17 unchanged sentences
In the fourth quarter of 2023, we also initiated a triplet combination arm with RLY-2608, fulvestrant and the cyclin dependent kinase 4/6, or CDK 4/6, inhibitor ribociclib.
+Added: In June 2024, we announced our plan to initiate 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.
• Clinical Data .
4 unchanged sentences
In the third quarter of 2020, we initiated a first-in-human clinical trial for lirafugratinib, or the ReFocus Trial, which is a two-part global trial in patients with FGFR2-altered tumors.
−Removed: The first part of the trial, or the dose escalation, is complete, and the second part of the trial, or the dose expansion, is ongoing at a 70 mg once daily, or QD, recommended Phase 2 dose.
−Removed: The dose expansion part of the trial includes four cholangiocarcinoma, or CCA, arms and three tumor agnostic (non-CCA) arms.
−Removed: With full enrollment of our pivotal cohort in patients with FGFR2-fusion CCA who have not previously received an FGFR inhibitor and sufficient enrollment of patients across the tumor agnostic arms that we believe will enable us to generate meaningful data, we have closed enrollment for the ReFocus Trial to allow the relevant data to mature and inform our future clinical development decisions.
+Added: The first part of the trial, or the dose escalation, is complete, and the second part of the trial, or the dose expansion, is ongoing at a 70 mg once daily, or QD, recommended Phase 2 dose in patients with cholangiocarcinoma, or CCA, and other FGFR2-altered solid tumors.
+Added: Enrollment for the ReFocus Trial has been closed to allow the data to mature and inform our future clinical development decisions.
• Clinical Data .
1 unchanged sentence
Additionally, the safety analysis from the interim clinical data disclosed to date for the CCA cohorts and tumor agnostic cohorts has been generally consistent.
−Removed: treatment emergent adverse events were expected FGFR2 on-target, low-grade, monitorable, manageable and largely reversible.
−Removed: • Migoprotafib (GDC-1971, formerly known as RLY - 1971).
−Removed: In the first quarter of 2020, we initiated a Phase 1a clinical trial for RLY-1971, our inhibitor of Src homology region 2 domain-containing phosphatase-2, or SHP2, as a monotherapy in patients with advanced or metastatic solid tumors.
−Removed: We completed enrollment of this trial in 2022.
−Removed: In December 2020, we entered into a global collaboration and license agreement with Genentech, Inc., a member of the Roche Group, or Genentech, for the development and commercialization of RLY-1971 (now referred to as migoprotafib, or GDC-1971), or the Genentech Agreement.
−Removed: Genentech initiated the cohort of migoprotafib in combination with GDC-6036, its KRAS G12C inhibitor, in a Phase 1b trial in July 2021.
−Removed: Genentech also initiated a Phase 1b trial of migoprotafib in combination with atezolizumab, its PD-L1 antibody, in August 2022, as well as a Phase 1b trial of migoprotafib in combination with either osimertinib or cetuximab, EGFR inhibitors, in July 2023.
+Added: Most treatment emergent adverse events were expected FGFR2 on-target, low-grade, monitorable, manageable and largely reversible.
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.
−Removed: In addition to the clinical stage product candidates described above, we have more than seven active discovery stage programs across both precision oncology and genetic diseases.
+Added: In addition to the clinical stage product candidates described above, we announced three discovery stage programs in June 2024, including two novel programs from our genetic disease portfolio to address clinically and commercially validated targets in vascular malformations and Fabry disease, respectively, and an NRAS-selective inhibitor.
+Added: We also have more than five additional active discovery stage programs across both precision oncology and genetic diseases.
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.
2 unchanged sentences
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.
−Removed: We have also received an aggregate of $121.8 million in connection with the Genentech Agreement through March 31, 2024.
+Added: We have also received an aggregate of $121.8 million in connection with the Genentech Agreement through June 30, 2024.
In August 2021, we entered into a sales agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $300.0 million from time to time in "at-the-market" offerings through Cowen, as our sales agent, or At-the-Market Offerings.
−Removed: As of March 31, 2024, we have sold 4,915,669 shares of common stock under the Sales Agreement, from which we have received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen.
+Added: As of June 30, 2024, we have sold 4,915,669 shares of common stock under the Sales Agreement, from which we have received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen.
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.
1 unchanged sentence
On April 15, 2021, we entered into an Agreement and Plan of Merger, or the Merger Agreement, and on April 22, 2021, we acquired ZebiAI Therapeutics, Inc., or ZebiAI.
−Removed: Pursuant to the Merger Agreement, upfront consideration included (a) payment of approximately $20.0 million in cash and (b) issuance of 1,914,219 shares of our common stock at an aggregate fair value of $61.8 million, both transferred to ZebiAI’s former stockholders, option holders, and warrant holders, or the ZebiAI Holders, upon closing.
−Removed: In addition, (i) the ZebiAI Holders are eligible to receive up to $85.0 million in payments upon the achievement of certain platform or program milestones, payable in shares of our common stock, or the Contingent Milestone Payments, a portion of which was paid to the ZebiAI Holders in 2022 and 2023, and (ii) we will pay 10% of payments we receive within three years of the closing date of the Merger Agreement from partnering, collaboration, or other agreements related to ZebiAI’s platform, up to an aggregate maximum amount of $100.0 million, payable in cash to the ZebiAI Holders.
−Removed: In December 2020, we entered into the Genentech Agreement with Genentech for the development and commercialization of migoprotafib.
−Removed: Under the terms of the Genentech Agreement, we received $75.0 million in an upfront payment in 2021, as well as $45.0 million in milestone payments from Genentech as of March 31, 2024.
−Removed: We are eligible to receive up to an aggregate of $675.0 million in additional payments upon the achievement of other specified development, commercialization, and sales-based milestones for migoprotafib worldwide, as well as tiered royalties ranging from low-to-mid teens on annual worldwide net sales of migoprotafib, on a country-by-country basis, subject to reduction in certain circumstances.
−Removed: Furthermore, we are also eligible to receive additional royalties in the event of regulatory approval of migoprotafib and Genentech’s compound, GDC-6036, that directly binds to and inhibits KRAS G12C, in combination.
−Removed: Finally, we retain the right to develop migoprotafib in combination with our FGFR2 and PI3Kα programs.
+Added: Pursuant to the Merger Agreement, upfront consideration included payment of approximately $20.0 million in cash and issuance of 1,914,219 shares of our common stock at an aggregate fair value of $61.8 million, both transferred to ZebiAI’s former stockholders, option holders, and warrant holders, or the ZebiAI Holders, upon closing.
+Added: ZebiAI Holders are also eligible to receive payments upon achievement of certain program milestones, payable in shares of our common stock, or Contingent Milestone Payments, per the terms of the Merger Agreement.
+Added: In December 2020, we entered into a global collaboration and license agreement with Genentech, Inc., a member of the Roche Group, or Genentech, for the development and commercialization of RLY-1971 (now referred to as migoprotafib, or GDC-1971), or the Genentech Agreement.
+Added: Under the terms of the Genentech Agreement, we received $75.0 million in an upfront payment in 2021, as well as $45.0 million in milestone payments from Genentech as of June 30, 2024.
+Added: On July 11, 2024, we received notice that Genentech exercised its right to terminate the Genentech Agreement.
+Added: Genentech elected to terminate the Genentech Agreement without cause, and the termination will become effective 180 days after the date of receipt of the notice of termination, or the Termination Date.
+Added: Until the Termination Date, the obligations of the parties under the Genentech Agreement will continue as currently provided.
+Added: As a result of the termination of the Genentech Agreement, we will not be entitled to receive any further milestones or other payments due after the Termination Date.
+Added: The parties will also cease to have any development or commercialization obligations after the Termination Date and the licenses that we granted to Genentech pursuant to the Genentech Agreement will cease to be in effect as of the Termination Date.
+Added: We will not continue development of migoprotafib.
Inflation generally affects us by increasing our employee-related costs and clinical trial expenses, as well as other operating expenses.
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 months ended March 31, 2024 and 2023.
+Added: 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, 2024 and 2023.
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 $81.4 million and $94.2 million for the three months ended March 31, 2024 and 2023, respectively.
−Removed: As of March 31, 2024, we had an accumulated deficit of $1.5 billion.
−Removed: These losses have resulted primarily from costs incurred in
−Removed: connection with research and development activities, licensing and patent investment, and general and administrative costs associated with our operations.
+Added: Our net losses were $173.6 million and $192.7 million for the six months ended June 30, 2024 and 2023, respectively.
+Added: As of June 30, 2024, we had an accumulated deficit of $1.6 billion.
+Added: 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.
We expect to continue to incur significant expenses , including the costs of operating as a public company, and generate significant operating losses for at least the next several years.
12 unchanged sentences
• add operational, financial, and management information systems and personnel, including personnel to support our drug development, any future commercialization efforts, and our operations as a public company.
−Removed: In addition, if we obtain marketing approval for any of our lead product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
+Added: 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.
As a result, we will need additional financing to support our continuing operations.
5 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 $749.6 million as of March 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026.
+Added: We believe our cash, cash equivalents, and investments of $688.4 million as of June 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026.
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.
18 unchanged sentences
Our lead product candidates are in clinical development.
−Removed: We also have more than seven active discovery stage programs across both precision oncology and genetic diseases.
+Added: We also have several active discovery stage programs across both precision oncology and genetic diseases.
Costs incurred for these programs include costs incurred to support our discovery research and translational science efforts up to the initiation of first-in-human clinical development.
21 unchanged sentences
Change in Fair Value of Contingent Consideration Liability
−Removed: Change in fair value of contingent consideration liability consists of fluctuations in the estimated fair value of Contingent Milestone Payments under the Merger Agreement with ZebiAI.
−Removed: Through the date on which any contingent milestones contractually expire, we expect the fair value of such Contingent Milestone Payments to increase or decrease based on our estimates of the probability of achieving the contingent milestones and timing in connection therewith.
+Added: Change in fair value of contingent consideration liability consists of fluctuations in the estimated fair value of Contingent Milestone Payments, as well as changes in the recorded amounts of Contingent Earnout Payments, under the Merger Agreement with ZebiAI.
General and Administrative Expenses
11 unchanged sentences
Results of Operations
−Removed: Comparison of the three months ended March 31, 2024 and 2023
−Removed: The following table summarizes our results of operations for the three months ended March 31, 2024 and 2023:
−Removed: Three Months Ended March 31,
+Added: Comparison of the three months ended June 30, 2024 and 2023
+Added: The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023:
+Added: Three Months Ended June 30,
(in thousands)
7 unchanged sentences
Other income, net
−Removed: We recognized revenue of $10.0 million and $0.2 million for the three months ended March 31, 2024 and 2023, respectively.
−Removed: The change of $9.8 million was primarily due to a payment of $10.0 million in connection with a milestone achieved under the Genentech Agreement during the three months ended March 31, 2024.
+Added: We recognized no revenue for the three months ended June 30, 2024 compared to $0.1 million for the three months ended June 30, 2023.
+Added: The change of $0.1 million was due to completion of research and development services provided under the Genentech Agreement in 2023.
Research and Development Expenses
−Removed: The following summarizes our research and development expenses for the three months ended March 31, 2024 and 2023:
−Removed: Three Months Ended March 31,
+Added: The following summarizes our research and development expenses for the three months ended June 30, 2024 and 2023:
+Added: Three Months Ended June 30,
(in thousands)
4 unchanged sentences
Total research and development expenses
−Removed: Research and development expenses were $82.4 million for the three months ended March 31, 2024 compared to $82.8 million for the three months ended March 31, 2023.
−Removed: The change of $0.4 million was primarily due to the impact of prioritization of certain programs in our pipeline, as previously disclosed in 2023 and earlier in 2024.
+Added: Research and development expenses were $92.0 million for the three months ended June 30, 2024 compared to $88.2 million for the three months ended June 30, 2023.
+Added: The change of $3.8 million was primarily due to additional external costs in connection with the ReDiscover Trial for RLY-2608.
Change in Fair Value of Contingent Consideration Liability
−Removed: Change in fair value of our contingent consideration liability for milestones under the Merger Agreement with ZebiAI was a decrease of $1.8 million for the three months ended March 31, 2024 compared to a decrease of $1.0 million for the three months ended March 31, 2023.
−Removed: The change of $0.8 million was attributable to shifts in the assumptions underlying the fair value measurement between periods, which we expect to continue through the date on which any contingent milestones contractually expire.
+Added: Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was a decrease of $11.4 million for the three months ended June 30, 2024 compared to a decrease of $2.2 million for the three months ended June 30, 2023.
+Added: During the three months ended June 30, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0.
General and Administrative Expenses
−Removed: General and administrative expenses were $19.8 million for the three months ended March 31, 2024 compared to $19.6 million for the three months ended March 31, 2023.
+Added: General and administrative expenses were $20.1 million for the three months ended June 30, 2024 and 2023.
+Added: In comparing the periods, increases in stock compensation expense were offset by decreases in other employee costs, insurance fees, and other expenses.
+Added: Other Income, Net
+Added: Other income, net, was $8.5 million for the three months ended June 30, 2024 compared to $7.5 million for the three months ended June 30, 2023.
+Added: The change of $1.0 million was primarily a result of fluctuations in interest rates.
+Added: Comparison of the six months ended June 30, 2024 and 2023
+Added: The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:
+Added: Six Months Ended June 30,
+Added: (in thousands)
+Added: License and other revenue
+Added: Operating expenses:
+Added: Research and development expenses
+Added: Change in fair value of contingent consideration liability
+Added: General and administrative expenses
+Added: Total operating expenses
+Added: Loss from operations
+Added: Other income, net
+Added: We recognized revenue of $10.0 million for the six months ended June 30, 2024 compared to $0.3 million for the six months ended June 30, 2023.
+Added: The change of $9.7 million was primarily due to a payment of $10.0 million in connection with a milestone achieved under the Genentech Agreement during the six months ended June 30, 2024.
+Added: Research and Development Expenses
+Added: The following summarizes our research and development expenses for the six months ended June 30, 2024 and 2023:
+Added: Six Months Ended June 30,
+Added: (in thousands)
+Added: External costs for programs in clinical trials
+Added: External costs for platform technologies and preclinical programs
+Added: Employee related expenses
+Added: Other expenses
+Added: Total research and development expenses
+Added: Research and development expenses were $174.4 million for the six months ended June 30, 2024 compared to $171.0 million for the six months ended June 30, 2023.
+Added: The change of $3.4 million was primarily due to additional external costs in connection with the ReDiscover Trial for RLY-2608 and increases in stock compensation expense, offset by the impact of prioritization of certain programs in our pipeline, as previously disclosed in 2023 and earlier in 2024.
+Added: Change in Fair Value of Contingent Consideration Liability
+Added: Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was a decrease of $13.2 million for the six months ended June 30, 2024 compared to a decrease of $3.2 million for the six months ended June 30, 2023.
+Added: During the six months ended June 30, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0.
+Added: General and Administrative Expenses
+Added: General and administrative expenses were $39.9 million for the six months ended June 30, 2024 compared to $39.7 million for the six months ended June 30, 2023.
The change of $0.2 million was primarily due to an increase in stock compensation expense, offset by decreases in other employee compensation costs, insurance fees, and other expenses.
Other Income, Net
−Removed: Other income, net, was $9.0 million for the three months ended March 31, 2024 compared to $6.9 million for the three months ended March 31, 2023.
+Added: Other income, net, was $17.5 million for the six months ended June 30, 2024 compared to $14.5 million for the six months ended June 30, 2023.
The change of $3.0 million was primarily a result of fluctuations in interest rates.
Liquidity and Capital Resources
−Removed: As of March 31, 2024, we had cash, cash equivalents, and investments of $749.6 million.
+Added: As of June 30, 2024, we had cash, cash equivalents, and investments of $688.4 million.
Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses.
3 unchanged sentences
In August 2021, we also entered into the Sales Agreement with Cowen pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $300.0 million from time to time in At-the-Market Offerings through Cowen, as our sales agent.
−Removed: As of March 31, 2024, we have sold 4,915,669 shares of common stock under the Sales Agreement, from which we have received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen.
+Added: As of June 30, 2024, we have sold 4,915,669 shares of common stock under the Sales Agreement, from which we have received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen.
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.
We received $29.8 million in proceeds from the Private Placement, which were net of $0.2 million in offering expenses.
−Removed: As of March 31, 2024, we have received $120.0 million in upfront and milestone payments from Genentech pursuant to the Genentech Agreement.
+Added: As of June 30, 2024, we have received $120.0 million in upfront and milestone payments from Genentech pursuant to the Genentech Agreement.
The following table summarizes our sources and uses of cash for each of the periods presented:
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
(in thousands)
2 unchanged sentences
Cash provided by financing activities
−Removed: Net increase in cash, cash equivalents, and restricted cash
+Added: Net decrease in cash, cash equivalents, and restricted cash
Operating Activities
−Removed: During the three months ended March 31, 2024, we used $50.3 million of cash on operating activities, primarily resulting from our net loss of $81.4 million, offset by non-cash charges of $23.1 million and cash provided by changes in our operating assets and liabilities of $8.0 million.
−Removed: During the three months ended March 31, 2023, we used $67.1 million of cash on operating activities, primarily resulting from our net loss of $94.2 million, offset by non-cash charges of $19.7 million and cash provided by changes in our operating assets and liabilities of $7.4 million.
+Added: During the six months ended June 30, 2024, we used $116.2 million of cash on operating activities, primarily 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 six months ended June 30, 2023, we used $135.7 million of cash on operating activities, primarily resulting from our net loss of $192.7 million, offset by non-cash charges of $40.1 million and cash provided by changes in our operating assets and liabilities of $16.9 million.
Investing Activities
−Removed: During the three months ended March 31, 2024, net cash provided by investing activities was $10.5 million, primarily consisting of $12.3 million in proceeds from net maturities of investments, offset by $1.8 million for the acquisition of property and equipment.
−Removed: During the three months ended March 31, 2023, net cash provided by investing activities was $75.3 million, primarily consisting of $77.2 million in proceeds from net maturities of investments, offset by $1.9 million for the acquisition of property and equipment.
+Added: During the six months ended June 30, 2024, net cash provided by investing activities was $56.1 million, primarily consisting of $57.9 million in proceeds from net maturities of investments, offset by $1.8 million for the acquisition of property and equipment.
+Added: During the six months ended June 30, 2023, net cash provided by investing activities was $126.6 million, primarily consisting of $130.0 million in proceeds from net maturities of investments, offset by $3.4 million for the acquisition of property and equipment.
Financing Activities
−Removed: During the three months ended March 31, 2024, net cash provided by financing activities was $48.9 million, primarily consisting of $47.7 million in net proceeds from the Private Placement and At-the-Market Offerings, as well as $1.2 million in proceeds from the exercise of stock options.
−Removed: During the three months ended March 31, 2023, net cash provided by financing activities was $1.3 million, primarily consisting of $1.3 million in proceeds from the exercise of stock options.
+Added: During the six months ended June 30, 2024, net cash provided by financing activities was $50.5 million, primarily 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 2020 Employee Stock Purchase Plan, or ESPP.
+Added: During the six months ended June 30, 2023, net cash provided by financing activities was $3.4 million, primarily consisting of $3.4 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 March 31, 2024, we had cash, cash equivalents, and investments of $749.6 million.
+Added: As of June 30, 2024, we had cash, cash equivalents, and investments of $688.4 million.
We believe that our existing cash, cash equivalents, and investments will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026.
9 unchanged sentences
• the success of any existing or future collaborations that we may enter into with third parties;
−Removed: • the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates, such as the Genentech Agreement;
+Added: • the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates;
• the achievement of milestones or occurrence of other developments that trigger payments under any existing or future collaboration agreements, if any;
16 unchanged sentences
Contractual Obligations and Commitments
−Removed: There were no material changes to our contractual obligations and commitments during the three months ended March 31, 2024.
+Added: There were no material changes to our contractual obligations and commitments during the three months ended June 30, 2024.
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, 2023, 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.
6 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, 2023 filed with the SEC on February 22, 2024, 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 March 31, 2024 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2023.
+Added: There have been no material changes to these critical accounting policies and estimates through June 30, 2024 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2023.
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 March 31, 2024, our cash equivalents consisted of money market funds.
−Removed: As of March 31, 2024, our investments consisted of investments in U.S.
+Added: As of June 30, 2024, our cash equivalents consisted of money market funds.
+Added: As of June 30, 2024, 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 March 31, 2024, 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 March 31, 2024, we had no debt outstanding and, therefore, are not exposed to interest rate risk with respect to debt.
+Added: As of June 30, 2024, 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 June 30, 2024, 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 months ended March 31, 2024 and 2023.
+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 six months ended June 30, 2024 and 2023.
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 March 31, 2024, 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 June 30, 2024, 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 March 31, 2024 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 June 30, 2024 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.