Item 1. Legal Proceedings
ITEM 1. LEGAL PROCEEDINGS
On August 15, 2025, a putative shareholder class
action complaint captioned Elkhodari v. Unicycive Therapeutics, Inc., et al. , Case No. 3:25-cv-06923-JD (the “Securities
Class Action”), was filed in the U.S. District Court for the Northern District of California (“Northern District of California”),
naming the Company and certain current officers and/or directors of the Company as defendants. The lawsuit generally alleges that the
Company made material misrepresentations and/or omissions of material fact relating to the Company’s manufacturing of oxylanthanum
carbonate (“OLC”) and the approval prospects of its New Drug Application for OLC for the treatment of hyperphosphatemia in
CKD patients on dialysis in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”)
and Rule 10b-5 promulgated thereunder. The putative class action is brought on behalf of persons or entities who purchased or otherwise
acquired the Company’s securities between March 29, 2024, and June 27, 2025, inclusive, and seeks unspecified monetary damages
on behalf of the putative class and an award of costs and expenses, including attorneys’ fees. On January 27, 2026, lead plaintiff
filed an amended complaint. On March 13, 2026, defendants filed their motion to dismiss the amended complaint. On April 27, 2026, lead
plaintiff filed his opposition to the motion to dismiss.
On October 30 and November 7, 2025, two purported
stockholders of the Company filed derivative complaints in the Northern District of California against certain of the Company’s
current officers and directors (collectively, the “Derivative Actions”). The Company is named as a nominal defendant. The
complaints are based on the same alleged misconduct as in the Securities Class Action. The complaints assert state law claims on behalf
of the Company against the individual defendants for breach of fiduciary duty, unjust enrichment, gross mismanagement, and waste of corporate
assets, and federal law claims under Section 14(a) of the Exchange Act. On November 20, 2025, the Court issued an order relating the
Derivative Actions to the Securities Class Action, and on April 30, 2026, the Court consolidated the Derivative Actions. The Derivative
Actions seek unspecified damages on behalf of the Company, corporate governance reforms, disgorgement and restitution, and an award of
costs and expenses, including attorneys’ fees.
On March 12, 2026, a purported stockholder made
a demand on the Company’s Board of Directors to commence a civil action against certain of the Company’s current and former
officers and directors for breaching their fiduciary duties based on the same alleged misconduct as alleged in the above-mentioned Securities
Class Action and Derivative Actions (the “Demand”). On March 30, 2026, the Company’s Board of Directors responded that
it would defer a final decision on the Demand given the pendency of the Securities Class Action and the Derivative Actions.
At this early stage of the proceedings, the Company
is unable to make any prediction regarding the outcome of the Securities Class Action, the Derivative Actions, or the Demand.
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It is possible that additional lawsuits will
be filed or allegations will be made by stockholders with respect to these same or other matters also naming the Company and/or our officers
and directors as defendants. The Company intends to vigorously defend against the claims brought by the plaintiffs in each of these matters.
Such lawsuits are subject to inherent uncertainties,
and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the pending lawsuits and any other
related lawsuits is necessarily uncertain. The Company could be forced to expend significant resources and may incur substantial legal
fees and costs in defending against the pending lawsuits and any other related lawsuits, and we may not prevail. Monitoring, initiating
and defending against legal actions is time-consuming for our management, is likely to be expensive, and may detract from the ability
to fully focus internal resources on business activities. Additionally, the Company may not be successful in having any such lawsuits
dismissed or settled within the limits of insurance coverage. Given the early stage of these lawsuits and the inherent uncertainty of
litigation, the Company cannot predict how long it may take to resolve the pending lawsuits or the potential outcome or possible amount
of any damages. As such, we currently are unable to reasonably estimate the possible losses or a range of possible losses that may result
from these matters, if any. Expenses associated with the pending lawsuits and any potential related lawsuits could be material to the
financial statements if we do not prevail in the defense of such lawsuits, or even if we do prevail.
In addition, from time to time, we may become
involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent
uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently
not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our
business, financial condition or operating results.
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