Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2097

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2097
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adults, with the Phase 1a goal being to establish the safety of ODA-570 and Phase 1b goals to demonstrate the generation of antibodies
following a ODA-570 administration and to find a preferred dosing regimen for the vaccine. The Phase 1a/b design is intended to allow
for cost-effective and rapid assessment of ODA-570 on a preliminary basis. We anticipate that our Phase 2 clinical trial would proceed
with the GSK RTS, S model (NCT00197041), comparing the efficacy of ODA-570 to standard of care. We expect that our Phase 3 clinical trial
of ODA-570 will likely have a similar design to the Phase 2 clinical trial, although in a greater geographic area and with a participation
of more volunteers, such as was done by GSK in the development of their RTS, S vaccine (NCT00866619). We expect the ODA-570 program to
qualify for priority NDA review based on the neglected tropical diseases qualification and, if approved, may be eligible for a tropical
disease priority review voucher.

36

The
ODA-611 and ODA-579 Plasmodium falciparum therapeutic product candidates are also in the optimization stage, with ODA-611 anticipated
to begin IND-enabling studies (including antibody humanization) within 18 months of raising sufficient capital to fund such IND projects.

The
chemical structure of ODA-579 allows for the possibility of further refinement, so we plan for limited SAR work to be conducted prior
to the initiation of IND-enabling studies. However, we believe that the relatively short manufacturing development period for small molecules,
such as ODA-579, should allow for the filing of IND applications for both ODA-579 and ODA-611 within 18 months of raising sufficient
capital to fund such IND projects.

It
is our intention that the ODA-611 and ODA-579 Plasmodium falciparum therapeutic product candidates will initially follow the clinical
development example of Takeda and AbbVie’s DSM265 (ACTRN12613000522718 and ACTRN12613000527763). The Phase 1a portion of the trial
of ODA-611 will likely be a single-ascending dose, or SAD, trial based on the expected long half-life of this antibody, that is aimed
at evaluating safety and pharmacokinetics. The Phase 1a portion of O