Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1604

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1604
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Item 1A. Risk Factors.

In evaluating our business, careful consideration
should be given to the following risk factors, in addition to the other information set forth in this Annual Report and in other documents
that we file with the SEC. An investment in our securities involves a high degree of risk. You should carefully consider the risks described
below before making an investment decision. Our business, prospects, financial condition or operating results could be harmed by any of
these risks, as well as other risks not currently known to us or that we currently consider immaterial. The trading price of our securities
could decline due to any of these risks, and, as a result, you may lose all or part of your investment. Additional risks and uncertainties
not presently known to us or that we currently deem immaterial may also impair our business operations. This Annual Report also contains
forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in
the forward-looking statements as a result of a number of factors, including the risks described below. Certain statements in this “Risk
Factors” section are forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements.”

Risks Related to our Business and Industry

We have incurred significant losses in every
year since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.

We are a clinical stage biopharmaceutical company with a limited operating
history, and we have incurred significant net losses since our inception in 2016. We incurred net losses of approximately $8.3 million
and $7.3 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit
of approximately $70.9 million. We have funded our operations to date primarily with proceeds from the sale of our equity securities in
private financing transactions.

We have no products approved
for commercial sale and we are devoting, and expect to continue devoting, substantially all of our financial resources and efforts to
R&D of our only programmed CER-T cell product candidate, CER-1236, as well as to building out our manufacturing infrastructure, CDMO
relationships and CER-T cell programming technologies. Investment in biopharmaceutical product development, especially preclinical products,
is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate
will not successfully undergo or