What changed in this filing

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Item 1A. Risk Factors

2025-05-15 compared with 2024-11-14 · 70 added, 3 removed, 4 unchanged (95% of the section changed)

3 unchanged sentences

from the results described in or implied by the forward-looking statements contained in this Quarterly Report.

Additional risks and uncertainties

not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial

condition and/or operating results.

Except as set forth below,

there have been no material changes to the risk factors previously disclosed in such Annual Report on Form 10-K.

Additional risks and

uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business,

financial condition and/or operating results.

to trade policy, including new or increased tariffs and changing import and export regulations, could have a material adverse effect

on our business, results of operations and financial condition.

business, results of operations, and financial condition could be adversely affected by uncertainty and changes in U.S.

or international

trade policies, including tariffs, quotas, trade agreements, or other trade restrictions imposed by the U.S.

or other governments.

example, the U.S.

has instituted certain changes, and has proposed additional changes, in trade policies that include the negotiation

or termination of trade agreements, the imposition of higher tariffs on imports into the U.S., and other government regulations affecting

trade between the U.S.

and other countries.

The new tariffs and other changes in U.S.

trade policy have triggered retaliatory actions

by affected countries, and foreign governments have instituted or are considering imposing trade sanctions on U.S.

Several tariff

announcements have been followed by announcements of limited exemptions, revisions, and temporary pauses, resulting in significant uncertainty.

imposition of tariffs and other trade restrictions, as well as the escalation of trade disputes and any downturns in the global economy

resulting therefrom, could materially and adversely affect our business, financial condition and results of operations.

The extent and

duration of the tariffs and other trade restrictions and the resulting impact on general economic conditions and on our business are

uncertain and depend on various factors, such as negotiations between the U.S.

and affected countries, the responses of other countries

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.

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.

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

will impact the FDA and other federal agencies with jurisdiction over our activities.

For example, since taking office, the President

has issued a number of executive orders that could have a significant impact on the manner in which the FDA conducts its operations and

engages in regulatory and oversight activities.

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.

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