What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-04-30 · 103 added, 79 removed, 143 unchanged (56% of the section changed)

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Nomlabofusp Program Update

We have completed two Phase 1 clinical trials and a Phase 2 dose exploration trial, and have an ongoing Phase 2 OLE trial in patients with FA and an ongoing run-in study in adolescent patients with FA.

In May 2021, we reported positive top-line data from our Phase 1 FA program after completing dosing of the single ascending dose ("SAD") trial in December 2020 and of the multiple ascending dose ("MAD") trial in March 2021.

Data from these trials demonstrated proof-of-concept by showing that daily subcutaneous injections of nomlabofusp for up to 13 days resulted in dose-dependent increases in FXN levels from baseline compared to placebo in all evaluated tissues (buccal cells, skin, and platelets).

There were no serious adverse events associated with either the MAD or SAD trials.

In May 2023, we reported preliminary unblinded top-line data from the 25 mg cohort of the Phase 2 four-week, placebo-controlled, dose exploration trial of nomlabofusp in FA patients.

Data from the cohort indicated nomlabofusp was generally well tolerated and showed increases in FXN levels from baseline compared to placebo in all evaluated tissues (skin and buccal cells) at day 14.

In July 2023, the FDA cleared initiation of a second cohort (50 mg) of the four-week, placebo-controlled, Phase 2 dose exploration trial of nomlabofusp in patients with FA and the initiation of the OLE trial with daily dosing of 25 mg.

In February 2024, we reported positive top-line data and successful completion of the Phase 2 dose exploration study.

Nomlabofusp was generally well tolerated throughout the four-week treatment periods, had a predictable pharmacokinetic profile and led to dose dependent increases in FXN levels in all evaluated tissues (skin

and buccal cells) after daily dosing of 14 days followed by every other day dosing until day 28 in the 25 mg and 50 mg cohorts.

Participants in the 25 mg (n=13) and 50 mg (n=15) cohorts were randomized 2:1 to receive subcutaneous injections of nomlabofusp or placebo.

Patients who completed treatment in the Phase 2 dose exploration study or who previously completed a prior clinical trial of nomlabofusp are eligible to screen and possibly participate in the OLE study.

In March 2024, we dosed the first patient in the OLE trial, evaluating daily subcutaneous injections of 25 mg of nomlabofusp self-administered or administered by a caregiver.

The OLE study will evaluate the safety and tolerability, pharmacokinetics, and frataxin levels in peripheral tissues as well as other exploratory pharmacodynamic markers (lipid profiles and gene expression data) following long-term subcutaneous administration of nomlabofusp.

In addition, following the completion of enrollment, as well as at least one participant completing one year of dosing, clinical assessments collected during the study will be compared to data from a matched control arm derived from participants in the Friedreich’s Ataxia Clinical Outcome Measures Study ("FACOMS") database.

On May 30, 2024, we announced that the FDA's Center for Drug Evaluation and Research ("CDER") had selected nomlabofusp as one of a few programs for participation in the Support for Clinical Trials Advancing Rare Disease Therapeutics ("START") Pilot Program.

The objective of the program is to accelerate the development of drugs for rare diseases that lead to significant disability or death by facilitating frequent advice and regular communication with the FDA staff to expedite the review process of biologics and drugs.

In September 2024, we received access to the Medicines and Healthcare Regulatory Agency ("MHRA”) Innovative Licensing and Access Pathway (“ILAP”) for the treatment of adults and children with FA.

The ILAP is facilitating patient access to novel treatments by accelerating time to market through opportunities for enhanced engagements with UK regulatory authorities and other stakeholders.

Along with the receipt of the ILAP designation, nomlabofusp has already been granted orphan drug designations in the U.S.

and the European Union (the “EU”), and access to the PRIME scheme in the EU.

In December 2024, we reported positive initial data from the ongoing OLE study.

This data included safety, FXN levels, clinical, pharmacokinetic data and dose escalation:

• Nomlabofusp was generally well tolerated for up to 260 days in subjects.

The most common adverse events were injection site reactions, with most being mild, brief in duration, and self-limited.

Two participants had serious adverse events (one seizure and one anaphylactic reaction) that resolved within 24 hours and withdrew from the study;

• Long-term 25 mg tissue FXN levels showed positive mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90 and that 25 mg of nomlabofusp increased and maintained tissue FXN levels over time, increasing from a mean level of 15% of HV at baseline to 30% in buccal cells and from 16% to 72% in skin cells at Day 90;

• Tissue FXN levels appear to reach steady-state levels by Day 30 in buccal cells;

• Early clinical data showed trends toward improvement across a number of clinical outcomes for long-term 25 mg daily nomlabofusp including:

(1) decreased values indicating early trends towards improvement in the Modified Friedreich's Ataxia Rating Scale (mFARS) and the FARS-Activities of Daily Living ("ADL"), Modified Fatigue Impact Scale and 9 hole peg test at 90 days relative to baseline;

• Key pharmacokinetic data showed rapid absorption after subcutaneous administration with exposure appearing to reach steady state in plasma by day 30 with no further accumulation, which is consistent with data from our Phase 1 and Phase 2 studies.

Also in December 2024, we announced that we were increasing the dose in the OLE to 50 mg of nomlabofusp daily for then currently enrolled and all future OLE study participants.

We initiated human clinical studies of nomlabofusp in 2019.

Since then, we have completed two Phase 1 clinical studies, a Phase 2 dose exploration study and a PK run-in study in adolescents (12-17 years old).

In 2024, we initiated our open label extension study in patients with FA.

The open label extension study's eligibility criteria only allowed patients who previously participated in our prior nomlabofusp Phase 1 or Phase 2 studies.

In 2025, we changed the name of the open label extension study to the open label study, due to the inclusion of patients who had not participated in prior nomlabofusp clinical studies.

Our ongoing open label study is currently screening and enrolling eligible adolescents that completed dosing in the recently completed PK run-in study into the open label study.

In addition, we are also screening and enrolling patients with FA who have not participated in prior nomlabofusp clinical studies.

We are also planning to enroll children (2-11 years of age) directly into the open label study.

We have engaged in multiple discussions and interactions with the U.S.

Food and Drug Administration (“FDA”) in connection with our clinical development of nomlabofusp.

Communications remain ongoing.

We currently participate in the FDA’s Center for Drug Evaluation and Research (“CDER”) Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program.

The objective of this program is to accelerate the development of drugs for rare diseases that lead to significant disability or death by facilitating frequent advice and regular communication with the FDA staff to expedite the review process.

We have also had numerous interactions with the European Medicines Agency ("EMA") and the United Kingdom’s Medicines and Healthcare Regulatory Agency (“MHRA”) regarding the clinical development of nomlabofusp.

We have received Orphan Drug Designation and Fast Track Designation from the FDA.

We have been granted orphan drug designation in the European Union (the ”EU”) and access to the EU’s Priority Medicines Program (“PRIME”) Scheme.

We have also received access to the EMA’s Innovative Licensing and Access Pathway (“ILAP”).

All these programs are designed to facilitate drug development of therapeutics for rare and/or orphan indications.

Recent significant developments are as follows:

• In December 2024, we reported positive initial data from our ongoing open label study.

This data included safety, FXN levels, clinical and pharmacokinetic data.

Also in December 2024, we announced that we were increasing the dose in the open label study to 50 mg of nomlabofusp daily for then currently enrolled participants.

All newly enrolled participants will start dosing at 50 mg of nomlabofusp daily.

In March 2025, we announced that our Safety Monitoring Team has deemed anaphylaxis as an adverse drug reaction likely associated with nomlabofusp and therefore, we expect to see additional reactions.

To reduce the risk of allergic reactions, including anaphylaxis, we amended the OLE protocol to administer premedication for the first month of dosing.

The OLE study is ongoing with seven sites activated and participants continuing to enroll.

Active study participants are currently receiving the 50 mg dose of nomlabofusp.

We plan to provide an update on OLE data on at least 30 to 40 study participants, some of whom have been receiving nomlabofusp for more than a year, in September 2025.

In January 2025, we initiated dosing of adolescents (12-17 years old) in a PK run-in study for pediatric patients with FA.

Study participants in the PK run-in study were randomized 2:1 to receive either nomlabofusp at a weight-base dose expected to match the PK of adults receiving the 50 mg dose, or placebo, daily for seven days.

Dosing of this adolescent PK run-in study was completed in March 2025.

Following assessment of safety and PK

data, participants will be eligible to screen for the OLE study.

The data from this cohort is expected to be presented in the nomlabofusp program update in September 2025.

In February 2025, FDA accepted the data supporting the comparability of the lyophilized drug product to the frozen solution and agreed with our plans to introduce the lyophilized product into our clinical development program in mid-2025.

The frozen solution is the dosage form currently being used in the OLE.

The lyophilized drug product is the formulation that we intend to commercialize.

In March 2025, we announced that FDA stated as part of a START pilot program that it is open to considering the use of FXN concentration as a reasonably likely surrogate endpoint (“RLSE”) and the acceptability of FXN concentration as an RLSE to support will be a matter of review in a future marketing application.

FDA recommended focusing on assessments of skin FXN concentrations rather than buccal FXN concentrations due to more consistent sampling and less variability.

To reduce the risk of allergic reactions, including anaphylaxis, we amended the open label study protocol to administer premedication with antihistamines for the first month of dosing.

• In January 2025, we initiated dosing of adolescents (12-17 years old) in our PK run-in study for patients with FA.

Study participants were randomized 2:1 to receive either nomlabofusp at a weight-base dose expected to match the PK of adults receiving the 50 mg dose, or placebo, daily for seven days.

We completed dosing of 14 adolescents in March 2025.

• In February 2025, the FDA accepted the data supporting the comparability of the lyophilized drug product to the frozen solution and agreed with our plans to introduce the lyophilized product into our clinical development program.

The frozen solution is the dosage form currently being used in the open label study.

In May 2025, we began to introduce the lyophilized product formulation, which is intended for commercialization, into the open label study with new study participants.

• In March 2025, we announced that FDA stated as part of a START pilot program that it is open to considering the use of FXN concentration as a reasonably likely surrogate endpoint (“RLSE”) and the acceptability of FXN concentration as an RLSE to support accelerated approval will be a matter of review in a future marketing application.

The FDA recommended focusing on assessments of skin FXN concentrations rather than buccal FXN concentrations due to more consistent sampling and less variability.

FDA acknowledged that data we recently submitted appear to support a relationship between increased FXN concentrations in skin cells and relevant tissues such as the heart, dorsal root ganglion and skeletal muscle.

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FDA also suggested that we consider exploring the relationship between increases in FXN in skin and changes in pharmacodynamic (“PD") markers such as lipid profiles and/or clinical measures to provide additional support for the use of FXN as an RLSE.

We continue to interact with the FDA under the START pilot program, including seeking on the adequacy of the safety data set for a BLA submission seeking accelerated approval targeted for the end of 2025.

Additionally, we have obtained feedback from both FDA and EMA on the global Phase 3 study protocol and we are on track to initiate the study by mid-2025 with potential sites in the U.S., E.U., U.K, Canada, and Australia.

We continue to interact with the FDA under the START pilot program.

• In June 2025, the FDA provided safety database recommendations for a Biologics License Application, (“BLA”) seeking accelerated approval, which included evaluating safety in at least 30 participants with continuous study drug exposure for six months and a subset of at least 10 of those participants with continuous study drug exposure for one year, with the large majority of data coming from participants receiving the 50 mg dose.

In a prior communication received in March, FDA stated that it is open to the use of skin FXN concentrations as a RLSE and acknowledged the submitted data appear to support a relationship between increased skin FXN and relevant tissues such as the heart, dorsal root ganglion, and skeletal muscle.

Acceptability of increases in skin FXN for accelerated approval will be decided during future BLA review.

• In July 2025, we announced the publication of nonclinical data evaluating the mechanism of action, pharmacodynamics and pharmacology of nomlabofusp as a novel FXN protein replacement therapy designed to address the underlying cause of FA in two peer-reviewed articles.

These data were included in the briefing package reviewed by the U.S.

FDA in support of using skin FXN concentrations as a RLSE for our registrational program seeking accelerated approval for nomlabofusp.

Nomlabofusp plans and milestones include the following:

• The ongoing open label study continues to enroll, and active study participants are currently receiving the 50 mg dose of nomlabofusp.

We plan to provide an update in September 2025 on open label data on at least 30 to 40 study participants who received at least one dose of nomlabofusp.

Safety and PK data from the recently completed adolescent PK run-in study are also expected as part of the September 2025 update.

• Adolescent participants from the PK run-in study are currently screening and enrolling in the open label study.

We are also screening and enrolling into the open label study patients with FA who have not participated in prior nomlabofusp clinical studies.

In addition, we plan to enroll children (2 to 11 years of age) directly into the open label study.

• In the second quarter of 2026, we plan to submit a BLA seeking accelerated approval.

• Following feedback from FDA and EMA on the study protocol, global Phase 3 study sites in the U.S., European Union, U.K., Canada, and Australia were identified and are currently being qualified and initiated.

We expect to begin patient recruitment later this year.

Financing Activities, including Recent Material Financings

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To date, we have made no sales under the 2024 ATM agreement.

Subsequent to June 30, 2025, we completed an underwritten public offering in which we issued and sold 21,562,500 shares of our common stock, including the exercise in full of the underwriters' option to purchase additional shares, at a public offering price of $3.20 per share.

We received net proceeds of approximately $65.1 million.

Critical Accounting Policies and Significant Judgments and Estimates

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We expect to increase our investment in research and development in order to advance nomlabofusp through additional clinical trials.

As a result, we expect that our research and development expenses will continue to

increase in the foreseeable future as we pursue clinical development of nomlabofusp and/or any other product candidates we develop.

As a result, we expect that our research and development expenses will continue to increase in the foreseeable future as we pursue clinical development of nomlabofusp and/or any other product candidates we develop.

Stock Compensation Expense

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Prior to May 28, 2020, we were a private company and lacked company-specific historical and implied volatility information for our common stock.

Prior to January 1, 2023, the Company estimated its expected common stock price volatility solely based on the historical volatility of publicly traded peer companies with comparable characteristics including enterprise value, risk profiles and position within the industry.

Beginning on January 1, 2023, the Company began blending its historical data starting in June 2020 (following its merger with Zafgen in 2020) with its historical peer group.

Prior to January 1, 2023, we estimated our expected common stock price volatility solely based on the historical volatility of publicly traded peer companies with comparable characteristics including enterprise value, risk profiles and position within the industry.

Beginning on January 1, 2023, we began blending our historical data starting in June 2020 (following our merger with Zafgen in 2020) with its historical peer group.

We regularly evaluate our peer group to assess changes in circumstances where identified companies may no longer be similar to us, in which case, more suitable companies whose share prices are publicly available would be utilized in the calculation.

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In January, 2025, our Board of Directors ("Board") approved the issuance of an aggregate of 200,000 performance-based restricted stock units ("RSUs") to certain of our executive officers (the "January 2025 PSU Awards").

The Board established specified performance criteria and a corresponding performance period over which such performance criteria must be achieved, the satisfaction of which are conditions to earning the January 2025 Awards and vesting of the underlying RSUs.

As of March 31, 2025, the underlying performance criteria of the January 2025 PSU Awards were determined to be not probable of achievement, and no stock-based compensation expense was recognized for the three months ended March 31, 2025.

As of June 30, 2025, the underlying performance criteria of the January 2025 PSU Awards were determined to be not probable of achievement, and no stock-based compensation expense was recognized for the three months ended June 30, 2025.

We classify stock-based compensation expense in our consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

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Results of Operations

Comparison of three months ended March 31, 2025 and 2024

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024:

Three Months Ended March 31,

Comparison of three months ended June 30, 2025 and 2024

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

Three Months Ended June 30,

(in thousands)

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Research and Development Expenses

Research and development expenses for the three months ended March 31, 2025 increased $13.6 million compared to the three months ended March 31, 2024.

The increase was primarily driven by an increase of $7.1 million in nomlabofusp manufacturing costs, an increase of $2.8 million in clinical costs primarily associated with the ongoing pediatric study which started and completed patient enrollment in the quarter ended March 31, 2025 and the start of our planned global Phase 3 study in the first quarter of 2025, an increase of $1.6 million in personnel expense due to increased headcount, and an increase of $1.2 million in consulting fees.

Research and development expenses for the three months ended June 30, 2025 increased $3.7 million compared to the three months ended June 30, 2024.

The increase in research and development expenses was primarily attributable to an increase of $2.4 million in professional consulting fees associated with ongoing clinical studies and worldwide regulatory activities, an increase of $1.3 million in personnel costs associated with increased headcount, an increase of $0.6 million in clinical costs primarily associated with the start of an anticipated confirmatory study that would be required as part of an accelerated approval of our planned BLA submission expected in the second quarter of 2026, partially offset by a decrease of $0.8 million in costs incurred under related to the Friedreich’s Ataxia Research Alliance (FARA) TRACK-FA program (a neuroimaging consortium that includes pharmaceutical, biotechnology, academic and clinical partners.

The consortium will conduct a natural history study designed to establish disease-specific neuroimaging biomarkers to track disease progression in the brain and spinal cord and provide a basis for utilizing these biomarkers in clinical trials).

General and Administrative expenses

General and administrative expenses for the three months ended March 31, 2025 increased $0.8 million compared to the three months ended March 31, 2024.

The increase in general and administrative expenses was primarily driven by an increase of $0.7 million in personnel expense, an increase of $0.5 million in consulting fees primarily associated with commercial activities, partially offset by a decrease of $0.3 million in stock compensation expense.

General and administrative expenses for the three months ended June 30, 2025 decreased $0.5 million compared to the three months ended June 30, 2024.

The decrease in general and administrative expenses was primarily due to a decrease of $0.4 million in stock compensation costs related to the full vesting of stock options granted at higher value stock options and a decrease of $0.3 million in professional service expenses primarily related to legal services performed, partially offset by an increase of $0.1 million of personnel costs associated with increased headcount.

Other Income (expense), net

Other income (expense), net was $1.9 million income in the three months ended March 31, 2025 compared to $2.1 million income in the three months ended March 31, 2024.

Other income consists primarily of interest income.

Other income (expense), net was $1.6 million income in the three months ended June 30, 2025 compared to $3.0 million income in the three months ended June 30, 2024.

The decrease relates to a lower levels of investable cash, cash equivalents and marketable securities.

Comparison of six months ended June 30, 2025 and 2024

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

Six Months Ended June 30,

(in thousands)

Statement of Operations Data:

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense), net

Research and Development Expenses

Research and development expenses for the six months ended June 30, 2025 increased $17.3 million compared to the six months ended June 30, 2024.

The increase in research and development expenses was primarily attributable to an increase of $7.1 million in nomlabofusp manufacturing costs, an increase of $3.5 million in professional consulting fees associated with increasing clinical, regulatory and quality operations, an increase of $3.4 million in clinical costs primarily associated with the start of an anticipated confirmatory study that would be required as part of an accelerated approval of our planned BLA submission expected in the second quarter of 2026, an increase of $2.9 million in personnel costs, an increase of $0.8 million in nonclinical costs related to assay development, and partially offset by a decrease of $0.8 million in costs incurred under the TRACK-FA program discussed above.

General and Administrative expenses

General and administrative expenses for the six months ended June 30, 2025 increased $0.3 million compared to the six months ended June 30, 2024.

The increase in general and administrative expenses was primarily due to an increase of $0.8 million in personnel costs and an increase of $0.3 million in professional services primarily related to consulting fees associated with ongoing pre-commercial pre-launch activities, partially offset by a decrease of $0.7 million in stock compensation costs related to the full vesting of stock options granted at higher value stock options higher value stock options than those that have recently been granted.

Other Income (expense), net

Other income (expense), net was $3.5 million income in the six months ended June 30, 2025 compared to $5.1 million income in the six months ended June 30, 2024.

The decrease primarily relates to a lower levels of investable cash, cash equivalents and marketable securities.

Liquidity and Capital Resources

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

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Net cash used in operating activities

During the three months ended March 31, 2025, operating activities used $26.5 million of cash, resulting from our net loss of $29.3 million, adjusted for noncash expenses of $1.1 million and changes in our operating assets and liabilities resulting in a source of cash of $1.6 million.

During the six months ended June 30, 2025, operating activities used $45.9 million of cash, resulting from our net loss of $55.5 million, adjusted for noncash expenses of $2.5 million and changes in our operating assets and liabilities resulting in a source of cash of $7.1 million.

Our net loss was primarily attributed to research and development activities related to our nomlabofusp program and our general and administrative expenses as described above.

Noncash expenses are primarily stock-based compensation expenses.

The change in operating assets and liabilities was primarily due to an increase in accounts payable and decrease in both prepaid expense and accrued expenses.

During the three months ended March 31, 2024, operating activities used $10.4 million of cash, resulting from our net loss of $14.7 million, adjusted for noncash expenses of $1.6 million and changes in our operating assets and liabilities resulting in a source of cash of $2.7 million.

Noncash expenses primarily relate to stock-based compensation expenses.

The change in operating assets and liabilities was primarily due to a increases in prepaid expenses, accounts payable and accrued expenses.

During the six months ended June 30, 2024, operating activities used $24.4 million of cash, resulting from our net loss of $36.3 million, adjusted for noncash expenses of $2.1 million and changes in our operating assets and liabilities resulting in a source of cash of $9.7 million.

Our net loss was primarily attributed to research and development activities related to our nomlabofusp program and our general and administrative expenses as described above.

Noncash expenses are primarily stock-based compensation expenses.

The change in operating assets and liabilities was primarily due to an increase in accounts payable and accrued expenses.

The change in operating assets and liabilities was primarily due to an increase in accrued expenses and accounts payable partially offset by a decrease in prepaid expense.

Net cash provided by (used in) investing activities

During the three months ended March 31, 2025, investing activities provided $14.4 million primarily from $67.0 million of cash provided by maturities of marketable securities, partially offset by the purchase of $52.3 million in marketable securities.

During the three months ended March 31, 2024, investing activities used $68.4 million of cash to purchase $84.9 million of marketable securities, partially offset by $16.5 million of cash provided by maturities of marketable securities.

During the six months ended June 30, 2025, investing activities provided $33.3 million.

This source of cash resulted from the maturities of $113.5 million of marketable securities partially offset by purchases of $80.1 million of marketable securities.

During the six months ended June 30, 2024, investing activities used $131.9 million of cash.

This net use of cash was due to the purchase of $166.6 million of marketable securities, partially offset by $35.0 million of cash provided by maturities of marketable securities.

Net cash provided by financing activities

During the three months ended March 31, 2025, there were no financing activities.

During the three months ended March 31, 2024, financing activities provided approximately $162.2 million of cash flows primarily from an offering of common stock.

During the six months ended June 30, 2025, there were no financing activities.

During the six months ended June 30, 2024, financing activities provided $161.8 million of cash flows primarily from an offering of common stock.

Operating Capital Requirements

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We have to date incurred net losses.

We incurred net losses of approximately $29.3 million and $14.7 million for the three months ended March 31, 2025 and 2024, respectively.

As of March 31, 2025, we had an accumulated deficit of $298.4 million and cash, cash equivalents and marketable securities of $157.5 million, excluding restricted cash of $0.6 million.

We incurred net losses of approximately $55.5 million and $36.3 million for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $324.6 million and cash cash equivalents and marketable securities of $138.5 million, excluding restricted cash of $0.6 million.

Losses have resulted principally from costs incurred in connection with research and development activities, and general and administrative costs associated with the development of nomlabofusp and our operations.

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• expand our operational, financial, commercial and management systems and personnel, including personnel to support our clinical development and future commercialization efforts and our operations as a public company.

We anticipate that our current cash, cash equivalents and marketable securities will fund operations into the second quarter of 2026.

We anticipate that current cash, cash equivalents and marketable securities as of June 30, 2025,combined with the net proceeds of $65.1 million from our July, 2025 underwritten public offering, will fund operations into the fourth quarter of 2026.

If we encounter unexpected delays in our clinical trials or if there are other unanticipated changes to our operating plan from our current assumptions that negatively impact our operations, we may reduce expenditures in order to further extend our existing cash resources.

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In addition, geopolitical tensions including regional conflicts around the world, adverse macroeconomic events, including those due to inflationary pressures, rising interest rates, banking instability, monetary policy changes, changes in trade policies, including tariffs (including tariffs and trade protection measures that have been or may in the future be imposed by the U.S.

or other countries), economic slowdowns or recessions, health epidemics, unforeseen emergencies and other outbreaks of communicable diseases could disrupt our operations, the operations of third parties on which we rely or the operations of regulatory agencies we interact with in the development of nomlabofusp and any other product candidates that we may develop which may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern.

or other countries), new laws and regulations, including, but not limited to the recently enacted Public Law 119-21,economic slowdowns or recessions, health epidemics, unforeseen emergencies and other outbreaks of communicable diseases could disrupt our operations, the operations of third parties on which we rely or the operations of regulatory agencies we interact with in the development of nomlabofusp and any other product candidates that we may develop which may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern.

If we are unable to obtain sufficient funding when needed and/or on acceptable terms, we may be required to significantly curtail, delay or discontinue one or more of our research and development programs, the manufacture of clinical and commercial supplies, product portfolio expansion and/or pre commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations.

Certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

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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