What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-08-06 compared with 2026-05-05 · 85 added, 52 removed, 219 unchanged (38% of the section changed)

9 unchanged sentences

Zovegalisib (RLY-2608).

Zovegalisib is the first known allosteric, pan-mutant and isoform-selective phosphoinostide 3 kinase alpha, or PI3Kα, inhibitor in clinical development.

Zovegalisib is the first known allosteric, pan-mutant and isoform-selective phosphoinositide 3 kinase alpha, or PI3Kα, inhibitor in clinical development.

It is the lead program in our efforts to discover and develop mutant selective inhibitors of PI3Kα.

• Breast Cancer and Solid Tumors

• ReDiscover Trial .

o ReDiscover Trials .

In December 2021, we dosed the first patient in a first-in-human clinical trial for zovegalisib, or the ReDiscover Trial.

Since then, we have predominantly focused on evaluating zovegalisib in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer.

We are also advancing triplet combination arms with zovegalisib, fulvestrant and cyclin dependent kinase 4/6, or CDK 4/6, inhibitors, 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 is designed to evaluate the safety and efficacy of zovegalisib plus fulvestrant in PI3Kα-mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor.

Since then, we have predominantly focused on evaluating zovegalisib in combination with other therapies for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer.

The comparator arm in the ReDiscover-2 Trial is capivasertib plus fulvestrant.

In February 2026, we announced that the FDA granted Breakthrough Therapy designation to zovegalisib in combination with fulvestrant for the treatment of adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

We are also advancing triplet combination arms with zovegalisib, fulvestrant and CDK 4/6 inhibitors, or atirmociclib, the investigative selective-CDK4 inhibitor from Pfizer Inc., or Pfizer, to support a potential future trial in frontline breast cancer.

In April 2026, we announced that we selected atirmociclib as our go-forward triplet combination partner.

o Clinical Data .

7 unchanged sentences

Enrollment is continuing in this clinical trial.

o Clinical Data.

In May 2026, we announced initial clinical data from the ReInspire Trial, which we believe demonstrate that zovegalisib has potential for differentiated safety and efficacy in patients with PIK3CA-driven vascular anomalies.

In addition to the programs mentioned above, we have initiated a clinical trial studying RLY-8161, our NRAS-selective inhibitor, in patients with NRAS-mutant melanoma and other NRAS-mutant solid tumors.

2 unchanged sentences

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.

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.

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 May 2026, we completed a public offering, or the May 2026 Offering, of 26,354,167 shares of common stock, which share amount includes the exercise in full of the underwriters' option to purchase an additional 3,437,500 shares, at an offering price of $12.00 per share.

We received proceeds of $296.8 million, which was net of $19.4 million in underwriting discounts and other offering expenses.

In December 2024, we and Elevar Therapeutics, Inc., or Elevar, entered into an exclusive global licensing agreement, or the Elevar Agreement, 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 upon execution, $3.4 million upon transfer of active pharmaceutical ingredient and other materials, and $10.0 million in milestone payments as of March 31, 2026.

Under the terms of the Elevar Agreement, we received $5.0 million upon execution, $3.7 million upon transfer of active pharmaceutical ingredient and other materials, and $10.0 million in milestone payments as of June 30, 2026.

We are eligible to receive up to $485.0 million in regulatory and commercial milestone payments, as well as tiered royalties.

2 unchanged sentences

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 March 31, 2026, we have sold 14,141,569 shares of common stock under the 2024 Sales Agreement, from which we received $140.4 million in gross proceeds.

As of June 30, 2026, we sold 16,006,569 shares of common stock under the 2024 Sales Agreement, from which we received $163.0 million in gross proceeds.

In connection therewith, we paid $3.8 million in commissions to TD Securities, yielding $159.2 million in net proceeds.

In April 2026, we sold an additional 1,865,000 shares of common stock under the 2024 Sales Agreement, from which we received an additional $22.6 million in gross proceeds and paid an additional $0.5 million in commissions to TD Securities, yielding an additional $22.1 million in net proceeds.

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, 2026 and 2025.

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, 2026.

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 $73.3 million and $77.1 million for the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026 we had an accumulated deficit of $2.1 billion.

Our net losses were $157.0 million and $147.4 million for the six months ended June 30, 2026 and 2025, respectively.

As of June 30, 2026 we had an accumulated deficit of $2.2 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.

We believe our cash, cash equivalents, and investments of $642.1 million as of March 31, 2026 will enable us to fund our operating expenses and capital expenditure requirements into 2029.

We believe our cash, cash equivalents, and investments of $910.9 million as of June 30, 2026 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.

18 unchanged sentences

Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid expenses or accrued research and development expenses.

Our lead product candidate is in clinical development.

Two of our product candidates are in clinical development.

We also have earlier 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.

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.

Platform research and other research and development activities include costs that are not specifically allocated to active product candidates, including facilities costs, depreciation expense, and other costs.

32 unchanged sentences

Results of Operations

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

Comparison of the three months ended June 30, 2026 and 2025

The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:

Three Months Ended June 30,

(in thousands)

6 unchanged sentences

Other income, net

During the three months ended March 31, 2026 the Company recognized $3.0 million of revenue from the Elevar Agreement, specifically upon receipt of certain milestone payments.

During the three months ended March 31, 2025, the Company recognized $7.7 million of revenue from the Elevar Agreement, specifically in connection with the completion of each of our performance obligations thereunder in the period.

During the three months ended June 30, 2026 the Company recognized $0.4 million of revenue from the Elevar Agreement, specifically upon transfer of active pharmaceutical ingredient and other materials.

During the three months ended June 30, 2025, the Company recognized $0.7 million of revenue from the Elevar Agreement, specifically upon transfer of active pharmaceutical ingredient and other materials.

Research and Development Expenses

The following summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

The following summarizes our research and development expenses for the three months ended June 30, 2026 and 2025:

Three Months Ended June 30,

(in thousands)

4 unchanged sentences

Total research and development expenses

Research and development expenses were $70.6 million for the three months ended March 31, 2026 compared to $73.8 million for the three months ended March 31, 2025.

The decrease of $3.2 million was primarily due to the series of strategic choices made to streamline the research organization prior to 2026, offset by increases in costs related to the ReDiscover-2 Trial.

Research and development expenses were $76.5 million for the three months ended June 30, 2026 compared to $63.9 million for the three months ended June 30, 2025.

The increase of $12.6 million was primarily due to increases in costs across ongoing clinical trials for zovegalisib, partially offset by the impact from strategic choices made to streamline the research organization prior to 2026.

General and Administrative Expenses

General and administrative expenses were $11.0 million for the three months ended March 31, 2026 compared to $18.7 million for the three months ended March 31, 2025.

The decrease of $7.7 million was primarily due to decreases in employee compensation costs, including stock compensation expense, and costs to obtain the Elevar Agreement, which were expensed during the three months ended March 31, 2025.

General and administrative expenses were $14.7 million for the three months ended June 30, 2026 compared to $13.6 million for the three months ended June 30, 2025.

The increase of $1.1 million was primarily due to increased legal expenses, offset by decreases in employee compensation costs, including stock compensation expense.

Other Income, Net

Other income, net, was $5.3 million for the three months ended March 31, 2026 compared to $7.8 million for the three months ended March 31, 2025.

Other income, net, was $7.1 million for the three months ended June 30, 2026 compared to $6.5 million for the three months ended June 30, 2025.

The increase of $0.6 million was primarily a result of changes in the amounts invested between periods, as well as fluctuations in interest rates.

Comparison of the six months ended June 30, 2026 and 2025

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

Six Months Ended June 30,

(in thousands)

License and other revenue

Operating expenses:

Research and development expenses

General and administrative expenses

Total operating expenses

Loss from operations

Other income, net

During the six months ended June 30, 2026 the Company recognized $3.4 million of revenue from the Elevar Agreement, specifically upon receipt of certain milestone payments, as well as upon transfer of active pharmaceutical ingredient and other materials.

During the six months ended June 30, 2025, the Company recognized $8.4 million of revenue from the Elevar Agreement, specifically in connection with the completion of each of our performance obligations thereunder in the period.

Research and Development Expenses

The following summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:

Six Months Ended June 30,

(in thousands)

External costs for programs in clinical trials

External costs for platform technologies and preclinical programs

Employee related expenses

Other expenses

Total research and development expenses

Research and development expenses were $147.0 million for the six months ended June 30, 2026 compared to $137.7 million for the six months ended June 30, 2025.

The increase of $9.3 million was primarily due to increases in costs across ongoing clinical trials for zovegalisib, partially offset by the impact from strategic choices made to streamline the research organization prior to 2026.

General and Administrative Expenses

General and administrative expenses were $25.7 million for the six months ended June 30, 2026 compared to $32.4 million for the six months ended June 30, 2025.

The decrease of $6.6 million was primarily due to decreases in employee compensation costs, including stock compensation expense, and costs to obtain the Elevar Agreement, which were expensed during the six months ended June 30, 2025.

Other Income, Net

Other income, net, was $12.4 million for the six months ended June 30, 2026 compared to $14.3 million for the six months ended June 30, 2025.

The decrease of $1.9 million was primarily a result of changes in the amounts invested between periods, as well as fluctuations in interest rates.

Liquidity and Capital Resources

As of March 31, 2026, we had cash, cash equivalents, and investments of $642.1 million.

As of June 30, 2026, we had cash, cash equivalents, and investments of $910.9 million.

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses.

1 unchanged sentence

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 May 2026, we completed the May 2026 Offering of 26,354,167 shares of common stock, which share amount includes the exercise in full of the underwriters' option to purchase an additional 3,437,500 shares, at an offering price of $12.00 per share.

We received proceeds of $296.8 million, which was net of $19.4 million in underwriting discounts and other offering expenses.

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, 2026, we had received $5.0 million in upfront consideration, $3.4 million in conjunction with transfer of active pharmaceutical ingredient and other materials, and $10.0 million in milestone payments pursuant to the Elevar Agreement.

In September 2024, we completed a public offering, or 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.

As of June 30, 2026, we had received $5.0 million in upfront consideration, $3.7 million in conjunction with transfer of active pharmaceutical ingredient and other materials, and $10.0 million in milestone payments 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.

We received proceeds of $218.2 million, which was net of $11.8 million in underwriting discounts and other offering expenses.

1 unchanged sentence

In August 2024, we 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.

As of March 31, 2026, we sold 14,141,569 shares of common stock under the 2024 Sales Agreement, from which we received $140.4 million in gross proceeds.

As of June 30, 2026, we sold 16,006,569 shares of common stock under the 2024 Sales Agreement, from which we received $163.0 million in gross proceeds.

In connection therewith, we paid $3.8 million in commissions to TD Securities, yielding $159.2 million in net proceeds.

The following table summarizes our sources and uses of cash for each of the periods presented:

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

Cash used in operating activities

Cash provided by investing activities

Cash (used in) provided by investing activities

Cash provided by financing activities

1 unchanged sentence

Operating Activities

During the three months ended March 31, 2026, we used $51.1 million of cash on operating activities, primarily resulting from our net loss of $73.3 million, offset by non-cash charges of $10.3 million and cash provided by changes in our operating assets and liabilities of $11.9 million.

During the three months ended March 31, 2025, we used $73.2 million of cash on operating activities, primarily 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.

During the six months ended June 30, 2026, we used $105.2 million of cash on operating activities, primarily resulting from our net loss of $157.0 million, offset by non-cash charges of $19.2 million and cash provided by changes in our operating assets and liabilities of $32.6 million.

During the six months ended June 30, 2025, we used $128.5 million of cash on operating activities, primarily resulting from our net loss of $147.4 million 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.

Investing Activities

During the three months ended March 31, 2026, net cash provided by investing activities was $32.9 million, consisting of $32.9 million in proceeds from net maturities of investments.

During the three months ended March 31, 2025, net cash used in 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.

During the six months ended June 30, 2026, net cash used in investing activities was $320.1 million, consisting of $320.1 million in net purchases of investments.

During the six months ended June 30, 2025, net cash used in 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.

Financing Activities

During the three months ended March 31, 2026, net cash provided by financing activities was $138.8 million, consisting of $137.1 million in net proceeds from at-the-market offerings, as well as $1.7 million from the exercise of stock options.

During the three months ended March 31, 2025, net cash provided by financing activities was $0.

During the six months ended June 30, 2026, net cash provided by financing activities was $462.5 million, consisting of $456.0 million in net proceeds from at-the-market and follow-on offerings, as well as $6.5 million from the exercise of stock options and purchases under our 2020 Employee Stock Purchase Plan, or ESPP.

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 ESPP.

Funding Requirements

1 unchanged sentence

In addition, we continue to incur additional costs associated with operating as a public company.

As of March 31, 2026, we had cash, cash equivalents, and investments of $642.1 million.

As of June 30, 2026, we had cash, cash equivalents, and investments of $910.9 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.

28 unchanged sentences

Contractual Obligations and Commitments

There were no material changes to our contractual obligations and commitments during the three months ended March 31, 2026.

There were no material changes to our contractual obligations and commitments during the three months ended June 30, 2026.

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, 2025, 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, 2025 filed with the SEC on February 26, 2026, 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.

There have been no material changes to these critical accounting policies and estimates through March 31, 2026 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2025.

There have been no material changes to these critical accounting policies and estimates through June 30, 2026 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2025.

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.

As of March 31, 2026, our cash equivalents consisted of money market funds.

As of March 31, 2026, our investments consisted of investments in U.S.

As of June 30, 2026, our cash equivalents consisted of money market funds.

As of June 30, 2026, 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.

As of March 31, 2026, we estimate that such hypothetical 100 basis point adverse movement would not result in a material impact on our condensed consolidated results of operations.

As of March 31, 2026, we had no debt outstanding and, therefore, are not exposed to interest rate risk with respect to debt.

As of June 30, 2026, we estimate that such hypothetical 100 basis point adverse movement would not result in a material impact on our condensed consolidated results of operations.

As of June 30, 2026, 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.

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, 2026 and 2025.

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, 2026 and 2025.

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.

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of March 31, 2026, our disclosure controls and procedures were effective.

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of June 30, 2026, our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

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, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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, 2026 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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis