Relay Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-05.
0000950170-25-063553
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0000950170-25-105054
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 149 previous paragraphs and 151 current paragraphs.
113 unchanged; 26 reworded; 9 added; 7 removed; 3 previous and 3 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
impairment of any intangible assets capitalized upon the acquisition of in-process research and development assets; and
Current report
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.
Current report
During the three months ended June 30, 2024, the Company recognized $0 of revenue from the Genentech Agreement.
Current report
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. The decrease of $6.5 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.
Current report
Comparison of the six months ended June 30, 2025 and 2024
Current report
Revenue
Current report
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. 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.
Current report
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. The decrease of $3.2 million was primarily a result of changes in the amounts invested between periods, as well as fluctuations in interest rates.
Current report
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. 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 paragraphs (7)
Previous report
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. 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. 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.
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Income, Net
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Income, Net
Reworded paragraphs (26)
Previous wording
ReDiscover Trial. In December 2021, we dosed the first patient in a first-in-human clinical trial for RLY-2608, or the ReDiscover Trial. 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. 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. 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. We also intend to initiate a Phase 3 registrational study, or the ReDiscover-2 Trial, 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. The comparator arm in the ReDsicover-2 Trial will be capivasertib plus fulvestrant.
Current wording
ReDiscover Trial. In December 2021, we dosed the first patient in a first-in-human clinical trial for RLY-2608, or the ReDiscover Trial. 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. 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. 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. 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. The comparator arm in the ReDsicover-2 Trial will be capivasertib plus fulvestrant.
Previous wording
Clinical Data. 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. 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.
Current wording
Clinical Data. 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. 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. 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. RLY-2608 + fulvestrant was generally well tolerated in the 118 patients treated across all doses as of the data cut-off date. The overall tolerability profile consisted of mostly low-grade treatment-related adverse events (TRAEs) 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.
Previous wording
RLY-2608-201 Clinical Trial. In the first quarter of 2025, we initiated the global Phase 2 clinical trial for RLY-2608 in patients with PIK3CA-related overgrowth spectrum, or PROS, and malformations driven by PIK3CA mutations.
Current wording
RLY-2608-201 Clinical Trial. 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. Enrollment is continuing in this clinical trial.
Previous wording
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. Under the terms of the Elevar Agreement, we received $5.0 million in upfront consideration and $2.7 million in conjunction with the transfer of active pharmaceutical ingredient and other materials as of March 31, 2025. We are eligible to receive up to $495.0 million in regulatory and commercial milestone payments, as well as tiered royalties.
Current wording
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. 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. We are eligible to receive up to $495.0 million in regulatory and commercial milestone payments, as well as tiered royalties.
Previous wording
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. We do not believe that such factors had a material adverse impact on our results of operations during the three months ended March 31, 2025 and 2024.
Current wording
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. 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.
Previous wording
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. Our net losses were $77.1 million and $81.4 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $1.8 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. We expect to continue to incur significant expenses, including the costs of operating as a public company, andgenerate significant operating losses for at least the next several years.
Current wording
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. Our net losses were $147.4 million and $173.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $1.9 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. We expect to continue to incur significant expenses, including the costs of operating as a public company, andgenerate significant operating losses for at least the next several years.
Previous wording
We believe our cash, cash equivalents, and investments of $710.4 million as of March 31, 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. We will need to raise additional capital in the future to continue developing the drugs in our pipeline and to commercialize any approved drug. We may seek to obtain additional financing in the future through the issuance of our common stock, through other equity or debt financings, or through collaborations or partnerships with other companies. We may not be able to raise additional capital on terms acceptable to us, or at all, and any failure to raise capital as and when needed could compromise our ability to execute on our business plan.
Current wording
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. 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. We will need to raise additional capital in the future to continue developing the drugs in our pipeline and to commercialize any approved drug. We may seek to obtain additional financing in the future through the issuance of our common stock, through other equity or debt financings, or through collaborations or partnerships with other companies. We may not be able to raise additional capital on terms acceptable to us, or at all, and any failure to raise capital as and when needed could compromise our ability to execute on our business plan.
Previous wording
costs related to compliance with regulatory requirements; and
Current wording
costs related to compliance with regulatory requirements;
Previous wording
Research and development expenses were $73.8 million for the three months ended March 31, 2025 compared to $82.4 million for the three months ended March 31, 2024. The decrease of $8.6 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024.
Current wording
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. 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.
Previous wording
Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was $0 for the three months ended March 31, 2025 compared to a decrease of $1.8 million for the three months ended March 31, 2024. During the year ended December 31, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0. During the three months ended March 31, 2025, there were no further changes to such amounts.
Current wording
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. During the year ended December 31, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0. During the three months ended June 30, 2025, there were no further changes to such amounts.
Previous wording
Other income, net, was $7.8 million for the three months ended March 31, 2025 compared to $9.0 million for the three months ended March 31, 2024. The decrease of $1.2 million was primarily a result of fluctuations in interest rates.
Current wording
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. The decrease of $2.1 million was primarily a result of changes in the amounts invested between periods, as well as fluctuations in interest rates.
Previous wording
During the three months ended March 31, 2025, the Company recognized $7.7 million of revenue from the Elevar Agreement, as each of the Company's performance obligations thereunder were completed in the current period.
Current wording
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.
Previous wording
During the three months ended March 31, 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.
Current wording
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.
Previous wording
General and administrative expenses were $18.7 million for the three months ended March 31, 2025 compared to $19.8 million for the three months ended March 31, 2024. The decrease of $1.1 million was primarily due to a decrease in stock compensation expense, partially offset by costs to obtain the Elevar Agreement, which were expensed commensurate with the timing of revenue recognized during the three months ended March 31, 2025.
Current wording
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. 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.
Previous wording
As of March 31, 2025, we had cash, cash equivalents, and investments of $710.4 million.
Current wording
As of June 30, 2025, we had cash, cash equivalents, and investments of $656.8 million.
Previous wording
In December 2024, we entered into the Elevar Agreement pursuant to which Elevar was granted global development and commercialization rights for lirafugratinib. As of March 31, 2025, we had received $5.0 million in upfront consideration and $2.7 million in conjunction with the transfer of active pharmaceutical ingredient and other materials from Elevar pursuant to the Elevar Agreement.
Current wording
In December 2024, we entered into the Elevar Agreement pursuant to which Elevar was granted global development and commercialization rights for lirafugratinib. 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.
Previous wording
In August 2021, we entered into the 2021 Sales Agreement with Cowen, pursuant to which we could 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. In August 2024, the 2021 Sales Agreement was terminated by mutual agreement between us and Cowen. 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.
Current wording
In August 2021, we entered into the 2021 Sales Agreement with Cowen, pursuant to which we could 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. In August 2024, the 2021 Sales Agreement was terminated by mutual agreement between us and Cowen. Through termination of the
Previous wording
In August 2021, we entered into a sales agreement, or the 2021 Sales Agreement, with Cowen and Company, LLC, or Cowen, pursuant to which we could 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. In August 2024, the 2021 Sales Agreement was terminated by mutual agreement between us and Cowen. 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.
Current wording
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.
Previous wording
During the three months ended March 31, 2025, we used $73.2 million of cash on operating activities, resulting from our net loss of $77.1 million and cash used to fund changes in our operating assets and liabilities of $15.1 million, offset by non-cash charges of $18.9 million.
Current wording
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.
Previous wording
During the three months ended March 31, 2024, we used $50.3 million of cash on operating activities, 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.
Current wording
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.
Previous wording
During the three months ended March 31, 2025, net cash provided by investing activities was $42.5 million, consisting of $42.8 million in proceeds from net maturities and sales of investments, offset by $0.4 million for the acquisition of property and equipment.
Current wording
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.
Previous wording
During the three months ended March 31, 2024, net cash provided by investing activities was $10.5 million, consisting of $12.3 million in proceeds from net maturities and sales of investments, offset by $1.8 million for the acquisition of property and equipment.
Current wording
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.
Previous wording
During the three months ended March 31, 2025, net cash provided by financing activities was $0.
Current wording
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.
Previous wording
During the three months ended March 31, 2024, net cash provided by financing activities was $48.9 million, 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.
Current wording
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.
Previous wording
As of March 31, 2025, we had cash, cash equivalents, and investments of $710.4 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. 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.
Current wording
As of June 30, 2025, we had cash, cash equivalents, and investments of $656.8 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. 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.
Previous wording
Effective as of January 7, 2025, Genentech elected to terminate the Genentech Agreement without cause, as further discussed in the section "Management's Discussion and Analysis of Financial Condition and Results of Operations" in this Quarterly Report on Form 10-Q. There were no other material changes to our contractual obligations and commitments during the three months ended March 31, 2025. 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.
Current wording
There were no other material changes to our contractual obligations and commitments during the three months ended June 30, 2025. 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.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following summarizes our research and development expenses for the six months ended June 30, 2025 and 2024
Current report — wording carried from elsewhere
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. During the year ended December 31, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0. During the six months ended June 30, 2025, there were no further changes to such amounts.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
In September 2022, we completed a public offering, or the September 2022 Offering, of 11,320,755 shares of common stock at an offering price of $26.50 per share. 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.
Previous report — wording carried elsewhere
Change in Fair Value of Contingent Consideration Liability
Previous report — wording carried elsewhere
Change in Fair Value of Contingent Consideration Liability