What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-05 compared with 2025-11-06 · 73 added, 127 removed, 198 unchanged (50% of the section changed)

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As a result of many factors, including those factors set forth in the "Risk Factors" section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

We are a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients.

As we believe we are among the first of a new breed of biotech created at the intersection of complementary techniques and technologies, we aim to push the boundaries of what’s possible in drug discovery.

We are a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease.

Our Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed.

Our initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications.

We have deployed our technology platform to build a pipeline of product candidates to address targets in precision medicine where there is clear evidence linking target proteins to disease and where molecular diagnostics can unambiguously identify relevant patients for treatment.

We believe this approach will increase the likelihood of successfully translating a specific pharmacological mechanism into clinical benefit.

We are advancing a pipeline of medicine candidates to address targets in precision oncology and genetic disease, including RLY-2608, our lead product candidate discussed below.

RLY-2608 is the first known allosteric, pan-mutant and isoform-selective phosphoinostide 3 kinase alpha, or PI3Kα, inhibitor in clinical development.

We are advancing a pipeline of medicine candidates to address targets in precision oncology and genetic disease, including zovegalisib (RLY-2608), our lead product candidate discussed below.

Zovegalisib (RLY-2608).

Zovegalisib is the first known allosteric, pan-mutant and isoform-selective phosphoinostide 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

o 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.

• ReDiscover Trial .

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.

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.

o 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.

• Vascular Malformations

In June 2025, we announced updated interim clinical data for the zovegalisib plus fulvestrant arm of the ReDiscover Trial from patients receiving the 600mg twice daily, or BID, fasted dose and in December 2025, we announced an efficacy subset analysis of interim clinical data for zovegalisib at the same dose.

In March 2026, we announced interim clinical data from the ReDiscover Trial of zovegalisib in combination with fulvestrant at the 400mg BID fed dose, which is the recommended Phase 3 dose in the ReDiscover-2 Trial.

In April 2026, we announced interim clinical data for the zovegalisib plus atirmociclib triplet combination.

We believe that while the clinical data from the ReDiscover Trial disclosed to date are preliminary, the data suggest differentiated interim efficacy signals in the specified patient population and support selective target engagement across doses and mutation types with an encouraging interim safety and tolerability profile.

• Vascular Anomalies

o 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.

In the first quarter of 2025, we initiated the global Phase 1/2 clinical trial for zovegalisib in patients with PIK3CA-related overgrowth spectrum, or PROS, and vascular anomalies driven by PIK3CA mutations, or the ReInspire Trial.

Enrollment is continuing in this clinical trial.

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.

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.

In our research pipeline, we are advancing our non-inhibitory chaperone for Fabry disease, as well as early-stage discovery programs across both precision oncology and genetic diseases.

We were incorporated in May 2015.

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.

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 September 30, 2025.

To date, we have principally financed our

operations through private placements of preferred stock and common stock, convertible debt, and proceeds from public offerings of our common stock.

In December 2024, we 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.

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

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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.

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.

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.

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.

Genentech elected to terminate the Genentech Agreement without cause, effective as of January 7, 2025, or the Termination Date.

As of the Termination Date, we are no longer entitled to receive any further milestones or other payments due after the Termination Date.

The parties also ceased to have any development or commercialization obligations as of the Termination Date and the licenses that we granted to Genentech pursuant to the Genentech Agreement ceased to be in effect as of the Termination Date.

We will not continue development of migoprotafib.

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.

In connection therewith, we paid $3.3 million in commissions to TD Securities, yielding $137.1 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 and nine months ended September 30, 2025 and 2024.

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.

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.

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.

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.

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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 $596.4 million as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2029.

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 have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

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Components of our Results of Operations

To date, our revenue primarily consists of amounts related to the Genentech Agreement and Elevar Agreement.

To date, our revenue primarily consists of amounts recognized under license agreements with third parties.

Operating Expenses

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Our lead product candidate is in clinical development.

We also have preclinical 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.

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.

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.

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For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant trial delays due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development.

Change in Fair Value of Contingent Consideration Liability

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

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Results of Operations

Comparison of the three months ended September 30, 2025 and 2024

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

Three Months Ended September 30,

(in thousands)

License and other revenue

Operating expenses:

Research and development expenses

Change in fair value of contingent consideration liability

General and administrative expenses

Total operating expenses

Loss from operations

Other income, net

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

Research and Development Expenses

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

Three Months Ended September 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 $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.

Change in Fair Value of Contingent Consideration Liability

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.

General and Administrative Expenses

General and administrative expenses were $12.1 million for the three months ended September 30, 2025 compared to $19.8 million for the three months ended September 30, 2024.

The decrease of $7.6 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.

Other Income, Net

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.

Comparison of the nine months ended September 30, 2025 and 2024

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

Nine Months Ended September 30,

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,

(in thousands)

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Research and development expenses

Change in fair value of contingent consideration liability

General and administrative expenses

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Other income, net

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.

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.

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.

Research and Development Expenses

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

Nine Months Ended September 30,

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

Three Months Ended March 31,

(in thousands)

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Total research and development expenses

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.

Change in Fair Value of Contingent Consideration Liability

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.

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.

General and Administrative Expenses

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.

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.

Other Income, Net

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.

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.

The decrease of $2.5 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 September 30, 2025, we had cash, cash equivalents, and investments of $596.4 million.

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

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

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In December 2024, we entered into the Elevar Agreement, pursuant to which Elevar was granted global development and commercialization rights for lirafugratinib.

As of September 30, 2025, we had received $5.0 million in upfront consideration and $3.4 million in conjunction with the transfer of active pharmaceutical ingredient and other materials from Elevar pursuant to the Elevar Agreement.

In September 2024, we completed the September 2024 Offering of 32,857,143 shares of common stock, including the exercise in full of the underwriters’ option to purchase an additional 4,285,714 shares, at an offering price of $7.00 per share.

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.

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

In August 2024, we filed a universal shelf registration statement on Form S-3ASR with the SEC, or the 2024 Shelf, to register for sale an amount of our common stock, preferred stock, debt securities, warrants and/or units in one or more offerings, which became effective upon filing with the SEC (File No.

The 2024 Shelf replaced our prior universal shelf registration statement filed with the SEC in August 2021 (File No.

333-258768), which would have expired in August 2024.

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.

In August 2024, we also entered into the 2024 Sales Agreement with TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings through TD Securities, as our sales agent.

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

In January 2024, we entered into a securities purchase agreement with Nextech Crossover I SCP for the Private Placement.

We received $29.8 million in proceeds from the Private Placement, which were net of $0.2 million in offering expenses.

Through the Termination Date, we received $120.0 million in upfront and milestone payments from Genentech pursuant to the Genentech Agreement.

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.

In connection therewith, we paid $3.3 million in commissions to TD Securities, yielding $137.1 million in net proceeds.

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

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

Cash used in operating activities

Cash provided by (used in) investing activities

Cash provided by investing activities

Cash provided by financing activities

Net (decrease) increase in cash, cash equivalents, and restricted cash

Net increase (decrease) in cash, cash equivalents, and restricted cash

Operating Activities

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.

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.

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.

Investing Activities

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.

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.

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.

Financing Activities

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.

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.

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.

Funding Requirements

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

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

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

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Contractual Obligations and Commitments

There were no material changes to our contractual obligations and commitments during the three months ended September 30, 2025.

Commitments and Contingencies, of the notes to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

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

Critical Accounting Policies and Use of Estimates

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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 September 30, 2025 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.

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.

Recently Issued and Adopted Accounting Pronouncements

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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 September 30, 2025, our cash equivalents consisted of money market funds.

As of September 30, 2025, our investments consisted of investments in U.S.

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.

treasury bills and United States agency securities that have contractual maturities of less than two years.

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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 September 30, 2025, we estimate that such hypothetical 100 basis point adverse movement would not result in a material impact on our condensed consolidated results of operations.

As of September 30, 2025, we had no debt outstanding and, therefore, are not exposed to interest rate risk with respect to debt.

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.

Foreign currency exchange risk

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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 and nine months ended September 30, 2025 and 2024.

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.

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.

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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 September 30, 2025, our disclosure controls and procedures were effective.

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.

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 September 30, 2025 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 March 31, 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