What changed in this filing

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Item 1A. Risk Factors

2025-11-10 compared with 2025-08-11 · 29 added, 19 removed, 0 unchanged (100% of the section changed)

Other than as set forth below, there were no material changes from the

risk factors set forth under Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended

December 31, 2024.

You should carefully consider the risk factors set forth below and in our Annual Report on Form 10-K for the fiscal

year ended December 31, 2024, as well as other reports and statements that we file and have filed with the SEC, in addition to the other

information set forth in this report which could materially affect our business, financial condition or future results.

The risks and

uncertainties described in this report and in our Annual Report on Form 10-K for the year ended December 31, 2024, as well as other reports

and statements that we file with the SEC, are not the only risks and uncertainties facing us.

Additional risks and uncertainties not currently

known to us or that we currently deem to be immaterial may also have a material adverse effect on our financial position, results of operations

or cash flows.

Changes in tax laws

could adversely affect our business and financial condition.

Tax legislation continues to evolve globally with new laws and regulations that create uncertainty in the global economy.

For example, on July 4, 2025, legislation commonly referred to as the One Big Beautiful Bill Act (the "OBBBA") was signed into law, which includes significant provisions, including tax cut extensions and modifications to the international tax framework.

We are currently assessing the impact the OBBBA may have on our financial condition, results of operations, cash flows or effective tax rate, and will continue to evaluate the impact of the legislative changes as additional guidance becomes available.

Uncertainty remains regarding timing and interpretation by the tax authorities in the affected jurisdictions.

Future tax reform and legislative changes could have an adverse impact on our future effective tax rate, tax liabilities, and cash tax.

than as set forth below, as well as other reports and statements that we have filed with the SEC, there were no material changes from

the risk factors set forth under Part I, Item 1A., “Risk Factors” in our Annual Report on Form 10-K for the fiscal year

ended December 31, 2024.

You should carefully consider the risk factors set forth below and in our Annual Report on Form 10-K for

the fiscal year ended December 31, 2024, as well as other reports and statements that we file and have filed with the SEC, in

addition to the other information set forth in this report which could materially affect our business, financial condition or future

The risks and uncertainties described in this report and in our Annual Report on Form 10-K for the year ended December 31,

2024, as well as other reports and statements that we file with the SEC, are not the only risks and uncertainties facing us.

Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also have a material

adverse effect on our financial position, results of operations or cash flows.

Our prospects are dependent

on the successful commercialization of Tonmya.

If Tonmya is not commercially successful, our business, financial condition and results of

operations may be materially adversely affected and the price of our common stock may decline.

not able to successfully commercialize Tonmya.

Our inability to commercialize Tonmya may be based on, among other things, lack of adequate

coverage or reimbursement from third-party payors, including government health administration authorities, pharmacy benefit managers, managed

care organizations and other private health insurers;

healthcare legislative or regulatory reform measures;

lack of market acceptance;

serious adverse events or undesirable side effects;

existing, or the introduction of new, products targeting the same or similar indication;

the failure to adequately maintain the manufacturing, marketing, sales and distribution channels.

Any one or combination of these factors

would limit our ability to successfully commercialize Tonmya and would harm our business, financial condition, and results of operations.

Unregistered Sales of Equity Securities and Use of Proceeds

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