What changed in this filing

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Item 1A. Risk Factors

2025-11-13 compared with 2025-08-14 · 23 added, 25 removed, 100 unchanged (32% of the section changed)

45 unchanged sentences

and secure approval of our product candidates in a timely manner, which would negatively impact our business.

FDA and comparable regulatory agencies in foreign jurisdictions, such as the European Medicines Agency (“EMA”), play an important

role in the development of our product candidates by providing guidance on our clinical development programs and reviewing our regulatory

submissions, including investigational new drug applications (“INDs”), requests for special designations and marketing applications.

FDA and comparable regulatory agencies in foreign jurisdictions, such as the European Medicines Agency , play an important role in the

development of our product candidates by providing guidance on our clinical development programs and reviewing our regulatory submissions,

including NDAs, investigational new drug applications (“INDs”), requests for special designations and marketing applications.

If these oversight and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of our

1 unchanged sentence

example, the recent loss of FDA leadership and personnel, and new leadership at the U.S.

Department of Health and Human Services, FDA

and the Center for Drug Evaluation and Research could lead to disruptions and delays in FDA guidance and review and approval of our product

Further, while the FDA’s review of marketing applications and other activities for new drugs is largely funded through

the user fee program established under the Prescription Drug User Fee Act, it remains unclear how the administration’s recent reduction

in force and budget cuts will impact this program and the ability of the FDA to provide guidance and review our product candidate in

a timely manner.

Department of Health and Human Services, the

FDA and the Center for Drug Evaluation and Research could lead to disruptions and delays in FDA guidance and review and approval of our

product candidate.

Further, while the FDA’s review of marketing applications and other activities for new drugs is largely funded

through the user fee program established under the Prescription Drug User Fee Act, it remains unclear how the administration’s

recent reduction in force and budget cuts will impact this program and the ability of the FDA to provide guidance and review our product

candidate in a timely manner.

is also substantial uncertainty as to how regulatory reform measures being implemented by the Trump Administration across the government

4 unchanged sentences

if any of the foregoing developments and others impact the ability of the FDA to provide us with guidance regarding our clinical development

programs or delay the agency’s review and processing of our regulatory submissions, including INDs and new drug applications, our

business would be negatively impacted.

programs or delay the agency’s review and processing of our regulatory submissions, including INDs and NDAs, our business would

be negatively impacted.

indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our

business, financial condition and results of operations and impair our ability to satisfy our debt obligations.

of June 30, 2025, we had $100.0 million aggregate principal amount of indebtedness for borrowed money, all of which was secured indebtedness

consisting of the Term Loans.

We incurred $201.25 million principal amount of additional indebtedness as a result of the offering of

We may incur additional indebtedness to meet future financing needs.

For example, we intend to draw down our $30.0 million

Term D Loan in late August 2025 prior to the expiration of the Term D Draw Period on August 31, 2025, and have an additional $50.0 million

in incremental Term Loans that can be drawn under the A&R Loan Agreement upon the achievement of certain clinical milestones.

indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial

condition by, among other things:

of September 30, 2025, we had $331.3 million aggregate principal amount of indebtedness for borrowed money, of which $130.0 million

was secured indebtedness consisting of the Term Loans.

Included in the aggregate principal amount is $201.3 million principal

amount of additional indebtedness as a result of the offering of the Notes.

We may incur additional indebtedness to meet future

financing needs.

For example, we have an additional $220.0 million in incremental Term Loans that can be drawn under the A&R

Loan Agreement upon the achievement of certain clinical milestones and product revenue thresholds.

Our indebtedness could have

significant negative consequences for our security holders and our business, results of operations and financial condition by, among

other things:

our vulnerability to adverse economic and industry conditions;

41 unchanged sentences

in a transaction that holders of our common stock may view as favorable.

Unregistered Sales of Equity Securities and Use of Proceeds

Unregistered Sales of Equity Securities

Purchases of Equity Securities

Defaults Upon Senior Securities

Mine Safety Disclosures

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 1A. Risk Factors