Item 1A. Risk Factors
ITEM
1A: RISK FACTORS
Our
operations and financial results are subject to various risks and uncertainties, including those described in Part I, Item 1A, “Risk
Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026. No material
changes to such risk factors have occurred during the three months ended March 31, 2026, except as described below:
We
are involved in litigation with Villani, Inc. relating to our Spongilla-based products and commercialization activities, which could
adversely affect our business, operations, financial condition and ability to commercialize our products.
On
April 23, 2026, Villani, Inc. (“Villani”) filed a complaint against us in the U.S. District Court for the Central District
of California asserting claims for false advertising under the Lanham Act, breach of contract, and conversion, and seeking injunctive
relief. Villani has also stated that it intends to initiate an arbitration proceeding against us seeking monetary damages. Although no
arbitration demand has been served to date, we may become subject to additional claims, damages, costs, or other remedies in connection
with any such proceeding.
In
connection with the litigation, Villani sought a temporary restraining order (“TRO”) and preliminary injunction against
us. On May 6, 2026, the Court denied the TRO in part related to a breach of contract and conversion claims and granted the TRO in
part on the false or misleading advertising statements, which imposes certain temporary restrictions on specific statements the
Company can make pending further proceedings. Villani has also requested a preliminary injunction, which, if granted, could extend
or grant new restrictions imposed by the Court during the pendency of any arbitration proceeding or related litigation. We intend to
vigorously defend ourselves against these claims; however, litigation and arbitration proceedings are inherently uncertain, costly,
and time-consuming.
While
we are not currently restrained from manufacturing, promoting, advertising, using, selling, offering for sale, distributing, or
delivering in commerce any product or regimen containing Spongilla, if Villani were to obtain a preliminary injunction, arbitration
award, or otherwise, we could be restricted or delayed in our ability to market, manufacture, distribute, advertise, sell, or
commercialize certain of our current or planned products, including products containing our Spongilla . Such restrictions
could disrupt our planned product launches, impair relationships with suppliers, manufacturers, distributors, marketing partners, or
customers, require us to modify our products, branding, formulations, or marketing claims, or otherwise adversely affect our
commercialization strategy. In addition, defending this matter may require significant management attention and financial resources, result in substantial legal expenses,
divert resources from our business operations and strategic initiatives, and expose us to reputational harm.
ITEM
2: UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3: DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4: MINE SAFETY DISCLOSURES
Not
applicable.
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