What changed in this filing

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Item 1A. Risk Factors

2025-08-14 compared with 2025-05-15 · 78 added, 27 removed, 47 unchanged (69% of the section changed)

31 unchanged sentences

or regions, exemptions or exclusions that may be granted, and availability and cost of alternative sources of supply.

we plan to maintain adequate inventory of the gedatolisib active pharmaceutical ingredient (“API”) and to qualify

a second source of gedatolisib API, any imposition of, or increase in, tariffs or other restrictions on imports of equipment or other

materials (or the components of these materials) could increase the cost for such materials and also increase the prices for such materials

available domestically or locally, if any, which in turn could increase our costs.

Such cost increases could materially and adversely

affect our results of operations and financial condition.

Tariffs or other trade restrictions may lead to continuing uncertainty and

volatility in U.S.

and global financial and economic conditions and commodity markets, declining consumer confidence, significant inflation,

and diminished expectations for the economy.

we plan to maintain adequate inventory of the gedatolisib active pharmaceutical ingredient (“API”) and to qualify a second

source of gedatolisib API, any imposition of, or increase in, tariffs or other restrictions on imports of equipment or other materials

(or the components of these materials) could increase the cost for such materials and also increase the prices for such materials available

domestically or locally, if any, which in turn could increase our costs.

Such cost increases could materially and adversely affect our

results of operations and financial condition.

Tariffs or other trade restrictions may lead to continuing uncertainty and volatility

and global financial and economic conditions and commodity markets, declining consumer confidence, significant inflation, and

diminished expectations for the economy.

Such conditions could have a material adverse impact on our business, results of operations

and financial position.

at the FDA, and other government agencies from funding cuts, personnel losses, leadership changes,

regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our

clinical development programs and develop 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.

If these oversight

and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of our product candidates

could be impacted in a negative manner.

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.

at the FDA, and other government agencies from funding cuts, personnel losses, leadership changes, regulatory reform, government shutdowns

and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development programs and develop

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.

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

product candidates could be impacted in a negative manner.

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.

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

6 unchanged sentences

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:

our vulnerability to adverse economic and industry conditions;

our ability to obtain additional financing on acceptable terms or at all;

the dedication of a substantial portion of our cash flow from operations to service our indebtedness, which will reduce the amount

of cash available for other purposes;

our flexibility to plan for, or react to, changes in our business;

the interests of our existing stockholders as a result of issuing shares of our common stock upon conversion of the Notes;

us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital.

business may not generate sufficient funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under

our indebtedness, and our cash needs may increase in the future.

In addition, the A&R Loan Agreement contains, and any future indebtedness

that we may incur in the future may contain, financial and other restrictive covenants that limit our ability to operate our business,

raise capital or make payments under our other indebtedness.

If we fail to comply with these covenants or to make payments under our

indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in that and our other indebtedness

becoming immediately due and payable in full.

may be unable to raise the funds necessary to repurchase the Notes for cash following a fundamental change or to pay any cash amounts

due upon maturity and our other indebtedness may limit our ability to repurchase the Notes or to pay any cash amounts due upon their

may, subject to a limited exception, require us to repurchase their Notes following a fundamental change at a cash repurchase price generally

equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental

change repurchase date.

Upon maturity of the Notes, we must pay their principal amount and accrued and unpaid interest in cash, unless

they have been previously converted, redeemed or repurchased.

We may not have enough available cash or be able to obtain financing at

the time we are required to repurchase the Notes or pay any cash amounts due upon their maturity.

In addition, applicable law, regulatory

authorities and the agreements governing our other indebtedness may restrict our ability to repurchase the Notes or to pay any cash amounts

due upon their maturity.

Our failure to repurchase Notes or to pay any cash amounts due upon their maturity when required will constitute

a default under the Indenture.

A default under the Indenture or the fundamental change itself could also lead to a default under agreements

governing our other indebtedness, which may result in that other indebtedness becoming immediately payable in full after any applicable

notice or grace periods.

We may not have sufficient funds to satisfy all amounts due under our indebtedness.

in the Indenture could delay or prevent an otherwise beneficial takeover of us.

provisions in the Notes and the Indenture could make a third-party attempt to acquire us more difficult or expensive.

For example, if

a takeover constitutes a fundamental change, then, subject to limited exceptions, Noteholders will have the right to require us to repurchase

their Notes for cash.

In addition, if a takeover constitutes a make-whole fundamental change, then we may be required to temporarily

increase the conversion rate of the Notes.

In either case, and in other cases, our obligations under the Notes and the Indenture could

increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including

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

Unregistered Sales of Equity Securities and Use of Proceeds

4 unchanged sentences

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