Company: PFSA
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112723
Chunk: 138

Company: Profusa, Inc.
Filing Date: 2025-11-19
Form: 10-Q
Item: Part I, Item 8
Chunk 138
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 The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. The Company is
monitoring the minimum bid price of its listed securities and is considering available options to regain compliance with
Nasdaq’s continued listing standards. There can be no assurance that the Company will be able to regain compliance with Nasdaq
Listing Rule 5450(a)(1) or maintain compliance with other applicable Nasdaq listing requirements.

Significant Risks and Uncertainties

The Company operates in a dynamic and highly competitive industry and
believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position,
results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards;
results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels;
certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory,
or other factors; and the Company’s ability to attract and retain employees necessary to support its growth.

Products developed by the Company require approvals from the U.S. Food
and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance
that the products will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable
to maintain approval, it could have a materially adverse impact on the Company.

The Company has expended and will continue to expend substantial funds
to complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional
funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive
regulatory approval. As of September 30, 2025, the Company may be required to seek additional equity or debt financing to commercialize
its products. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may
have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely
affect its business, financial condition and results of operations.

Inflation, Monetary Response, and Economic Impacts

The world economy is experiencing stubbornly high inflation, a challenge
not faced for decades. Following the global financial crisis, with inflationary pressures muted, interest rates were extremely low for
years and investors became accustomed to low volatility. The resulting easing of financial conditions supported economic growth, but it