Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 124

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 124
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innate and adaptive immune systems and a sustained signaling environment. We believe this novel mechanism of action will enable our advance
of a single therapeutic construct to address the substantial unmet need for a safe and effective cell therapy offering an improved therapeutic
profile, despite significant competition. We subsequently anticipate initiating clinical trials for additional indications, including
the possible application of CER-1236 in the treatment of certain solid tumors such as EGFR mutation positive NSCLC and ovarian cancer.

Manufacturing Strategy

The manufacture of product
candidates derived from our autologous CER-1236 T cells involves the same type of equipment, materials and protocols already used in the
manufacture of currently FDA-approved CAR-T cell therapies, which we believe will provide us numerous benefits. We are planning for CER-1236
cell product to be manufactured using an automated closed process, with product manufacture continuous from bulk harvested cells through
to cryopreserved drug product bags. There are multiple factors involved in the manufacturing process needed to ensure proper CER-T cell
cryopreservation both preceding and following freezing, including the thawing process and post-thaw handling prior to patient administration.
These factors are well understood and procedures have been identified to optimize yield, activity, stability and consistency. In addition,
we may be able to take advantage of the increasing regulatory familiarity with these established protocols. Our expected manufacturing
process embraces a fully automated, closed-system design intended to minimize exposure to potential contaminants and ensure consistent
successful manufacture of the product. The product will be manufactured in a contract manufacturing facility which maintains a quality
system compliant with current Good Manufacturing Practice (“cGMP”) requirements.

Lentivirus containing CER-1236
will be produced following a cGMP process using cGMP plasmids.

We have entered into a contract
manufacturing agreement related to the production of drug product for our clinical trials, and we anticipate entering into similar arrangements
regarding plasmid, viral vector and final drug product manufacture for drug product to be used in subsequent clinical trial phases in
the future. We intend to advance related process development work both internally and with our contract manufacturing organization (“CMO”)
partners. In the event a product candidate receives regulatory approval, we anticipate entering into contract manufacturing agreements
with one or more CMOs to support product launch and commercial manufacture.

20

Intellectual Property

Intellectual property is
of vital importance in our field and in biotechnology generally. Our commercial success will depend in part on obtaining and maintaining