What changed in this filing

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Item 1A. Risk Factors

2025-11-13 compared with 2025-08-12 · 52 added, 5 removed, 3 unchanged (95% of the section changed)

1 unchanged sentence

Risk Factors" in our Annual Report, there are a number of risks and uncertainties that may have a material effect on the operating results of our business and our financial condition.

There are no additional material updates or changes to our risk factors since the filing of our Annual Report.

There are no additional material updates or changes to our risk factors since the filing of our Annual Report, except as discussed below.

In evaluating our risks, readers also should carefully consider the risk factors discussed in our Annual Report, which could materially affect our business, financial condition, or operating results, in addition to the other information set forth in this report and in our other filings with the SEC.

Unregistered Sales of Equity Securities and Use of Proceeds

Defaults on Senior Securities

Mine Safety Disclosures

Not applicable.

Risks Related to Our Financial Position and Capital Needs

Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more

difficult for us to fund our operations.

On September 3, 2025, we and certain of our subsidiaries party thereto as guarantors entered into a Loan Agreement (the “Loan

Agreement”) with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership as the lenders thereunder (the

“Lenders”) and BioPharma Credit PLC as the collateral agent, each of which are investment entities managed by Pharmakon

Advisors, LP.

The Loan Agreement provides for a 5-year senior secured term loan facility of up to $125.0 million, composed of

two committed tranches:

(i) an initial tranche in an aggregate principal amount of $100.0 million, which was funded on

September 3, 2025;

and (ii) a delayed draw tranche in an aggregate principal amount of $25.0 million, which is available,

subject to certain conditions, until June 29, 2027 (such tranches, collectively, the “Term Loans”).

The Term Loans mature on

September 3, 2030 (the “Maturity Date”).

The Term Loans bear interest at Term SOFR (three-month tenor), subject to a 3.75%

floor, plus 6.50%, payable quarterly.

The Term Loans amortize in eight equal quarterly installments beginning on September

29, 2028 through the Maturity Date.

The Term Loans may be voluntarily prepaid in whole (but not in part), and are subject to

make-whole, prepayment premium and exit fees, and must be prepaid upon a Change in Control (as defined in the Loan

Our obligations under the Loan Agreement are secured by substantially all of our U.S.

assets, including intellectual property.

Certain of our subsidiaries will, on and after September 3, 2025, be required to guarantee our obligations under the Loan

Agreement and, in connection with such guarantee, pledge substantially all of their assets, including intellectual property, to

secure such guarantee.

The Loan Agreement contains customary affirmative and restrictive covenants and representations and

warranties, which place restrictions on our operating and financial flexibility.

We and our subsidiaries are bound by certain

affirmative covenants, including, without limitation, (i) information delivery requirements, (ii) obligations to maintain

insurance, (iii) preservation of intellectual property and regulatory approvals, and (iv) compliance with applicable laws.

Additionally, we and our subsidiaries are subject to certain restrictive covenants, including, without limitation, (i) limitations on

the incurrence of additional indebtedness, (ii) limitations on the incurrence of liens, (iii) restrictions on the payment of

dividends and other restricted payments, (iv) restrictions on investments, (v) restrictions on asset transfers, (vi) restrictions on

mergers and similar transactions, (vii) restrictions on amendments to organizational documents and material contracts, in each

case subject to specified exceptions, (viii) minimum net sales and (ix) minimum liquidity.

The Loan Agreement also contains customary representations and warranties, including, without limitation, with respect to (i) organization, authority and

enforceability, (ii) financial condition, (iii) compliance with laws, (iv) intellectual property and regulatory matters, and (v) the

absence of a material adverse change.

Our indebtedness could also have important negative consequences for our security holders and our business, results of

operations and financial condition, including:

• we will need to repay the indebtedness by making payments of interest and principal, which will reduce the amount of

cash available to finance our operations, our research and development efforts and other general corporate activities;

• our failure to comply with the obligations of our affirmative and restrictive covenants in the Loan Agreement could

result in an event of default that, if not cured or waived, would permit the Lenders to accelerate our obligation to repay

this indebtedness, and the Lenders could seek to enforce their security interest in the assets securing such indebtedness;

• we may be more vulnerable to downturns in our business, our industry or the economy in general.

In addition, we may borrow additional capital in the future to fund clinical development and our future growth, including

pursuant to the Loan Agreement or potentially pursuant to new arrangements with different lenders.

To the extent additional

debt is added to our current debt levels, the risks described above could increase.

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