What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-05 compared with 2025-08-04 · 94 added, 85 removed, 244 unchanged (42% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (the "SEC") on February 28, 2025.

Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties.

As a result of many factors, including those factors set forth in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2024 and in the "Risk Factors" section of this Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, 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.

As a result of many factors, including those factors set forth in the “Risk Factors” sections of our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, 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 biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance.

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Our platforms utilize a deliberate, pragmatic and patient-guided approach, leveraging a suite of translational tools, including novel transgenic and predictive translational animal models and electrophysiology markers, to enable an efficient path to proof-of-concept in patients.

Through this approach, we have established a diversified, multimodal CNS portfolio with four clinical-stage product candidates across epilepsy and movement disorders.

For our vormatrigine program (formerly known as PRAX-628) within the Cerebrum™ platform, we announced positive results from our Photo-Paroxysmal Response, or PPR, study in the first quarter of 2024, and initiated the ENERGY program to generate patient eligibility, efficacy, safety and pharmacokinetics (PK) data.

Through this approach, we have established a diversified, multimodal CNS portfolio with four clinical-stage product candidates across movement disorders and epilepsy.

For our ulixacaltamide program, we announced positive topline results for the two studies in the Phase 3 Essential3 program in essential tremor in October 2025.

Following the FDA's receipt of the Essential3 topline results, the FDA granted a Type B pre-NDA meeting that is scheduled to take place in the fourth quarter of 2025.

The ENERGY program includes five studies:

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We initiated the EMPOWER study, an observational study of vormatrigine in patients with epilepsy, in the third quarter of 2024.

In August 2025, we announced positive topline results from our first efficacy study, RADIANT, an open label study in patients with focal onset seizures or generalized epilepsy.

We are currently enrolling the POWER1 study, a double-blind, placebo-controlled, 12-week study in focal onset seizures, and expect to finalize the study in the fourth quarter of 2025.

POWER2, our third efficacy study, is planned to begin in the third quarter of 2025, with enrollment expected to be completed in the second half of 2026.

We intend to initiate POWER3, a clinical trial which will assess vormatrigine as a single-agent treatment for focal onset seizures, in the first half of 2026.

In August 2025, we announced positive topline results from the first cohort of our first efficacy study, RADIANT, an open label study in patients with focal onset seizures or generalized epilepsy.

We plan to share additional RADIANT study results at the American Epilepsy Society Annual Meeting in December 2025.

We have completed recruitment of the POWER1 study, a double-blind, placebo-controlled, 12-week study in focal onset seizures, and expect to announce topline results in the first half of 2026.

POWER2, our third efficacy study, has started, with enrollment expected to be completed in the second half of 2026.

We intend to initiate POWER3, a clinical trial evaluating vormatrigine as a single-agent treatment for focal onset seizures, in the first half of 2026.

For our relutrigine program (formerly known as PRAX-562), we announced positive topline results from the first cohort of our EMBOLD study in the third quarter of 2024, and disclosed updated data from the study's open-label extension through 11 months in May 2025.

We are enrolling the second cohort of the EMBOLD study, with topline results expected no later than the first half of 2026.

In July 2025, the U.S.

Food and Drug Administration granted breakthrough therapy designation for relutrigine for the treatment of seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies, or DEEs.

We have also initiated the EMERALD study in a broader DEE patient population, and expect to complete enrollment in 2026.

For our ulixacaltamide program, we shared the results of a pre-planned statistic interim analysis of Study 1 of our Phase 3 Essential 3 clinical program for essential tremor in February 2025.

We are making certain adjustments to the analysis of the Essential3 program based upon review of blinded data, and expect to conduct and disclose

the results of such analysis by early-fall 2025.

The decision about whether the data supports the submission of an NDA will be made after analyzing the final results for Study 1 and Study 2.

In July 2025, the FDA granted breakthrough therapy designation for relutrigine for the treatment of seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies, or DEEs.

Following a comprehensive Type B meeting with the FDA, we will be performing an interim analysis of the second cohort of the ongoing EMBOLD study in the fourth quarter of 2025.

If positive, these

study results may support an NDA filing in early 2026.

We have also started enrollment of the EMERALD study that is investigating relutrigine in a broader DEE patient population, and expect to be completed in the second half of 2026.

For our most advanced product candidate under the Solidus™ platform, elsunersen (formerly known as PRAX-222), we shared results from Part 1 of the EMBRAVE study in the fourth quarter of 2023.

We are currently enrolling the second cohort of the EMBRAVE study in Brazil, with topline results expected in the first half of 2026, and have initiated EMBRAVE3, a Phase 3 registrational study for SCN2A gain-of-function DEE.

We are currently enrolling the second cohort of the EMBRAVE study in Brazil, with topline results expected in the first half of 2026.

We have initiated EMBRAVE3, a Phase 3 registrational study for SCN2A gain-of-function DEE, and expect to complete in 2026.

We also have three earlier stage novel ASOs with preclinical proof of mechanism.

PRAX-080 is focused on PCDH19 mosaic expression, PRAX-090 is targeting SYNGAP1 loss-of-function, or LoF, mutations which is a leading cause of severe intellectual disability and epilepsy in DEEs, and PRAX-100 is targeting SCN2A LoF mutations, the predominant generic link to de novo autism spectrum disorders, or ASD.

We anticipate nominating a development candidate for PRAX-100 by mid- 2025, and development candidates for PRAX-080 and PRAX-090 by the end of 2025.

We anticipate nominating a development candidate for PRAX-080, PRAX-090 and PRAX-100 in the first half of 2026.

We were incorporated in 2015 and commenced operations in 2016.

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Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates, if approved.

We have incurred recurring operating losses since inception, including a net loss of $140.4 million for the six months ended June 30, 2025.

As of June 30, 2025, we had an accumulated deficit of $977.2 million.

We have incurred recurring operating losses since inception, including a net loss of $214.4 million for the nine months ended September 30, 2025.

As of September 30, 2025, we had an accumulated deficit of $1.1 billion.

We expect to incur significant expenses and operating losses for the foreseeable future as we expand our research and development activities.

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We anticipate that our expenses will be maintained or increased in connection with our ongoing activities, as we:

• advance vormatrigine (formerly PRAX-628) in the ENERGY program;

• advance relutrigine (formally PRAX-562) in the EMBOLD and EMERALD clinical trials;

• advance elsunersen (formerly PRAX-222) in the EMBRAVE and EMBRAVE3 clinical trials;

• advance ulixacaltamide through the Phase 3 Essential3 clinical trial program for ET;

• prepare for potential commercialization of ulixacaltamide, following our positive Phase 3 results in the Essential3 clinical trial program for ET;

• advance vormatrigine in the ENERGY program;

• advance relutrigine in the EMBOLD and EMERALD clinical trials;

• advance elsunersen in the EMBRAVE and EMBRAVE3 clinical trials;

• advance our preclinical candidates to clinical trials;

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As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

Until such time as we can generate significant revenue from product sales, if ever, we expect to

finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions.

We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.

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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 be forced to reduce or terminate our operations.

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $446.6 million.

We expect that our cash, cash equivalents, and marketable securities as of June 30, 2025 will be sufficient to fund our operating expenditures and capital expenditure requirements necessary to advance our research efforts and clinical trials into 2028.

The analysis included consideration of our current financial needs and ongoing research and development plans.

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $389.2 million.

We expect that our cash, cash equivalents, and marketable securities as of September 30, 2025, together with proceeds from our follow-on pubic offering in October 2025, will be sufficient to fund our operating expenditures and capital expenditure requirements necessary to advance our program activities into 2028.

The analysis included consideration of our current financial needs and ongoing research, development and commercialization plans.

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

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As discussed in Note 7 to our condensed consolidated financial statements, we entered into an Option and License Agreement, or the Collaboration Agreement, with UCB Biopharma SRL, or UCB, in December 2022.

During the three and six months ended June 30, 2024, we recognized $0.4 million and $0.8 million of collaboration revenue, respectively.

During the three and nine months ended September 30, 2024, we recognized $0.3 million and $1.1 million of collaboration revenue, respectively.

In December 2024, UCB exercised its option to in-license global development and commercialization rights under the terms of the Collaboration Agreement.

Accordingly, we did not recognize any collaboration revenue from the Collaboration Agreement during the three and six months ended June 30, 2025.

Accordingly, we did not recognize any collaboration revenue from the Collaboration Agreement during the three and nine months ended September 30, 2025.

We have no further research service obligations under the terms of the Collaboration Agreement.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2025 2024 2025 2024

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Our income tax provision may be significantly affected by changes to our estimates.

There was no income tax provision recognized for the three and six months ended June 30, 2025 and 2024.

There was no income tax provision recognized for the three and nine months ended September 30, 2025 and 2024.

Results of Operations

Comparison of the Three Months Ended June 30, 2025 and 2024

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes our condensed consolidated statements of operations for each period presented (in thousands):

Three Months Ended

June 30, Change

September 30, Change

Collaboration revenue $ — $ 302 $ (302)

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In December 2024, UCB exercised its option to in-license global development and commercialization rights for a development candidate as part of the Collaboration Agreement.

As such, we have no further research service obligations under the terms of the Collaboration Agreement and did not record any associated revenue during the three months ended June 30, 2025.

As such, we have no further research service obligations under the terms of the Collaboration Agreement and did not record any associated revenue during the three months ended September 30, 2025.

Research and Development Expense

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Three Months Ended

June 30, Change

September 30, Change

$ 49,182 $ 27,474 $ 21,708

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• $21.7 million increase in expense related to our Cerebrum™ platform, driven primarily by:

◦ a $15.9 million increase in spend for our vormatrigine program, primarily driven by spend related to Radiant and POWER1, as well as phase 1 study spend;

◦ a $9.1 million increase in spend for our relutrigine program, primarily related to spend for our EMBOLD study, startup expense for our EMERALD study, phase 1 study spend and current quarter manufacturing spend;

◦ a $6.4 million increase in spend for our ulixacaltamide program, primarily due to Essential3 study spend;

◦ a $0.6 million increase in activities for our earlier stage assets as we advance our portfolio.

• $3.0 million increase in personnel-related costs due to increased headcount;

• $0.4 million increase in indirect expenses, none of which were individually significant;

• $0.3 million increase in expense related to our Solidus™ platform, primarily elsunersen program spend.

◦ a $14.6 million increase for our vormatrigine program, primarily driven by POWER1 and RADIANT study activities;

◦ a $13.4 million increase in spend for our relutrigine program, primarily related to EMBOLD and EMERALD study activities and manufacturing spend;

◦ a $1.9 million increase in development activities for our earlier stage assets as we advance our portfolio, partially offset by;

◦ a $8.2 million decrease in spend for our ulixacaltamide program, primarily due to decreased activity for Essential3 program and phase 1 spending.

• $1.9 million increase in expense related to our Solidus™ platform, driven primarily by elsunersen program spend for EMBRAVE3;

• $0.3 million increase in personnel-related costs and indirect expenses.

General and Administrative Expense

The $2.5 million increase in general and administrative expenses was primarily attributable to the following:

• $1.3 million increase in indirect expenses, primarily software to support operations and increased sponsorships and advocacy activities;

• $0.8 million increase in personnel-related costs due to increased headcount;

• $0.4 million increase in professional expenses primarily related to audit fees.

Other income for the three months ended June 30, 2025 and 2024 was comprised of interest income on our cash, cash equivalents and marketable securities and investment premium and discount amortization.

The $2.7 million decrease in general and administrative expenses was primarily attributable to the following:

• $2.6 million decrease in personnel-related costs due to decreased stock compensation expense;

• $0.6 million decrease in indirect expenses;

• $0.5 million increase in professional expenses.

Other income for the three months ended September 30, 2025 and 2024 was comprised of interest income on our cash, cash equivalents and marketable securities and investment premium and discount amortization.

Results of Operations

Comparison of the Six Months Ended June 30, 2025 and 2024

Comparison of the Nine Months Ended September 30, 2025 and 2024

The following table summarizes our condensed consolidated statements of operations for each period presented (in thousands):

Six Months Ended

June 30, Change

Nine Months Ended

September 30, Change

Collaboration revenue $ — $ 1,090 $ (1,090)

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In December 2024, UCB exercised its option to in-license global development and commercialization rights for a development candidate as part of the Collaboration Agreement.

As such, we have no further research service obligations under the terms of the Collaboration Agreement and did not record any associated revenue during the six months ended June 30, 2025.

As such, we have no further research service obligations under the terms of the Collaboration Agreement and did not record any associated revenue during the nine months ended September 30, 2025.

Research and Development Expense

The following table summarizes our research and development expenses for each period presented, along with the changes in those items (in thousands):

Six Months Ended

June 30, Change

Nine Months Ended

September 30, Change

$ 138,991 $ 55,226 $ 83,765

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• $83.8 million increase in expense related to our Cerebrum™ platform, driven primarily by:

◦ a $29.0 million increase in spend for our vormatrigine program, driven primarily by spend related to Radiant and POWER1, as well as phase 1 study spend;

◦ a $18.7 million increase in spend for our ulixacaltamide program, primarily due to increased Essential3 activity compared to prior year;

◦ a $13.5 million increase in spend for our relutrigine program, primarily spend for our EMBOLD study, startup expense for our EMERALD study, manufacturing spend and phase 1 study spend;

◦ a $0.9 million increase in activities for our earlier stage assets.

◦ a $43.5 million increase in spend for our vormatrigine program, primarily driven by POWER1 and RADIANT study spend as well as phase 1 study activities;

◦ a $27.0 million increase in spend for our relutrigine program, primarily related to our EMBOLD and EMERALD trial activities, manufacturing spend and Phase 1 trial spending;

◦ a $10.5 million increase in spend for our ulixacaltamide program, primarily due to Essential3 study activity;

◦ a $2.8 million increase in activities for our earlier stage assets as we advance our portfolio.

• $5.1 million increase in personnel-related costs due to increased headcount;

• $2.4 million increase in expense related to our Solidus™ platform, driven by elsunersen program spend;

• $2.2 million increase in indirect expenses driven primarily by software and consulting spend to support operations.

• $0.5 million increase in expense related to our Solidus™ platform, primarily elsunersen program spend for our EMBRAVE study and EMBRAVE3 startup costs.

General and Administrative Expense

The $1.1 million increase in general and administrative expenses was primarily attributable to the following:

• $1.6 million increase in professional expenses primarily related to consulting, legal and audit expenses;

• $1.5 million increase in indirect expenses, primarily software to support operations and increased sponsorships and advocacy activities;

The $1.6 million decrease in general and administrative expenses was primarily attributable to the following:

• $3.8 million decrease in personnel-related costs mainly due to decreased stock-based compensation expense;

Other income for the six months ended June 30, 2025 and 2024 was comprised of interest income on our cash, cash equivalents, and marketable securities and investment premium and discount amortization.

• $1.3 million increase in professional expenses primarily related to legal and audit expenses;

• $0.9 million increase in indirect expenses, including increased sponsorships and advocacy activities.

Other income for the nine months ended September 30, 2025 and 2024 was comprised of interest income on our cash, cash equivalents, and marketable securities and investment premium and discount amortization.

Liquidity and Capital Resources

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Since our inception, we have incurred significant losses in each period.

We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all.

To date, we have financed our operations primarily with proceeds from the issuance of redeemable convertible preferred stock and from the sale of common stock through an initial public offering, common stock and pre-funded warrants through follow-on public offerings and common stock from at-the-market offerings under our shelf

registration statement.

From inception through June 30, 2025, we have raised $1.2 billion in aggregate cash proceeds from such transactions, net of issuance costs.

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $446.6 million.

We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we may not generate revenue from sales of any products for several years, if at all.

From inception through September 30, 2025, we have raised $1.2 billion in aggregate cash

proceeds from such transactions, net of issuance costs.

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $389.2 million.

In December 2023, we entered into an Open Market Sale Agreement, or the 2023 Sales Agreement, with Jefferies, to provide for the offering, issuance and sale of up to an aggregate amount of $75.0 million of common stock from time to time in at-the-market offerings.

The 2023 Sales Agreement was terminated in January 2024.

During the six months ended June 30, 2024, we issued and sold an aggregate of 192,190 shares under the 2023 Sales Agreement for aggregate net proceeds of $5.3 million, after deducting commissions and offering expenses payable by us.

During the nine months ended September 30, 2024, we issued and sold an aggregate of 192,190 shares under the 2023 Sales Agreement for aggregate net proceeds of $5.3 million, after deducting commissions and offering expenses payable by us.

In January 2024, we completed a public offering of:

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Total net proceeds generated from the offering were approximately $161.6 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.

As of June 30, 2025, 352,500 warrants associated with this offering were exercised on a cashless basis with no cash proceeds received by us.

As of September 30, 2025, 352,500 warrants associated with this offering were exercised on a cashless basis with no cash proceeds received by us.

In March 2024, we entered into an Open Market Sale Agreement, or the 2024 Sales Agreement, with Jefferies, to provide for the offering, issuance, and sale of up to an aggregate amount of $150.0 million of common stock in at-the-market offerings.

During the six months ended June 30, 2024, we issued and sold an aggregate of 17,662 shares under the 2024 Sales Agreement for aggregate net proceeds of $0.9 million, after deducting commissions and offering expenses payable by us.

During the nine months ended September 30, 2024, we issued and sold an aggregate of 42,851 shares under the 2024 Sales Agreement for aggregate net proceeds of $2.3 million, after deducting commissions and offering expenses payable by us.

In April 2024, we completed a public offering of:

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Total net proceeds generated from the offering were approximately $216.0 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.

As of September 30, 2025, none of the pre-funded warrants have been exercised and all remained outstanding.

In December 2024, we entered into an amendment to the 2024 Sales Agreement with Jefferies to provide for the offering, issuance and sale of up to an aggregate of $250.0 million of common stock from time to time in at-the-market offerings.

During the six months ended June 30, 2025, we issued and sold an aggregate of 1,351,689 shares under the amended 2024 Sales Agreement for aggregate net proceeds of $83.3 million, after deducting commissions and offering expenses payable by us.

During the nine months ended September 30, 2025, we issued and sold an aggregate of 1,351,689 shares under the amended 2024 Sales Agreement for aggregate net proceeds of $83.3 million, after deducting commissions and offering expenses payable by us.

The amended 2024 Sales Agreement was terminated in September 2025.

In September 2025, we entered into a Sales Agreement, or the 2025 Sales Agreement, with TD Securities (USA) LLC, or TD Cowen, to provide for the offering, issuance and sale of up to an aggregate of $250.0 million of common stock from time to time in at-the-market offerings.

During the nine months ended September 30, 2025, we issued and sold an aggregate of 119,364 shares under the 2025 Sales Agreement for aggregate net proceeds of $5.8 million, after deducting commissions and offering expenses payable by us.

In October 2025, we completed a public offering of:

(i) an aggregate of 3,527,072 shares of our common stock at a public offering price of $157.00 per share, including the underwriters' full exercise of their option to purchase 501,592 additional shares of common stock, and (ii) pre-funded warrants to purchase 318,470 shares of common stock at a public offering price of $156.9999 per share of common stock underlying the warrants.

The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, less the $0.0001 per share exercise price of each underlying share.

Total net proceeds generated from the offering were approximately $567.0 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.

The following table provides information regarding our cash flows for each period presented (in thousands):

Six Months Ended

Nine Months Ended

September 30,

Net cash (used in) provided by:

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Our cash flows from operating activities are greatly influenced by our use of cash for operating expenses and working capital requirements to support our business.

We have historically experienced negative cash flows from

operating activities as we have invested in developing our portfolio, drug discovery efforts and related infrastructure.

We have historically experienced negative cash flows from operating activities as we have invested in developing our portfolio, drug discovery efforts and related infrastructure.

The cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in operating assets and liabilities, which are primarily the result of increased expenses and timing of vendor payments.

During the six months ended June 30, 2025, net cash used in operating activities of $107.7 million was primarily due to our $140.4 million net loss, partially offset by $17.8 million in changes in operating assets and liabilities primarily related to an increase in accounts payable and $14.9 million of non-cash charges primarily related to stock-based compensation.

During the six months ended June 30, 2024, net cash used in operating activities of $48.1 million was primarily due to our $72.2 million net loss, partially offset by $2.2 million in changes in operating assets and liabilities primarily related to increases in accounts payable and accrued expenses, and $21.9 million of non-cash charges primarily related to stock-based compensation.

During the nine months ended September 30, 2025, net cash used in operating activities of $172.7 million was primarily due to our $214.4 million net loss, partially offset by $19.7 million in changes in operating assets and liabilities primarily related to an increase in accounts payable and $22.0 million of non-cash charges primarily related to stock-based compensation.

During the nine months ended September 30, 2024, net cash used in operating activities of $75.6 million was primarily due to our $124.1 million net loss, partially offset by $15.8 million in changes in operating assets and liabilities primarily related to increases in accounts payable and accrued expenses, and $32.7 million of non-cash charges primarily related to stock-based compensation.

Investing Activities

During the six months ended June 30, 2025, net cash used in investing activities of $33.2 million was primarily related to purchases of marketable securities offset by maturities of marketable securities.

During the six months ended June 30, 2024, net cash used in investing activities of $287.1 million was primarily related to maturities of marketable securities.

During the nine months ended September 30, 2025, net cash provided by investing activities of $17.2 million was primarily related to maturities of marketable securities offset by purchases of marketable securities.

During the nine months ended September 30, 2024, net cash used in investing activities of $237.6 million was primarily related to purchases of marketable securities partially offset by maturities of marketable securities.

Financing Activities

During the six months ended June 30, 2025, net cash provided by financing activities of $82.9 million consisted primarily of net proceeds from our at-the-market offerings.

During the six months ended June 30, 2024, net cash provided by financing activities of $399.1 million consisted primarily of net proceeds from our January 2024 and April 2024 follow-on public offerings, our at-the-market offerings and our collaboration and license agreement with Tenacia Biotechnology (Shanghai) Co., Ltd.

During the nine months ended September 30, 2025, net cash provided by financing activities of $89.7 million consisted primarily of net proceeds from our at-the-market offerings.

During the nine months ended September 30, 2024, net cash provided by financing activities of $400.6 million consisted primarily of net proceeds from our January 2024 and April 2024 follow-on public offerings, our at-the-market offerings and our collaboration and license agreement with Tenacia.

Plan of Operation and Future Funding Requirements

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• seek to obtain regulatory approvals for our product candidates;

• potentially establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;

• establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;

• when needed, add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts and to support our operations as a public company;

• experience any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges.

We are unable to estimate the exact amount of our working capital requirements, but based on our current operating plan, we believe that our cash, cash equivalents, and marketable securities as of June 30, 2025 will be sufficient to fund our operating expenses and capital expenditure requirements into 2028.

We are unable to estimate the exact amount of our working capital requirements, but based on our current operating plan, we believe that our cash, cash equivalents, and marketable securities as of September 30, 2025, together with proceeds from our follow-on public offering in October 2025, will be sufficient to fund our operating expenses and capital expenditure requirements into 2028.

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

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In addition, our product candidates, if approved, may not achieve commercial success.

Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever.

Our commercial revenues, if any, will be derived

from sales of products that we do not expect to be commercially available for many years, if ever.

Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.

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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