PG-102 delivered orally via the RaniPill HC, to subcutaneously administered PG-102. RT-114 yielded a relative bioavailability of 111% compared to PG-102 delivered subcutaneously with comparable pharmacokinetic profiles and weight loss. The RaniPill capsule was well tolerated with no changes in drug-related safety profile compared to subcutaneous delivery and was excreted without sequelae in all canines. RT-114 achieved a 90% delivery success rate (9 out of 10 canines).
In February 2025, we announced results from a nonclinical pharmacokinetic and pharmacodynamic study of the GLP-1 agonist semaglutide administered via the RaniPill HC.
The nonclinical pharmacokinetic and pharmacodynamic study was conducted to examine the effects of semaglutide delivered orally via the RaniPill (RT-116) versus a subcutaneous injection comparator group. The 2x2 crossover study was conducted in two parts with a period of four weeks separating the two groups to evaluate the PK, PD and safety of RT-116. Eight canines were randomized into two groups who received 0.5mg of semaglutide delivered via oral administration of the RaniPill HC (N=4) or subcutaneous injection (N=4). Endpoints included plasma drug concentrations, body weight, food intake, lipid profile, and safety.
Data Highlights
Semaglutide was successfully delivered in 7 of 8 canines that received the RaniPill capsule. Semaglutide administered via the RaniPill capsule was well tolerated with no serious adverse events. Cmax, Tmax, and AUC were comparable for semglutide administered via RaniPill capsule and subcutaneous administration of semaglutide. Oral administration via the RaniPill capsule demonstrated bioavailability and biological activity comparable to subcutaneous administration. The relative bioavailability of oral semaglutide was 107% versus subcutaneous administration. Both groups saw comparable weight loss which appeared to be driven by decreased food intake that coincided with rises in plasma drug levels thus indicating there is a PD effect to treatment. Both groups saw comparable moderate decreases in serum triglycerides and cholesterol.
Next Steps
We intend to initiate clinical testing of the RaniPill HC in mid-2025.
60-Day GLP Study
In October 2023, we announced preclinical data from a 60-day repeat oral administration study of the RaniPill capsule in healthy animals. The preclinical GLP study evaluated the safety and tolerability of the RaniPill drug delivery platform, following 60-day repeat oral administration of the test article, RT-100, in healthy animals. RT-100 is an enteric-coated capsule identical to RT-102, but instead of PTH contained the pharmaceutical excipient mannitol. The control group received a RaniPill capsule (Mock-RP) of similar weight to RT-100 but filled with potato starch. Male and female (1:1) animals were divided into two groups and were administered either Mock-RP (N=12) or RT-100 (N=24) once daily for 60 days, with half of the animals completing an additional 14-day clinical observation and safety evaluation period. RT-100 was well-tolerated with no treatment-related adverse events and all animals remained clinically healthy throughout the study.
Reduction in Force
In November 2023, we committed to a plan for strategic prioritization of our programs, expansion of our manufacturing and streamlining of our business operations to support potential near-term value drivers and long-term growth (the “Restructuring”). The Restructuring included a reduction of our workforce and was substantially completed by the end of the second quarter of 2024.
CEO Compensation Reduction
In November 2023, our Board of Directors (the “Board”) approved a reduction in the annual salary of Talat Imran, our Chief Executive Officer, from $520,000 to $100,000, effective November 1, 2023 through December 31, 2024 or until such time as we receive gross proceeds of $50,000,000 or more, in the aggregate, from equity financing and/or one or more non-dilutive strategic, licensing or partnering transactions (the “Financing Threshold”). In November 2024, the Board approved to extend the reduction in annual salary of Talat Imran through December 31, 20252025, or until the Financing Threshold is met.
In October 2025, the Board deemed it advisable to reinstate Talat Imran’s salary to its full amount in view of the gross proceeds received from the Private Placement and the non-dilutive Chugai Collaboration and License Agreement in excess of the Financing Threshold. Accordingly, the Board reinstated Talat Imran’s salary to $625,100, effective October 20, 2025.
Exclusive License Agreement
In November 2025, as part of a strategic focusing of our resources, we notified ICL that we are terminating the Amended and Restated Exclusive License Agreement in its entirety. The termination became effective on January 18, 2026, and we no longer have any obligations to ICL under the Amended and Restated Exclusive License Agreement. See “Intellectual Property – Exclusive License Agreement” in the Business section above for more information.
Lease
In November 2023, Rani LLC and BKM South Bay 240, LLC (“Landlord”) entered into the Standard Industrial/Commercial Multi-Tenant Lease - Net (the “Lease”). Pursuant to the terms of the Lease, we are leasing 33,340 square feet of space in Fremont, California, which is part of a two-building project (the “Project”).
The initial term of the Lease commenced in February 2024, and the duration of the initial term is 63 months. Subject to certain conditions, we have an option to renew the Lease for one additional 5-year term at the then-prevailing market rate. The monthly base rent for the initial term of the Lease is approximately $95,000 per month, subject to a 4% increase each year. We are also responsible for the payment of additional rent to cover our share of common area operating expenses, including taxes, insurance, utilities, and repair and maintenance of the premises and common areas of the Project.
*Not meaningful
Contract revenue of $1.6 million for the year ended December 31, 2025, was attributable to $1.5 million from Chugai License and Collaboration Agreement and $0.1 million from evaluation services performed for Chugai. There was $1.0 million of contract revenue for the same period in 2024 attributable to evaluation services performed for a customer.
Contract revenue of $1.0 million for the year ended December 31, 2024, was attributable to evaluation services performed for a customer. There was no contract revenue for the same period in 2023.
The decrease of $12.9$6.5 million in research and development expenses for the year ended December 31, 2024,2025, as compared to the same period in 2023,2024, was primarily attributed to lower compensation costs of $6.3$5.3 million, $0.6 million due to reduction in workforce,facilities, $5.6materials and supplies, $0.5 million reduction in third-party services and $0.9$0.1 million reductiondecrease in materialsother andexpenses. suppliesThese duereductions toreflect cost containment efforts, including the timingtemporary pause or termination of certain preclinicalR&D programs. We anticipate the R&D expenses to increase in future periods as we resume some of these programs and clinicalcontinue studies.to invest in product development.
The decrease of $2.5$4.2 million in general and administrative expenses in the year ended December 31, 2024,2025, as compared to the same period in 2023,2024, was primarily attributed to lower compensation costs of $2.0$2.6 millionmillion, due to reduction in workforce, $1.2$0.5 million reduction in third-party services and other costs primarily due to lower insurance premiums, offset by an increase in facility costs ofservices, $0.7 million due to the leasereduction in Fremont,other California.costs, and $0.4 million reduction in facilities, materials and supplies.
TheAs of December 31, 2024, the impairment loss of $3.7 million was attributable to construction-in-progress property and equipment. Rani considers many factors in evaluating whether the value of its construction-in-progress property and equipment may not be recoverable, including, but not limited to, alternative use, cost-savings and strategic considerations. As a result, it was determined that the carrying amount of the construction-in-progress property and equipment exceeded its fair value and was written down to its salvage value. There was no impairment loss for the same period in 2023.2025.
The decrease of $1.5$0.6 million in interestother income and other,expenses, net, in the year ended December 31, 2024,2025, as compared to the same period in 2023,2024, was primarily attributed to a decrease in interest income of $0.9 million from our investment in marketable securities.securities, the recognition of a $0.6 million loss on the extinguishment of debt, offset by a decrease in interest expense of $2.1 million driven by the repayment and extinguishment of debt in 2025.
We have incurred recurring losses and negative cash flows from operations since inception, including net loss of $56.6$41.0 million for the year ended December 31, 2024.2025. As of December 31, 2024,2025, we had an accumulated deficit of $102.9$132.6 million and for the year ended December 31, 2024,2025, had negative cash flows from operations of $35.5$18.7 million. As of December 31, 2024,2025, our cash, cash equivalents and marketable securities totaled $27.6$49.7 million. We expect to continue to incur losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities. Our existing capital resources, including the net proceeds from our IPO and term loans we received under the Loan Agreement and the Offerings, will not be sufficient to enable us to initiate any pivotal clinical trials. Based on our available cash resources and current operating plan, there is substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that our financial statements for the year ended December 31, 2024 are issued. If we are unable to 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.
Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date of issuance of these consolidated financial statements.
In October 2025, we entered into a Private Placement pursuant to which we sold (i) 42,633,337 shares of our Class A Common Stock, (ii) warrants to purchase up to an aggregate of 125,000,004 shares of Class A Common Stock or pre-funded warrants (the “Common Warrants”) and (iii) pre-funded warrants to purchase up to an aggregate of 82,366,667 shares of Class A Common Stock (the “Pre-Funded Warrants”), for the aggregate purchase price of approximately $60.3 million (including conversion of the Loan amount of $6.0 million described below).
The Common Warrants are exercisable following the effective date of stockholder approval in December 2025 and have a term of five years following the initial exercise date. The Common Warrants have an exercise price of $0.48 per share. The Pre-Funded Warrants are exercisable immediately, have an unlimited term and an exercise price of $0.0001 per share.
In October 2024, we entered into the October Securities Purchase Agreement with an institutional investor relating to the October Offering. The aggregate net proceeds from the October Offering totaled $9.4 million, after deducting placement agent fees and other offering expenses payable by us, and excluding potential proceeds, if any, from the exercise of the Series C common warrants issued in the October Offering. Pursuant to the October Offering, the Series A Warrants were cancelled. In October 2024, the pre-funded warrants were fully exercised for de minimis proceeds.
In July 2024, we entered into the July Securities Purchase Agreement with an institutional investor relating to the July Offering. The aggregate net proceeds from the July Offering totaled $8.9 million, after deducting placement agent fees and other offering expenses, and excluding potential proceeds, if any, from the exercise of the Series B common warrants issued in the July Offering. In August 2024, the pre-funded warrants were fully exercised for de minimis proceeds.
In August 2022, we entered into the Loan Agreement with the Lender. The Loan Agreement providesprovided for term loans (the “Loans”) in an aggregate principal amount up to $45.0 million. A Loan of $30.0 million was committed at closing, with $15.0 million funded immediately and $15.0 million available to be drawn between October 1, 2022 and December 31, 2022, which was drawn in December 2022. The remaining $15.0 million of Loans was uncommitted and subject to certain conditions and iswas no longer available under the Loan Agreement. The Loan Agreement also containscontained various covenants and restrictive provisions. There have been no material adverse events in connection with the Loan Agreement and the substantial doubt regarding our ability to continue as a going concern does not currently constitute a material adverse event under the terms of the Loan Agreement. The Loan principal iswas repayable in equal monthly installments which began in September 2024. As of December 31, 2024, we were in compliance with all applicable debt covenants under the Loan Agreement.
In October 2025, we entered into the LSA Amendment with the Lender, pursuant to which the Lender, among other things, converted $6.0 million of outstanding Loans into 12,500,000 shares of our Class A Common Stock (or Pre-Funded Warrants in lieu thereof) and Common Warrants to purchase up to 12,500,000 shares of Class A Common Stock (or Pre-Funded Warrants in lieu thereof), on the same terms as other investors in the Private Placement. In January 2026, the Lender exercised 2,099,844 shares of Pre-Funded Warrants, resulting in 80,266,823 shares of Pre-Funded Warrants outstanding. In December 2025, we repaid $7.9 million in cash to settle all obligations under the Loan Agreement, including the remaining principal balance of $6.2 million, a final payment of $1.7 million, and a prepayment fee of $0.1 million, offset by an interest refund of $0.1 million. We recognized a loss on the extinguishment of the debt of $0.6 million. Upon repayment of these amounts, all obligations under the Loan Agreement were fully satisfied. We no longer have any outstanding debt obligations as of December 31, 2025.
In October 2025, we entered into the Chugai Collaboration and License Agreement to develop, manufacture, seek regulatory approvals for and, if approved, commercialize the Chugai Product combining Chugai’s Compound, which is in development for hemophilia, and the RaniPill HC oral delivery device for use in humans. Under the Chugai Collaboration and License Agreement, we received a $10.0 million upfront payment and we are eligible to receive up to $18.0 million in technology transfer milestones, up to $57.0 million in development milestones, up to $100.0 million in a series of sales-based milestones, contingent upon approval and the commercial success of the Chugai Product, and single digit royalties on net sales, contingent on approval and commercialization of the Chugai Product. Of the $10.0 million upfront payment, $8.0 million was received in cash and $2.0 million remains in accounts receivable relates to tax withheld by the Japanese tax authorities, which is expected to be refunded to us upon submission and acceptance of the required residency certificate.
In July 2025, we entered into the July 2025 Securities Purchase Agreement with an institutional investor, relating to the issuance and sale of 4,354,000 shares of Class A common stock and pre-funded warrants to purchase 3,146,000 shares of Class A common stock. The pre-funded warrants are exercisable immediately following the closing date of the Offering and have an unlimited term and an exercise price of $0.0001 per share. The Offering price was $0.40 per share of Class A common stock and $0.3999 per pre-funded warrant for total gross proceeds of $3.0 million. After closing of the Offering, the institutional investor fully exercised all pre-funded warrants.
In May 2025, we entered into the Letter Agreement with an existing institutional investor (the “Equity Investor”) pursuant to which the Equity Investor exercised for cash all outstanding Series B and Series C warrants at a reduced exercise price of $0.65 per share in consideration for our issuance of a the Series D Warrant to purchase an aggregate of 13,160,172 shares of Class A common stock with the exercise price of $0.65 per share. In October 2025, the Equity Investor exercised 6,967,150 shares of Series D Warrants, resulting in 6,193,022 shares of Series D Warrants outstanding. We received cash proceeds of $4.5 million as a result of the exercise.
In addition, in August 2022, we entered into a Controlled EquitySM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC (collectively, the “Agents”), pursuant to which we may offer and sell from time to time through the Agents up to $150.0 million of shares of our Class A common stock, in such share amounts as we may specify by notice to the Agents, in accordance with the terms and conditions set forth in the Sales Agreement (“ATM Sales”). The potential proceeds from the Sales Agreement are expected to be used for general corporate purposes. As of December 31, 2024, we had not delivered any placement notices to either of the Agents and there had been no ATM Sales.
See Note 12 to the consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K.
Notwithstanding the sharing of development costs for the RT-114 program under the ProGen Agreement, our existing capital resources, including the net proceeds from our IPO, the Loans and the Offerings, will not be sufficient to enable us to initiate any pivotal clinical trials with respect to any of our product candidates. 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 and seek regulatory approval thereof, to expand our manufacturing capabilities, to further develop the RaniPill technology and to commercialize any of our product candidates.
What changed in the latest 10-Q
Risk Factors
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Financial Update”
New heading “Recent Developments”
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Contract Revenue”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Other Income (Expense), Net”
Largest changes
Full comparison: every changed paragraph (42)
The following discussion contains references to the three and six months ended MarchJune 31,30, 2026 and 2025, respectively, which represents the condensed consolidated financial results of Rani Therapeutics Holdings, Inc. (the "Company") and its subsidiary, Rani Therapeutics, LLC (“Rani LLC”) for the three and six months ended MarchJune 31,30, 2026 and 2025, respectively. Unless we state otherwise or the context otherwise requires, the terms “we,” “us,” “our,” and “Rani” and similar references refer to the Company and its consolidated subsidiary.
We are a clinical-stageclinical stage biotherapeutics company focusing on advancing technologies to enable the administration of biologics and drugs orally, to provide patients, physicians, and healthcare systems with a convenient alternative to painful injections. Our technology comprises a drug-agnostic oral delivery platform, the RaniPill capsule, which is designed to deliver a wide variety of drug substances, including antibodies, proteins, peptides, and oligonucleotides. We are advancing a portfolio of oral therapeutics using the RaniPill capsule and we are actively pursuing partnering the technology with third party biopharmaceutical companies for the oral delivery of their biologics and drugs.
Financial Update
In May 2026, we entered into a securities purchase agreement (the "May 2026 Securities Purchase Agreement") with several institutional investors, relating to the issuance and sale of 12,476,637 shares of Class A common stock, par value $0.0001 per share, and pre-funded warrants to purchase 6,214,953 shares of Class A common stock (the "May 2026 Pre-Funded Warrants"). The May 2026 Pre-Funded Warrants are exercisable immediately, have no expiration date and remain exercisable until exercised in full, and have an exercise price of $0.0001 per share. The offering price was $1.07 per share of Class A common stock, and $1.0699 per May 2026 Pre-Funded Warrant for total gross proceeds of $20.0 million. We incurred issuance costs of approximately $1.6 million. As of June 30, 2026, all May 2026 Pre-Funded Warrants were outstanding.
In December 2025, we initiated a Phase 1 clinical trial with RT-114, a RaniPill HC capsule containing a bispecific GLP-1/GLP-2 receptor agonist (PG-102) in collaboration with ProGen.ProGen, The Phase 1 trial willto evaluate the safety, tolerability, bioavailability, and pharmacokinetics / pharmacodynamics of single and multiple doses of RT-114 for the treatment of obesity. The single-center Phase 1 study of RT-114 is being conducted in Australia.
Recent Developments
Phase 1a Data for RT-114. On July 15, 2026, we announced positive initial data from the single-dose, open-label Phase 1a portion of our ongoing Phase 1 clinical trial of RT-114. Thirty healthy volunteers were randomized to receive an identical 12 mg dose of PG-102, delivered either orally via RT-114 or by subcutaneous injection. Oral RT-114 achieved bioavailability exceeding 150% relative to the matched subcutaneous dose, with an elimination half-life of 5.6 days for oral RT-114 versus 5.3 days for the subcutaneous arm. No serious adverse events were reported in either arm, and no adverse events were attributed to the RaniPill capsule itself; treatment-related adverse events (nausea, vomiting, and diarrhea) were mild, transient and consistent with the known profile of GLP-1/GLP-2 dual agonists.
Based on these results, we expanded the Phase 1a study to include an additional cohort of 15 healthy volunteers, each receiving two separate 12 mg doses of PG-102 via the RaniPill (24 mg total administered dose), to further characterize the oral-to-subcutaneous pharmacokinetic relationship ahead of dose selection for the planned Phase 1b portion of the study. The first participants in the Phase 1a study expansion cohort have been dosed. The Phase 1b study will assess the safety, tolerability, and pharmacodynamic effect of eight weeks of repeat dosing with RT-114 in patients with obesity, and is expected to begin in 2026, with data anticipated in 2027.
PegBio Collaboration. On July 9, 2026, we entered into a research and development collaboration agreement with PegBio Co., Ltd. to explore oral delivery of multiple novel candidates from PegBio’s obesity and metabolic disease pipeline using the RaniPill platform. Under the agreement, we and PegBio will collaborate on preclinical development of RaniPill formulations for molecules selected from PegBio’s portfolio, with the goal of advancing the most promising candidates into clinical development. No consideration was exchanged between the parties in connection with entering into the agreement. This collaboration builds on our growing obesity franchise alongside RT-114 and our completed preclinical work evaluating other obesity candidates including semaglutide.
The single-center Phase 1 study of RT-114 is being conducted in Australia. The single dose portion of the study is underway and will evaluate the safety, tolerability and bioavailability of RT-114 administered in up to 30 healthy human participants. This part of the trial consists of two cohorts, with one cohort evaluating RT-114 containing 12 mg of PG-102, administered orally as a RaniPill capsule. The second cohort, as the control group, will receive 12 mg of PG-102 via subcutaneous injection.
The Phase 1 trial of RT-114 is ongoing as of the date of this filing, and we expect to provide an update following completion of the study in 2027.
Comparison of the three months ended MarchJune 31,30, 2026 and 2025
* Not meaningful
Contract revenue of $1.7 million for the three months ended MarchJune 31,30, 2026, was attributable to the Chugai Collaboration and License Agreement entered into in October 2025. There was $0.2 million ofno contract revenue from evaluation services performed for Chugai for the same period in 2025.
The decrease of $1.4$0.5 million in research and development expenses in the three months ended MarchJune 31,30, 2026, as compared to the same period in 2025, was primarily attributed to lower compensation costs of $1.1$0.4 million,million $0.2and $0.1 million reduction in facilities, materials and supplies and $0.1 million decrease in third-party services.supplies.
The decreaseincrease of $0.7$0.5 million in general and administrative expenses in the three months ended MarchJune 31,30, 2026, as compared to the same period in 2025, was primarily attributed to lowerhigher compensation costs of $1.2$0.3 million and $0.1increase of $0.2 million reduction in facilities, materials and supplies, offset by an increase in third-party services of $0.6 million.services.
The increase of $1.1$1.2 million in other income (expense), net, in the three months ended MarchJune 31,30, 2026, as compared to the same period in 2025, was primarily attributed to an increase in interest income of $0.2$0.3 million from our investment in marketable securities and a decrease in interest expense of $0.9 million.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations (in thousands):
Contract Revenue
Contract revenue of $3.4 million for the six months ended June 30, 2026, was attributable to the Chugai Collaboration and License Agreement entered into in October 2025. There was $0.2 million in contract revenue for the same period in 2025 attributable to evaluation services performed for the evaluation agreement with Chugai.
Research and Development Expenses
The following table reflects our research and development costs by nature of expense (in thousands):
The decrease of $1.9 million in research and development expenses in the six months ended June 30, 2026, as compared to the same period in 2025, was primarily attributed to lower compensation costs of $1.5 million, $0.3 million reduction in facilities, materials and supplies and $0.1 million reduction in third-party services.
General and Administrative Expenses
The decrease of $0.2 million in general and administrative expenses in the six months ended June 30, 2026, as compared to the same period in 2025, was primarily attributed to lower compensation costs of $0.9 million and $0.1 million reduction in facilities, materials and supplies offset by an increase of $0.8 million in third-party services.
Other Income (Expense), Net
The increase of $2.2 million in other income (expense), net, in the six months ended June 30, 2026, as compared to the same period in 2025, was primarily attributed to an increase in interest income of $0.5 million from our investment in marketable securities and decrease in interest expense of $1.7 million.
We have incurred recurring losses and negative cash flows from operations since inception, including net loss of $8.0$16.4 million for the threesix months ended MarchJune 31,30, 2026. As of MarchJune 31,30, 2026, we had an accumulated deficit of $139.6$147.0 million and for threethe six months ended MarchJune 31,30, 2026, had negative cash flows from operations of $6.5$15.5 million. As of MarchJune 31,30, 2026, our cash, cash equivalents and marketable securities totaled $43.4$53.4 million. We expect to continue to incur losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.
In May 2026, we entered into the May 2026 Securities Purchase Agreement with several institutional investors, relating to the issuance and sale of 12,476,637 shares of Class A common stock, par value $0.0001 per share, and pre-funded warrants to purchase 6,214,953 shares of Class A common stock (the "May 2026 Pre-Funded Warrants"). The May 2026 Pre-Funded Warrants are exercisable immediately, have no expiration date and remain exercisable until exercised in full, and have an exercise price of $0.0001 per share. The offering price was $1.07 per share of Class A common stock, and $1.0699 per May 2026 Pre-Funded Warrant for total gross proceeds of $20.0 million. We incurred issuance costs of approximately $1.6 million. As of June 30, 2026, all May 2026 Pre-Funded Warrants were outstanding.
Based on our current operating plans and assumptions, we believe that our cash, cash equivalents, and marketable securities will be sufficient to fund our operations through at least twelve months from the date that our condensed consolidated financial statements for the threesix months ended MarchJune 31,30, 2026 are issued.
To date, we have not generated any commercial product revenue. We do not expect to generate any commercial product revenue unless and until we obtain regulatory approval and commercialize any of our commercial product candidates, and we do not know when, or if at all, that will occur. We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. Our primary uses of cash are to fund our operations, which consist primarily of research and development expenses related to our programs, manufacturing automation and scaleup, and general and administrative expenses. We expect our expenses to continue to increase in connection with our ongoing activities as we continue to advance the RaniPill technology and our product candidates.
Net cash used in operating activities for the three months ended March 31, 2026 was $6.5 million, which was primarily attributable to a net loss of $8.0 million and net accretion and amortization of investments in marketable securities of $0.2 million, partially offset by stock-based compensation expense of $2.1 million, depreciation and amortization expense of $0.2 million and, non-cash lease expense of $0.5 million. Additionally, there was an increase in accounts payable of $0.5 million, an increase in accrued expenses and other current liabilities of $0.7 million, a decrease in deferred revenue of $1.7 million, an increase in prepaid expenses and other current assets of $0.1 million, and a decrease in operating lease liabilities of $0.5 million for the three months ended March 31, 2026.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 20252026 was $8.1$15.5 million, which was primarily attributable to a net loss of $12.7$16.4 million and net accretion and amortization of investments in marketable securities of $0.2$0.5 million, partially offset by the stock-based compensation expense of $3.9$4.5 million, non-cash operating lease expense of $1.0 million and depreciation and amortization expense of $0.3 million. Additionally, there was an increase in accounts receivable of $0.6 million, accounts payable of $0.2$0.3 million, prepaid expenses and other current assets of $0.5 million and a decrease in deferred revenue of $3.4 million, operating lease liabilities of $1.0 million and accrued expenses and other current liabilities of $0.2 million, and a decrease in contract assets of $0.4 million and prepaid expenses and other current assets of $0.3$0.8 million for the threesix months ended MarchJune 31,30, 2025.2026.
Net cash used in operating activities for the six months ended June 30, 2025 was $13.9 million, which was primarily attributable to a net loss of $24.0 million and net accretion and amortization of investments in marketable securities of $0.2 million, partially offset by stock-based compensation expense of $7.2 million and depreciation and amortization expense of $0.5 million. Additionally, there was an increase in accounts payable of $0.4 million, accrued expenses and other current liabilities of $0.6 million and a decrease in contract asset of $0.4 million and prepaid expenses and other current assets of $0.8 million for the six months ended June 30, 2025.
For the threesix months ended MarchJune 31,30, 2026, net cash used in investing activities was $2.5$17.0 million, which primarily consisted of $21.0$41.0 million in proceeds from maturities of marketable securities,securities partially offset by $23.5$58.0 million in purchases of marketable securities.
For the threesix months ended MarchJune 31,30, 2025, net cash provided by investing activities was $18.2$23.9 million, which primarily consisted of $21.0$26.8 million in proceeds from maturities of marketable securities,securities partially offset by $2.7 million in purchases of marketable securities and $0.1 million in purchases of property and equipment.
For the three months ended March 31, 2026, net cash used in financing activities was de minimis.
For the threesix months ended MarchJune 31,30, 2025,2026, net cash usedprovided inby financing activities was $3.7$18.8 million, which primarily consisted of repaymentnet proceeds from issuance of debtcommon stock and pre-funded warrants in connection with the May 2026 Securities Purchase Agreement of $3.8$18.7 million and the exercise of stock options of $0.1 million.
For the six months ended June 30, 2025, net cash used in financing activities was $3.5 million, which primarily consisted of repayment of debt of $7.5 million offset by the exercise of warrants of $3.9 million.
As of MarchJune 31,30, 2026, there have been no material changes to our contractual obligations and other commitments compared to those disclosed in our Annual Report on Form 10-K.
The following table summarizes our contractual obligations and commitments as of MarchJune 31,30, 2026 (in thousands):
RANI insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 2 Form 4 filings (2 insiders, 2 trade dates, 71,000 shares, about $50.0K) and open-market sales in 2 filings (2 insiders, 2 trade dates, 8,400 shares, about $11.6K). Net open-market shares: 62,600 (purchases minus sales); net value about $38.4K.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.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-27 | Imran Talat |
Shares withheld for tax | 7,928 | $0.76 | $6.0K |
| 2026-09-27 | Javadi Alireza |
Shares withheld for tax | 309 | $0.76 | $235 |
| 2026-07-21 | Imran Mir A |
Open-market purchase | 36,000 | $0.69 | $24.8K |
| 2026-07-17 | Imran Talat |
Open-market purchase | 35,000 | $0.72 | $25.2K |
| 2026-06-27 | Javadi Alireza |
Shares withheld for tax | 309 | $0.74 | $229 |
| 2026-06-27 | Imran Talat |
Shares withheld for tax | 7,927 | $0.74 | $5.9K |
| 2026-03-27 | Javadi Alireza |
Open-market sale | 386 | $0.78 | $301 |
| 2026-03-27 | Imran Talat |
Shares withheld for tax | 9,099 | $0.81 | $7.4K |
| 2026-03-22 | Imran Talat |
Shares withheld for tax | 8,916 | $1.13 | $10.1K |
| 2025-12-27 | Imran Talat |
Shares withheld for tax | 7,906 | $1.40 | $11.1K |
| 2025-09-27 | Imran Talat |
Shares withheld for tax | 9,077 | $0.48 | $4.4K |
| 2025-06-27 | Imran Talat |
Shares withheld for tax | 9,076 | $0.55 | $5.0K |
| 2024-12-27 | Imran Talat |
Open-market sale | 8,014 | $1.41 | $11.3K |
Well-known investors holding RANI (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 641,995 | $488.2K | 0.0% | New position |
| Renaissance Technologies | 2026-06-30 | 430,737 | $327.5K | 0.0% | New position |
| Millennium Management (Israel Englander) | 2026-06-30 | 405,669 | $298.1K | — | Sold out |