Rani Therapeutics Holdings, Inc.

Previous wording

You should read the following management's discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes and other information included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission ("SEC"). Some of the information contained in this discussion and analysis or set forth elsewhere in this document, includes forward looking statements that involve risks, uncertainties, and assumptions. Our actual results could differ materially from those discussed in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors” in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2025. Please also see the section titled “Forward Looking Statements.”

Current wording

You should read the following management's discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes and other information included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission ("SEC"). Some of the information contained in this discussion and analysis or set forth elsewhere in this document, includes forward looking statements that involve risks, uncertainties, and assumptions. Our actual results could differ materially from those discussed in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors” in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2025. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”

Previous wording

The following discussion contains references to the three and six months ended June 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 June 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.

Current wording

The following discussion presents the condensed consolidated financial results of Rani Therapeutics Holdings, Inc. (the "Company") and its subsidiary, Rani Therapeutics, LLC (“Rani LLC”), for the three and nine months ended September 30, 2026 and 2025. 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.

Previous wording

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. 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.

Current wording

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. 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 partnerships with third-party biopharmaceutical companies for the oral delivery of their biologics and drugs using our technology.

Previous wording

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 Phase 1 clinical trial with the RT-114, a RaniPill HC capsule, containing a bispecific GLP-1/GLP-2 receptor agonist (PG-102) in collaboration with ProGen.

Current wording

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 200 µL, 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 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.

Previous wording

As is common with biotechnology companies, we rely on third-party suppliers for the supply of raw materials and active pharmaceutical ingredients ("APIs") and drug substances required for the production of our product candidates. In addition, we work with third parties to manufacture and develop biologics and drugs for inclusion in the RaniPill capsule. Design work, prototyping and pilot manufacturing are performed in house, and we have utilized third-party engineering firms to assist with the design of manufacturing lines that support our supply of the RaniPill capsule. Certain of our suppliers of components and materials are single source suppliers. We believe our vertically integrated manufacturing strategy will offer significant advantages, including rapid product iteration, control over our product quality and the ability to rapidly scale our manufacturing capacity. This capability also allows us to develop future generations of products while maintaining the confidentiality of our intellectual property. Our vertically integrated manufacturing strategy will result in material future capital outlays and fixed costs related to constructing and operating a manufacturing facility. We have invested and plan to continue to invest in automated manufacturing production lines for the RaniPill capsule. Those assets deemed to have an alternative future use have been capitalized as property and equipment while those projects related to our assets determined to not have an alternative future use have been expensed as research and development costs.

Current wording

As is common with biotechnology companies, we rely on third-party suppliers for the supply of raw materials and active pharmaceutical ingredients ("APIs") and drug substances required for the production of our product candidates. In addition, we work with third parties to manufacture and develop biologics and drugs for inclusion in the RaniPill® capsule. Design work, prototyping and pilot manufacturing are performed in house, and we have utilized third-party engineering firms to assist with the design of manufacturing lines that support our supply of the RaniPill® capsule. Certain of our suppliers of components and materials are single source suppliers. We believe our vertically integrated manufacturing strategy will offer significant advantages, including rapid product iteration, control over our product quality and the ability to rapidly scale our manufacturing capacity. This capability also allows us to develop future generations of products while maintaining the confidentiality of our extensive intellectual property portfolio. Our vertically integrated manufacturing strategy will result in material future capital outlays and fixed costs related to constructing and operating a manufacturing facility. We have invested and plan to continue to invest in automated manufacturing production lines for the RaniPill® capsule. Those assets deemed to have an alternative future use have been capitalized as property and equipment while those projects related to our assets determined to not have an alternative future use have been expensed as research and development costs.

Previous wording

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.

Current wording

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 (the "Class A Common Stock"), 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 September 30, 2026, all May 2026 Pre-Funded Warrants were outstanding.

Previous wording

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.

Current wording

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 and data is expected by the end of 2026. 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, with data anticipated in 2027.

Previous wording

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.

Current wording

The increase of $2.8 million in research and development expenses in the three months ended September 30, 2026, as compared to the same period in 2025, was primarily attributed to higher compensation costs of $2.3 million, $0.3 million increase in third-party services and $0.2 million increase in facilities, materials and supplies.

Previous wording

The increase of $0.5 million in general and administrative expenses in the three months ended June 30, 2026, as compared to the same period in 2025, was primarily attributed to higher compensation costs of $0.3 million and increase of $0.2 million in third-party services.

Current wording

The increase of $0.9 million in general and administrative expenses in the three months ended September 30, 2026, as compared to the same period in 2025, was primarily attributed to an increase of $0.7 million in third-party services and higher other expenses of $0.2 million.

Previous wording

The increase of $1.2 million in other income (expense), net, in the three months ended June 30, 2026, as compared to the same period in 2025, was primarily attributed to an increase in interest income of $0.3 million from our investment in marketable securities and a decrease in interest expense of $0.9 million.

Current wording

The increase of $1.1 million in other income (expense), net, in the three months ended September 30, 2026, as compared to the same period in 2025, was primarily attributed to an increase in interest income of $0.4 million from our investment in marketable securities and a decrease in interest expense of $0.7 million.

Previous wording

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.

Current wording

Contract revenue of $5.1 million for the nine months ended September 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.

Previous wording

The decrease of $0.5 million in research and development expenses in the three months ended June 30, 2026, as compared to the same period in 2025, was primarily attributed to lower compensation costs of $0.4 million and $0.1 million reduction in facilities, materials and supplies.

Current wording

The increase of $0.9 million in research and development expenses in the nine months ended September 30, 2026, as compared to the same period in 2025, was primarily attributed to higher compensation costs of $0.8 million, $0.2 million increase in third-party services offset by $0.1 million reduction in facilities, materials and supplies.

Previous wording

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.

Current wording

The increase of $0.7 million in general and administrative expenses in the nine months ended September 30, 2026, as compared to the same period in 2025, was primarily attributed to an increase of $1.4 million in third-party services and higher other expenses of $0.2 million offset by lower compensation costs of $0.8 million and $0.1 million reduction in facilities, materials and supplies.

Previous wording

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.

Current wording

The increase of $3.2 million in other income (expense), net, in the nine months ended September 30, 2026, as compared to the same period in 2025, was primarily attributed to an increase in interest income of $0.8 million from our investment in marketable securities and a decrease in interest expense of $2.4 million.

Previous wording

We have incurred recurring losses and negative cash flows from operations since inception, including net loss of $16.4 million for the six months ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $147.0 million and for the six months ended June 30, 2026, had negative cash flows from operations of $15.5 million. As of June 30, 2026, our cash, cash equivalents and marketable securities totaled $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.

Current wording

We have incurred recurring losses and negative cash flows from operations since inception, including net loss of $25.2 million for the nine months ended September 30, 2026. As of September 30, 2026, we had an accumulated deficit of $154.7 million and for the nine months ended September 30, 2026, had negative cash flows from operations of $23.3 million. As of September 30, 2026, our cash, cash equivalents and marketable securities totaled $45.3 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.

Previous wording

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.

Current wording

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 (the "Class A Common Stock"), 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 September 30, 2026, all May 2026 Pre-Funded Warrants were outstanding.

Previous wording

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 six months ended June 30, 2026 are issued.

Current wording

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 nine months ended September 30, 2026 are issued.

Previous wording

the economic and other terms, timing of and success of any collaboration, licensing, or other arrangements which we may enter in the future.

Current wording

the economic and other terms, timing of and success of any collaboration, licensing, or other arrangements which we may enter into in the future.

Previous wording

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 in the U.S. and worldwide resulting from the effects of ongoing military conflicts, inflationary pressures, potential future bank failures, or otherwise. In this regard, the ongoing Russia-Ukraine military conflict and the ongoing military conflict involving the U.S., Israel and Iran have created extreme volatility in the global credit and financial markets and have had and may continue to have further global economic consequences, including continued disruptions of the global supply chain and energy markets, which could continue to drive inflationary pressures and increase global recession risk.

Current wording

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 if our Class A common stock is delisted from Nasdaq, by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the U.S. and worldwide resulting from the effects of ongoing military conflicts, inflationary pressures, potential future bank failures, or otherwise. In this regard, the ongoing Russia-Ukraine military conflict and the ongoing military conflict involving the U.S., Israel and Iran have created extreme volatility in the global credit and financial markets and have had and may continue to have further global economic consequences, including continued disruptions of the global supply chain and energy markets, which could continue to drive inflationary pressures and increase global recession risk.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 was $15.5 million, which was primarily attributable to a net loss of $16.4 million and net accretion and amortization of investments in marketable securities of $0.5 million, partially offset by stock-based compensation expense of $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 payable of $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 $0.8 million for the six months ended June 30, 2026.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 was $23.3 million, which was primarily attributable to a net loss of $25.2 million and net accretion and amortization of investments in marketable securities of $0.7 million, partially offset by stock-based compensation expense of $6.7 million, non-cash operating lease expense of $1.4 million, depreciation and amortization expense of $0.4 million and an allowance for expected credit losses of $0.1 million. Additionally, changes in operating assets and liabilities included increases in accounts payable of $0.1 million and accrued expenses and other current liabilities of $0.1 million, and decreases in prepaid expenses and other current assets of $0.3 million, deferred revenue of $5.1 million and operating lease liabilities of $1.4 million for the nine months ended September 30, 2026.

Previous wording

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.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $19.0 million, which was primarily attributable to a net loss of $31.9 million and net accretion and amortization of investments in marketable securities of $0.2 million, partially offset by stock-based compensation expense of $9.6 million, depreciation and amortization expense of $0.7 million and $0.2 million in warrant issuance costs and expenses. Additionally, there was an increase in accounts payable of $1.1 million, accrued expenses and other current liabilities of less than $0.1 million, and a decrease in contract asset of $0.4 million and prepaid expenses and other current assets of $0.9 million for the nine months ended September 30, 2025.

Previous wording

For the six months ended June 30, 2026, net cash used in investing activities was $17.0 million, which primarily consisted of $41.0 million in proceeds from maturities of marketable securities partially offset by $58.0 million in purchases of marketable securities.

Current wording

For the nine months ended September 30, 2026, net cash used in investing activities was $10.1 million, which primarily consisted of $63.0 million in proceeds from maturities of marketable securities offset by $72.9 million in purchases of marketable securities and $0.2 million in purchases of property and equipment.

Previous wording

For the six months ended June 30, 2025, net cash provided by investing activities was $23.9 million, which primarily consisted of $26.8 million in proceeds from maturities of marketable securities partially offset by $2.7 million in purchases of marketable securities and $0.1 million in purchases of property and equipment.

Current wording

For the nine months ended September 30, 2025, net cash provided by investing activities was $23.9 million, which primarily consisted of $26.8 million in proceeds from maturities of marketable securities partially offset by $2.7 million in purchases of marketable securities and $0.1 million in purchases of property and equipment.

Previous wording

For the six months ended June 30, 2026, net cash provided by financing activities was $18.8 million, which primarily consisted of net proceeds from issuance of common stock and pre-funded warrants in connection with the May 2026 Securities Purchase Agreement of $18.7 million and the exercise of stock options of $0.1 million.

Current wording

For the nine months ended September 30, 2026, net cash provided by financing activities was $18.4 million, which primarily consisted of net proceeds from issuance of common stock and pre-funded warrants in connection with the May 2026 Securities Purchase Agreement of $18.3 million and the exercise of stock options of $0.1 million.

Previous wording

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.

Current wording

For the nine months ended September 30, 2025, net cash used in financing activities was $4.6 million, which primarily consisted of repayment of debt of $11.3 million offset by the exercise of warrants of $3.9 million, and the issuance of common stock and pre-funded warrants of $2.8 million.