What changed in this filing

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Item 1A. Risk Factors

2025-11-12 compared with 2025-08-12 · 70 added, 11 removed, 0 unchanged (100% of the section changed)

There have been no material

changes from the risk factors previously disclosed in Part I, Item 1A of the Form 10-K.

Investors should review the risks disclosed in

the Form 10-K and in this Report, prior to making an investment in the Company.

The business, financial condition and operating results

of the Company can be affected by a number of factors, whether currently known or unknown, including but not limited to those described

in the Form 10-K,this Report, and other reports we have filed with the SEC, any one or more of which could, directly or indirectly, cause

the Company’s actual financial condition and operating results to vary materially from past, or from anticipated future, financial

condition and operating results.

Any of these factors, in whole or in part, could materially and adversely affect the Company’s

business, financial condition, operating results and stock price.

than the following risk factor, there have been no material changes from the risk factors previously disclosed in Part I, Item 1A of

the Annual Report on Form 10-K filed on March 26, 2025.

Investors should review the risks disclosed in the Form 10-K and in this Report,

prior to making an investment in the Company.

The business, financial condition and operating results of the Company can be affected

by a number of factors, whether currently known or unknown, including but not limited to those described in the Form 10-K,this Report,

and other reports we have filed with the SEC, any one or more of which could, directly or indirectly, cause the Company’s actual

financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating

Any of these factors, in whole or in part, could materially and adversely affect the Company’s business, financial condition,

operating results and stock price.

Disruptions at the FDA, the SEC and other government

agencies, including from government shutdowns, or funding changes, or other disruptions to these agencies’ operations, could hinder

their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized

in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business

may rely, which could negatively impact our business.

Beginning on October 1, 2025, the U.S.

government shut down and remains shut down as of the date of this filing, during which time certain regulatory agencies, such as the FDA

and the SEC, have furloughed certain employees and stopped certain activities.

Additionally, on October 10, 2025, the U.S.

implemented substantial layoffs and workforce reductions in connection with the ongoing federal government shutdown, which has resulted

in the suspension or delay of various government-funded programs.

While we continue to monitor developments, there is no assurance that

affected government employees or contractors will be reinstated and that government-funded programs will resume.

The ability of the FDA

to review and approve new products, to provide feedback on clinical trials and development programs, to meet with sponsors and to otherwise

review regulatory submissions can be affected by a variety of factors, including government budget and funding levels, reductions in workforce,

ability to hire and retain key personnel and accept the payment of user fees, substantial changes in leadership and shifting policy priorities

as a result of changes in the presidential administration and its appointees tasked to oversee the agency, and statutory, regulatory,

and policy changes.

In the past, average review times at the agency have fluctuated, and this may continue in the future.

government funding of other agencies on which our operations may rely is subject to the political process, which is inherently fluid and

unpredictable.

Disruptions at the FDA and other agencies,

including as a result of reductions in force, significant organizational changes, substantial leadership departures, and policy changes,

may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would

adversely affect our business.

With the change in presidential administrations in 2025, there is substantial uncertainty as to how the

administration will continue to modify or revise the requirements and policies of the FDA and other regulatory agencies with

jurisdiction over our product candidates.

For example, the current U.S.

administration has discussed several changes to the reach and

oversight of the FDA, which could affect its relationship with the pharmaceutical industry, transparency in decision making and ultimately

the cost and availability of prescription drugs.

The impending uncertainty could present new challenges or potential opportunities as

we navigate the clinical development and approval process for our product candidates.

Additionally, over the last several years, including

for 35 days beginning on December 22, 2018, the U.S.

government has shut down several times, and certain regulatory agencies, such as

the FDA , have had to furlough critical employees and stop certain critical activities.

The current U.S.

administration also recently

announced plans to reduce the number of federal employees by establishing voluntary termination programs, by position eliminations or

by involuntary terminations.

If funding for the FDA is reduced, if the FDA workforce is reduced, or if the current government shutdown continues,

it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material

adverse effect on our business.

If we or our collaborators experience delays in obtaining approval or if we or they fail to obtain approval

of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenue will

be materially impaired.

Further, a prolonged or future shutdown of the U.S.

federal government could materially

impact the operations of the SEC.

For example, the SEC announced that during the current U.S.

federal government shutdown, it will

not declare registration statements effective.

In the event of an extended shutdown, the SEC may operate with limited staff or suspend

certain functions altogether, which could delay the review or effectiveness of our filings, including registration statements or other

financing-related disclosures.

Such delays could adversely affect our ability to access the public markets and obtain necessary capital

in order to properly capitalize and continue to fund our operations.

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