Relay Therapeutics, Inc.

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 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.

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. 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. 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. The comparator arm in the ReDiscover-2 Trial is 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. 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.

Current wording

Clinical Data. 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. 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. 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.

Previous 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.

Current wording

ReInspire 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, or the ReInspire Trial. Enrollment is continuing in this clinical trial.

Previous wording

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. 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.

Current wording

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. 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.

Previous wording

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. As of June 30, 2025, we have not sold any shares under the 2024 Sales Agreement.

Current wording

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. As of September 30, 2025, we have not sold any shares under the 2024 Sales Agreement.

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 and six months ended June 30, 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 nine months ended September 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 $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.

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 $221.6 million and $261.7 million for the nine months ended September 30, 2025 and 2024, respectively. 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. 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 $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.

Current wording

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. 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

During the three months ended June 30, 2024, the Company recognized $0 of revenue from the Genentech Agreement.

Current wording

During the three months ended September 30, 2025 and 2024, the Company recognized $0 of revenue.

Previous 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.

Current wording

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. 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.

Previous 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.

Current wording

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. During the three months ended September 30, 2025, there were no further changes to such amounts.

Previous wording

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 wording

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.

Previous 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.

Current wording

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.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous wording

The following summarizes our research and development expenses for the six months ended June 30, 2025 and 2024

Current wording

The following summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:

Previous wording

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 wording

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. 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.

Previous wording

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.

Current wording

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. During the nine months ended September 30, 2025, there were no further changes to such amounts.

Previous 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.

Current wording

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. 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.

Previous wording

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 wording

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.

Previous wording

As of June 30, 2025, we had cash, cash equivalents, and investments of $656.8 million.

Current wording

As of September 30, 2025, we had cash, cash equivalents, and investments of $596.4 million.

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

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 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 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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.

Previous 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.

Current wording

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. 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

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.

Current wording

There were no material changes to our contractual obligations and commitments during the three months ended September 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,