16 unchanged sentences
Since then, we have predominantly focused on evaluating RLY-2608 in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer.
−Removed: In the fourth quarter of 2023, we initiated a triplet combination arm with RLY-2608, fulvestrant and the cyclin dependent kinase 4/6, or CDK 4/6, inhibitor ribociclib.
−Removed: In the fourth quarter of 2024, we initiated an additional triplet combination arm with RLY-2608, fulvestrant, and atirmociclib, Pfizer Inc.’s, or Pfizer’s, investigative selective-CDK4 inhibitor, pursuant to a clinical trial collaboration with Pfizer.
−Removed: We are preparing to initiate a global Phase 3 ReDiscover-2 (NCT06982521) clinical trial in mid-2025 of RLY-2608 + fulvestrant, which will evaluate the safety and efficacy of RLY-2608 plus fulvestrant in PI3Kα-mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor.
−Removed: The comparator arm in the ReDsicover-2 Trial will be capivasertib plus fulvestrant.
+Added: We are also advancing three triplet combination arms with RLY-2608, fulvestrant and the cyclin dependent kinase 4/6, or CDK 4/6, inhibitors, ribociclib or palbociclib, or atirmociclib, the investigative selective-CDK4 inhibitor from Pfizer Inc., or Pfizer.
+Added: In the second quarter of 2025, we initiated a global Phase 3 registrational study, or the ReDiscover-2 Trial, which evaluates the safety and efficacy of RLY-2608 plus fulvestrant in PI3Kα-mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor.
+Added: The comparator arm in the ReDiscover-2 Trial is capivasertib plus fulvestrant.
o Clinical Data .
−Removed: In September 2024, we announced interim clinical data for RLY-2608 with a data cut-off date of August 12, 2024, and in December 2024, we announced additional updated interim clinical data for RLY-2608 at the San Antionio Breast Cancer Symposium 2024 with a data cut-off date of November 4, 2024.
−Removed: On June 2, 2025, we announced updated interim clinical data for the RLY-2608 + fulvestrant arm of the study with a data cut-off date of March 26, 2025.
−Removed: Updated interim data remain consistent with prior interim results, showing 10.3-month median progression free survival (PFS) overall and 11.0-month median PFS in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.
−Removed: RLY-2608 + fulvestrant was generally well tolerated in the 118 patients treated across all doses as of the data cut-off date.
−Removed: The overall tolerability profile consisted of mostly low-grade treatment-related adverse events (TRAEs) that were manageable and reversible.
+Added: In June 2025, we announced updated interim clinical data for the RLY-2608 plus fulvestrant arm of the ReDiscover Trial with a data cut-off date of March 26, 2025.
+Added: This updated interim data is consistent with prior interim results, showing 10.3-month median progression free survival, or PFS, overall and 11.0-month median PFS in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.
+Added: The updated interim clinical data show that RLY-2608 plus fulvestrant was generally well tolerated in the 118 patients treated across all doses as of the March 26, 2025 data cut-off date and the overall tolerability profile consisted of mostly low-grade treatment-related adverse events that were manageable and reversible.
We believe that, overall, while the clinical data from the ReDiscover Trial disclosed to date are preliminary, the data suggest differentiated interim efficacy signals in the specified patient population and support selective target engagement across doses and mutation types with an encouraging interim safety and tolerability profile.
• Vascular Malformations
−Removed: o RLY-2608-201 Clinical Trial .
−Removed: In the first quarter of 2025, we initiated the global Phase 1/2 clinical trial for RLY-2608 in patients with PIK3CA-related overgrowth spectrum, or PROS, and malformations driven by PIK3CA mutations.
+Added: o ReInspire Trial .
+Added: In the first quarter of 2025, we initiated the global Phase 1/2 clinical trial for RLY-2608 in patients with PIK3CA-related overgrowth spectrum, or PROS, and malformations driven by PIK3CA mutations, or the ReInspire Trial.
Enrollment is continuing in this clinical trial.
−Removed: While our initial focus is on precision oncology, we believe our Dynamo® platform may also be broadly applied to other areas of precision medicine, such as genetic diseases.
In addition to the programs mentioned above, we are progressing our NRAS-selective inhibitor, RLY-8161, to address NRAS-mutated solid tumors as well as our non-inhibitory chaperone for Fabry disease.
−Removed: We also have one active
−Removed: early-stage discovery program.
+Added: We also have one active early-stage discovery program.
We are focused on using the novel insights derived from our approach to transform the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of our therapies.
We were incorporated in May 2015.
−Removed: We have devoted substantially all of our resources to developing our product candidates, developing our innovative computational and experimental approaches on protein motion, building our intellectual property portfolio, business planning, raising capital, and providing general and administrative support for these operations.
+Added: We have devoted substantially all of our resources to developing our product candidates, developing our innovative computational and experimental approaches on protein motion, building our intellectual property portfolio, business
+Added: planning, raising capital, and providing general and administrative support for these operations.
To date, we have principally financed our operations through private placements of preferred stock and common stock, convertible debt, and proceeds from public offerings of our common stock.
In December 2024, we entered into an exclusive global licensing agreement, or the Elevar Agreement, with Elevar Therapeutics, Inc., or Elevar, pursuant to which Elevar was granted global development and commercialization rights for lirafugratinib.
−Removed: Under the terms of the Elevar Agreement, we received $5.0 million in upfront consideration and $3.4 million in conjunction with the transfer of active pharmaceutical ingredient and other materials as of June 30, 2025.
+Added: Under the terms of the Elevar Agreement, we received $5.0 million in upfront consideration and $3.4 million in conjunction with the transfer of active pharmaceutical ingredient and other materials as of September 30, 2025.
We are eligible to receive up to $495.0 million in regulatory and commercial milestone payments, as well as tiered royalties.
1 unchanged sentence
We received proceeds of $218.2 million, which was net of $11.8 million in underwriting discounts and other offering expenses.
−Removed: In August 2024, we also entered into a new sales agreement, or the 2024 Sales Agreement, with TD Securities (USA) LLC, or TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings through TD Securities, as our sales agent.
−Removed: As of June 30, 2025, we have not sold any shares under the 2024 Sales Agreement.
+Added: In August 2024, we entered into a sales agreement, or the 2024 Sales Agreement, with TD Securities (USA) LLC, or TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings through TD Securities, as our sales agent.
+Added: As of September 30, 2025, we have not sold any shares under the 2024 Sales Agreement.
In January 2024, we entered into a securities purchase agreement with Nextech Crossover I SCP for the private placement of 2,500,000 shares of common stock at $12.00 per share, or the Private Placement.
8 unchanged sentences
Our financial condition and results of operations may also be impacted by other factors we may not be able to control, such as public health crises, global supply chain disruptions, uncertain global economic conditions, global trade disputes or political instability as further discussed in the section "Risk Factors" in this Quarterly Report on Form 10-Q.
−Removed: We do not believe that such factors had a material adverse impact on our results of operations during the three and six months ended June 30, 2025 and 2024.
+Added: We do not believe that such factors had a material adverse impact on our results of operations during the three and nine months ended September 30, 2025 and 2024.
Since our inception, we have incurred significant operating losses on an aggregate basis.
Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our current or future product candidates.
−Removed: Our net losses were $147.4 million and $173.6 million for the six months ended June 30, 2025 and 2024, respectively.
−Removed: As of June 30, 2025, we had an accumulated deficit of $1.9 billion.
+Added: Our net losses were $221.6 million and $261.7 million for the nine months ended September 30, 2025 and 2024, respectively.
+Added: As of September 30, 2025, we had an accumulated deficit of $2.0 billion.
These losses have resulted primarily from costs incurred in connection with research and development activities, licensing and patent investment, and general and administrative costs associated with our operations.
21 unchanged sentences
If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce or terminate our operations.
−Removed: We believe our cash, cash equivalents, and investments of $656.8 million as of June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2029.
+Added: We believe our cash, cash equivalents, and investments of $596.4 million as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2029.
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.
57 unchanged sentences
Results of Operations
−Removed: Comparison of the three months ended June 30, 2025 and 2024
−Removed: The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024:
−Removed: Three Months Ended June 30,
+Added: Comparison of the three months ended September 30, 2025 and 2024
+Added: The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:
+Added: Three Months Ended September 30,
(in thousands)
7 unchanged sentences
Other income, net
−Removed: During the three months ended June 30, 2025, the Company recognized $0.7 million of revenue from the Elevar Agreement, specifically in conjunction with delivery of additional inventory and other materials.
−Removed: During the three months ended June 30, 2024, the Company recognized $0 of revenue from the Genentech Agreement.
+Added: During the three months ended September 30, 2025 and 2024, the Company recognized $0 of revenue.
Research and Development Expenses
−Removed: The following summarizes our research and development expenses for the three months ended June 30, 2025 and 2024:
−Removed: Three Months Ended June 30,
+Added: The following summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:
+Added: Three Months Ended September 30,
(in thousands)
4 unchanged sentences
Total research and development expenses
−Removed: Research and development expenses were $63.9 million for the three months ended June 30, 2025 compared to $92.0 million for the three months ended June 30, 2024.
−Removed: The decrease of $28.1 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the Elevar Agreement in December 2024.
+Added: Research and development expenses were $68.3 million for the three months ended September 30, 2025 compared to $76.6 million for the three months ended September 30, 2024.
+Added: The decrease of $8.4 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the Elevar Agreement in December 2024, offset by increases in costs related to the ReDiscover-2 Trial and ReInspire Trial.
Change in Fair Value of Contingent Consideration Liability
−Removed: Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was $0 for the three months ended June 30, 2025 compared to a decrease of $11.4 million for the three months ended June 30, 2024.
+Added: Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was $0 for the three months ended September 30, 2025 and 2024.
During the year ended December 31, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0.
−Removed: During the three months ended June 30, 2025, there were no further changes to such amounts.
+Added: During the three months ended September 30, 2025, there were no further changes to such amounts.
General and Administrative Expenses
−Removed: General and administrative expenses were $13.6 million for the three months ended June 30, 2025 compared to $20.1 million for the three months ended June 30, 2024.
+Added: General and administrative expenses were $12.1 million for the three months ended September 30, 2025 compared to $19.8 million for the three months ended September 30, 2024.
The decrease of $7.6 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.
Other Income, Net
−Removed: Other income, net, was $6.5 million for the three months ended June 30, 2025 compared to $8.5 million for the three months ended June 30, 2024.
+Added: Other income, net, was $6.2 million for the three months ended September 30, 2025 compared to $8.3 million for the three months ended September 30, 2024.
The decrease of $2.0 million was primarily a result of changes in the amounts invested between periods, as well as fluctuations in interest rates.
−Removed: Comparison of the six months ended June 30, 2025 and 2024
−Removed: The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
−Removed: Six Months Ended June 30,
+Added: Comparison of the nine months ended September 30, 2025 and 2024
+Added: The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
+Added: Nine Months Ended September 30,
(in thousands)
7 unchanged sentences
Other income, net
−Removed: During the six months ended June 30, 2025, the Company recognized $8.4 million of revenue from the Elevar Agreement, as each of the Company's performance obligations thereunder were completed in the current period.
−Removed: During the six months ended June 30, 2024, the Company recognized $10.0 million of revenue from the Genentech Agreement, specifically in connection with a milestone achieved thereunder in the prior period.
+Added: During the nine months ended September 30, 2025, the Company recognized $8.4 million of revenue from the Elevar Agreement, as each of the Company's performance obligations thereunder were completed in the current period.
+Added: During the nine months ended September 30, 2024, the Company recognized $10.0 million of revenue from the Genentech Agreement, specifically in connection with a milestone achieved thereunder in the prior period.
Research and Development Expenses
−Removed: The following summarizes our research and development expenses for the six months ended June 30, 2025 and 2024
−Removed: Six Months Ended June 30,
+Added: The following summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:
+Added: Nine Months Ended September 30,
(in thousands)
4 unchanged sentences
Total research and development expenses
−Removed: Research and development expenses were $137.7 million for the six months ended June 30, 2025 compared to $174.4 million for the six months ended June 30, 2024.
−Removed: The decrease of $36.7 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the Elevar Agreement in December 2024.
+Added: Research and development expenses were $206.0 million for the nine months ended September 30, 2025 compared to $251.0 million for the nine months ended September 30, 2024.
+Added: The decrease of $45.0 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the Elevar Agreement in December 2024, offset by increases in costs related to the ReDiscover-2 Trial and ReInspire Trial.
Change in Fair Value of Contingent Consideration Liability
−Removed: Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was $0 for the six months ended June 30, 2025 compared to a decrease of $13.2 million for the six months ended June 30, 2024.
+Added: Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was $0 for the nine months ended September 30, 2025 compared to a decrease of $13.2 million for the nine months ended September 30, 2024.
During the year ended December 31, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0.
−Removed: During the six months ended June 30, 2025, there were no further changes to such amounts.
+Added: During the nine months ended September 30, 2025, there were no further changes to such amounts.
General and Administrative Expenses
−Removed: General and administrative expenses were $32.4 million for the six months ended June 30, 2025 compared to $39.9 million for the six months ended June 30, 2024.
−Removed: The decrease of $7.6 million was primarily due to a decrease in stock compensation expense, as well as other employee costs, partially offset by costs to obtain the Elevar Agreement, which were expensed commensurate with the timing of revenue recognized during the six months ended June 30, 2025.
+Added: General and administrative expenses were $44.5 million for the nine months ended September 30, 2025 compared to $59.7 million for the nine months ended September 30, 2024.
+Added: The decrease of $15.2 million was primarily due to a decrease in stock compensation expense, as well as other employee costs, partially offset by costs to obtain the Elevar Agreement, which were expensed commensurate with the timing of revenue recognized during the nine months ended September 30, 2025.
Other Income, Net
−Removed: Other income, net, was $14.3 million for the six months ended June 30, 2025 compared to $17.5 million for the six months ended June 30, 2024.
+Added: Other income, net, was $20.5 million for the nine months ended September 30, 2025 compared to $25.8 million for the nine months ended September 30, 2024.
The decrease of $5.3 million was primarily a result of changes in the amounts invested between periods, as well as fluctuations in interest rates.
Liquidity and Capital Resources
−Removed: As of June 30, 2025, we had cash, cash equivalents, and investments of $656.8 million.
+Added: As of September 30, 2025, we had cash, cash equivalents, and investments of $596.4 million.
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses.
2 unchanged sentences
In December 2024, we entered into the Elevar Agreement pursuant to which Elevar was granted global development and commercialization rights for lirafugratinib.
−Removed: As of June 30, 2025, we had received $5.0 million in upfront consideration and $3.4 million in conjunction with the transfer of active pharmaceutical ingredient and other materials from Elevar pursuant to the Elevar Agreement.
+Added: As of September 30, 2025, we had received $5.0 million in upfront consideration and $3.4 million in conjunction with the transfer of active pharmaceutical ingredient and other materials from Elevar pursuant to the Elevar Agreement.
In September 2024, we completed the September 2024 Offering of 32,857,143 shares of common stock, including the exercise in full of the underwriters’ option to purchase an additional 4,285,714 shares, at an offering price of $7.00 per share.
5 unchanged sentences
In August 2024, the 2021 Sales Agreement was terminated by mutual agreement between us and Cowen.
−Removed: Through termination of the
−Removed: 2021 Sales Agreement, we sold 4,915,669 shares of common stock under the 2021 Sales Agreement, from which we received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen and other offering expenses.
+Added: Through termination of the 2021 Sales Agreement, we sold 4,915,669 shares of common stock under the 2021 Sales Agreement, from which we received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen and other offering expenses.
In August 2024, we also entered into the 2024 Sales Agreement with TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings through TD Securities, as our sales agent.
−Removed: As of June 30, 2025, we have not sold any shares under the 2024 Sales Agreement.
+Added: As of September 30, 2025, we have not sold any shares under the 2024 Sales Agreement.
In January 2024, we entered into a securities purchase agreement with Nextech Crossover I SCP for the Private Placement.
1 unchanged sentence
Through the Termination Date, we received $120.0 million in upfront and milestone payments from Genentech pursuant to the Genentech Agreement.
−Removed: In September 2022, we completed the September 2022 Offering of 11,320,755 shares of common stock at an offering price of $26.50 per share.
−Removed: We received proceeds of $284.7 million, which was net of $15.3 million in underwriting discounts and commissions, as well as other offering expenses.
The following table summarizes our sources and uses of cash for each of the periods presented:
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
(in thousands)
Cash used in operating activities
−Removed: Cash provided by investing activities
+Added: Cash provided by (used in) investing activities
Cash provided by financing activities
−Removed: Net decrease in cash, cash equivalents, and restricted cash
+Added: Net (decrease) increase in cash, cash equivalents, and restricted cash
Operating Activities
−Removed: During the six months ended June 30, 2025, we used $128.5 million of cash on operating activities, resulting from our net loss of $147.4 and cash used to fund changes in our operating assets and liabilities of $17.0 million, offset by non-cash charges of $36.0 million.
−Removed: During the six months ended June 30, 2024, we used $116.2 million of cash on operating activities, resulting from our net loss of $173.6 million, offset by non-cash charges of $36.6 million and cash provided by changes in our operating assets and liabilities of $20.8 million.
+Added: During the nine months ended September 30, 2025, we used $190.6 million of cash on operating activities, resulting from our net loss of $221.6 million and cash used to fund changes in our operating assets and liabilities of $20.5 million, offset by non-cash charges of $51.5 million.
+Added: During the nine months ended September 30, 2024, we used $191.2 million of cash on operating activities, resulting from our net loss of $261.7 million, offset by non-cash charges of $57.3 million and cash provided by changes in our operating assets and liabilities of $13.2 million.
Investing Activities
−Removed: During the six months ended June 30, 2025, net cash provided by investing activities was $117.6 million, consisting of $118.0 million in proceeds from net maturities and sales of investments, offset by $0.4 million for the acquisition of property and equipment.
−Removed: During the six months ended June 30, 2024, net cash provided by investing activities was $56.1 million, consisting of $57.9 million in proceeds from net maturities and sales of investments, offset by $1.8 million for the acquisition of property and equipment.
+Added: During the nine months ended September 30, 2025, net cash provided by investing activities was $157.3 million, consisting of $157.7 million in proceeds from net maturities and sales of investments, offset by $0.4 million for the acquisition of property and equipment.
+Added: During the nine months ended September 30, 2024, net cash used in investing activities was $70.1 million, consisting of $68.1 million in proceeds from net purchases of investments and $2.0 million for the acquisition of property and equipment.
Financing Activities
−Removed: During the six months ended June 30, 2025, net cash provided by financing activities was $0.7 million, consisting of $0.7 million in purchases under our 2020 Employee Stock Purchase Plan, or ESPP.
−Removed: During the six months ended June 30, 2024, net cash provided by financing activities was $50.5 million, consisting of $47.7 million in net proceeds from the Private Placement and at-the-market offerings, as well as $2.7 million in proceeds from the exercise of stock options and purchases under our ESPP.
+Added: During the nine months ended September 30, 2025, net cash provided by financing activities was $0.7 million, consisting of $0.7 million in proceeds from the exercise of stock options and purchases under our 2020 Employee Stock Purchase Plan, or ESPP.
+Added: During the nine months ended September 30, 2024, net cash provided by financing activities was $269.4 million, consisting of $265.9 million in net proceeds from the Private Placement, at-the-market offerings, and the September 2024 Offering, as well as $3.5 million in proceeds from the exercise of stock options and purchases under our ESPP.
Funding Requirements
1 unchanged sentence
In addition, we continue to incur additional costs associated with operating as a public company.
−Removed: As of June 30, 2025, we had cash, cash equivalents, and investments of $656.8 million.
+Added: As of September 30, 2025, we had cash, cash equivalents, and investments of $596.4 million.
We believe that our existing cash, cash equivalents, and investments will enable us to fund our operating expenses and capital expenditure requirements into 2029.
19 unchanged sentences
In addition, our product candidates, if approved, may not achieve commercial success.
−Removed: Our commercial revenues, if any, will be
−Removed: derived from sales of drugs that we do not expect to be commercially available for many years, if ever.
+Added: Our commercial revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for many years, if ever.
Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
6 unchanged sentences
Contractual Obligations and Commitments
−Removed: During the three months ended June 30, 2025, the Company (a) terminated its lease for 46,631 square feet of office and laboratory space at 399 Binney Street, Cambridge, MA and (b) executed a lease for 12,190 square feet of office space in Building 300 at One Kendall Square, Cambridge, MA.
−Removed: For more information, please refer to Note 10, Long-Lived Assets, of the notes to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
−Removed: There were no other material changes to our contractual obligations and commitments during the three months ended June 30, 2025.
−Removed: For more information on our contractual obligations and commitments, please refer to "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2024, as well as Note 9, Commitments and Contingencies, of the notes to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
+Added: There were no material changes to our contractual obligations and commitments during the three months ended September 30, 2025.
+Added: For more information on our contractual obligations and commitments, please refer to "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2024, as well as Note 9,
+Added: Commitments and Contingencies, of the notes to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Critical Accounting Policies and Use of Estimates
5 unchanged sentences
For a discussion of our critical accounting estimates, see "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 26, 2025, the notes to our audited financial statements appearing in our Annual Report on Form 10-K, and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
−Removed: There have been no material changes to these critical accounting policies and estimates through June 30, 2025 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.
+Added: There have been no material changes to these critical accounting policies and estimates through September 30, 2025 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Recently Issued and Adopted Accounting Pronouncements
3 unchanged sentences
We are exposed to market risk related to changes in interest rates of our investment portfolio of cash equivalents and short-term investments.
−Removed: As of June 30, 2025, our cash equivalents consisted of money market funds.
−Removed: As of June 30, 2025, our investments consisted of investments in U.S.
+Added: As of September 30, 2025, our cash equivalents consisted of money market funds.
+Added: As of September 30, 2025, our investments consisted of investments in U.S.
treasury bills and United States agency securities that have contractual maturities of less than two years.
3 unchanged sentences
The potential change in fair value for interest rate sensitive instruments has been assessed on a hypothetical 100 basis point adverse movement across all maturities.
−Removed: As of June 30, 2025, we estimate that such hypothetical 100 basis point adverse movement would not result in a material impact on our condensed consolidated results of operations.
−Removed: As of June 30, 2025, we had no debt outstanding and, therefore, are not exposed to interest rate risk with respect to debt.
+Added: As of September 30, 2025, we estimate that such hypothetical 100 basis point adverse movement would not result in a material impact on our condensed consolidated results of operations.
+Added: As of September 30, 2025, we had no debt outstanding and, therefore, are not exposed to interest rate risk with respect to debt.
Foreign currency exchange risk
4 unchanged sentences
To date, foreign currency transaction gains and losses have not been material to our financial statements and we have not had a formal hedging program with respect to foreign currency.
−Removed: We estimate that a 10% increase or decrease in current exchange rates would not have a material effect on our financial results for the three and six months ended June 30, 2025 and 2024.
+Added: We estimate that a 10% increase or decrease in current exchange rates would not have a material effect on our financial results for the three and nine months ended September 30, 2025 and 2024.
While we have not engaged in the hedging of our foreign currency transactions to date, we are evaluating the costs and benefits of initiating such a program and may in the future hedge selected significant transactions denominated in currencies other than the U.S.
7 unchanged sentences
Our disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives.
−Removed: Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of June 30, 2025, our disclosure controls and procedures were effective.
+Added: Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of September 30, 2025, our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
−Removed: There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
+Added: There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHE R INFORMATION
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.