Company: SMNR
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001193125-25-179226
Chunk: 801

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 801
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 Company’s contract
manufacturing organizations (“CMOs”) comply with Current Good Manufacturing Practice (“cGMP”) and regulatory requirements. The CMOs are selected for specific competencies having met the Company’s development,
manufacturing, quality and the FDA regulatory requirements. These CMOs manufacture the Company’s clinical supplies and commercial batches. The Company currently has no plans to build its own manufacturing or distribution infrastructure. As
clinical trial development progresses forward, the Company will continue to explore both internal capabilities as well as deepening and expanding external relationships to ensure it is able to meet manufacturing requirements.

Historically, the Company has purchased its clinical and commercial supply requirements for sodium hyaluronate, one of the excipients for SP-102, from Genzyme Corporation (“Genzyme”) pursuant to a supply agreement, which terminated as of May 31, 2024. Management anticipates that the current
on-hand supply of sodium hyaluronate will be sufficient to satisfy the Company’s clinical and commercial supply requirements for sodium hyaluronate for at least 12 months following the future
commercial launch of SP-102 estimated to be in

F-73

2027. The Company is in discussions with Sanofi S.A., an affiliate of Genzyme, for a new supply agreement, and is in the process of identifying and certifying new suppliers, in each case to
fulfill its future supply requirements for sodium hyaluronate.

Lifecore Master Services Agreement

On January 27, 2017, the Company entered into a Master Services Agreement (as amended, the “Lifecore Master Services Agreement”), with
Lifecore Biomedical, LLC (“Lifecore”). Pursuant to the Lifecore Master Services Agreement, Lifecore is responsible for clinical trial material manufacturing and development services for SP-102 as
set forth in each separate statement of work (each a “Lifecore Statement of Work”). The parties entered into a Lifecore Statement of Work on January 27, 2017, pursuant to which Lifecore agreed to provide, among other things,
(1) project management support, (2) development services, (3) clinical trial materials, and (4) stability studies. The Company paid Lifecore for the development and clinical trial material manufacturing services, which was
invoiced at the completion of each service.

For the purposes of Lifecore’s development and clinical trial material manufacturing obligations, the
Company granted Lifecore