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RANI on Nasdaq

Rani Therapeutics Holdings, Inc.

In its 2026 annual report the company says: “We are a clinical 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. We are advancing a portfolio of oral therapeutics using our proprietary delivery technology and we are actively pursuing partnering the technology with third party biopharmaceutical companies for the oral delivery of their biologics and drugs.”5 It is headquartered in San Jose, California.1 Its shares trade on Nasdaq under the symbol RANI.1

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Last updated Oct 21, 2026.

Overview

$1.6MRevenue, fiscal 20252
-$29.7MNet income, fiscal 20252

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  • TickerRANI on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSan Jose, California1
  • Incorporated inCA3
  • Business address2051 Ringwood Avenue, San Jose, Ca 951313
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company3
  • Legal formCorporation

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We are a clinical 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. We are advancing a portfolio of oral therapeutics using our proprietary delivery technology and we are actively pursuing partnering the technology with third party biopharmaceutical companies for the oral delivery of their biologics and drugs.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-2346.0%Operating margin2
-1817.1%Net margin2
58.9%Revenue growth, 20252
-89.9%Return on equity2
0.00×Debt to equity2
-$18.8MFree cash flow2

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development87¢$20.2M
  • Interest13¢$2.9M

Out of $1.6M in revenue.2 The company lost money this year.

Financial statements

Revenue6782$1.6M in 2025+253% since 2020
0$1.0M$2.0M$3.0M2020: $462.0K$462.0K20202021: $2.7M$2.7M2021+488%2022: $0$020222023: $0$020232024: $1.0M$1.0M20242025: $1.6M$1.6M2025+59%
Operating income67982-$38.3M in 2025+132% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$16.5M-$16.5M20202021: -$51.6M-$51.6M2021+212%2022: -$63.5M-$63.5M2022+23%2023: -$66.1M-$66.1M2023+4%2024: -$53.3M-$53.3M2024−19%2025: -$38.3M-$38.3M2025−28%
Net income67982-$29.7M in 2025+78% since 2020
-$40.0M-$30.0M-$20.0M-$10.0M02020: -$16.7M-$16.7M20202021: -$8.3M-$8.3M2021−50%2022: -$30.6M-$30.6M2022+267%2023: -$34.0M-$34.0M2023+11%2024: -$30.0M-$30.0M2024−12%2025: -$29.7M-$29.7M2025−1%

Every line of the income statement as filed: the last 2 fiscal years, latest first.2

Period ending2025-12-312024-12-31
Contract revenue$1.6M$1.0M
Research and development$20.2M$26.7M
General and administrative$19.7M$23.9M
Impairment loss$0$3.7M
Total operating expenses$39.9M$54.3M
Loss from operations-$38.3M-$53.3M
Interest income and other, net$827.0K$1.8M
Interest expense and other, net-$2.9M-$5.0M
Loss on extinguishment of debt-$576.0K$0
Net loss-$41.0M-$56.6M
Net loss attributable to non-controlling interest-$11.3M-$26.6M
Net loss attributable to Rani Therapeutics Holdings, Inc.-$29.7M-$30.0M
Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc.-basic-$0.45-$1.05
Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc.-diluted-$0.45-$1.05
Weighted average Class A common share outstanding-basic66.1K shares28.5K shares
Weighted average Class A common share outstanding-diluted66.1K shares28.5K shares

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Corporate structure

Rani Therapeutics Holdings, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Rani Therapeutics Holdings, Inc.

  • Rani Therapeutics Holdings, Inc. San Jose, California
    • Rani Therapeutics, LLC Subsidiary · California, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Rani Therapeutics Holdings, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Accumulated depreciation$5.5M2 Dec 31, 2025$4.6M2 Dec 31, 2024+19.4%
Property and equipment, net$736.0K2 Dec 31, 2025$1.5M2 Dec 31, 2024−52.5%
Operating-lease assets (leased space)$4.3M2 Dec 31, 2025$5.1M2 Dec 31, 2024−15.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$18.6M2 Dec 31, 2025$3.8M2 Dec 31, 2024+394.9%
Debt securities available for sale$48.5M2 Dec 31, 2025$25.8M2 Dec 31, 2024+88.2%

Properties, in its own words

Our corporate headquarters are currently located in San Jose, California. We lease approximately 57,000 square feet of office, research and development, production and manufacturing, and laboratory space for our business. In February 2024, we began occupying approximately 33,000 square feet in Fremont, California, under a lease with a third party. The term of the lease 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. We also lease approximately 24,000 square feet in San Jose, California, pursuant to a service agreement with ICL, a related party. The lease for the San Jose facility has a twelve month term that renews automatically on January 1st of each year for a successive twelve-month period, subject to termination by either party upon a six months’ notice. In March 2024, we amended our lease for the San Jose facility to increase our use from 23,000 square feet to 24,000 square feet. If required, we believe that suitable additional or alternative space would be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 26, 2026.5

Leadership

Who has led Rani Therapeutics Holdings, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Talat Imran2021–now

Chief financial officer

  1. Svai S. Sanford2021–2026
  2. Nicholas Maestas2026–now
2025
Board members and other officers (15)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Rani Therapeutics, LLC California, United States of America4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Aug 13, 20268-K Results of operations31
  2. Aug 4, 20268-K Executive or director change32
  3. Jun 30, 20268-K Executive or director change33
  4. May 29, 20268-K Shareholder vote34
  5. May 27, 20268-K Other events35
  6. May 15, 20268-K Results of operations; Listing notice or transfer; Executive or director change36
  7. Mar 26, 20268-K Results of operations37
  8. Jan 2, 20268-K Ended a material agreement; Change to shareholders' rights; Bylaws or fiscal year changed38
  9. Nov 6, 20258-K Results of operations39
  10. Oct 27, 20258-K Executive or director change; Other events40
  11. Oct 17, 20258-K Entered a material agreement; New debt or obligation; Unregistered sale of shares41
  12. Aug 7, 20258-K Results of operations42
  13. Jul 29, 2021New chief executive Talat Imran becomes CEO14

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.12) a share, on Nov 6, 2025.43

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results31
  2. May 15, 2026Reported quarterly or annual results36
  3. Mar 26, 2026Reported quarterly or annual results37
  4. Nov 6, 2025Reported quarterly or annual results39
  5. Aug 7, 2025Reported quarterly or annual results42
  6. May 13, 2025Reported quarterly or annual results44
  7. Mar 31, 2025Reported quarterly or annual results45
  8. Nov 14, 2024Reported quarterly or annual results46

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

332 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 61 major events, 168 insider forms, 26 large holders, 1 private raises, 56 other. The latest 20:

  1. Sep 29, 20264 EDGAR
  2. Sep 29, 20264 EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 13, 202610-Q EDGAR
  5. Aug 13, 20268-K EDGAR
  6. Aug 4, 20264 EDGAR
  7. Aug 4, 20263 EDGAR
  8. Aug 4, 20268-K EDGAR
  9. Jul 31, 2026SCHEDULE 13G/A EDGAR
  10. Jul 23, 20264 EDGAR
  11. Jul 21, 20264 EDGAR
  12. Jul 21, 20264 EDGAR
  13. Jul 21, 20264 EDGAR
  14. Jul 21, 20264 EDGAR
  15. Jul 15, 2026S-8 EDGAR
  16. Jul 8, 20263 EDGAR
  17. Jun 30, 20268-K EDGAR
  18. Jun 5, 20264 EDGAR
  19. Jun 5, 20264 EDGAR
  20. Jun 5, 20264 EDGAR

The 332 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

91 open-market trades by officers, directors and large owners since October 2021: 83 buys and 8 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 21, 2026IMRAN MIR ADirectorBuy36,000$0.69$24.8KForm 4
Jul 17, 2026Imran TalatChief Executive OfficerBuy35,000$0.72$25.2KForm 4
Mar 27, 2026Javadi AlirezaChief Technical OfficerSale386$0.78$301Form 4
Oct 23, 2025IMRAN MIR ADirectorBuy2,083,334$0.61$1.3MForm 4
Oct 21, 2025South Cone Investments Limited Partnership10% ownerSale4,000,000$2.77$11.1MForm 4
Oct 20, 2025South Cone Investments Limited Partnership10% ownerSale1,923,000$2.41$4.6MForm 4
Dec 27, 2024Imran TalatChief Executive OfficerSale8,014$1.41$11.3KForm 4
Dec 13, 2024McKinley KateChief Business OfficerBuy17,960$1.67$30.0KForm 4
Dec 9, 2024Imran TalatChief Executive OfficerBuy10,296$1.94$20.0KForm 4
Oct 15, 2024South Cone Investments Limited Partnership10% ownerSale3,829,360$2.65$10.1MForm 4
Dec 6, 2023Imran TalatChief Executive OfficerBuy10,000$2.27$22.7KForm 4
Dec 4, 2023Imran TalatChief Executive OfficerBuy5,000$2.57$12.8KForm 4
Nov 29, 2023Imran TalatChief Executive OfficerBuy20,000$2.05$41.0KForm 4
Nov 24, 2023Aequanimitas Limited Partnership10% ownerSale5,265,165$2.01$10.6MForm 4
Nov 24, 2023South Cone Investments Limited Partnership10% ownerBuy5,265,165$2.01$10.6MForm 4
Nov 17, 2023BUTEL JEAN LUCDirectorBuy50,500$2.03$102.5KForm 4
Nov 16, 2023Nanavaty MaulikDirectorBuy500$1.98$990Form 4
Nov 7, 2023Imran TalatChief Executive OfficerBuy5,000$2.00$10.0KForm 4
May 12, 2023South Lake One LLC10% ownerBuy2,645$3.98$10.5KForm 4
May 11, 2023South Lake One LLC10% ownerBuy2,610$3.87$10.1KForm 4

All 91 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Talat ImranChief Executive Officer45$502.2K$1.1M61
2025Svai SanfordChief Financial Officer56$155.0K$946.4K61
2025Kate McKinleyChief Business Officer49$201.6K$943.9K61
2024Talat ImranChief Executive Officer45$3.0M61
2024Svai SanfordChief Financial Officer56$416.0K$1.3M61
2024Kate McKinleyChief Business Officer49$390.0K$1.3M61

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$60.3M 2025–2025
Money received by yearMoney received by year, 2025–2025: $60.3M in all. Private raises (Form D) $60.3M.$0$20M$40M$60M$80M2025 · Private raises (Form D): $60.3M2025
Figures by year
YearPrivate raises (Form D)Total
2025$60.3M$60.3M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Oct 23, 2025Raised $60.3 million in a private offering of equity62 Form D: 15 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 67. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Samsara Biocapital, LLC10,369,159$7.9M0.6%+1,869,159
Ra Capital Management, L.P.8,500,000$6.5M0.1%No change
AWM Investment Company, Inc.7,500,000$5.7M0.5%+1,000,000
Vanguard Capital Management LLC4,562,985$3.5M0.0%−59,582
Longaeva Partners L.P.2,329,459$1.8M0.1%No change
Polar Asset Management Partners Inc.2,318,542$1.8M0.0%New
Siren, L.L.C.2,000,000$1.5M0.0%No change
Heights Capital Management, Inc934,580$710.7K0.2%New
Geode Capital Management, LLC890,618$677.6K0.0%−12,680
Citadel Advisors LLC641,995$488.2K0.0%New
Marshall Wace, Llp586,265$445.6K0.0%New
Nan Fung Group Holdings Ltd493,584$375.3K0.3%No change
Jane Street Group, LLC485,899$369.5K0.0%+320,300
Vanguard Fiduciary Trust Co458,126$348.2K0.0%+3,076
Renaissance Technologies LLC430,737$327.5K0.0%New
State Street Corp373,142$283.7K0.0%No change
BlackRock, Inc.342,113$260.1K0.0%−214,776
United Services Automobile Association302,743$230.2K0.0%No change
UBS Group AG297,270$225.9K0.0%+70,047
Kestra Private Wealth Services, LLC282,340$214.7K0.0%+17,181
Northern Trust Corp170,471$129.6K0.0%No change
CWA Asset Management Group, LLC150,000$114.1K0.0%No change
Bridgeway Capital Management, LLC114,500$87.1K0.0%No change
King Luther Capital Management Corp58,000$44.1K0.0%No change
Susquehanna International Group, Llp57,790$43.9K0.0%−130,432

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Rani Therapeutics Holdings, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARRani Therapeutics Holdings, Inc.1
  • CIK0001856725
  • Employer ID (EIN)86-31147895
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2051 Ringwood Avenue, San Jose, CA 951311
  • Phone(408) 457-37001
  • Shares outstanding99,721,927 Common Class A shares; 23,970,359 Common Class B shares as of Feb 28, 20265
  • Public float$65.0M as of Jun 30, 20255
  • AuditorCBIZ CPAS P.C., San Francisco, California PCAOB ID 199; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceApr 27, 20211
  • Filings380 in all: 4 (162), 8-K (63), 3 (20), 10-Q (16), 3/A (11), CORRESP (10), 424B5 (9), SCHEDULE 13G (8)1
    All 37 form types

    S-8 (7), DEFA14A (6), EFFECT (6), SCHEDULE 13G/A (6), UPLOAD (6), 10-K (5), DEF 14A (5), S-3 (5), SC 13D/A (5), ARS (3), SC 13D (3), SCHEDULE 13D/A (3), DEF 14C (2), PRE 14C (2), S-1/A (2), SC 13G (2), 4/A (1), 424B4 (1), 424B7 (1), 8-A12B (1), CERT (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), NT 10-Q (1), S-1 (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 16, 2026
    Latest 8-K (8-K) Aug 13, 2026

Securities registered for trading

ClassSymbolExchange
Class A common stock, par value $0.0001 per shareRANIThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Rani Therapeutics Holdings, Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 73 risks under these headings, as written.5

  • Risks Related to Operating History, Financial Position and Capital Requirements
  • We have incurred operating losses since our inception and expect to incur significant losses for the foreseeable future. We may never generate any revenue from commercial products or become profitable or, if we achieve profitability, we may not be able to sustain it.
  • We are an early clinical stage biopharmaceutical company with no approved products and no historical commercial product revenue, which makes it difficult to assess our future prospects and financial results.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates or technologies.
  • Risks Related to the Development and Regulatory Approval of Our Product Candidates
  • We are early in our development efforts and have only a limited number of product candidates in clinical development, and our other product candidates are still in preclinical development. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Clinical failure can occur at any stage of clinical development.
  • Any inability to develop, or difficulties or delays in developing, formulations of drugs for our product candidates could prevent or delay our ability to advance our existing product candidates or develop new product candidates, which could adversely affect our commercial prospects and ability to generate revenues.
  • Any difficulties or delays in the commencement or completion, or termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
  • Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • Our product candidates or similar investigational or approved drugs may cause undesirable side effects or have other properties impacting safety that could delay or prevent the regulatory approval of, limit the commercial profile of an approved label for, or result in limiting the commercial opportunity for our product candidates if approved.
The other 63 risks
  • As an organization, we have conducted limited early clinical development, have not submitted an IND to the FDA and we have never conducted later-stage clinical trials or submitted a BLA or NDA, and may be unable to do so for any of our product candidates.
  • Our product candidates are subject to extensive regulation and compliance, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.
  • Because we have multiple product candidates in our clinical pipeline and are considering a variety of target indications, we may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • A breakthrough therapy designation or Fast Track designation by the FDA for a drug may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the drug will receive marketing approval.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Product candidates comprising a biologic or drug within the RaniPill capsule employ novel technologies that have not yet been approved by the FDA or comparable foreign regulatory authorities, and we anticipate that our applications will have to be submitted as original, standalone BLAs or NDAs. These regulatory authorities have limited experience in evaluating our technologies and product candidates. Our novel technologies also make it difficult to predict the time and cost of product candidate development.
  • We have limited clinical data on our product candidates to indicate whether they are safe or effective for long-term use in humans.
  • We have conducted and may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Negative results arising from ProGen’s development or future commercialization of PG-102, the therapeutic compound used in RT-114, could have materially adverse effects on our development of RT-114, or limit the commercial profile or an approved label for or result in limiting the commercial opportunity for RT-114, if approved.
  • Risks Related to Commercialization of Our Product Candidates
  • Even if we receive regulatory approval for any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
  • Even if our product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, government payors (including Medicare and Medicaid programs), private insurers, and other third-party payors, or others in the medical community necessary for commercial success.
  • The FDA and comparable foreign regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
  • The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates could limit our ability to generate revenue.
  • We face significant competition from other biotherapeutics and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • We currently have no marketing and sales organization. To the extent any of our product candidates for which we maintain commercial rights is approved for marketing, if we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to effectively market and sell any of our product candidates, or generate product revenue.
  • If the market opportunities for any product that we develop are smaller than we believe they are, our commercial revenue may be adversely affected and our business may suffer.
  • Additional time may be required to obtain regulatory approval for our product candidates because they are combination products.
  • Even if we obtain and maintain approval for any of our product candidates from the FDA, we may never obtain approval for our product candidates outside of the United States, which would limit our market opportunities and adversely affect our business.
  • Risks Related to Our Reliance on Third Parties
  • Our collaboration with Chugai may not be successful, and we may not realize the anticipated benefits of the Chugai Collaboration and License Agreement.
  • We may not be successful in obtaining or maintaining development, manufacturing and/or commercialization collaborations, and any potential partner may not devote sufficient resources to our product candidates or may otherwise fail in development, manufacturing and/or commercialization efforts, which could adversely affect our ability to develop certain of our product candidates and adversely affect our financial condition and operating results.
  • We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or do not meet regulatory requirements or expected deadlines, we may not be able to obtain timely regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
  • Our collaboration agreement with ProGen Co., Ltd. includes certain restrictions and obligations that may limit our flexibility in developing and commercializing RT-114 or require us to bear costs we otherwise would not incur or did not expect to incur.
  • We depend on third-party suppliers for key materials used in our manufacturing processes as well as for the manufacturing of APIs and drug substances. The loss of third-party suppliers or their inability to supply us with adequate materials and APIs or drug substances could prevent or delay the conduct of our clinical trials and the commercialization of our products, if approved, and could harm our business.
  • We may seek to enter into collaborations, licenses and other similar arrangements and may not be successful in doing so, and even if we are, we may not realize the benefits of such relationships.
  • Risks Related to Our Business and Industry
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • We are heavily dependent on the success of our product candidates in our core programs, and if any of these product candidates fail to enter clinical trials, receive regulatory approval or are not successfully commercialized, our business would be adversely affected.
  • We may not be successful in our efforts to use and expand our proprietary RaniPill platform to build a pipeline of product candidates and partnered programs.
  • Changes in regulatory requirements and guidance may also occur and we may need to amend clinical trial protocols submitted to applicable regulatory authorities to reflect these changes. Amendments may require us to resubmit clinical trial protocols to IRBs or ethics committees for re-examination, which may impact the costs, timing or successful completion of a clinical trial.
  • Most of our product candidates are in research or preclinical development and have not entered into clinical trials. If we are unable to develop, test and commercialize our product candidates, our business will be adversely affected.
  • Our proprietary RaniPill platform may not result in any products of commercial value.
  • Our high-capacity oral delivery device, RaniPill HC, is in early stages of development, and it is subject to the inherent risks and uncertainties of developing a novel, innovative technology. Our efforts to develop RaniPill HC may not be successful.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any of our product candidates, if approved.
  • The manufacture and packaging of biologics is subject to FDA requirements and those of comparable foreign regulatory authorities. If we or our third-party manufacturers fail to satisfy these requirements, our product development and commercialization efforts may be harmed.
  • As a vertically-integrated manufacturer of a novel oral delivery technology, we may require significant time to develop manufacturing operations and processes capable of producing safe and reliable product at sufficient scale to meet business needs, if we are able to do so at all.
  • We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws health information privacy and security laws, and other healthcare laws and regulations. Violations of such laws and regulations could subject us to significant penalties.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Our future success depends on our ability to retain our executive officers and to attract, retain and motivate highly qualified personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We will need to expand the size of our organization, and we may experience difficulties in managing this growth.
  • If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed, and our business will be harmed.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Our employees, independent contractors, principal investigators, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • Our headquarters and certain of our data storage facilities are located near known earthquake fault zones. The occurrence of an earthquake, fire or any other catastrophic event could disrupt our operations or the operations of third parties who provide vital support functions to us, which could have a material adverse effect on our business and financial condition.
  • A public health crisis could adversely impact our business including our ongoing and planned preclinical studies and clinical trials.
  • If our information technology systems or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
  • Risks Related to Our Intellectual Property
  • Our commercial success may depend in part on our ability to build and maintain our intellectual property portfolio.
  • We may not be able to obtain sufficient patent coverage.
  • We may not be able to obtain sufficient brand protection.
  • Intellectual property law and regulation could affect the value of our intellectual property portfolio.
  • Intellectual property rights do not provide complete protection for our business activities.
  • We may not be able to successfully commercialize our products prior to patent expiration.
  • Our intellectual property rights may not be effective against certain competitive products.
  • Third parties may hold intellectual property rights that cover our product candidates.
  • Others may challenge our intellectual property in administrative proceedings.
  • Our European patents are presently being, or have been, challenged in Europe, and additional patents of ours may be challenged in the future, which could reduce the patent protection we have on our oral delivery technology or product candidates and make it easier for third parties to compete with our business or product candidates.
  • We may assert challenges against others of infringement of our intellectual property.
  • We may be subject to challenges asserting infringement of intellectual property of a third party.
  • We may be subject to challenges asserting misappropriation of intellectual property of a third party.
  • We may be subject to challenges to the inventorship or ownership of our intellectual property.
  • Third parties may obtain our proprietary information, which could harm our business and competitive position.
  • Risks Related to Our Organizational Structure
  • We are a holding company and our principal asset is our interest in Rani LLC. Accordingly, we will depend on distributions from Rani LLC to pay our taxes, expenses and dividends. Rani’s ability to make such distributions may be subject to various limitations and restrictions.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.

The opening of Item 3, Legal Proceedings.5

Sources

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