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Latest 10-Q filed 11/13/2025 · Compared against 8/12/2025
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Item 1A. Risk Factors
As disclosed in "Summary of Risk Factors" and "Item 1A. 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, 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.
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
Agreement).
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
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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;
and
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.