What changed in this filing

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Item 1A. Risk Factors

2025-12-11 compared with 2025-09-09 · 15 added, 26 removed, 87 unchanged (32% of the section changed)

52 unchanged sentences

to the following, may affect our ability to develop our business and operate profitably:

our ability to

obtain necessary funding to develop our proposed products;

the success of clinical trials for

our products;

our ability to obtain FDA approval

for us to market any proposed product in our pipeline in the United States;

any delays in regulatory review

and approval of product in development;

if we obtain FDA approval to market

our product, our ability to establish manufacturing and distribution operations or entering into manufacturing and distribution agreements

with qualified third parties;

our ability to obtain necessary funding to develop our proposed products;

the success of clinical trials for our products;

our ability to obtain FDA approval for us to market any proposed product in our pipeline in the United States;

any delays in regulatory review and approval of product in development;

if we obtain FDA approval to market our product, our ability to establish manufacturing and distribution operations or entering into manufacturing and distribution agreements with qualified third parties;

market acceptance of our products;

our ability to establish an effective

sales and marketing infrastructure;

our ability to protect our intellectual

competition from existing products

or new products that may emerge;

potential product liability claims

and adverse events;

our ability to adequately support

future growth;

our ability to attract and retain

key personnel to manage our business effectively.

our ability to establish an effective sales and marketing infrastructure;

our ability to protect our intellectual property;

competition from existing products or new products that may emerge;

potential product liability claims and adverse events;

our ability to adequately support future growth;

our ability to attract and retain key personnel to manage our business effectively.

Our stock price has

8 unchanged sentences

In addition, in the past, following periods of volatility in the overall market

and the market price of a company’s securities, securities class action litigation has often been instituted against companies

(primarily those that are larger than us) that experienced such volatility.

This type of litigation, if instituted against us, regardless

of its outcome, could result in substantial costs and a diversion of our management’s attention and resources.

and the market price of a company’s securities, securities class action litigation has often been instituted against companies (primarily

those that are larger than us) that experienced such volatility.

This type of litigation, if instituted against us, regardless of its

outcome, could result in substantial costs and a diversion of our management’s attention and resources.

Stockholders may experience significant

22 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