Kailera Therapeutics, Inc.

Previous wording

We are rapidly progressing four clinical-stage product candidates, leveraging multiple glucagon-like peptide-1, or GLP-1, based mechanisms of action and routes of administration. Our lead product candidate, ribupatide injection (also known as KAI-9531), is currently being evaluated in global Phase 3 trials as a once-weekly injectable GLP-1/glucose-dependent insulinotropic polypeptide, or GIP, receptor dual agonist peptide that we believe offers the potential for the greatest weight loss compared to all obesity management medications currently available or in development. However, we have not conducted head-to-head clinical trials of ribupatide injection or any of our other product candidates against currently approved products or those in development; all of our product candidates are still in clinical development in the United States, and it will take several years to develop and, if approved, commercialize them; and even if we are successful in obtaining regulatory approval, there can be no guarantee as to our product candidates’ ability to outperform other therapies in terms of efficacy or tolerability. We are expanding our ribupatide franchise by developing a once-daily oral tablet formulation, ribupatide oral, to provide a convenient oral option with the potential for highly differentiated tolerability with compelling weight loss among oral treatments. Additionally, we are advancing a second oral product candidate, KAI-7535, a once-daily small molecule GLP-1 receptor agonist with the potential to improve on the clinical profile of existing oral treatments. Finally, we are developing KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist that leverages an incremental mechanism to potentially deliver compelling weight loss, improved liver fat reduction and a differentiated tolerability profile.

Current wording

We are rapidly progressing four clinical-stage product candidates, leveraging multiple glucagon-like peptide-1, or GLP-1, based mechanisms of action and routes of administration. Our lead product candidate, ribupatide injection (also known as KAI-9531), is currently being evaluated in global Phase 3 trials as a once-weekly injectable GLP-1/glucose-dependent insulinotropic polypeptide, or GIP, receptor dual agonist peptide that we believe offers the potential for the greatest weight loss compared to all obesity management medications currently available or in development. However, we have not conducted head-to-head clinical trials of ribupatide injection or any of our other product candidates against currently approved products or those in development; all of our product candidates are still in clinical development in the United States, and it will take several years to develop and, if approved, commercialize them; and even if we are successful in obtaining regulatory approval, there can be no guarantee as to our product candidates’ ability to outperform other therapies in terms of efficacy or tolerability. We are expanding our ribupatide franchise by developing a once-daily oral tablet formulation, ribupatide oral, to provide a convenient oral option with the potential for highly differentiated tolerability with compelling weight loss among oral treatments. Additionally, we are advancing a second oral product candidate, safiglipron (also known as KAI-7535), a once-daily small molecule GLP-1 receptor agonist with the potential to improve on the clinical profile of existing oral treatments. Finally, we are developing KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist that leverages an incremental mechanism to potentially deliver compelling weight loss, improved liver fat reduction and a differentiated tolerability profile.

Previous wording

Since our inception, we have incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates. Our net loss was $190.2 million for the six months ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $558.8 million. We expect to continue to incur significant expenses and recognize operating losses for at least the next several years as we advance our product candidates through later stage clinical development and seek regulatory approval of our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses in connection with the in-licensing or acquisition of additional product candidates.

Current wording

Since our inception, we have incurred significant operating losses. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates. Our net loss was $285.8 million for the nine months ended September 30, 2026. As of September 30, 2026, we had an accumulated deficit of $654.5 million. We expect to continue to incur significant expenses and recognize operating losses for at least the next several years as we advance our product candidates through later stage clinical development and seek regulatory approval of our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses in connection with the in-licensing or acquisition of additional product candidates.

Previous wording

As of June 30, 2026, we had cash, cash equivalents and marketable securities of $1,171.8 million. We believe that the cash, cash equivalents and marketable securities on hand as of June 30, 2026 will be sufficient to fund our operations into mid-2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.”

Current wording

As of September 30, 2026, we had cash, cash equivalents and marketable securities of $1,037.6 million. We believe that the cash, cash equivalents and marketable securities on hand as of September 30, 2026 will be sufficient to fund our operations into mid-2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.”

Previous wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development, particularly in obesity, generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next several years for increased costs related to the development of our product candidates, which were acquired in May 2024, as we conduct our global Phase 3 trials for ribupatide injection which were initiated in December 2025 and January 2026, as well as continue to advance the development of our other product candidates. We also expect to incur additional expenses related to milestone payments payable related to the acquired intellectual property rights to these product candidates.

Current wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development, particularly in obesity, generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next several years for increased costs related to the development of our product candidates as we conduct our global Phase 3 trials for ribupatide injection, initiate our global Phase 3 trials for ribupatide oral, as well as continue to advance the development of our other product candidates. We also expect to incur additional expenses related to milestone payments payable related to the acquired intellectual property rights to these product candidates.

Previous wording

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, and director and officer insurance costs, as well as investor and public relations expenses associated with being a public company.

Current wording

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, and director and officer insurance costs, as well as investor and public relations expenses associated with being a public company.

Previous wording

Other income, net primarily consists of the change in fair value of the preferred stock tranche right liability, convertible promissory notes for which we elected the fair value measurement option, as well as miscellaneous income and expense unrelated to our core operations.

Current wording

Other income (expense), net, primarily consists of the change in fair value of the preferred stock tranche right liability, convertible promissory notes for which we elected the fair value measurement option, as well as miscellaneous income and expense unrelated to our core operations.

Previous wording

Research and development expenses increased by $81.5 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The increase was primarily driven by product candidate development and the related nonclinical, clinical, and contract manufacturing costs associated with our portfolio of injectable and oral development programs, as well as an increase in headcount, resulting in an increase in personnel-related expenses, including stock-based compensation expense, to support our ongoing research and development activities.

Current wording

Research and development expenses increased by $57.7 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily driven by product candidate development and the related nonclinical, clinical, and contract manufacturing costs associated with our portfolio of injectable and oral development programs, as well as an increase in headcount, resulting in an increase in personnel-related expenses, including stock-based compensation expense, to support our ongoing research and development activities.

Previous wording

General and administrative expenses increased by $9.2 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The increase was primarily driven by the expansion of our operations, resulting in increases in professional service costs and personnel-related expenses, including an increase of $4.6 million in stock-based compensation expenses.

Current wording

General and administrative expenses increased by $8.6 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily driven by the expansion of our operations, resulting in increases in professional service costs and personnel-related expenses, including an increase of $3.0 million in stock-based compensation expenses.

Previous wording

Interest income increased by $7.9 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The increase was primarily driven by higher cash equivalents and marketable securities balances.

Current wording

Interest income increased by $8.4 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily driven by higher cash equivalents and marketable securities balances.

Previous wording

Other income, net decreased by $0.2 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. Other income, net for the six months ended June 30, 2026 primarily consisted of miscellaneous income unrelated to our core operations. Other income, net for the six months ended June 30, 2025 consisted primarily of income due to the change in fair value of the preferred stock tranche right liability, partially offset by expense due to the change in fair value of our convertible promissory notes issued in May 2025.

Current wording

Other income, net, increased by $1.8 million for the three months ended September 30, 2026, compared to other expense, net, during the three months ended September 30, 2025. Other income, net for the three months ended September 30, 2026 primarily consisted of miscellaneous income unrelated to our core operations. Other expense, net, for the three months ended September 30, 2025 primarily consisted of expense due to the change in fair value of our convertible promissory notes issued in May 2025.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

The following table summarizes our research and development expenses by program for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our research and development expenses by program for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Research and development expenses increased by $142.3 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, primarily driven by product candidate development and the related nonclinical, clinical, and contract manufacturing costs associated with our portfolio of injectable and oral development programs, as well as an increase in headcount, resulting in an increase in personnel-related expenses, including stock-based compensation expense, to support our ongoing research and development activities.

Current wording

Research and development expenses increased by $200.0 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, primarily driven by product candidate development and the related nonclinical, clinical, and contract manufacturing costs associated with our portfolio of injectable and oral development programs, as well as an increase in headcount, resulting in an increase in personnel-related expenses, including stock-based compensation expense, to support our ongoing research and development activities.

Previous wording

General and administrative expenses increased by $12.6 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The increase was primarily driven by the expansion of our operations, resulting in increases in professional service costs and personnel-related expenses, including an increase of $6.2 million in stock-based compensation expenses.

Current wording

General and administrative expenses increased by $21.2 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase was primarily driven by the expansion of our operations, resulting in increases in professional service costs and personnel-related expenses, including an increase of $9.2 million in stock-based compensation expenses.

Previous wording

Interest income increased by $11.9 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The increase was primarily driven by higher cash equivalents and marketable securities balances.

Current wording

Interest income increased by $20.3 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase was primarily driven by higher cash equivalents and marketable securities balances.

Previous wording

Other income, net increased by $0.5 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. Other income, net for the three months ended June 30, 2026 primarily consisted of miscellaneous income unrelated to our core operations. Other income, net for the three months ended June 30, 2025 primarily consisted of expense due to the change in fair value of our convertible promissory notes issued in May 2025, partially offset by income due to the change in fair value of the preferred stock tranche right liability.

Current wording

Other income, net, increased by $1.6 million for the nine months ended September 30, 2026, compared to other expense, net, during the nine months ended September 30, 2025. Other income, net for the nine months ended September 30, 2026 primarily consisted of miscellaneous income unrelated to our core operations. Other expense, net, for the nine months ended September 30, 2025 consisted primarily of expense due to the change in fair value of our convertible promissory notes issued in May 2025, partially offset by income due to the change in fair value of the preferred stock tranche right liability.

Previous wording

Since our inception, we have not generated revenue from any sources, including from product sales, and have incurred significant operating losses and negative cash flows from our operations. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $1,171.8 million and an accumulated deficit of $558.8 million. Through June 30, 2026, we have funded our operations primarily with proceeds from the sale and issuance of shares of convertible preferred stock, the issuance of convertible promissory notes, which converted into shares of convertible preferred stock and the sale and issuance of common stock as part of our initial public offering.

Current wording

Since our inception, we have not generated revenue from any sources, including from product sales, and have incurred significant operating losses and negative cash flows from our operations. As of September 30, 2026, we had cash, cash equivalents and marketable securities of $1,037.6 million and an accumulated deficit of $654.5 million. Through September 30, 2026 we have funded our operations primarily with proceeds from the sale and issuance of shares of convertible preferred stock, the issuance of convertible promissory notes, which converted into shares of convertible preferred stock, and the sale and issuance of common stock as part of our initial public offering.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

During the six months ended June 30, 2026, operating activities used $145.8 million of cash, cash equivalents and restricted cash, primarily due to our net loss of $190.2 million, offset by a $34.2 million net decrease in our operating assets and liabilities and non-cash charges of $10.1 million. The changes in operating assets and liabilities primarily related to a net increase in accrued expenses and other current liabilities of $24.4 million, a net increase in accounts payable of $11.8 million and a net decrease in other non-current assets of

Current wording

During the nine months ended September 30, 2026, operating activities used $279.5 million of cash, cash equivalents and restricted cash, primarily due to a net loss of $285.8 million and changes in operating assets and liabilities of $11.7 million, partially offset by net non-cash expenses of $18.1 million. The changes in operating assets and liabilities primarily related to an increase in prepaid expenses and other current assets of $7.1 million, a net decrease in accrued expenses and other current liabilities of $6.1 million, an increase in non-current clinical deposits of $1.9 million, partially offset by a $2.1 million increase in accounts payable and a $2.3 million decrease in other non-current assets. Non-cash changes primarily consisted of $22.2 million in stock-based compensation expense, partially offset by $5.2 million in net accretion of discounts on our investment portfolio.

Previous wording

During the six months ended June 30, 2025, operating activities used $44.4 million of cash, cash equivalents and restricted cash, primarily due to our net loss of $46.9 million, offset by a net decrease of $0.4 million in our operating assets and liabilities and non-cash charges of $2.1 million. The changes in operating assets and liabilities primarily related to a net increase in accrued expenses and other current liabilities of $7.2 million and a net increase in prepaid expenses and other current assets of $6.2 million. Non-cash changes primarily consisted of $3.2 million in stock-based compensation expense and $1.0 million in changes in the fair value of the convertible promissory notes, partially offset by $1.4 million in changes in the fair value of the preferred stock tranche right liability and by $1.0 million in net accretion of discounts on our investment portfolio.

Current wording

During the nine months ended September 30, 2025, operating activities used $74.1 million of cash, cash equivalents and restricted cash, primarily due to a net loss of $86.6 million, partially offset by non-cash charges of $8.2 million and changes in operating assets and liabilities of $4.2 million. Non-cash changes primarily consisted of $7.4 million in stock-based compensation expense and $2.8 million change in the fair value of the convertible promissory notes, partially offset by $1.4 million change in the fair value of the preferred stock tranche right liability and by $1.1 million in net accretion of discounts on our investment portfolio. The net change in operating assets and liabilities was primarily driven by a $12.3 million increase in accrued expenses and other current liabilities, partially offset by a $7.7 million increase in prepaid expenses and other current assets.

Previous wording

During the six months ended June 30, 2026, investing activities used $548.2 million in cash, cash equivalents and restricted cash consisting of purchases of investments of $738.3 million, partially offset by maturities of investments of $190.1 million.

Current wording

During the nine months ended September 30, 2026, investing activities used $437.3 million in cash, cash equivalents and restricted cash consisting of purchases of investments of $775.3 million, partially offset by maturities of investments of $338.0 million.

Previous wording

During the six months ended June 30, 2025, investing activities used $128.6 million in cash, cash equivalents and restricted cash consisting of purchases of investments of $136.6 million, partially offset by maturities of investments of $8.0 million.

Current wording

During the nine months ended September 30, 2025, investing activities used $102.1 million in cash, cash equivalents and restricted cash consisting primarily of purchases of investments of $178.9 million, partially offset by maturities of investments of $77.2 million.

Previous wording

During the six months ended June 30, 2026, financing activities provided $664.0 million in cash, cash equivalents and restricted cash consisting of $668.4 million in net proceeds received from the initial public offering after deducting commissions and underwriting discounts, $0.5 million in proceeds from the exercise of stock options, offset by $4.9 million in payments of deferred offering costs related to our initial public offering.

Current wording

During the nine months ended September 30, 2026, financing activities provided $663.1 million in cash, cash equivalents and restricted cash consisting of $668.4 million in net proceeds received from our initial public offering after deducting commissions and underwriting discounts and payments of deferred offering costs, and $0.8 million in proceeds from the exercise of stock options, partially offset by $6.1 million in payments of deferred offering costs related to our initial public offering.

Previous wording

During the six months ended June 30, 2025, financing activities provided $100.0 million in cash, cash equivalents and restricted cash consisting of proceeds from the issuance of convertible promissory notes.

Current wording

During the nine months ended September 30, 2025, financing activities provided $99.8 million in cash, cash equivalents and restricted cash consisting of proceeds from the issuance of convertible promissory notes.

Previous wording

continue the development of our other product candidates, including initiating Phase 3 clinical trials for ribupatide oral and initiating a Phase 1 trial for KAI-4729;

Current wording

continue the development of our other product candidates, including advancing an ongoing global Phase 2 clinical trial for safiglipron and initiating a Phase 1 clinical trial for KAI-4729;

Previous wording

We enter into contracts in the normal course of business with CROs, CMOs and other third parties for nonclinical, clinical, manufacturing, and other development services. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. These payments are not included in the preceding table as the amount and timing of such payments are not known.

Current wording

We enter into contracts in the normal course of business with CROs, CMOs and other third parties for nonclinical, clinical, manufacturing, and other development services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including noncancelable or committed obligations of our service providers, up to the date of cancellation. These payments are not included in the preceding table as the amount and timing of such payments are not known.

Previous wording

During the six months ended June 30, 2026, there were no material changes to our critical accounting estimates or in the methodology used for estimates from those described in “Management’s discussion and analysis of financial condition and results of operations” for the year ended December 31, 2025 included in the Prospectus, except as noted below.

Current wording

During the nine months ended September 30, 2026, there were no material changes to our critical accounting estimates or in the methodology used for estimates from those described in “Management’s discussion and analysis of financial condition and results of operations” for the year ended December 31, 2025 included in the Prospectus, except as noted below.