RenovoRx (RNXT) FY2025 10-K Risk Factors: 75 New, 68 Dropped

What the changes say

RenovoCath generated $1.1 million in 2025, but commercialization remains limited and the company still reported an $11.2 million net loss.
IAG’s Phase III TIGeR-PaC results will not be final until 2027, increasing development and funding uncertainty.
A $10.0 million March 2026 private placement provides funding, but additional capital will likely be needed.
New disclosures emphasize potential dilution, litigation costs, public-company expenses and changes in warrant values.

What changed since the prior 10-K

New

New
IT EM 3. LEGAL PROCEEDINGS
Litigation could create defense and settlement costs, divert management attention, and cause negative publicity or reputational harm even without a material case pending.
New
Holders of Record of Common Stock
The company retains earnings to fund operations and growth and does not expect to pay cash dividends in the foreseeable future.
New
Securities Authorized for Issuance Under Equity Compensation Plans
Equity compensation-plan information is incorporated from Item 12 rather than described in this section.
New
Recent Sales of Unregistered Securities
The March 2026 financing issued 8.4 million shares and warrants for 7.5 million shares, creating potential dilution after approximately $10.0 million of gross proceeds.
New
The purchase price paid by the Institutional Investors for each Share and related Milestone Warrant was $0.938. To comply with Nasdaq Stock Market rules, the purchase price paid by the Insiders for each Share and related Milestone Warrant was $1.0288
The company must register resale of the March 2026 shares and warrant shares with the SEC within specified filing and effectiveness deadlines.
New
ITE M 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-looking plans for fiscal 2025 and later periods may differ materially from actual results because they depend on uncertain business assumptions.
New
Expand our operational, financial and management systems
Commercializing IAG would require substantial distribution infrastructure and additional costs beyond standalone RenovoCath commercialization, while final Phase III results are not expected until 2027.
New
entering into agreements on unfavorable terms. Failure to obtain additional capital on acceptable terms, or at all, would result in a material and adverse impact on our operations
Recurring losses mean the company may need additional equity, debt, or collaboration financing, potentially on unfavorable terms, despite cash expected to fund at least 12 months.
New
allocated selling, general and administrative expenses which includes facilities and other indirect administrative expenses including employee-related overhead expenses as salaries, stock-based compensation and travel to support research and development activities
Research and development costs depend on clinical-trial enrollment, site activation, animal studies, and third-party progress estimates, creating timing uncertainty in expense recognition.
New
Selling, General and Administrative
Public-company compliance, insurance, professional services, investor relations, and other overhead costs are expected to increase selling, general and administrative expenses.
New
Change in Fair Value of Warrant Liability
Changes in RenovoRx’s stock price and remaining warrant term can materially change the fair value of its common-stock warrant liability.
New
Comparison of the Years Ended December 31, 2025 and 2024
RenovoCath revenue reached approximately $1.1 million in 2025, but limited staff, customers, and patients constrain current commercialization and revenue growth.
New
Selling, General and Administrative Expenses
New
Interest income (expense), net
New
Liquidity and Capital Resources
New
On November 14, 2025, we filed a shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million of our securities subject to various limitations, including limited sales in any twelve-month period while the Company is subject to the “baby-shelf” rules
New
Contractual Obligations and Other Commitments
New
Commercial Supply Agreement
New
Critical Accounting Policies and Significant Judgments and Estimates
New
For grants issued after our initial public offering, we rely on the closing price of our common stock as reported on the date of grant to determine the fair value of our common stock, as shares of our common stock are traded in the public market
New
offering awards. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the options
New
Convertible Instruments and Embedded Derivatives
New
Pre-Funded Common Stock Warrants and Common Stock Warrants
New
Emerging Growth Company and Smaller Reporting Company Status
New
we do not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements
New
ITE M 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
New
(a) Management's Evaluation of Disclosure Controls and Procedures
New
(b) Management’s Annual Report on Internal Control over Financial Reporting
New
Our management recognizes its responsibility for fostering a strong ethical climate so that our affairs are conducted according to the highest standards of personal and corporate conduct
New
Remediation of Material Weakness
New
All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation
New
(c) Changes in Internal Control over Financial Reporting
New
IT EM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
New
ITE M 11. EXECUTIVE COMPENSATION
New
ITE M 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
New
IT EM 13. CERTAIN RELATIONSHIPS AND RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
New
I TEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
New
2. Financial Statement Schedules
New
Indicates management contract or compensatory plan or arrangement
New
# Certain information has been omitted from this exhibit pursuant to Item 601(a)(6) or Item 601(b)(10)(iv) of Regulation S-K
New
Opinion on the Financial Statements
New
Liabilities and Stockholders' Equity
New
Commitments and contingencies
New
Net cash used in investing activities
New
Fair Value of Financial Instruments
New
Level 1 – Valuations based on quoted prices for identical assets and liabilities in active markets
New
Level 3 – Valuations based on unobservable inputs reflecting the Company’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment
New
Cash, Cash Equivalents and Investments
New
Property and Equipment, Net
New
The Company generally provides warranties for its products from manufacturing defects on a limited basis for a period of up to 120 days after purchase. During the term of the warranty, if the device fails to operate properly from defects in materials and workmanship, the Company will replace the defective product
New
Research and Development Costs
New
For grants issued post-IPO the closing price of the Company’s common stock as reported on the date of grant will determine the fair value of the Company’s common stock, as shares of the Company’s common stock are traded in the public market
New
Dividend Rate —The dividend yield assumption is zero as the Company has no plans to make dividend payments
New
Recently Adopted Accounting Pronouncements
New
Recently Issued Accounting Pronouncements
New
4. Property and Equipment, Net
New
As of December 31, 2025, and 2024 , the Company held $ 6.6 million and $ 7.0 million, respectively, in a money market account
New
Common Stock Warrants Liability, Changes on Level 3 Liabilities Measured at Fair Value on a Recurring Basis
New
Fair value as of December 31, 2025
New
The current operating lease of $ 105,000 is classified as an accrued expense on the balance sheet, see “Note 5. Accrued Expenses” in Notes to Financial Statements
New
Present value of operating lease liability
New
Guarantees and Indemnification
New
2021 Omnibus Equity Incentive Plan
New
Restricted stock units (“RSU”) are valued based on the closing price of the Company’s common stock on the date of the grant. The fair value of RSU is recognized and amortized on a straight-line basis over the requisite service period of the award
New
Outstanding as of December 31, 2025
New
In connection with the Company’s February 2025 Offering, the Company issued to the underwriter warrants to purchase up to 576,191 shares of common stock at $ 1.21 per share over a five-year term. All such warrants under the February 2025 Offering expire on February 10, 2030
New
For the years ended December 31, 2025 and 2024, the Company has a full valuation allowance against the deferred tax assets
New
Income Tax Provision/(Benefit) and Effective Income Tax Rate
New
(1) Federal and state tax credit carryforward are presented net of certain liabilities for unrecognized tax benefits
New
Uncertain Income Tax Positions
New
Balance at January 1, 2025
New
Balance at December 31, 2025
New
For the years ended December 31, 2025, and 2024, the Company had a net loss and as such, all outstanding shares of potentially dilutive securities were excluded from the calculation of diluted net loss per share as the inclusion would be anti-dilutive
New
13. Related Party Transactions
New
14. Employee Benefit Plans

Dropped

Dropped
Our estimates of total addressable market, potential revenues and similar metrics related to our commercialization efforts for RenovoCath may prove inaccurate, particularly given that our commercialization efforts are relatively new and are evolving
Unreliable RenovoCath market-size, revenue, and revenue-recognition estimates could distort reported financial results.
Dropped
Our revenues and results of operations may be difficult to predict and may fluctuate from quarter to quarter, which could adversely affect our business and the market price of our common stock
Quarterly revenue and results could fluctuate, while delayed financing could force reductions in IAG development, commercialization, or collaborations.
Dropped
As our ongoing TIGeR-PaC study is our most advanced clinical trial to date, the failure of the study to achieve results conducive to progressing the study or filing and receiving NDA approval would cause our company significant harm
TIGeR-PaC failure, development delays, or product side effects could prevent approval or restrict product use.
Dropped
The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our investors
Stock-price volatility and Nasdaq delisting could cause investor losses and reduce financing access.
DroppedRisks Related to Our Business, Financial Condition and Capital Requirements
Alongside our Phase III clinical activities related to IAG, in 2024 we commenced efforts to commercialize our FDA-approved RenovoCath device on a standalone basis. Our commercialization efforts for RenovoCath are relatively new and evolving and we presently have very little operating experience in this business model
RenovoRx lacked meaningful experience commercializing RenovoCath as a standalone medical device.
DroppedRisks Related to Our Business, Financial Condition and Capital Requirements
These factors make any assessment of our future success and viability subject to significant uncertainty. As a result, it may be more difficult for investors to accurately predict our likelihood of success and viability than it could be if we had a more mature operating history
The transition from clinical research to commercial operations created uncertainty typical of early-stage biopharmaceutical and medical-device companies.
DroppedRisks Related to Our Business, Financial Condition and Capital Requirements
We have incurred significant net losses in each period since inception, and we expect to continue to incur net losses until we receive FDA approval for our product candidate or until our commercial strategy for RenovoCath generates sufficient revenues
Persistent losses and a $50.2 million accumulated deficit were expected to continue until IAG approval or sufficient RenovoCath revenue.
DroppedRisks Related to Our Business, Financial Condition and Capital Requirements
We are executing on a commercial strategy for selling our RenovoCath device on a standalone basis, which is a new activity for our company and subject to significant inherent risks
Standalone RenovoCath sales and marketing were new activities with significant inherent execution risks.
DroppedRisks Related to Our Business, Financial Condition and Capital Requirements
Due to all of the foregoing factors, in some future quarters our operating results may fall below the expectations of securities analysts and investors. In such event, the market price of our common stock would likely decrease
Weak quarterly results or insufficient financing could cause the company to miss expectations and reduce development or commercialization efforts.
DroppedRisks Related to Our Business, Financial Condition and Capital Requirements
We may consider strategic alternatives in order to maximize stockholder value, including financing, strategic alliances, and licensing arrangements. We may not be able to identify or consummate any suitable strategic alternatives and any consummated strategic alternatives may not be successful
Financing, alliances, licensing, or a RenovoCath sales partner might not be identified, completed, or successful.
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
As our ongoing TIGeR-PaC study is our most advanced clinical trial to date, the failure of the study to achieve results conducive to progressing the study or filing and receiving NDA approval would cause our company significant harm
Negative second interim TIGeR-PaC data could prevent the Phase III study from continuing.
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
If we do not achieve our projected development goals in the timeframes we announce and expect, our stock price may decline
Missed scientific, clinical, regulatory, or product-development milestones could reduce the stock price.
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
Our product candidates may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products or investigational new drugs, which may delay or preclude further development or regulatory approval or limit their use if approved
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
Interim, preliminary or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
We have limited capacity for recruiting and managing clinical trials, which could impair our timing to initiate or complete clinical trials of our product candidate and materially harm our business
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
We, and our collaborators, if any, must comply with extensive government regulations in order to advance our product candidates through the development process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
Delays in clinical testing and formulating the results of such test could result in increased costs to us and delay our ability to obtained necessary regulatory approves and generate revenue
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business, results of operations, prospects and our underlying stock price
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
We may be required to suspend or discontinue clinical trials due to unexpected side effects or other safety risks that could preclude approval of our product candidates
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
If we are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidates
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
If our product candidates are unable to compete effectively with marketed drugs targeting similar indications as our product candidates, our commercial opportunity will be reduced or eliminated
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
If the manufacturers upon whom we rely fail to produce our product candidates, in the volumes that we require on a timely basis or fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of our product candidates
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
We may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product candidates
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
Our product candidates, if approved for sale, may not gain acceptance among physicians, patients, and the medical community, thereby limiting our potential to generate revenues
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
Guidelines and recommendations published by various organizations can impact the use of our products
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
The market for our lead drug/device combination product and our other product candidates may not be as large as we expect
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
In the event that we need to change our third-party contract manufacturers, our preclinical studies, clinical trials or the commercialization of our product candidates or FDA-approved products could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
We currently do not have any internal drug discovery capabilities, and therefore we are dependent on identifying drugs that are off patent or on in-licensing or acquiring development programs from third parties in order to obtain additional product candidates
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
If a product liability claim is successfully brought against us for uninsured liabilities, or such a claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business
DroppedRisks Related to the Discovery, Development, and Commercialization of Our Product Candidates
We may delay or terminate the development of our product candidates at any time if we believe the perceived market or commercial opportunity does not justify further investment, which could materially harm our business
DroppedRisks Related to Our Operations
Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel
DroppedRisks Related to Our Operations
We will need to increase the size of our organization, and we may experience difficulties in managing growth
DroppedRisks Related to Our Operations
Business disruptions could seriously harm future revenue and financial condition and increase our costs and expenses
DroppedRisks Related to Our Operations
Catastrophic events and man-made problems, such as terrorism, war, or climate change may disrupt our business
DroppedRisks Related to Our Operations
Security threats to our information technology infrastructure and/or our physical buildings could expose us to liability and damage our reputation and business
DroppedRisks Related to Our Operations
We and our third-party contract manufacturers must comply with environmental, health and safety laws and regulations, and failure to comply with these laws and regulations could expose us to significant costs or liabilities
DroppedRisks Related to Our Operations
A variety of risks associated with operating internationally could materially adversely affect our business
DroppedRisks Related to Our Operations
General economic or business conditions may have a negative impact on our business
DroppedRisks Related to Our Operations
Our operations are subject to the effects of a rising rate of inflation
DroppedRisks Related to Our Operations
Healthcare reform measures could adversely affect our business. The impact of recent healthcare reform legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown and may adversely affect our business model
DroppedRisks Related to Our Operations
Reimbursement for any approved products may be limited or unavailable, which could make it difficult for us to sell our product candidates profitably
DroppedRisks Related to Our Operations
Adverse pricing limitations may hinder our ability to recoup our investment in our existing and any future product candidates, even if such product candidates obtain marketing approval
DroppedRisks Related to Our Operations
Any legal proceedings or claims against us could be costly and time-consuming to defend and could harm our reputation regardless of the outcome
DroppedRisks Related to Our Operations
Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
DroppedRisks Related to Our Operations
Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations
DroppedRisks Related to Intellectual Property
If we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our technologies, which would impair our competitive advantage
DroppedRisks Related to Intellectual Property
If any of our patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively
DroppedRisks Related to Intellectual Property
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
DroppedRisks Related to Intellectual Property
The patents issued to us may not be broad enough to provide any meaningful protection, one or more of our competitors may develop more effective technologies, designs or methods without infringing our intellectual property rights and one or more of our competitors may design around our proprietary technologies
DroppedRisks Related to Intellectual Property
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights
DroppedRisks Related to Intellectual Property
Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
DroppedRisks Related to Intellectual Property
If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed
DroppedRisks Related to Our Common Stock
An active trading market for our common stock may not be sustained
DroppedRisks Related to Our Common Stock
The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for investors
DroppedRisks Related to Our Common Stock
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms to us
DroppedRisks Related to Our Common Stock
Our common stock is listed on the Nasdaq Capital Market. In order to maintain our listing, we must meet minimum financial and other requirements, including a minimum amount in stockholders’ equity
DroppedRisks Related to Our Common Stock
We could be subject to securities class action litigation
DroppedRisks Related to Our Common Stock
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market price for the shares and trading volume could decline
DroppedRisks Related to Our Common Stock
We do not expect to pay dividends in the foreseeable future, and you must rely on price appreciation of your shares for return on your investment
DroppedRisks Related to Our Common Stock
We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management has devoted and will continue to devote substantial time to new compliance initiatives and corporate governance practices
DroppedRisks Related to Our Common Stock
Pursuant to Section 404 of SOX (“Section 404”), we are required to furnish a report by our senior management on our internal control over financial reporting beginning with our second filing of an Annual Report on Form 10-K with the SEC
DroppedRisks Related to Our Common Stock
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
DroppedRisks Related to Our Common Stock
We are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our common stock less attractive to investors
DroppedRisks Related to Our Common Stock
Anti-takeover and other provisions contained in our certificate of incorporation and bylaws, as well as provisions of Delaware law, could impair a takeover attempt and have other impacts on our corporate governance
DroppedRisks Related to Our Common Stock
The exclusive forum provision is limited to the extent permitted by law, and it will not apply to claims arising under the Exchange Act or for any other federal securities laws which provide for exclusive federal jurisdiction

All 75 risk factors

Headings as the filing states them, in filing order.

Other

01IT EM 3. LEGAL PROCEEDINGSNew
02Holders of Record of Common StockNew
03Securities Authorized for Issuance Under Equity Compensation PlansNew
04Recent Sales of Unregistered SecuritiesNew
05The purchase price paid by the Institutional Investors for each Share and related Milestone Warrant was $0.938. To comply with Nasdaq Stock Market rules, the purchase price paid by the Insiders for each Share and related Milestone Warrant was $1.0288New
06ITE M 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSNew
07Expand our operational, financial and management systemsNew
08entering into agreements on unfavorable terms. Failure to obtain additional capital on acceptable terms, or at all, would result in a material and adverse impact on our operationsNew
09allocated selling, general and administrative expenses which includes facilities and other indirect administrative expenses including employee-related overhead expenses as salaries, stock-based compensation and travel to support research and development activitiesNew
10Selling, General and AdministrativeNew
11Change in Fair Value of Warrant LiabilityNew
12Comparison of the Years Ended December 31, 2025 and 2024New
13Selling, General and Administrative ExpensesNew
14Interest income (expense), netNew
15Liquidity and Capital ResourcesNew
16On November 14, 2025, we filed a shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million of our securities subject to various limitations, including limited sales in any twelve-month period while the Company is subject to the “baby-shelf” rulesNew
17Contractual Obligations and Other CommitmentsNew
18Commercial Supply AgreementNew
19Critical Accounting Policies and Significant Judgments and EstimatesNew
20For grants issued after our initial public offering, we rely on the closing price of our common stock as reported on the date of grant to determine the fair value of our common stock, as shares of our common stock are traded in the public marketNew
21offering awards. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the optionsNew
22Convertible Instruments and Embedded DerivativesNew
23Pre-Funded Common Stock Warrants and Common Stock WarrantsNew
24Emerging Growth Company and Smaller Reporting Company StatusNew
25we do not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangementsNew
26ITE M 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATANew
27(a) Management's Evaluation of Disclosure Controls and ProceduresNew
28(b) Management’s Annual Report on Internal Control over Financial ReportingNew
29Our management recognizes its responsibility for fostering a strong ethical climate so that our affairs are conducted according to the highest standards of personal and corporate conductNew
30Remediation of Material WeaknessNew
31All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentationNew
32(c) Changes in Internal Control over Financial ReportingNew
33IT EM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCENew
34ITE M 11. EXECUTIVE COMPENSATIONNew
35ITE M 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERSNew
36IT EM 13. CERTAIN RELATIONSHIPS AND RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCENew
37I TEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICESNew
382. Financial Statement SchedulesNew
39 Indicates management contract or compensatory plan or arrangementNew
40# Certain information has been omitted from this exhibit pursuant to Item 601(a)(6) or Item 601(b)(10)(iv) of Regulation S-KNew
41Opinion on the Financial StatementsNew
42Liabilities and Stockholders' EquityNew
43Commitments and contingenciesNew
44Net cash used in investing activitiesNew
45Fair Value of Financial InstrumentsNew
46Level 1 – Valuations based on quoted prices for identical assets and liabilities in active marketsNew
47Level 3 – Valuations based on unobservable inputs reflecting the Company’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgmentNew
48Cash, Cash Equivalents and InvestmentsNew
49Property and Equipment, NetNew
50The Company generally provides warranties for its products from manufacturing defects on a limited basis for a period of up to 120 days after purchase. During the term of the warranty, if the device fails to operate properly from defects in materials and workmanship, the Company will replace the defective productNew
51Research and Development CostsNew
52For grants issued post-IPO the closing price of the Company’s common stock as reported on the date of grant will determine the fair value of the Company’s common stock, as shares of the Company’s common stock are traded in the public marketNew
53Dividend Rate —The dividend yield assumption is zero as the Company has no plans to make dividend paymentsNew
54Recently Adopted Accounting PronouncementsNew
55Recently Issued Accounting PronouncementsNew
564. Property and Equipment, NetNew
57As of December 31, 2025, and 2024 , the Company held $ 6.6 million and $ 7.0 million, respectively, in a money market accountNew
58Common Stock Warrants Liability, Changes on Level 3 Liabilities Measured at Fair Value on a Recurring BasisNew
59Fair value as of December 31, 2025New
60The current operating lease of $ 105,000 is classified as an accrued expense on the balance sheet, see “Note 5. Accrued Expenses” in Notes to Financial StatementsNew
61Present value of operating lease liabilityNew
62Guarantees and IndemnificationNew
632021 Omnibus Equity Incentive PlanNew
64Restricted stock units (“RSU”) are valued based on the closing price of the Company’s common stock on the date of the grant. The fair value of RSU is recognized and amortized on a straight-line basis over the requisite service period of the awardNew
65Outstanding as of December 31, 2025New
66In connection with the Company’s February 2025 Offering, the Company issued to the underwriter warrants to purchase up to 576,191 shares of common stock at $ 1.21 per share over a five-year term. All such warrants under the February 2025 Offering expire on February 10, 2030 New
67For the years ended December 31, 2025 and 2024, the Company has a full valuation allowance against the deferred tax assetsNew
68Income Tax Provision/(Benefit) and Effective Income Tax RateNew
69(1) Federal and state tax credit carryforward are presented net of certain liabilities for unrecognized tax benefitsNew
70Uncertain Income Tax PositionsNew
71Balance at January 1, 2025New
72Balance at December 31, 2025New
73For the years ended December 31, 2025, and 2024, the Company had a net loss and as such, all outstanding shares of potentially dilutive securities were excluded from the calculation of diluted net loss per share as the inclusion would be anti-dilutiveNew
7413. Related Party TransactionsNew
7514. Employee Benefit PlansNew

Other RenovoRx 10-Ks

FY2024 10-K risk factors
68 risks
RenovoRx faces significant financial losses and relies heavily on the success of its Phase III TIGeR-PaC clinical trial. The company is newly commercializing the RenovoCath device on a standalone basis with no prior operating experience. Substantial additional capital will be required to develop lead product candidate IAG and commercialize RenovoCath.
Filed Apr 01, 2025

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.