ITEM 7. MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis of our financial condition and plan of operations together with our accompanying financial statements and the related notes
appearing elsewhere in this Annual Report on Form 10-K. In addition to historical information, this discussion and analysis contains
forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those discussed
below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those
discussed in the section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K. All amounts in this
report are in U.S. dollars, unless otherwise noted.
Overview
We are a clinical-stage biotechnology company
focused on identifying, developing, and commercializing innovative therapies to address significant unmet medical needs, with an initial
focus on kidney disease. Founded in 2016, we were established to create a streamlined and efficient drug development platform capable
of accelerating the advancement of promising therapies from discovery to commercialization. Currently, our two programs are focused on
kidney disease, an area we believe we have the potential to offer medical benefit. Our initial focus is on developing drugs and getting
them approved in the U.S., and then to partner with global biopharmaceutical companies in the rest of the world. As we grow the company
and build our team, we intend to focus on identifying medical conditions within and outside of kidney disease. Our business model is
to license technologies and drugs in order to pursue development, regulatory approval, and commercialization of those products in global
markets. Many biotechnology companies utilize similar strategies of in-licensing and then developing and commercializing drugs. We believe,
however, that our management team’s broad network, expertise in the biopharmaceutical industry, and successful track record gives
us an advantage in identifying and bringing these assets into our company.
Our current development programs are focused
on two novel therapies: oxylanthanum carbonate, a next-generation phosphate binder for the treatment of hyperphosphatemia in chronic
kidney disease patients on dialysis, and UNI-494, a novel drug candidate in development for the treatment of acute kidney injury. oxylanthanum
carbonate and UNI-494 were initially developed by and licensed to us from Spectrum Pharmaceuticals (“Spectrum”) and Sphaera
Pharma, respectively. Spectrum conducted a Phase 1 clinical trial with oxylanthanum carbonate in 2012, prior to the grant of our license
in 2018. Sphaera conceived and performed initial characterization of various potential pro-drug linkers, including the initial patent
application. As discussed herein, after completing IND enabling preclinical studies, we have completed a Phase I clinical study in healthy
volunteers with UNI-494 in 2024.
Chronic kidney disease (CKD) is the gradual loss
of kidney (renal) function that can get worse over time leading to lasting damage and possibly Stage 5 or end-stage renal disease (ESRD).
CKD affects nearly 36 million Americans; approximately 550,000 of them have end stage renal disease and require dialysis. Hyperphosphatemia
is common in people with CKD and has been directly linked to increased morbidity and mortality for people on dialysis. For an estimated
75% of people in the U.S. on dialysis, hyperphosphatemia remains uncontrolled due to challenges with the six currently available phosphate
binders, namely insufficient potency, pill burden and unpalatable formulations. To address this significant and growing challenge, Unicycive
is developing oxylanthanum carbonate, which leverages proprietary nanoparticle technology to address the shortcomings of current therapies
by delivering higher potency that enables fewer and smaller pills — all in a formulation that is more acceptable for patients because
it is swallowed, not chewed. With OLC, if approved, people on dialysis and their physicians may have a better option to control hyperphosphatemia.
AKI is a sudden episode of kidney failure or
kidney damage (within the first 90 days of injury). After 90 days, the patient is considered to have progressed into CKD. AKI affects
more than 2 million U.S. patients and costs the healthcare system in excess of $9 billion per year. More than 300,000 patients per year
in the U.S. die due to AKI. Currently there are no FDA approved medicines to treat DGF and/or AKI. Treatment options for AKI include
continuous renal replacement therapy, renal transplant, and dialysis. In most cases the damage to the kidney is irreversible, and the
patient needs to have a renal transplant or be on dialysis for life. Therefore, there is a high unmet medical need. If approved, UNI-494
has the potential to be a first-in-class drug for the treatment of AKI.
Our business model is to license technologies
and drugs in order to pursue development, regulatory approval, and commercialization of those products in global markets. Many biotechnology
companies utilize similar strategies of in-licensing and then developing and commercializing drugs. We believe, however, that our management
team’s broad network, expertise in the biopharmaceutical industry, and successful track record gives us an advantage in identifying
and bringing these assets into our company.
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Since our formation we have devoted substantially
all of our resources to developing our product candidates. We have incurred significant operating losses to date. Our net losses were
$36.7 million and $26.6 million for the years ended December 31, 2024 and 2025 respectively. As of December 31, 2025, we had an
accumulated deficit of $127.8 million. We expect that our operating expenses will increase significantly as we advance our product candidates
through pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization;
acquire, discover, validate, and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property
portfolio; and hire additional personnel.
We have funded our operations primarily from
the sale and issuance of common stock, convertible promissory notes and from a loan, including cash and deferred salary from our Chief
Executive Officer and principal stockholder.
Our ability to generate product revenue will
depend on the successful development, regulatory approval and eventual commercialization of our current product candidates and future
product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations
through private or public equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources
of financing. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into agreements
to raise capital as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization
of our current product candidates and future product candidates.
We plan to continue to use third-party service
providers, including contract manufacturing organizations, to carry out our pre-clinical and clinical development and to manufacture
and supply the materials to be used during the development and commercialization of our product candidates.
Recent Developments
On October 28, 2025,we announced an update from our meeting with the
U.S. Food and Drug Administration (FDA) and timing of the resubmission of our New Drug Application (NDA) for oxylanthanum carbonate (OLC)
following receipt of a CRL on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified
in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to us, including
pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A
meeting and engaging in discussions with our third-party manufacturing vendor, we resubmitted our NDA to the FDA in December 2025. In
January 2026, the FDA accepted the resubmission of the NDA for OLC, deeming the resubmission to be a Class II complete response which
has a six-month review period from the date of resubmission, and set a PDUFA target action date of June 29, 2026
Subsequent to December 31, 2025, pursuant to a sales agreement dated November 13, 2024 between the Company and Guggenheim
Securities, LLC, as amended by Amendment No. 1 thereto dated November 14, 2025, the Company sold 3,123,537 shares of common stock at
an average price of $6.51 per share, resulting in net proceeds to the Company of approximately $19.6 million.
Components of Results of Operations
Research and Development Expenses
Substantially all of our research and development
expenses consist of expenses incurred in connection with the development of our product candidates. These expenses include fees paid
to third parties to conduct certain research and development activities on our behalf, consulting costs, costs for laboratory supplies,
product acquisition and license costs, certain payroll and personnel-related expenses, including salaries and bonuses, employee benefit
costs and stock-based compensation expenses for our research and product development employees and allocated overheads, including information
technology costs and utilities and expenses for the issuance of shares pursuant to the anti-dilution clause in the purchase of in process
research and development technology. We expense both internal and external research and development expenses as are incurred.
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We do not allocate our costs by product candidate,
as a significant amount of research and development expenses include internal costs, such as payroll and other personnel expenses, laboratory
supplies and allocated overhead, and external costs, such as fees paid to third parties to conduct research and development activities
on our behalf, are not tracked by product candidate.
We expect our research and development expenses
to increase substantially for at least the next few years, as we seek to initiate additional clinical trials for our product candidates,
complete our clinical programs, pursue regulatory approval of our product candidates and prepare for the possible commercialization of
such product candidates. Predicting the timing or cost to complete our clinical programs or validation of our commercial manufacturing
and supply processes is difficult and delays may occur because of many factors, including factors outside of our control. For example,
if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, we
could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore,
we are unable to predict when or if our product candidates will receive regulatory approval with any certainty.
General and Administrative Expenses
General and administrative
expenses consist principally of payroll and personnel expenses, including salaries and bonuses, benefits and stock-based compensation
expenses, professional fees for legal (including patent costs), consulting, accounting and tax services, including information technology
costs and utilities, and other general corporate overhead expenses.
We anticipate that our general and administrative
expenses will increase as a result of increased personnel costs, expanded infrastructure and higher consulting, legal and accounting
services costs associated with complying with the applicable stock exchange and the SEC requirements, investor relations costs and director
and officer insurance premiums associated with being a public company.
Other Expenses
Other expenses consist of the change in fair
value of our warrant liability, interest income and interest expense.
Results of Operations
Comparison of the Years Ended December 31,
2024 and 2025 (in thousands)
Years Ended December 31, %
Operating expenses:
Other income (expenses):
Interest expense (71 ) (71 ) - 0 %
Research and Development Expenses
Research and development
expenses decreased by approximately $10.9 million, or 54%, from approximately $20.0 million for the year ended December 31, 2024 to approximately
$9.1 million for the year ended December 31, 2025. This decrease was primarily driven by a reduction in drug development costs of $8.0
million and a decline in clinical costs of $3.4 million. These decreases were partially offset by increased costs, including $0.2 million
in consulting and professional services and $0.2 million in labor. Additionally, stock-based compensation rose by $0.1 million.
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General and Administrative Expenses
General and administrative expenses increased
by $8.3 million, or 69%, from approximately $12.1 million for the year ended December 31, 2024 to approximately $20.4 million for the
year ended December 31, 2025. This increase was primarily driven by a $2.4 million rise in marketing expenses associated with the commercial
launch, $3.5 million in higher consulting and professional service costs, and $1.8 million in labor and related expenses. Additionally,
rent, travel, supplies, and other costs increased by $0.5 million, while stock-based compensation grew by $0.1 million.
Other Income (Expenses)
Other income (expenses)
improved by $7.6 million, or 164%, from an expense of $4.6 million for the year ended December 31, 2024, to income of $3.0 million for
the year ended December 31, 2025. This was primarily driven by a favorable change in the fair value of our warrant liability, partially
offset by a decrease of earned interest income during the year as a result of lower average cash balances available for interest-bearing
accounts.
Liquidity and Capital Resources
Sources of Liquidity
Since our formation through December 31,
2020, we have funded our operations with the sale of common and preferred stock, convertible notes and from a loan from our Chief Executive
Officer and principal stockholder.
As a result of our initial public offering (“IPO”),
on July 13, 2021 we began trading on the Nasdaq Capital Market under the symbol “UNCY”, and on July 15, 2021 we received
approximately $22.3 million in net proceeds after deducting the underwriting discounts, commissions and offering expenses. We have used
the net proceeds from the IPO to complete pre-clinical and clinical studies, submit regulatory filings to the FDA, and for general and
corporate purposes, including hiring additional management and conducting market research and other commercial planning.
Future revenue streams may consist of collaboration
or licensing revenue as well as product sales.
On March 3, 2023, we entered into a securities
purchase agreement with certain healthcare-focused institutional investors that may provide up to $130.0 million in gross proceeds through
a private placement and that included initial upfront funding of $30.0 million.
On March 13, 2024, we entered into a securities
purchase agreement with certain accredited investors to provide $50 million in gross proceeds through a private placement. Pursuant to
the securities purchase agreement, we issued institutional purchasers $50.0 million in shares of Series B Convertible Preferred Stock.
We received $46.2 million in net proceeds.
On November 13, 2024, we entered into a sales agreement, with Guggenheim
Securities, LLC pursuant to which, we may offer and sell shares of common stock having an aggregate offering price of up to $50.0 million,
subject to certain limitations and in accordance with the terms of the sales agreement, from time to time through or to Guggenheim Securities,
LLC acting as sales agent or principal. On November 14, 2025, the Company entered into an Amendment No. 1 to sales agreement with Guggenheim
Securities LLC to increase the number of shares that may be sold under the sales agreement to $100,000,000 (collectively with the November
13, 2024 sales agreement, the “Sales Agreement”). During the period from October 1, 2025 through December 31, 2025, the Company
sold 1,263,882 shares of common stock pursuant to the Sales Agreement, at an average price of $5.77 per share and paid $0.2 million in
commissions, resulting in net proceeds to the Company of approximately $6.6 million. During the year ended December 31, 2025, the Company
sold 9,310,618 shares of common stock pursuant to the Sales Agreement, at an average price of $5.40 per share and paid $1.4 million in
commissions, resulting in net proceeds to the Company of approximately $45.2 million.
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Future Funding Requirements
We have incurred net losses since our inception.
For the year ended December 31, 2025, we had a net loss of $26.6 million, and we expect to incur substantial additional losses in future
periods. As of December 31, 2025, we had an accumulated deficit of $127.8 million.
We anticipate that our current cash will be sufficient to fund our
operations for more than 12 months from the date of this report.
We expect to continue incurring losses in the
future and will be required to raise additional capital in the future to complete our clinical trials, pursue product development initiatives
and penetrate markets for the sale of our products. We believe that we will continue to have access to capital resources through possible
equity offerings, debt financings, corporate collaborations or other means. There can be no assurance that we will be able to obtain
additional financing on terms acceptable to us, on a timely basis or at all. If we are unable to secure additional capital, we may be
required to curtail any clinical trials and development of new or existing products and take additional measures to reduce expenses in
order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. Based on our current level of expenditures,
we believe that we have sufficient resources such that there is not substantial doubt about our ability to continue operations for at
least one year after the date that these financial statements are available to be issued.
We anticipate that we will need to raise substantial
additional capital, the requirements for which will depend on many factors, including:
● the number and scope of clinical programs we decide to pursue;
● the scope and costs of development and commercial manufacturing activities;
● the impact, if any, of the coronavirus pandemic on our business operations;
● our ability to access capital;
● our implementation of operational, financial and management systems; and
● the costs associated with being a public company.
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A change in the outcome of any of these or other
variables with respect to the development of any of our current product candidates or future product candidates could significantly change
the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future,
and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating
plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing
into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur
liens or additional debt, pay dividends, repurchase our common stock, make certain investments or engage in certain merger, consolidation
or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our
stockholders.
Adequate funding may not be available to us on
acceptable terms or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and
our ability to pursue our business strategies. If we are unable to raise additional funds when needed, we may be required to delay, reduce,
or terminate some or all of our development programs and clinical trials or we may also be required to sell or license to others rights
to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves. If we are
required to enter into collaborations and other arrangements to supplement our funds, we may have to give up certain rights that limit
our ability to develop and commercialize our product candidates or may have other terms that are not favorable to us or our stockholders,
which could materially affect our business and financial condition.
Summary of Cash Flows
The following table sets forth the primary sources
and uses of cash for each of the periods presented below (in thousands):
Years ended December 31,
Net cash (used in) provided by:
Investing activities (72 ) (12,095 )
Net increase in cash and cash equivalents $ 16,441 $ 3,056
Cash Flows from Operating Activities
Net cash used in operating activities was $31.3
million for the year ended December 31, 2025. Cash used in operating activities was primarily due to the use of funds for development
costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations,
compliance, and legal services. We incurred a net loss of $26.6 million after including the effect of non-cash adjustments for stock
compensation and change in fair value of our warrant liability.
Net cash used in operating activities was $28.6
million for the year ended December 31, 2024. Cash used in operating activities was primarily due to the use of funds for development
costs associated with our drug candidates, labor costs, consulting services, and other corporate expenditures for investor relations,
compliance, and legal services. We incurred a net loss of $36.7 million after including the effect of non-cash adjustments for stock
compensation and change in fair value of our warrant liability.
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Cash Flows from Investing Activities
Net cash used in investing activities was $12.1
million for the year ended December 31, 2025 and was due primarily to the purchase of marketable securities.
Net cash used in investing activities was $72,000
for the year ended December 31, 2024 and was due to the purchase of furniture and fixtures for our corporate office.
Cash Flows from Financing Activities
Net cash provided by
financing activities was $46.5 million during the year ended December 31, 2025, due primarily to sales made under the sales
agreement with Guggenheim Securities LLC dated November 13, 2024 as amended by Amendment No. 1 thereto dated November 14, 2025.
Net cash provided by
financing activities was $45.1 million during the year ended December 31, 2024 due primarily to the private placement financing
agreement we signed on March 13, 2024 and sales made under the sales agreement with Guggenheim Securities LLC dated November 13, 2024,
partially offset by dividends paid to preferred stockholders.
Off-Balance Sheet Arrangements
As of December 31, 2025 and through the
filing date of this Annual Report on Form 10-K, we do not have any off-balance sheet arrangements, as defined in the rules and regulations
of the SEC.
Critical Accounting Policies, Significant Judgments and Use of
Estimates
Our financial statements have been prepared in
accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires
us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets
and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. Our estimates
are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results
of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under different assumptions or conditions. We consider our critical accounting
policies and estimates to be related to debt and equity classification, warrant liabilities, research and development,
and stock-based compensation. There have been no other material changes to our critical accounting policies and estimates during the
year ended December 31, 2025 from those used for the year ended December 31, 2024. The below policies represent our critical accounting
policies.
Debt and Equity Classification
In conjunction with the issuance of Series A-1
Preferred Stock in March 2023, and in conjunction with the issuance of Series B-1 Preferred Stock in March 2024, we initially account
for the preferred stock as temporary or mezzanine equity. The Series A-1 and Series B-1 Preferred Stock do not fall within the scope
of ASC 480, Distinguishing Liabilities from Equity, do not contain any embedded derivatives that require bifurcation, and are
not classified as liabilities. However, as the Series A-1 and Series B-1 Preferred Stock, at issuance, are contingently redeemable upon
the occurrence of an event that is not solely within our control, they are required to be initially classified as mezzanine equity and
measured at the amount of net proceeds received. As the Series A-1 and Series B-1 Preferred Stock are not currently redeemable or probable
of becoming redeemable, no subsequent remeasurement is required.
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Warrant Liabilities
In conjunction with the issuance of Series A-1
Preferred Stock (see Note 10), we established a warrant liability as of March 3, 2023, representing the fair value of warrants that may
be issued, subject to shareholder approval, upon conversion of the Series A-1 Preferred Stock. We account for these warrants as liabilities
(in accordance with ASC 480, Distinguishing Liabilities from Equity) on the balance sheets as a result of certain redemption clauses
that are not within the control of the Company. The warrant liabilities are initially measured at fair value, resulting in an implied
discount on the related preferred stock financing arrangement (recognized as a partial offset to the carrying value of the Series A-1
Preferred Stock), and are remeasured at fair value each reporting period. Changes in the fair value of the warrant liabilities are recognized
in earnings during each period. The warrant liabilities are measured using Level 3 fair value inputs. See Note 10 to our audited financial
statements included elsewhere in this Annual Report on Form 10-K for a description of warrant liabilities and the related valuations
Research and Development
We expense costs when incurred related to the
research and development associated with the design, development and testing of product candidates, as well as acquisition of product
candidates or compounds. Research and development expenses include fees paid to third parties to conduct certain research and development
activities on our behalf, consulting costs, costs for laboratory supplies, product acquisition and license costs, certain payroll and
personnel-related expenses, including salaries and bonuses, employee benefit costs and stock-based compensation expenses for our research
and product development employees. We expense both internal and external research and
development expenses as they are incurred.
Stock-Based Compensation
We account for stock-based
compensation for all share-based payments made to employees and non-employees by estimating the fair value on the date of grant and recognizing
compensation expense over the requisite service period on a straight-line basis. We recognize forfeitures related to stock-based compensation
as they occur. We estimate the fair value of stock options using the Black-Scholes option-pricing model. The Black-Scholes model requires
the input of subjective assumptions, including expected common stock volatility, expected dividend yield, expected term, risk-free interest
rate, and the public market closing price of the Company’s underlying common stock on the date of grant.
JOBS Act Accounting Election
On April 5, 2012, the JOBS Act was enacted.
Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period
provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging
growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We have chosen to take advantage of the extended
transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting standards until
those standards would otherwise apply to private companies provided under the JOBS Act. As a result, our financial statements may not
be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting standards.
Subject to certain conditions set forth in the
JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including, without limitation,
(i) providing an auditor’s attestation report on our internal controls over financial reporting pursuant to Section 404(b) of the
Sarbanes-Oxley Act and (ii) complying with the requirement adopted by the Public Company Accounting Oversight Board (“PCAOB”)
regarding the communication of critical audit matters in the auditor’s report on financial statements. We will remain an “emerging
growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235
billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public
offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv)
the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Recent Accounting Pronouncements
See the section titled “Summary
of Significant Accounting Policies—Recent Accounting Pronouncements” in Note 2 to our audited financial statements included
elsewhere in this Annual Report on Form 10-K for additional information.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
As a smaller reporting company, we are not required
to provide the information required by this item.
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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY
DATA
UNICYCIVE THERAPEUTICS, INC.
INDEX TO
FINANCIAL STATEMENTS
Page
Audited Financial Statements for the years ended December 31, 2024 and 2025:
Report of Independent Registered Public Accounting Firm (PCAOB ID #606) F-2
Statements of Cash Flows for the years ended December 31, 2024 and 2025 F-6
Notes to the Financial Statements F-7
F-1
Report
of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Unicycive Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Unicycive Therapeutics,
Inc. (the “Company”) as of December 31, 2024 and 2025, and the related statements of operations and comprehensive loss, mezzanine
equity and stockholders’ (deficit) equity, and cash flows for each of the years then ended, and the related notes (collectively
referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2024 and 2025, and the results of its operations and its cash flows for the years
then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ GRASSI & CO., CPAs, P.C.
We have served as the Company’s auditor
since 2023.
Jericho, New York
March 30, 2026
F-2
Unicycive Therapeutics, Inc.
Balance Sheets
(In thousands, except for share and per share
amounts)
As of As of
December 31, December 31,
Assets
Current assets:
Prepaid expenses and other current assets 4,806 7,692
Marketable securities - 12,071
Right of use asset, net 645 108
Property and equipment, net 75 66
Liabilities and stockholders’ equity
Current liabilities:
Operating lease liability - current 564 117
Operating lease liability – long term 117 -
Commitments and contingencies (Note 7)
Stockholders’ equity:
Accumulated other comprehensive loss - (1 )
Total liabilities and stockholders’ equity $ 31,668 $ 49,135
See accompanying notes to the financial statements
F-3
Unicycive Therapeutics, Inc.
Statements of Operations and Comprehensive
Loss
(In thousands, except for share and per share
amounts)
Year Ended December 31, Year Ended December 31,
Operating expenses:
Other income (expenses):
Interest expense (71 ) (71 )
Change in fair value of warrant liability (5,802 ) 2,021
Total other income (expenses) (4,612 ) 2,962
Other comprehensive loss:
Unrealized loss on marketable securities, net - (1 )
Dividend to Series B-1 preferred stockholders (1,095 ) -
Net loss attributable to common stockholders $ (37,824 ) $ (26,555 )
See accompanying notes to the financial statements
F-4
Unicycive Therapeutics,
Inc.
Statements of Mezzanine
Equity and Stockholders’ (Deficit) Equity
(In thousands, except
share amounts)
Series B-1 Series A-2 Series A-2 Prime Series B-2 Additional Stockholders’
Dividends on Series B-1 preferred stock - - - - - - - - - (1,095 ) - (1,095 )
Issuance of common stock for exercise of options - - 1,136 - - - - - - - 4 - 4
Stock-based compensation expense - - - - - - - - - - 2,350 - 2,350
Series A-2 Prime Series B-2 Series A-3 Additional Accumulated Other
Reverse split share adjustment 48,491 - - - - - - - - - - -
Stock-based compensation expense - - - - - - - - 2,641 - - 2,641
See accompanying notes to the financial statements
F-5
Unicycive Therapeutics, Inc.
Statements of Cash Flows
(In thousands)
Cash flows from operating activities
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense 22 34
Stock-based compensation expense 2,350 2,641
Change in fair value of warrant liability 5,802 (2,021 )
Amortization of operating lease right of use asset 406 538
Changes in assets and liabilities:
Prepaid expense and other current assets (820 ) (2,884 )
Accounts payable and accrued liabilities 790 (2,505 )
Operating lease liability (397 ) (565 )
Net cash used in operating activities (28,575 ) (31,317 )
Cash flows from investing activities
Purchases of marketable securities - (12,071 )
Purchases of property and equipment (72 ) (24 )
Net cash used in investing activities (72 ) (12,095 )
Cash flows from financing activities
Gross proceeds from secondary public offering 683 46,582
Commissions paid on secondary public offering (1,398 )
Deferred cost of at the market offering (160 ) -
Payments on financed insurance policies (527 ) (212 )
Issuance costs related to issuance of Series B-1 preferred stock (3,813 ) -
Proceeds from issuance of Series B-1 preferred stock 50,000 -
Proceeds from exercise of warrants - 1,496
Dividends on preferred stock (1,095 ) -
Net cash provided by financing activities 45,088 46,468
Net increase in cash and cash equivalents 16,441 3,056
Cash and cash equivalents at the beginning of the period 9,701 26,142
Cash and cash equivalents at the end of the period $ 26,142 $ 29,198
Supplemental cash flow information
Cash paid for interest $ 12 $ -
See accompanying notes to the financial statements
F-6
Unicycive Therapeutics,
Inc.
Notes to the Financial
Statements
1. Organization and Description of Business
Overview
Unicycive Therapeutics, Inc. (“we”,
“the Company”) was incorporated in the State of Delaware on August 18, 2016.
The Company in-licensed the drug candidate UNI
494 from Sphaera Pharma Pte. Ltd, a Singapore-based corporation, (“Sphaera”) (Note 4). UNI 494 is a pro-drug of Nicorandill
that is being developed as a treatment for acute kidney injury.
In September 2018, the Company purchased a second
drug candidate, Renazorb RZB 012 and its trademark, RENALAN, and various patents from Spectrum Pharmaceuticals, Inc. (“Spectrum”)
(Note 4). Renazorb (“oxylanthanum carbonate”) is being developed for the treatment of hyperphosphatemia in patients with
Chronic Kidney Disease (“CKD”).
The Company continues
to evaluate the licensing of additional technologies and drugs in order to pursue development, regulatory approval, and
commercialization of those products in global markets.
Liquidity
The Company is subject to risks and uncertainties
common to early-stage companies in the biotechnology industry including, but not limited to, development by competitors of new technological
innovations, protection of proprietary technology, dependence on key personnel, compliance with governmental regulations and the need
to obtain additional financing to fund operations. The Company’s product candidates currently under development will require significant
additional research and development efforts prior to commercialization. Future revenue streams may consist of collaboration or licensing
revenue as well as product sales.
The Company has incurred operating losses and
negative cash flows from operations since inception and expects to continue to incur negative cash flows from operations in the future.
As the Company continues its drug development activities, the operating losses are expected to increase. The Company has historically
relied on private equity offerings, debt financing and loans from a stockholder to fund its operations. As of December 31, 2024 and December
31, 2025, the Company had an accumulated deficit of $101.3 million and $127.8 million, respectively.
In connection with its initial public offering
(“IPO”), on July 13, 2021, the Company began trading on the Nasdaq Capital Market under the symbol “UNCY”, and
on July 15, 2021, received approximately $22.3 million in net proceeds after deducting the underwriting discounts, commissions and other
offering expenses. The Company has used the net proceeds from the IPO to complete pre-clinical and clinical studies, prepare regulatory
filings for the FDA, and for general and corporate purposes, including hiring additional management and conducting market research and
other commercial planning.
On March 3, 2023, the Company entered into a
securities purchase agreement with certain healthcare-focused institutional investors that may provide up to $130.0 million in gross
proceeds through a private placement and that included initial upfront funding of $30.0 million in gross proceeds.
On March 13, 2024, the Company entered into a
securities purchase agreement with certain healthcare-focused institutional investors to provide $50 million in gross proceeds through
a private placement. Pursuant to the securities purchase agreement, the Company issued institutional investors $50 million in shares
of Series B Convertible Preferred Stock. The Company received $46.2 million in net proceeds.
On November 13, 2024, the Company entered into
a sales agreement, with Guggenheim Securities, LLC as amended by Amendment No. 1 thereto dated November 14, 2025 (as amended, the “Sales
Agreement”) pursuant to which, we may offer and sell shares of common stock having an aggregate offering price of up to $100.0
million, subject to certain limitations and in accordance with the terms of the sales agreement, from time to time through or to Guggenheim
Securities, LLC acting as sales agent or principal.
During the year ended December 31, 2025, the
Company sold 9,310,618 shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price of
$5.00 per share and paid $1.4 million in commissions, resulting in net proceeds to the Company of approximately $45.2 million.
F-7
The Company expects to continue incurring losses
in the future and will be required to raise additional capital in the future to complete its planned clinical trials, pursue product
development initiatives and penetrate markets for the sale of its products. Management believes that the Company will continue to have
access to capital resources through possible equity offerings, debt financings, corporate collaborations or other means. There can be
no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis or at
all. If the Company is unable to secure additional capital, it may be required to curtail any clinical trials and development of new
or existing products and take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations
and meet its obligations. Based on the Company’s currently anticipated level of expenditures, the Company believes that it has
sufficient resources such that there is not substantial doubt about the ability to continue operations for at least one year after the
date that these financial statements are available to be issued.
2. Summary of Significant Accounting Policies
Basis of Presentation
The financial statements and accompanying notes
have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and
the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during
the periods presented. Management believes that these estimates and assumptions are reasonable; however, actual results may differ and
could have a material effect on future results of operations and financial position. Significant items subject to such estimates and
assumptions include stock-based compensation, research contract progress estimates, incremental borrowing rate for leases, useful life
for assets, valuation of marketable securities, equity transactions, and the valuation of warrant liabilities. Actual results may materially
differ from those estimates.
Cash and Cash Equivalents
Highly liquid investments
that are readily convertible to cash and have original maturities of three months or less at the time of acquisition are considered cash
equivalents. As of December 31, 2025, cash and cash equivalents consist of cash deposited with banks, money market funds, investment
in corporate bonds with original maturities of three months or less, and U.S. Treasury bills. As of December 31, 2024, cash and
cash equivalents consist of cash deposited with banks and money market funds.
Marketable Securities
Marketable securities consist of corporate debt
securities with original maturities beyond three months at the date of purchase and which mature at, or less than 12 months from, the
balance sheet date. The Company classifies its investment in marketable securities as available-for-sale, as the sale of such securities
may be required prior to maturity. Management determines the appropriate classification of its investments in debt securities at the
time of purchase. The Company obtains pricing information from its investment manager and generally determines the fair value of investment
securities using standard observable inputs, including reported trades, broker/dealer quotes, and bid and/or offers. Available-for-sale
securities are carried at fair value, with the unrealized gains and losses reported as accumulated other comprehensive income (loss).The
carrying value of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, the net amount of
which, along with interest and realized gains and losses, is included under other income (expense) in the statements of comprehensive
income (loss).
At each balance sheet date, the Company reviews
its available-for-sale debt securities that are in an unrealized loss position to determine whether the unrealized loss or any potential
credit losses should be recognized in the statements of operations. For available-for-sale debt securities in an unrealized loss position,
the Company first assesses whether it intends to sell, or it is more likely than not that it will be required to sell the security before
recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s
amortized cost basis is written down to fair value through net income (loss). For available-for-sale securities that do not meet the
above criteria, the Company evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this
assessment, the Company considers the severity of the impairment, any changes in interest rates, changes to the underlying credit ratings
and forecasted recovery among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded
in other income, net through an allowance account. There have been no impairment or credit losses recognized during any of the periods
presented.
.
Warrant Liability
In conjunction with the issuance of Series A-1
Preferred Stock (see Note 9), the Company established a warrant liability as of March 3, 2023, representing the fair value of warrants
that may be issued (and have since been issued), subject to shareholder approval, upon conversion of the Series A-1
Preferred Stock which was received on June 26, 2023. The Company accounts for these warrants as liabilities (in accordance with ASC 480,
Distinguishing Liabilities from Equity) on the balance sheets as a result of certain redemption clauses that are not within the
control of the Company. The warrant liability was initially measured at fair value and is remeasured at fair value each reporting period.
Changes in the fair value of the warrant liability are recognized in earnings during each period. The warrant liability is measured using
Level 3 fair value inputs. See Note 11 for a description of warrant liability and the related valuations.
F-8
Segment Information
The Company reports its segment information to
reflect the manner in which the Company’s Chief Operating Decision Maker (“CODM”) reviews and assesses performance.
The Company’s Chief Executive Officer has the responsibility as the CODM to review and assess the performance of the Company as
a whole.
The primary financial measures used by the CODM
to evaluate performance and allocate resources are net (loss) income and operating (loss) income. The CODM uses net income (loss) and
operating (loss) income to evaluate the performance of the Company’s ongoing operations and as part of the Company’s internal
planning and forecasting processes. Information on net (loss) income and operating (loss) income is disclosed in the statements of operations.
Segment expenses and other segment items are provided to the CODM on the same basis as disclosed in the Statements of Operations.
The CODM does not evaluate performance or allocate
resources based on segment assets, and therefore such information is not presented in the notes to the financial statements.
Risks and Uncertainties
The Company operates in a dynamic and highly
competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s
future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies
and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development
of sales channels; certain strategic relationships; litigation or claims against the Company related to intellectual property, product,
regulatory, or other matters; and the Company’s ability to attract and retain employees necessary to support its growth.
The Company’s general business strategy
may be adversely affected by any such economic, volatile business environments and continued unstable or unpredictable economic and market
conditions.
Any product candidates developed by the Company
will require approvals from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that
the Company’s current product candidates or any future product candidates will receive the necessary approvals. If the Company
is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the
Company.