What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-02-28 compared with 2024-03-05 · 94 added, 65 removed, 284 unchanged (36% of the section changed)

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

For our most advanced product candidate under the Cerebrum™ platform, ulixacaltamide (formerly known as PRAX-944), we expect to announce topline results from the Phase 3 Essential3 clinical trial in essential tremor, or ET, in the second half of 2024.

Within our PRAX-628 program, we initiated a Phase 2a Photo-Paroxysmal Response, or PPR, study of PRAX-628 in the second quarter of 2023 and expect to report topline results in the first quarter of 2024.

We also plan to initiate a Phase 2b study of PRAX-628 in focal epilepsy in the second half of 2024.

Our PRAX-562 Phase 2 EMBOLD study was initiated in the first quarter of 2023, with initial cohorts in SCN2A-DEE and SCN8A-DEE, and we expect to announce topline results for both cohorts in mid-2024.

For our most advanced product candidate under the Solidus™ platform, PRAX-222, we initiated the EMBRAVE study in the second quarter of 2023, which was completed in the fourth quarter of 2023.

For our most advanced product candidate under the Cerebrum™ platform, ulixacaltamide, our Phase 3 Essential3 clinical trials in essential tremor, or ET, are ongoing.

A pre-planned interim analysis of Study 1 was conducted in the first quarter of 2025.

The Independent Data Monitoring Committee, or IDMC, overseeing the interim analysis of Study 1 of the Essential3 program has provided Praxis with the outcome of such analysis.

Based on the predefined decision framework for Study 1, the IDMC has recommended that the study be stopped for futility, due to the results being unlikely to meet the primary efficacy endpoint under the parameters set by the statistical model.

The committee also indicated that some underlying assumptions of the statistical model might have influenced this outcome and encouraged us to explore alternative analysis methods.

Given the advanced state of enrollment for both Study 1 and Study 2 in the Essential3 program, and in the context of the advice received by the IDMC, we have decided to continue both studies to completion, with topline results expected in the third quarter of 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.

Within our vormatrigine program (formerly known as PRAX-628), we announced positive results from our Photo-Paroxysmal Response ("PPR") study in the first quarter of 2024, and have initiated or plan to initiate four studies to generate patient eligibility, efficacy, safety and pharmacokinetics (PK) data for the program.

We initiated the EMPOWER study, an observational study of vormatrigine in patients with epilepsy, in the third quarter of 2024, and initiated or plan to initiate three efficacy studies.

The first efficacy study, RADIANT, is an open label eight-week study in patients with focal onset seizures or generalized epilepsy that is currently enrolling, with topline results expected by mid-year 2025.

We have also initiated the POWER1 study, a double-blind, placebo-controlled, 12-week study in focal onset seizures, with topline results expected in the second half of 2025, and plan to begin enrollment in the POWER2 study, a third efficacy study, in the second half of 2025.

Within 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 have initiated enrollment of the second cohort, with topline results expected in the first half of 2026.

We also plan to initiate the EMERALD study in a broader developmental and epileptic encephalopathies, or

DEE, patient population by mid-year 2025.

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 plan to initiate EMBRAVE3, a Phase 3 registrational study, by mid-year 2025.

For further details on our business, refer to the Business section of Part I of this report.

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As of December 31, 2024, we had an accumulated deficit of $836.7 million.

We expect to incur significant expenses and operating losses for the foreseeable future as

we expand our research and development activities.

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

In addition, our losses from operations may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.

We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:

• advance our lead product candidate, ulixacaltamide, through the Phase 3 Essential3 clinical trial program for ET;

• advance our PRAX-562 product candidate in the EMBOLD clinical trial;

• advance our PRAX-222 product candidate in the EMBRAVE clinical trial;

• advance our PRAX-628 product candidate in the Phase 2a PPR clinical trial and begin the Phase 2 focal epilepsy clinical trial;

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

• advance our lead product candidate, ulixacaltamide, through completion of the Phase 3 Essential3 clinical trial program for ET;

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

• advance vormatrigine (formerly PRAX-628) in efficacy clinical trials for focal onset seizures or generalized epilepsy;

• advance elsunersen (formerly PRAX-222) into the pivotal stage of the program;

• advance our preclinical candidates to clinical trials;

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In November 2021, we entered into an Open Market Sale Agreement, or the 2021 Sales Agreement, with Jefferies LLC, or Jefferies, to provide for the offering, issuance and sale of up to an aggregate amount of $125.0 million of common stock from time to time in at-the-market offerings for which Jefferies acted as sales agent.

The 2021 Sales Agreement was terminated in June 2023.

During the year ended December 31, 2023, we issued and sold an aggregate of 952,794 shares under the 2021 Sales Agreement for aggregate net proceeds of $24.1 million, after deducting commissions and offering expenses payable by us.

We terminated the 2021 Sales Agreement in June 2023.

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(i) an aggregate of 4,296,646 shares of common stock at a public offering price of $14.25 per share, including the underwriters' full exercise of their option to purchase 619,979 additional shares of common stock, and (ii) pre-funded warrants to purchase 470,000 shares of common stock at a public offering price of $14.2485 per share.

The purchase price per share for each pre-funded warrant represents the per share offering price for the common stock, less the $0.0015 per share exercise price for each underlying

The purchase price per share for each pre-funded warrant represents the per share offering price for the common stock, less the $0.0015 per share exercise price for each underlying share.

Total net proceeds generated from the offering were approximately $63.4 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.

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 in at-the-market offerings.

As of December 31, 2024, all warrants associated with this offering were exercised on a cashless basis with no proceeds received by us.

The 2023 Sales Agreement was terminated in January 2024.

During the year ended December 31, 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 issued and sold 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 year ended December 31, 2023, we issued and sold an aggregate of 212,453 shares under the 2023 Sales Agreement for aggregate net proceeds of $4.0 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 December 31, 2023, we had cash and cash equivalents of $81.3 million.

We expect that our current cash and cash equivalents, which includes proceeds from our January 2024 public offering and at-the-market offerings, will be sufficient to fund our operating expenditures and capital expenditure requirements necessary to advance our research efforts and clinical trials into 2026.

As of December 31, 2024, 152,145 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 March 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 from time to time in at-the-market offerings.

During the year ended December 31, 2024, we issued and sold an aggregate of 1,614,975 shares under the March 2024 Sales Agreement for aggregate net proceeds of $113.1 million, after deducting commissions and offering expenses payable by us.

In April 2024, we completed a public offering of:

(i) an aggregate of 3,849,558 shares of our common stock at a public offering price of $56.50 per share, including the underwriters' full exercise of their option to purchase 530,973 additional shares of common stock, and (ii) pre-funded warrants to purchase 221,238 shares of common stock at a public offering price of $56.4999 per share of common stock underlying the warrants.

The purchase price per share for 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 $216.0 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.

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

During the year ended December 31, 2024, we issued and sold an aggregate

of 16,487 shares under the amended March 2024 Sales Agreement for aggregate net proceeds of $1.0 million, after deducting commissions and offering expenses payable by us.

As of December 31, 2024, we had cash, cash equivalents and marketable securities of $469.5 million.

We expect that our cash, cash equivalents, and marketable securities as of December 31, 2024 will be sufficient to fund our operating expenditures and capital expenditure requirements necessary to advance our research efforts and clinical trials int o 2028.

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

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Stockholders who would otherwise be entitled to receive fractional shares as a result of the Reverse Stock Split were entitled to a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing price per share of the common stock (as adjusted for the Reverse Stock Split) on the Nasdaq Global Select Market on November 28, 2023, the last trading day immediately preceding the Effective Time.

Restructuring

In June 2022, we began a strategic realignment across our Cerebrum™ and Solidus™ platforms, which resulted in a reduction of our workforce.

We incurred $1.0 million of costs related to the realignment, of which $0.6 million was recognized in research and development expenses and $0.4 million was recognized in general and administrative expenses in the consolidated statement of operations during the year ended December 31, 2022.

These costs related to employee severance, benefits and related costs.

As of December 31, 2022, all costs related to the strategic realignment had been paid.

Financial Operations Overview

We have not generated any revenue since inception and do not expect to generate any revenue from the sale of products for several years, if at all.

We have not generated any revenue from the sale of products since inception and do not expect to generate any revenue from the sale of products for several years, if at all.

As discussed in Note 9 to our audited consolidated financial statements, we entered into an Option and License Agreement, or the Collaboration Agreement, with UCB Biopharma SRL, or UCB, in December 2022.

We recognized $2.4 million of collaboration revenue from the Collaboration Agreement during the year ended December 31, 2023 and did not recognize any revenue from the Collaboration Agreement during the year ended December 31, 2022.

We recognized $8.6 million and $2.4 million, respectively, of collaboration revenue from the Collaboration Agreement during the years ended December 31, 2024 and 2023.

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

Operating Expenses

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The capitalized amounts are expensed as the related goods are delivered or the services are performed.

As a company operating in a virtual environment, a significant portion of our research and development costs have been external costs.

As a company operating in a virtual environment, a significant portion of our research and development costs have been external costs incurred by third-parties.

We track direct external research and development expenses to specific platforms and product candidates upon commencement.

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$ 93,591 $ 31,680

18,449 17,500

Personnel-related (including stock-based compensation) 43,407 28,904

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A change in any of these variables with respect to the development of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product candidate.

For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial

resources and time to complete our clinical development activities.

We may never obtain regulatory approval for any of our product candidates.

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Collaboration Revenue

The $2.4 million increase in collaboration revenue is associated with the revenue recorded as research services provided and costs incurred under the Collaboration Agreement with UCB that was executed in December 2022.

The $6.1 million increase in collaboration revenue is associated with an increase in revenue recorded under the Collaboration Agreement with UCB that was executed in December 2022.

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.

Upon notice of the exercise, we recognized a $6.0 million option exercise fee, and also recognized the remaining $2.6 million of collaboration revenue associated with the $5.0 million up front payment earned upon execution of the Collaboration Agreement.

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

Research and Development Expense

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Total research and development expenses $ 152,413 $ 86,766 $ 65,647

The $68.3 million decrease in research and development expenses was primarily attributable to the following:

• $61.4 million decrease in expense related to our Cerebrum™ platform, driven primarily by:

◦ $29.9 million decrease in clinical-related spend for our PRAX-114 program due to our strategic realignment in the second quarter of 2022;

◦ $15.5 million decrease in spend for our PRAX-562 program primarily related to the prior year manufacturing spend and Phase 1 trial spending, partially offset by costs related to our EMBOLD Phase 2 clinical trial in 2023;

◦ $11.3 million decrease in spend for our ulixacaltamide program, primarily due to prior year Phase 2a and Phase 1 trial spend, prior year manufacturing costs, and decreased spend in the current year related to our Essential1 study, partially offset by costs related to our Essential3 study, which we initiated in the fourth quarter of 2023;

◦ $6.7 million decrease in activities for our earlier stage assets due to prioritization of our clinical-stage programs;

◦ $2.0 million increase in clinical-related spend for our PRAX-628 program driven by our Phase 1 clinical trial and our Phase 2 PPR clinical trial.

• $8.3 million decrease in personnel-related costs due to decreased headcount;

• $0.9 million increase in expense related to our Solidus™ platform for our PRAX-222 EMBRAVE study;

• $0.5 million increase in indirect expenses, none of which were individually significant.

The $65.6 million increase in research and development expenses was primarily attributable to the following:

• $61.9 million increase in expense related to our Cerebrum™ platform, driven primarily by:

◦ $49.8 million increase in spend for our ulixacaltamide program, primarily due to Essential3 study spend and Phase 1 trial spend, partially offset by completion of the Essential1 study in the prior year;

◦ $11.4 million increase in spend for our vormatrigine program, primarily driven by spend for our ENERGY program and manufacturing-related spend;

◦ $2.3 million increase in spend for our relutrigine program, primarily related to EMBOLD Phase 2 clinical trial spend;

partially offset by

◦ $1.6 million decrease in activities for our earlier stage assets;

• $14.5 million increase in personnel-related costs mainly due to increased headcount and stock-based compensation expense;

• $2.5 million increase in indirect expenses, primarily driven by increased consulting spend to support operations;

partially offset by

• $13.3 million decrease in expense related to our Solidus™ platform, primarily related to our elsunersen program, driven by a $6.9 million milestone payment to Ionis Pharmaceuticals Inc.

upon initiation of our EMBRAVE study in the prior year, as well as prior year study activity.

General and Administrative Expense

The $17.9 million decrease in general and administrative expenses was primarily attributable to the following:

• $7.6 million decrease in professional fees and consulting expenses;

• $7.4 million decrease in personnel-related costs due to decreased headcount;

• $2.9 million decrease in other general and administrative expenses.

The $14.3 million increase in general and administrative expenses was primarily attributable to the following:

• $11.7 million increase in personnel-related costs mainly due to increased stock-based compensation expense;

• $1.7 million increase in professional fees;

• $0.9 million increase in other general and administrative expenses, none of which were individually significant.

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, follow-on public offerings and at-the-market offerings under our shelf registration statement.

From inception through December 31, 2023, we have raised $617.5 million in aggregate cash proceeds from such transactions, net of issuance costs.

As of December 31, 2023, we had cash and cash equivalents of $81.3 million.

The 2021 Sales Agreement was terminated in June 2023.

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.

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 December 31, 2024, we have raised $1.1 billion in aggregate cash proceeds from such transactions, net of issuance costs.

As of December 31, 2024, we had cash, cash equivalents, and marketable securities of $469.5 million.

In November 2021, we entered into the 2021 Sales Agreement with Jefferies to provide for the offering, issuance and sale of up to an aggregate amount of $125.0 million of common stock from time to time in at-the-market offerings for which Jefferies acted as sales agent.

We terminated the 2021 Sales Agreement in June 2023.

On June 21, 2023, we completed a public offering of:

In June 2023, we completed a public offering of:

The purchase prices per share for each pre-funded warrant represents the per share offering price for the common stock, less the $0.0015 per share exercise price for each underlying share.

The purchase price per share for each pre-funded warrant represents the per share offering price for the common stock, less the $0.0015 per share exercise price for each underlying share.

Total net proceeds generated from the offering were approximately $63.4 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.

As of December 31, 2024, all warrants associated with this offering were exercised on a cashless basis with no proceeds received by us.

In December 2023, we entered into 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.

In January 2024, we issued and sold 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 December 31, 2024, 152,145 warrants associated with this offering were exercised on a cashless basis with no cash proceeds received by us.

In March 2024, we entered into the March 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 from time to time in at-the-market offerings.

In April 2024, we completed a public offering of:

The purchase price per share for 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 $216.0 million, after deducting underwriting discounts, commissions and other offering expenses payable by us.

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

During the year ended December 31, 2024, we issued and sold an aggregate of 16,487 shares under the amended March 2024 Sales Agreement for aggregate net proceeds of $1.0 million, after deducting commissions and offering expenses payable by us.

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

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Financing activities 514,323 91,871

Net increase (decrease) in cash, cash equivalents and restricted cash $ 19,685 $ (77,689)

Net increase in cash, cash equivalents and restricted cash $ 134,072 $ 19,685

Operating Activities

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The cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in operating assets and liabilities.

During the year ended December 31, 2024, net cash used in operating activities of $131.8 million was primarily due to our $182.8 million net loss and $10.9 million in changes in operating assets and liabilities primarily related to an increase in accrued expenses and accounts payable, partially offset by $40.1 million of non-cash charges primarily related to stock-based compensation.

During the year ended December 31, 2023, net cash used in operating activities of $111.1 million was primarily due to our $123.3 million net loss and $14.0 million in changes in operating assets and liabilities primarily related to a decrease in accrued expenses and accounts payable, partially offset by $26.2 million of non-cash charges primarily related to stock-based compensation.

During the year ended December 31, 2022, net cash used in operating activities of $185.0 million was primarily due to our $214.0 million net loss and $1.8 million in changes in operating assets and liabilities primarily related to a decrease in accrued expenses, partially offset by $30.8 million of non-cash charges primarily related to stock-based compensation.

Investing Activities

During the year ended December 31, 2024, net cash used in investing activities of $248.5 million primarily related to purchases of marketable securities, partially offset by maturities of marketable securities.

During the year ended December 31, 2023, net cash provided by investing activities of $39.0 million primarily related to maturities of marketable securities.

During the year ended December 31, 2022, net cash provided by investing activities of $96.9 million primarily related to maturities of marketable securities, partially offset by purchases of marketable securities.

Financing Activities

During the year ended December 31, 2024, net cash provided by financing activities of $514.3 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.

During the year ended December 31, 2023, net cash provided by financing activities of $91.9 million consisted primarily of net proceeds from our June 2023 follow-on public offering of $63.4 million and from at-the-market offerings of $28.2 million.

During the year ended December 31, 2022, net cash provided by financing activities of $10.5 million consisted primarily of net proceeds from at-the-market offerings of $9.6 million and $1.4 million in proceeds from purchases of common stock under our employee stock purchase plan and from the exercise of stock options.

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, technology 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 current cash and cash equivalents, which includes proceeds from our January 2024 public offering and at-the-market offerings, will be sufficient to fund our operating expenditures and capital expenditure requirements necessary to advance our research efforts and clinical trials into 2026.

We are unable to estimate the exact amount of our working capital requirements, but based on our current operating plan, we believe that our current cash, cash equivalents and marketable securities will be sufficient to fund our operating expenditures 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, we have entered into collaboration and license agreements with RogCon Inc., or RogCon, and Ionis Pharmaceuticals, Inc., or Ionis, under which we could be obligated to pay certain fees, milestone payments and cost reimbursements.

Under our license agreement with RogCon, Inc., or RogCon, we are obligated to reimburse RogCon for its out-of-pocket costs incurred for activities performed under the license agreement.

Under our license agreement with RogCon, we are obligated to reimburse RogCon for its out-of-pocket costs incurred for activities performed under the license agreement.

Additionally, we may be obligated to pay RogCon a milestone payment of $3.0 million and profit share payments.

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See “Business—License Agreements—License Agreement with RogCon.”

Under our collaboration agreement with Ionis Pharmaceuticals, Inc., or Ionis,, we reimbursed Ionis for identifying a development candidate and conducting an investigational new drug application, or IND, enabling toxicology study, as well as out of pocket costs incurred by Ionis related to research activities.

Under our collaboration agreement with Ionis, we reimbursed Ionis for identifying a development candidate and conducting an investigational new drug application, or IND, enabling toxicology study, as well as out of pocket costs incurred by Ionis related to research activities.

Ionis granted us an exclusive option to obtain the rights and license to further develop and commercialize the development candidate in the field of epilepsy and neurodevelopmental disorders, other than Dravet Syndrome, following the results of the IND-enabling toxicology study.

We exercised this exclusive option in January 2022 and paid a $2.0 million license fee.

In July 2023, upon initiation of the PRAX-222 EMBRAVE study in the second quarter of 2023, we paid a milestone payment of $6.9 million to Ionis.

In July 2023, upon initiation of the elsunersen EMBRAVE study in the second quarter of 2023, we paid a milestone payment of $6.9 million to Ionis.

Ionis may be entitled to additional development milestone payments, additional milestone payments, and sales royalties or sublicense fees.

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Quantitative and Qualitative Disclosures About Market Risk

We are not required to provide the information required by this Item 7A until our Quarterly Report on Form 10-Q for the first quarter after the fiscal year in which it is determined that we are no longer a smaller reporting company.

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-K

Item 7. Management’s Discussion and Analysis