10-Q

outstan

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2026

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

Commission File Number: 001-40738

RENOVORX, INC.

(Exact name of registrant as specified in its charter)

     Delaware

     27-1448452

     (State or other jurisdiction of
incorporation or organization)

     (I.R.S. Employer
Identification No.)


2570 West El Camino Real, Suite 640
Mountain View, California		94040
(Address of principal executive offices)		(Zip Code)

(650) 284-4433

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	RNXT	The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 7, 2026, the registrant had 45,129,508 shares of common stock, $0.0001 par value per share, outstanding.

TABLE OF CONTENTS


Cautionary Note Regarding Forward-Looking Statements

PART I. FINANCIAL INFORMATION	1

Item 1. Financial Statements	1

Condensed Balance Sheets as of June 30, 2026, and December 31, 2025	1

Condensed Statements of Operations for the three and six months ended June 30, 2026 and 2025	2

Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2026 and 2025	3

Condensed Statements of Cash Flows for the six months ended June 30, 2026 and 2025	5

Notes to the Unaudited Condensed Interim Financial Statements	6

Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations	18

Item 3. Quantitative and Qualitative Disclosures About Market Risk	31

Item 4. Controls and Procedures	31

PART II. OTHER INFORMATION	31

Item 1. Legal Proceedings	31

Item 1A. Risk Factors	31

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	34

Item 3. Defaults Upon Senior Securities	34

Item 4. Mine Safety Disclosures	34

Item 5. Other Information	34

Item 6. Exhibits	35

SIGNATURES	37

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q (this “Report”), particularly in the sections captioned “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to significant risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control. All statements other than present and historical facts and conditions contained in this Report, including statements regarding our commercialization efforts and future revenues, our ongoing clinical trial and other results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” "goal," "aim," “ongoing,” “plan,” “potential,” “predict,” “project,” "future," “should,” “will,” “would,” “in the future” or the negative or derivations of these terms or other comparable terminology referring to the future, although not all forward-looking statements contain such terminology. Actual events or results may differ from those expressed in these forward-looking statements, and these differences may be significant and adverse. Forward-looking statements include, but are not limited to, statements about:

•

the sufficiency of our existing cash, cash equivalents, and investments to fund our future operating expenses and capital expenditure requirements;

•

our estimates or expectations regarding future revenues from commercial operations or otherwise, expenses, potential for cashflow positive operations, anticipated capital requirements to fund our future operating expenses, and our need for additional financing;

•

our anticipated financial or operational performance;

•

our anticipated use of our existing cash, cash equivalents, and investments;

•

the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive clinical or related results;

•

the progress and focus of our current and future clinical trials;

•

projections for enrollment of our clinical trials and our expectations relating to the timing of the provision of updates on, public announcements (if any) for interim or top line data from, and completion of enrollment for and final results from our clinical trials (notably our ongoing Phase III TIGeR-PaC trial as well as investigator-initiated trials);

•

our continued reliance on third parties to conduct clinical trials of our product candidates, and for the manufacture of our product candidates;

•

the beneficial characteristics, safety, efficacy, and therapeutic effects of our product candidates;

•

our ability to advance product candidates into and successfully complete clinical trials;

•

our ability to further develop and expand our therapy platform, both to use different chemotherapeutic agents, to include new indications, or to market our catheter on a standalone basis;

•

our ability to obtain and maintain regulatory approval of our product candidates and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations, such as orphan drug designation, for our product candidates for various diseases;

•

existing regulations and regulatory developments in the United States and other jurisdictions;

•

our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and our potential and ability to successfully commercialize our product candidates and generate revenue;

•

the implementation of our strategic plans for our business and product candidates;

•

the expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with relevant and complementary expertise;

•

our estimates of the number of patients in the United States who suffer from the diseases we target;

•

our estimates of potential addressable market opportunities and our ability to successfully penetrate addressable markets;

•

the success of competing therapies or devices that are or may become available;

•

developments relating to our competitors and our industry, including competing product candidates, therapies and devices;

•

our plans relating to the further development and manufacturing of our devices and product candidates, including for additional indications which we may pursue;

•

our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;

•

the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform and product candidates;

•

our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners;

•

our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved;

•

our ability to retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel;

•

our ability to maintain compliance with the continuing listing requirements of the Nasdaq Stock Market; and

•

our expectations regarding the impact of major domestic and geopolitical events on our business.

We have based the forward-looking statements contained in this Report primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy and financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assumptions and other factors described in the section titled “Risk Factors” and elsewhere in this Report and in our other SEC filings. These risks are not exhaustive. Other sections of this Report include additional factors that could adversely affect our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Report. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all

potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

The forward-looking statements made in this Report relate only to events as of the date on which such statements are made. We undertake no obligation to update any forward-looking statements after the date of this Report or to conform such statements to actual results or revised expectations, except as required by law.

This Report contains market data and industry forecasts that were obtained from industry publications. These data and forecasts involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such information. We have not independently verified any third-party information. While we believe the market position, market opportunity and market size information included in this Report is generally reliable, such information is inherently imprecise.

In this Report, unless the context otherwise indicates, the terms “RenovoRx,” the “Company,” “we,” “our,” and “us” refer to RenovoRx, Inc., a Delaware corporation. Also, unless the context otherwise indicates, the term "common stock" means the Company's common stock, par value $0.0001 per share.

Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ended in December and the associated quarters, months and periods of those fiscal years.

Part I – FINANCIAL INFORMATION

Item 1. Financial Statements

RenovoRx, Inc.

Condensed Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)


	June 30, 2026			December 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	9,479		$	7,024
Accounts receivable		480			139
Prepaid expenses		315			324
Inventory		383			189
Other current assets		153			217
Total current assets		10,810			7,893
Operating lease right-of-use asset		368			190
Property and equipment, net		94			12
Other non-current assets		200			-
Total assets	$	11,472		$	8,095
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	866		$	799
Accrued expenses and other current liabilities		1,018			1,163
Total current liabilities		1,884			1,962
Common stock warrant liability		350			604
Operating lease liability, net of current portion		259			107
Total liabilities		2,493			2,673
Commitments and contingencies (Note 7)		-			-
Stockholders’ equity:
Common stock, $0.0001 par value, 250,000,000 shares authorized at June 30, 2026, and December 31, 2025; 45,121,982 and 36,613,916 shares issued and outstanding as of June 30, 2026, and December 31, 2025, respectively		5			4
Additional paid-in capital		76,793			66,805
Accumulated deficit		(67,819	)		(61,387	)
Total stockholders’ equity		8,979			5,422
Total liabilities and stockholders’ equity	$	11,472		$	8,095

The accompanying notes are an integral part of these condensed interim financial statements.

RenovoRx, Inc.

Condensed Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended June 30,						Six Months Ended June 30,
	2026			2025			2026			2025
Revenues	$	909		$	422		$	1,472		$	619
Cost of revenue		143			152			227			246
Gross profit		766			270			1,245			373
Operating expenses:
Research and development		1,200			1,426			2,428			3,068
Selling, general and administrative		2,915			1,522			5,635			3,093
Total operating expenses		4,115			2,948			8,063			6,161
Loss from operations		(3,349	)		(2,678	)		(6,818	)		(5,788	)
Other income (expense), net
Interest income, net		90			133			134			239
Loss on disposition of asset		(2	)		-			(2	)		-
Change in fair value of common stock warrant liability		350			(350	)	254				234
Total other income (expense), net		438			(217	)		386			473
Net loss	$	(2,911	)	$	(2,895	)	$	(6,432	)	$	(5,315	)
Net loss per share - basic and diluted	$	(0.06	)	$	(0.08	)	$	(0.15	)	$	(0.16	)
Weighted average shares of common stock - basic and diluted		47,298,148			36,576,567			42,690,881			34,000,539

The accompanying notes are an integral part of these condensed interim financial statements.

RenovoRx, Inc.

Condensed Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)


	Common Stock				Additional Paid-In		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Equity
Balance — December 31, 2025		36,613,916	$	4	$	66,805	$	(61,387	)	$	5,422
Issuance of common stock upon equity financing, net of issuance cost		8,438,790		1		9,046		-			9,047
Stock-based compensation expense		-		-		317		-			317
Net loss		-		-		—		(3,521	)		(3,521	)
Balance — March 31, 2026		45,052,706		5		76,168		(64,908	)		11,265
Issuance of restricted stock awards		69,276		-		-		-			—
Equity financing costs		-		-		55		-			55
Stock-based compensation expense		-		-		570		-			570
Net loss		-		-		-		(2,911	)		(2,911	)
Balance — June 30, 2026		45,121,982	$	5	$	76,793	$	(67,819	)	$	8,979

The accompanying notes are an integral part of these condensed interim financial statements.

RenovoRx, Inc.

Condensed Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)


	Common Stock				Additional Paid-In		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Equity
Balance — December 31, 2024		24,034,672	$	2	$	54,695	$	(50,219	)	$	4,478
Issuance of common stock upon equity financing, net of issuance cost		11,523,810		2		10,801	-				10,803
Issuance of common stock upon exercise of pre-funded common warrants		951,500	-		-		-			-
Issuance of restricted stock awards		30,000	-		-		-			-
Issuance of common stock upon exercise of stock options		6,770	-			8	-				8
Stock-based compensation expense	-		-			288	-				288
Net loss	-		-		-			(2,420	)		(2,420	)
Balance — March 31, 2025		36,546,752		4		65,792		(52,639	)		13,157
Issuance of restricted stock awards		41,000	-		-		-			-
'Issuance of common stock upon exercise of stock options		32,880	-			9	-				9
Issuance of common stock upon exercise of common warrants		25,252	-			25	-				25
Stock-based compensation expense	-		-			345	-				345
Net loss	-		-		-			(2,895	)		(2,895	)
Balance — June 30, 2025		36,645,884	$	4	$	66,171	$	(55,534	)	$	10,641

The accompanying notes are an integral part of these condensed interim financial statements.

RenovoRx, Inc.

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)


	Six Months Ended June 30,
	2026			2025
Cash flows from operating activities:
Net loss	$	(6,432	)	$	(5,315	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		887			633
Non-cash lease expense		57			42
Change in fair value of common warrants classified as a liability		(254	)		(234	)
Depreciation expenses		6			2
Loss on disposition of assets		2			-
Changes in operating assets and liabilities:
Accounts receivable		(341	)		(320	)
Inventory		(194	)		-
Prepaid expenses		9			(102	)
Other current assets		64			15
Other non-current assets		(200	)		-
Accounts payable		48			85
Accrued expenses		(228	)		(489	)
Net cash used in operating activities		(6,576	)		(5,683	)

Cash flows from investing activities:
Purchase of property and equipment		(71	)		(2	)
Net cash used in investing activities		(71	)		(2	)

Cash flows from financing activities:
Proceeds from common stock and pre-funded common stock warrants		10,000			12,102
Issuance cost of common stock upon private placement		(898	)		(1,299	)
Proceeds from exercise of common warrants		-			25
Proceeds from exercise of stock options		-			17
Net cash provided by financing activities		9,102			10,845
Net increase in cash and cash equivalents		2,455			5,160
Cash and cash equivalents:
Beginning of period		7,024			7,154
End of period	$	9,479		$	12,314
Supplemental disclosure of cash flow information:
Cash paid for income taxes	$	1		$	2
Cash paid for interest	$	6		$	7
Supplemental disclosure of non-cash investing activities
Purchase of property and equipment	$	19		$	-
Right-of-use assets obtained in exchange for modified operating lease obligations, net	$	235		$	-

The accompanying notes are an integral part of these condensed interim financial statements.

RenovoRx, Inc.

Notes to the Unaudited Condensed Interim Financial Statements

1. Business and Principal Activities

Description of Business

RenovoRx, Inc. (the “Company” or "RenovoRx") was incorporated in the state of Delaware in December 2012 and operates from its headquarters in Mountain View, California. The Company is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (“FDA”)-cleared local drug-delivery device, targeting high unmet medical needs.

The Company's patented Trans-Arterial Micro-Perfusion (TAMP™) platform, enabled by RenovoCath, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor locally, while potentially minimizing a therapy’s toxicities versus systemic intravenous chemotherapy. The Company's novel approach to targeted drug-delivery offers the potential for increased tolerance and improved safety and efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of therapeutic agents.

The Company is actively commercializing the TAMP platform and RenovoCath as a stand-alone device. The Company's commercial model is currently focused on active cancer center expansion, with additional centers driving increased procedures and revenue growth. The Company defines "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

The Company is also evaluating its novel drug-device combination oncology product candidate, intra-arterial gemcitabine (known as "IAG") delivered via RenovoCath, in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug (IND study that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

IAG is currently being evaluated and has not been approved for commercial sale. RenovoRx was granted Orphan Drug Designation ("ODD") for IAG for the treatment of pancreatic cancer and bile duct cancer in 2018 and 2020, respectively, which provides seven years of market exclusivity upon new drug application approval by the FDA. In the second quarter of 2026, the Company was granted an additional ODD of oxaliplatin for the treatment of pancreatic cancer.

The Company continues to advance broader clinical programs by generating new data through RenovoRx’s continued support of registry studies and investigator-initiated trials ("IITs") in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. In the second quarter of 2026, the Company began supporting a new IIT study for cholangiocarcinoma, or bile duct cancer, which is in process to begin soon. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP platform which is enabled by RenovoCath.

Liquidity and Capital Resources

From the Company’s inception through June 30, 2026, it has raised an aggregate of approximately $81.4 million from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in the Company’s August 2021 initial public offering (the “IPO”), other registered equity financings, and the exercise of warrants and common stock options. As of June 30, 2026, the Company had cash and cash equivalents of approximately $9.5 million.

The Company has incurred significant losses and negative cash flows from operations since its inception. For the six months ended June 30, 2026, the Company reported a net loss of $6.4 million and an accumulated deficit of $67.8 million and does not expect to generate positive cash flows from operations in the near future. The Company expects to incur significant losses until revenues from RenovoCath sales grow and outpace cash and non-cash

expenses. Losses may also continue until regulatory approval is granted for the Company's lead product candidate, IAG, and until IAG is commercially launched and revenues are generated from sales of IAG, all of which, with respect to IAG, will not occur for several years. The Company faces the risk that commercial sales of RenovoCath will not grow as anticipated, and regulatory approval of IAG is not guaranteed and may never be obtained.

The Company believes it will be able, if and when necessary, to raise additional capital through debt financings, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available if and when needed or will be at terms acceptable to the Company. The inability to raise capital as and when needed would have a negative impact on the Company’s liquidity financial condition and its ability to pursue its business strategy. The Company will need to generate significant revenue to achieve positive cash flows and profitability, and it may never do so.

On November 14, 2025, the Company has filed a shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million of the Company’s securities subject to various limitations, including limited sales in any twelve-month period while the Company is subject to the “baby-shelf” rules. Via this shelf registration, the Company expects to have access to an “at the market” financing program and other financing opportunities over the three-year life of such registration statement.

The accompanying unaudited condensed interim financial statements have been prepared assuming that the Company will continue as a going concern and has reviewed the relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected future results, negative cash flows from operations, including cash requirements for the upcoming year, funding capacity, net working capital, total stockholders’ equity and future access to capital. Based upon this review and the Company’s current financial condition, the Company has concluded its current cash and cash equivalents will be sufficient to fund its operations through at least the next 12 months from the issuance of these condensed interim financial statements.

2. Summary of Significant Accounting Policies

Basis of Presentation and Unaudited Condensed Interim Financial Information

The accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normally included in unaudited condensed interim financial statements prepared in accordance with GAAP have been condensed or omitted. The unaudited condensed interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly the Company’s results for the interim periods presented. The condensed balance sheet as of December 31, 2025, is derived from the Company’s audited financial statements. The results of operations for the three and six months ended June 30, 2026, are not necessarily indicative of the results to be expected for the year ending December 31, 2026, or for any other future annual or interim period. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

There have been no material changes to the significant accounting policies during the six months ended June 30, 2026, from those previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 30, 2026 (as amended, the “2025 Annual Report”).

For the six months ended June 30, 2026, the Company established a Sales Commissions Plan (the “Plan”), designed to provide performance-based compensation for the Regional Market Development Manager Team. In accordance ASC 340-40 , issued in the U.S. as part of ASU 2014-09, Revenue from Other Assets and Deferred Costs, Contracts with Customers, which was published in May 2014. The standard provides guidance on accounting for incremental costs incurred as part of obtaining or fulfilling contracts with customers. During the six months ended June 30, 2026, there were no sales commissions capitalized.

Risks and Uncertainties

The Company and its business are subject to a number of significant risks associated with clinical-stage and early commercial stage life science companies, including the risks associated with (i) its relatively early stage commercialization efforts for RenovoCath, (ii) the development of IAG or other product candidates that must receive regulatory approval before market launch, (iii) possible failure of current or future preclinical studies or clinical trials, (iv) dependence on key third parties such as device manufacturers and providers of clinical trial administration services; (v) the need to obtain and maintain insurance coding for its products and product candidates, (vi) dependence on key officer and employees, (vii) competition from larger and more established companies, (viii) obtaining and maintaining intellectual property protections, (ix) changes in the Company’s technology or industry, (x) volatility in the public capital markets and the Company’s ability to maintain the listing of its common stock on Nasdaq, (xi) the Company’s ability to obtain adequate financing when needed to support the Company’s business plan, (xii) the ability to attract and retain additional qualified personnel to manage the anticipated growth of the Company and (xiii) general economic and political conditions.

Use of Estimates

The preparation of the condensed interim financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, income and expenses as well as the disclosure of contingent assets and liabilities, at the date of the condensed interim financial statements during the reporting periods. In preparing these condensed interim financial statements, management has made its best estimates and judgments of certain amounts included in the condensed interim financial statements. Significant estimates and assumptions made in the accompanying condensed interim financial statements include, but are not limited to, accruals of certain liabilities, including clinical trial accruals and other contingencies, the valuation of financial instruments, the fair value of the Company’s common stock warrants and the fair value of options granted under the Company’s equity incentive plan. On an ongoing basis, the Company evaluates its estimates, including those related to the fair values of assets, stock-based compensation, clinical trial accruals and other contingencies. Management bases its estimates on historical experience or on various other assumptions that it believes to be reasonable under the circumstances. Actual results could differ materially from these estimates.

Emerging Growth Company and Smaller Reporting Company Status

The Company is currently an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of the JOBS Act exempts emerging growth companies from complying with new or revised financial accounting standards until private companies are required to comply with those standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards. The Company will lose its status as an emerging growth company status as of December 31, 2026, the last day of the fiscal year following the fifth anniversary of the closing of its IPO in August 2021.

The Company is also a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act. If the Company is a smaller reporting company at the time the Company ceases to be an emerging growth company, the Company may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, the Company may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and, like emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption.

Recently Issued and Adopted Accounting Pronouncements

There were no new accounting pronouncements that were issued or became effective since the issuance of the 2025 Annual Report that had, or are expected to have, a material impact on our unaudited condensed balance sheets, unaudited condensed statement of operations or unaudited condensed statement of cash flows.

The Company continues to monitor new accounting pronouncements issued by the FASB and does not believe any accounting pronouncements issued through the date of this report will have a material impact on the Company’s condensed interim financial statements.

3. Inventory

Inventory as of June 30, 2026, and December 31, 2025, at $383,000 and $189,000, respectively, consists of RenovoCath finished goods manufactured under contract by the Company’s third-party RenovoCath manufacturer. Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current on the condensed balance sheets. The Company periodically reviews its inventory to identify obsolete, slow-moving, or otherwise unsalable inventories based on ongoing assessments of market conditions, technological advancements, and historical sales patterns, and establishes allowances for situations in which the cost of the inventory is not expected to be recovered. Based on the Company’s assessment, no reserves needs to be established for inventory, as of June 30, 2026 and December 31, 2025, respectively.

4. Property and Equipment, Net

Property and equipment, net are as follows (in thousands):


	June 30, 2026			December 31, 2025
Property and equipment	$	100		$	14
Subtotal		100			14
Less accumulated depreciation		(6	)		(2	)
Property and equipment, net	$	94		$	12

During the six months ended June 30, 2026, the Company purchased approximately $71,000 in property and equipment and recorded a loss of disposition of assets of approximately $2,000.

Depreciation is computed on a straight-line basis over the estimated useful lives of the assets. The useful life for furniture and equipment is seven years.

Depreciation expense for the six months ended June 30, 2026, was approximately $6,000.

5. Accrued Expenses

The components of accrued expenses are as follows (in thousands):


	June 30, 2026		December 31, 2025
Employee benefits	$	516	$	748
Clinical trial		267		300
Current portion of operating lease liability		131		105
Other		104		10
Total accrued expenses	$	1,018	$	1,163

6. Fair Value Measurements

As of June 30, 2026, and December 31, 2025, the Company held cash equivalents of $9.1 million and $6.6 million, respectively, in a money market account.

The following tables summarize the Company’s financial assets and liabilities, measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):


	Fair Value Measurements at June 30, 2026 using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	9,094	$	-	$	-	$	9,094
Total cash equivalents	$	9,094	$	-	$	-	$	9,094
Liabilities:
Common stock warrant liability	$	-	$	-	$	350	$	350
Total liabilities	$	-	$	-	$	350	$	350


	Fair Value Measurements at December 31, 2025 using:
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	6,640	$	-	$	-	$	6,640
Total cash equivalents	$	6,640	$	-	$	-	$	6,640
Liabilities:
Common stock warrant liability	$	-	$	-	$	604	$	604
Total liabilities	$	-	$	-	$	604	$	604

There were no transfers between Level 1, Level 2 or Level 3 during the periods presented. The Company had no other financial assets or liabilities that were required to be measured at fair value on a recurring basis.

Common Stock Warrants Liability, Changes on Level 3 Liabilities Measured at Fair Value on a Recurring Basis

The following table reflects the change in the Company’s Level 3 common stock warrant liability for the six months ended June 30, 2026 (in thousands):


Fair value as of December 31, 2025	$	604
Change in fair value		(254	)
Fair value as of June 30, 2026	$	350

The Company remeasures the fair value of its common stock warrant liability at each reporting date. The fair value of the common stock warrants was determined using a probability weighted scenario method with a Monte Carlo simulation and Black-Scholes model. The scenario-based method estimates the fair value of the Company’s common stock warrants by considering various outcomes as assessed by the Company. Quantitative elements associated with the inputs impacting the fair value measurement of the common stock warrants include the underlying fair value of common stock, timing of the expected scenarios, risk-free rate, and volatility of the Company’s shares. The risk-free rate is determined by reference to the U.S. Treasury yield curve for the respective time periods based on the remaining contractual term of the warrants. The volatility is based on the historical volatility of the Company’s stock. The Monte Carlo simulation projects the Company’s volume weighted average stock price based on the various fundamental transaction scenarios considered and utilizes a Black-Scholes model to value the warrants within these scenarios.

The following table details the assumptions used in the Monte Carlo simulation to estimate the fair value of the common stock warrant liability:


	June 30, 2026		December 31, 2025
Stock price	$	0.98	$	0.84
Expected volatility	100.0% - 79.0%		102.0% - 122.0%
Expected term (years)	0.00- 2.26		0.00 - 2.76
Risk-free interest rate	4.14% -3.87%		3.53% - 3.67%
Dividend rate	- %		- %

7. Leases, Commitments and Contingencies

Operating Leases

On April 1, 2026, the Company terminated its existing lease agreement, without penalty, and entered into a 33-month non-cancelable operating lease for different space within the same office building , commencing on April 1, 2026 and ending on December 31, 2028. The lease has a one-time option to renew the term for an extension period of 36 months.

Classification of the Company’s operating lease on the condensed balance sheets are as follows (in thousands):


	June 30, 2026		December 31, 2025
Assets
Right-of-use operating asset	$	368	$	190
Liability
Operating lease liability – current		131		105
Operating lease liability – noncurrent		259		107
Total liability	$	390	$	212

The current operating lease of $131,000 is classified as an accrued expense on the condensed balance sheet, see “Note 5. Accrued Expenses” in Notes to Condensed Interim Financial Statements.

Lease expense and cash paid by lease type that was recognized during the three and six months ended June 30, 2026 and 2025 are as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2026		2025		2026		2025
Operating lease	$	40	$	28	$	67	$	57
Short-term lease		1		-		2		-
Total lease expense	$	41	$	28	$	69	$	57

The minimum lease payments are expected to be as follows for the years ending December 31, (in thousands):


Remainder of 2026	$	76
2027	$	156
2028		193
Total lease payments	$	425
Less imputed interest		(35	)
Present value of operating lease liability	$	390

The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate of 6.75% based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. As of June 30, 2026, the Company had a remaining lease term of 2.5 years.

Commercial Supply Agreement

The Company entered into a Supply Agreement with Medical Murray, Inc., the Company’s primary third-party RenovoCath manufacturer ("Medical Murray"), with an effective date of June 5, 2025. Under the supply agreement, the Company has agreed to purchase certain minimum order quantities of the Company’s RenovoCath device, based on issued purchase orders modified for limited cancellations or delays as provided in the supply agreement. Beginning with the quarter ended September 30, 2025, the Company recognizes the release of RenovoCath devices from Medical Murray as finished goods and records as inventory.

The supply agreement has an initial three-year term, with an automatic one-year renewal unless either party provides written notice of termination at least 30 days prior to the expiration date. The supply agreement may be terminated by either party in the event of a force majeure, bankruptcy or insolvency of the other party, and uncured material breach. The Company may terminate the supply agreement if RenovoCath is withdrawn or suspended by a government authority. In addition, either party may terminate for convenience with one-year written notice. In the event of early termination, the Company is obligated to pay the shortfall commitment as of the date of termination.

As of June 30, 2026, the value of the Company’s outstanding non-cancellable purchase commitments associated with the supply agreement is approximately $1.8 million, consisting of two separate purchase commitments for the RenovoCath device. As of June 30, 2026, approximately $0.8 million in total payments with approximately $0.3 million remaining on the original purchase commitment. In June 2026, the Company entered into a second purchase order for $1.5 million for its RenovoCath device under the supply agreement.

Warranties

The Company generally provides warranties for its products from manufacturing defects on a limited basis for a period of 60 days to 30 months. 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.

The Company estimates the costs that it may incur under its warranty program based on the number of units sold, historical and anticipated rates of warranty claims, and cost per claim. The Company has experienced minimal warranty claims to date, and significant warranty claims are not expected, and accordingly no liability for warranty claims was recorded for the three and six months ended June 30, 2026 and year ended December 31, 2025.

Legal Proceedings

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. The Company was not subject to any material legal proceedings during three and six months ended June 30, 2026 and no material legal proceedings are subsequently outstanding or pending.

Guarantees and Indemnification

In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. As permitted under Delaware law and in accordance with its bylaws, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its officers and directors. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments that the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company is not currently aware of any indemnification claims. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of June 30, 2026.

8. Equity Incentive Plan – Stock-Based Compensation Expense

2021 Omnibus Equity Incentive Plan

On July 19, 2021, the Company’s Board of Directors (the “Board”) adopted the RenovoRx, Inc. 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). The 2021 Plan, which became effective immediately prior to the closing of the IPO, initially reserved 2,185,832 shares of common stock, which included 10,832 shares of common stock reserved but unissued under the Amended and Restated 2013 Equity Incentive Plan (the “2013 Plan”). The Company’s 2013 Plan was terminated immediately prior to the closing of the IPO; however, shares subject to awards granted under the 2013 Plan continued to be governed by the 2013 Plan. In accordance with the terms of the 2021 Plan, on January 1, 2026, the number of shares reserved and available for issuance increased by 1,830,696 shares.

The Company accounts for stock-based compensation to employees, consultants and non-employee directors in accordance with ASC Topic 718, Compensation – Stock Compensation. The Company estimates the fair value of stock option awards using the Black-Scholes option pricing model on the date of grant using the assumptions in the

table below. Stock options granted to employees and consultants generally vest over four years and have a term of ten years. Stock-based compensation expense for stock options is recognized as expense over the requisite service period, which is the vesting period. As the Company has not paid dividends since inception, nor does it expect to pay any dividends for the foreseeable future, the expected dividend yield assumption is zero. The expected volatility is estimated based on the historical stock volatility of the Company’s own common stock over a period equal to the expected term of the options including by taking the average historic price volatility for industry peers, consisting of several public companies in the Company’s industry that are either similar in size, stage, or financial leverage, over a period equivalent to the expected term of the awards. The risk-free rate of the stock options is based on the U.S. Treasury rate in effect at the time of grant for the expected term of the stock options.

On April 16, 2026, the Board approved an amendment to the 2021 Plan to add 2,000,000 shares of common stock to the total number of shares of common stock reserved and available for issuance under the 2021 Plan, which amendment was subsequently approved by the Company's stockholders at the Company's 2026 annual meeting of stockholders held on June 30, 2026.

A summary of the stock option activity for the six months ended June 30, 2026 is as follows:


	Number of Stock Options			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life		Aggregate Intrinsic Value
Outstanding as of December 31, 2025		4,417,727		$	1.50		7.90	$	88
Granted		2,161,829		$	0.98		-	$	-
Exercised		-		$	-		-	$	-
Forfeited		(130,324	)	$	1.06		-	$	-
Expired		-		$	-		-	$	-
Outstanding as of June 30, 2026		6,449,232		$	1.35		8.07	$	285
Exercisable as of June 30, 2026		2,952,805		$	1.72		6.69	$	181
Vested and expected to vest as of June 30, 2026		6,449,232		$	1.35		8.07	$	285

As of June 30, 2026, there was $3.0 million of unrecognized stock-based compensation expense related to options granted but not yet amortized, which will be recognized over a weighted-average period of approximately 2.84 years.

For the six months ended June 30, 2026 and 2025, the Company utilized the Black-Scholes option-pricing model for estimating the fair value of the stock option granted. The Company estimated the fair value of each option grant on the grant date using the Black-Scholes option pricing model with the following weighted-average assumptions:


	Six Months Ended June 30,
	2026	2025
Expected volatility	109.9% - 116.2%	115.1% – 121.3%
Expected term (years)	5.06 - 10.00	6.02 – 10.00
Risk-free interest rate	3.92% - 4.35%	4.11% – 4.79%
Dividend rate	- %		-	%

The following table summarizes the components of stock-based compensation expense recognized in the Company’s Condensed Statements of Operations during the three and six months ended June 30, 2026 and 2025 (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2026		2025		2026		2025
Research and development	$	216	$	106	$	327	$	243
Selling, general and administrative		354		239		560		390
Total stock-based compensation expense	$	570	$	345	$	887	$	633

Restricted Stock Units and Restricted Stock Awards Issued for Services

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.

A summary of the restricted stock units activity for the six months ended June 30, 2026 is as follows:


	Shares			Weighted- Average Grant Date Value
Outstanding as of December 31, 2025		-		$	-
Granted		105,380		$	0.99
Vested		(76,802	)	$	1.00
Forfeited		-		$	-
Outstanding as of June 30, 2026		28,578		$	0.98

As of June 30, 2026, there was $ 28,000 of total unrecognized compensation cost related to unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of approximately 2 months.

The compensation expense is allocated on a departmental basis, based on the classification of the option holder. No income tax benefits have been recognized in the statements of operations and comprehensive loss for stock-based compensation arrangements.

9. Common Stock Warrants

On March 17, 2026, the Company entered into a securities purchase agreement (the “March 2026 Securities Purchase Agreement”) in connection with a private placement offering by the Company (the “March 2026 Offering”) to 15 accredited investors or qualified institutional buyers (the “Investors”), five of whom are directors, officers or employees of the Company (the “Insiders”) and the remaining are non-affiliated institutional investors (the “Institutional Investors”). The March 2026 Offering closed on March 20, 2026.

Pursuant to the March 2026 Securities Purchase Agreement, in connection with the March 2026 Offering, the Company sold to the Investors an aggregate of: (i) 8,438,790 shares of common stock, (ii) pre-funded warrants to purchase an aggregate of 2,200,000 shares of common stock and (iii) revenue milestone warrants (with an exercise price per share of $1.751 for the Institutional Investors and $1.9326 for the Insiders) to purchase an aggregate of 5,319,392 shares of common stock (the “Milestone Warrants”), representing 50% warrant coverage for aggregate gross proceeds of approximately $10.0 million, before deducting placement agent fees and expenses payable by the Company. 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 following is a summary of the common stock warrants activity during the six months ended June 30, 2026.


	Shares Issuable Upon Exercise of Outstanding Warrants			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life		Aggregate Intrinsic Value (In thousands)
Outstanding as of December 31, 2025		24,991,784		$	2.3900		2.47	$	59,802
Issued in March 2026 to:
Milestone Warrants		5,319,392		$	1.7549		2.75	$	9,335
Pre-funded warrants		2,200,000		$	0.0001		-	$	-
Expired		(3,956,182	)	$	1.2200		-	$	(4,826	)
Outstanding as of June 30, 2026		28,554,994		$	2.25		2.25	$	64,311

10. Income Taxes

The Company had no income tax expense for the six months ended June 30, 2026. The Company’s effective income tax rate was 0% for the three and six months ended June 30, 2026 and 2025. During the six months ended June 30, 2026 and 2025, the Company had a net operating loss (“NOL”) for each period that generated deferred tax assets for NOL carryforwards. Deferred income tax assets and liabilities are recognized for temporary differences between the financial statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income tax assets, the Company has determined that it is more likely than not that these deferred tax assets will not be realized. Accordingly, the Company has established a full valuation allowance against its deferred tax assets as of June 30, 2026.

The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. For the six months ended June 30, 2026 and 2025, the Company had no accrued interest or penalties related to uncertain tax positions.

11. Net Loss Per Share

Basic and diluted net loss per share of common stock was calculated as follows (in thousands except per share amounts):


	Three Months Ended June 30,						Six Months Ended June 30,
	2026			2025			2026			2025
Numerator:
Net loss	$	(2,911	)	$	(2,895	)	$	(6,432	)	$	(5,315	)
Denominator:
Weighted average shares used in computing net loss per share – basic and diluted		47,298,148			36,576,567			42,690,881			34,000,539
Net loss per share – basic and diluted	$	(0.06	)	$	(0.08	)	$	(0.15	)	$	(0.16	)

For the three and six months ended June 30, 2026 and 2025, 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.

Potentially dilutive securities not included in the computation of diluted net loss per share because to do so would be antidilutive are as follows (in common stock equivalent shares):


	As of June 30,
	2026		2025
Options to purchase common stock		6,449,232		936,657
Unvested restricted stock units		28,578		-
Common stock warrants		28,554,994		19,714,006
Total		35,032,804		20,650,663

12. Segment Information

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the chief operating decision maker (the "CODM") in deciding how to allocate resources to an individual segment and in assessing performance. The Company operates as a single reporting segment, focused on developing novel targeted oncology therapies and offering RenovoCath delivery system as stand-alone device targeting high unmet medical needs. The Company’s measure of segment profit or loss is net loss. The CODM is the Company's Chief Executive Officer (the "CEO"). The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a company basis enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions, clinical, manufacturing and research and development projects that are in line with the Company’s long-term company-wide strategic goals. Consistent with this decision-making process, the CEO uses financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The CODM also uses net loss in competitive

analysis by benchmarking to the Company’s peer group. The competitive analysis along with the monitoring of budgeted versus actual results are used in assessing performance of the segment. All the Company’s assets are held in the United States and all the Company’s revenues are derived from the United States.

The following table is representative of revenue and significant expense categories regularly provided to the CODM when managing the Company’s single reporting segment (in thousands):


	Three Months Ended June 30,						Six Months Ended June 30,
	2026			2025			2026			2025
Revenues	$	909		$	422		$	1,472		$	619
Program expenses (1)
Clinical trial studies(1)		502			539			924			1,209
Manufacturing, RenovoCath		260			383			496			720
Other research and development expenses		91			78			148			204
Non-program expenses (2)		1,398			998			2,925			2,104
Personnel compensation and related expenses, including share-based compensation		2,008			1,102			3,797			2,170
Other segment items (3)		(439	)		217			(386	)		(473	)

Net loss	$	(2,911	)	$	(2,895	)	$	(6,432	)	$	(5,315	)

(1)

Includes external research expenses, clinical studies, manufacturing including manufacturing and non-recurring engineering costs, professional and consulting, regulatory, and trade shows for 2026.

(2)

Includes selling, general and administrative expenses for professional and consulting expenses, audit fees, board fees, legal expenses, insurance expenses, travel, marketing expenses for 2026 and other office expenses.

(3)

Includes interest income and interest expense and gain recognized on the fair value of common stock warrant liability.

Major Customers

For the three and six months ended June 30, 2026, four cancer center customers for the Company's RenovoCath device, (referred to for these purposes as Customers A, B, C, and D) each accounted for more than 10% of the Company's total revenue. For the three months ended June 30, 2026, Customers A, B and C accounted for 20.0%, 16.8% and 15.2%, respectively. For the six months ended June 30, 2026, Customers A, B, C, and D accounted for 15.3%, 20.8%, 11.1%, and 10.4%, respectively.

For the three and six months ended June 30, 2025, five cancer center customers for the Company's RenovoCath device (referred to for these purposes as Customers A, B, C, D and E) each accounted for more than 10% of the Company's total revenue. For the three months ended June 30, 2025, Customers A, B, C, D, and E accounted for 28.3%, 14.1%, 16.2%, 11.3%, and 10.1%, respectively. For the six months ended June 30, 2025, Customers A, B, C, and E accounted for 23.5%, 20.7%, 19.3%, and 15.2%, respectively.

13. Related Party Transactions

Dr. Ramtin Agah has served as the Company’s Chief Medical Officer and Co-Founder since December 2009, as Chairman of the Board since May 2018. In January 2018, the Company entered into a consulting agreement with Dr. Agah pursuant to which Dr. Agah provides monthly consulting services as the Company’s Chief Medical Officer by overseeing Company-sponsored clinical trials. Since 2018, the Company has amended Dr. Agah’s consulting agreement and may, in the Company’s discretion, proportionally adjust the monthly consulting fee if Dr. Agah’s time commitment increases or decreases. The consulting agreement may be terminated by either party on 30 days’ notice. The consulting agreement amendment also provides for Dr. Agah’s eligibility for an annual target cash incentive bonus equal to 40% of his annualized base consulting fee. In November 2025, the Company amended and restated the Change in Control and Severance Agreement with Dr. Agah. In January 2024, Dr. Agah was awarded options to purchase 125,132 shares of the Company’s common stock, vesting monthly over four years. In addition, in January 2024, Dr. Agah was awarded 28,424 shares of fully vested options to purchase the Company’s common stock. In April

and July 2025, Dr. Agah was awarded options to purchase 254,542 and 63,636 shares, respectively, of the Company’s common stock vesting monthly over four years. Consulting fees paid to Dr. Agah for the years ended December 31, 2025 were $337,000. In addition, the Board approved a discretionary bonus to Dr. Agah in recognition of Company and individual performance during the periods ended March 31, 2026 and December 31, 2025, of $96,000 and $121,000, respectively.

On March 24, 2026, the Board appointed Dr. Agah to the newly created position of Executive Chairman, effective February 27, 2026. In connection with his roles as Chief Medical Officer and Executive Chairman, Dr. Agah accepted an offer letter from the Company on the same date (the “Agah Offer Letter”) to amend, restate and replace certain Consulting Agreement, dated January 1, 2018, between Dr. Agah and the Company. Dr. Agah acknowledged that certain Amended and Restated Change in Control and Severance Agreement, dated November 10, 2025, between the Company and Dr. Agah, remained in full force and effect.

Item 2: 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 results of operations in conjunction with our unaudited condensed interim financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2025, which is included in our 2025 Annual Report on Form 10-K, as amended.

This discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that reflect our plans, estimates, and beliefs that involve risks and uncertainties, including those described in the section of this Report titled “Cautionary Note Regarding Forward-Looking Statements.” Our actual results and the timing of selected events could 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 set forth under the section titled “Risk Factors” included elsewhere in this filing and in the 2025 Annual Report.

Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc

As used herein, the term “common stock” refers to our common stock, par value $0.0001 per share.

Overview

We are a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared local drug-delivery device, targeting high unmet medical needs.

Our patented Trans-Arterial Micro-Perfusion (TAMP™) platform, utilizing RenovoCath, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor locally, while potentially minimizing a therapy’s toxicities versus systemic intravenous chemotherapy. Our novel approach to targeted drug-delivery offers the potential for improved efficacy, safety, and tolerability, and our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of therapeutic agents.

We hold a strong and growing global intellectual property portfolio. As of June 30, 2026, we had 19 issued patents (9 US, 10 OUS), 1 allowed (US) patent and 14 published and pending patents (5 US, 7 OUS and 2 PCT) covering our TAMP platform and RenovoCath.

Commercialization of RenovoCath

Until 2025, we primarily focused our efforts on progressing our novel drug-device combination oncology product candidate, intra-arterial gemcitabine (known as "IAG") delivered via RenovoCath, through our ongoing Phase III TIGeR-PaC study for locally advanced pancreatic cancer ("LAPC"). IAG is currently under investigation and has not been approved for commercial sale. IAG received Orphan Drug Designation ("ODD") for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. In the second quarter of 2026, we were granted an additional ODD for oxaliplatin for the treatment of pancreatic cancer.

As the TIGeR-PaC study progressed, we received unsolicited (and subsequently solicited) feedback from oncologists, surgeons, and interventional radiologists highlighting strong interest in our technology, indicating a demand and commercial opportunity for targeted delivery of diagnostic and/or therapeutic agents. As a result, during the first half of 2024, we began to actively explore a new opportunity to market and sell RenovoCath as a standalone medical device. We launched this effort with relatively little capital outlay, and in December 2024, we announced our first commercial purchase orders for RenovoCath devices with more than ten medical institutions initiating the purchasing process, while in discussions with more than twenty additional institutions.

We are actively commercializing the TAMP platform and RenovoCath as a stand-alone device. In 2025, our first full year of commercial efforts, we generated approximately $1.1 million in RenovoCath sales with effectively zero sales and marketing infrastructure for the majority of the year. In the second quarter of 2026, we delivered record revenue and executed on all three of the milestones we set for the business: revenue growth, commercial momentum, and expansion beyond locally advanced pancreatic cancer (LAPC). We generated record revenue of $909,000, an increase

of approximately 61% compared to the first quarter of 2026 and approximately 115% compared to the second quarter of 2025. Our strong first half performance gives us confidence that our second half revenue will exceed our original full-year forecast. This outlook is driven by more active commercial cancer center customers, more patients treated via procedures with RenovoCath, and repeat ordering across our existing customer base. We define "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

Our commercial model is currently focused on active cancer center expansion, with additional centers driving increased procedures and revenue growth. At the time of our first quarter earnings announcement made on May 14, 2026, we had 16 active commercial cancer centers. We ended the second quarter with 21 active commercial cancer centers, an increase of more than 30% in less than a quarter. We remain on pace to meet or exceed our target of 36 active commercial cancer centers by year-end 2026.

In addition to our 21 active commercial centers, we have 42 additional centers in various stages of evaluation, approval, and activation. Combined with our 21 active commercial cancer centers, that represents a total of 63 centers in our total commercial funnel, a 31% increase over the 48 centers we reported as of May 14, 2026.

Furthermore, we currently have 15 clinical trial sites under our Phase III TIGeR-PaC study that have previously utilized RenovoCath and are expected to continue transitioning to commercial clinical use. These anticipated commercial conversions represent a meaningful opportunity to drive incremental revenue growth in the second half of 2026.

We continue to observe organic repeat ordering behavior from existing customers, which we view as a key indicator of physician satisfaction and clinical utility. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained revenue growth. The combination of record quarterly revenue, rapid active cancer center expansion, and strong repeat ordering behavior demonstrates accelerating commercial momentum and supports the long-term opportunity for RenovoCath as both a standalone device and a foundational platform for future drug-device combination therapies.

Moreover, there has been significant industry attention recently on new therapies for pancreatic cancer, and we believe those developments represent meaningful opportunities for our company. Because RenovoCath is a device to deliver treatments more optimally, we see breakthroughs in pancreatic cancer therapy as complementary and as an important tailwind for our business.

Our TAMP platform, enabled by RenovoCath, is a collaborative, localized drug-delivery platform, with two ways emerging therapies can strengthen our opportunity: 1. We can deliver established drugs locally sequentially to or concurrently with novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed, and 2. As new drugs come to market, we believe many of them can be delivered directly via our RenovoCath device. And in both cases, our view is that novel improved therapies make our targeted drug-delivery platform even more valuable.

In August 2026, we announced the first commercial clinical use of RenovoCath in sarcoma patient treatment at CARTI Cancer Center Little Rock, marking physician-driven expansion of our targeted drug-delivery device to other solid tumors. The case at CARTI shows the real world potential beyond pancreatic cancer for expansion of localized delivery of chemotherapy with RenovoCath. Treatment began in late June 2026 at CARTI and is ongoing. CARTI, among our growing base of cancer center customers, is concurrently using the RenovoCath device for localized drug delivery in pancreatic cancer treatment, a reflection of the broadening set of tumor types across which the technology is being applied by physicians.

We continue to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device could translate into an approximately $400 million peak annual U.S. sales opportunity for our company. Over time, as we expand the platform into additional solid tumor indications, we believe we could unlock more than $1 billion in peak annual sales potential.

Clinical Research and Scientific Programs

We are evaluating IAG delivered via RenovoCath in the ongoing Phase III TIGeR-PaC clinical trial. IAG is being studied under a U.S. investigational new drug (IND) study regulated by the FDA's Center for Drug Evaluation and Research (CDER) pursuant to 21 CFR Part 312. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

Advancement of the ongoing Phase III TIGeR-PaC clinical trial evaluating IAG via the RenovoCath device for the treatment of LAPC continued in the second quarter of 2026. On August 7, 2026, we notified TIGeR-PaC trial investigators that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial top line trial data is expected to be available during the second half of 2027.

The completion of enrollment in TIGeR-PaC is a significant milestone for our company which reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating IAG as a novel drug-device product candidate for difficult-to-treat LAPC. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether our patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane).

Pancreatic cancer continues to represent a major unmet medical need, with limited treatment options and current standards of care centered largely on systemic chemotherapy, which can cause significant toxicity and related side effects for patients. TAMP is designed to deliver therapy directly near the tumor site while potentially reducing systemic exposure.

More specifically, TIGeR-PaC is studying the intra-arterial ("IA") administration of gemcitabine to treat LAPC following stereotactic body radiation therapy (“SBRT”). The study compares the treatment of LAPC using IA delivery of gemcitabine with RenovoCath versus systemic, standard of care, intravenous (i.e., systemic) administration of gemcitabine and nab-paclitaxel. Our protocol for TIGeR-PaC involves systemic chemotherapy and SBRT during the induction phase of the study (prior to randomization). In December 2021, we amended our protocol and statistical analysis plan for TIGeR-PaC (the “Modified SAP”) to (i) enroll and analyze only patients receiving SBRT during the induction phase, (ii) include a second interim analysis, (iii) change the total number of patients randomized in the study to 114 with a total of 86 events (deaths) from SBRT patients required to complete the final analysis, and (iv) repower the study from 90% to 80%. The change to the 80% power calculation aligns with common practice for clinical trials and we believe this design will shorten the timeframe needed to complete the study, as well as significantly decrease its cost. We have not discussed the protocol amendment or the Modified SAP with the FDA, and we cannot provide any assurance that the FDA will agree with these modifications, but these modifications have been submitted to the FDA.

During the second quarter of 2026, we continued to execute on key operational priorities for TIGeR-PaC, including patient enrollment, site engagement, and maintaining protocol adherence across its clinical network. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent data monitoring committee ("DMC") recommended continuation of the trial without modification. In alignment with standard clinical trial practices and to preserve trial integrity, and after discussions with the DMC and consultation with our regulatory advisors, we elected to defer publication of interim data until after study completion. We will revisit publishing the actual second interim data, most likely after completion of the study as is common practice for Phase III trials.

We continue to view the TIGeR-PaC trial as an important long-term value driver, while emphasizing that our commercial strategy and revenue outlook are not dependent on the trial's ultimate outcome or timing. Importantly, we expect TIGeR-PaC trial sites will continue transitioning to commercial use, which we believe will serve as a meaningful driver of revenue growth in the second half of 2026.

The first interim analysis in the Phase III TIGeR-PaC study at the 26th event (death) of the specified events was completed in March 2023, with the study's DMC recommending a continuation of the study. The interim analysis showed a 6-month median overall survival benefit for IAG patients (nearly a 60% improvement) versus the study control arm patients treated with current standard of care. Patients also had greater than 65% reduction in adverse events with RenovoCath with gemcitabine vs. standard of care.

We continue to advance broader clinical programs by generating new data through the Company’s continued support of registries and IITs in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. In the second quarter of 2026, we began supporting a new IIT study for cholangiocarcinoma, or bile duct cancer, which is in process to begin soon. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP platform which is enabled by RenovoCath.

In the second quarter of 2026, several scientific data updates supported the use of intra-arterial gemcitabine delivery via TAMP in LAPC. A peer-reviewed case study by researchers at Moffitt Cancer Center, published in Radiology Case Reports, found that PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment. These findings suggest that PET imaging may help optimize monitoring of therapeutic response following TAMP-delivered treatment.

In addition, the PK sub-study of the TIGeR-PaC trial has been accepted and will be published in the near future in the Journal of Cancer Chemotherapy and Pharmacology. The findings support TAMP as a targeted delivery method for gemcitabine, demonstrating its potential to increase local drug potency while reducing systemic exposure and common side effects.

Finally, a peer-reviewed case series in Case Reports in Oncology from researchers at Hackensack Meridian Health’s Jersey Shore University’s Medical Center was accepted and will also be published in the near future. The case series highlights their experience with the TAMP procedure in LAPC.

We believe that increases in the number publications reporting the use of the TAMP procedure by physicians is another sign of adoption as TAMP traverses from an experimental procedure to becoming a standard of care.

Cash Resources, History of Losses and Planned Activities

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of June 30, 2026, we had cash and cash equivalents of $9.5 million. We reported net losses of $2.9 million and $6.4 million for the three and six months ended June 30, 2026, respectively. As of June 30, 2026, we had an accumulated deficit of $67.8 million. We expect to continue to incur significant expenses, operating losses and negative cash flows while we seek to grow our revenues from RenovoCath commercial sales and work towards our goal of cashflow positive operations. We will not generate revenues from IAG sales unless and until we successfully complete development, obtain regulatory approval for, and commercially launch IAG. Given economic and market conditions and timing of regulatory approval, we expect that our expenses will increase in connection with our ongoing commercial, research and development activities, particularly if and when we decide to:

•

Advance clinical development of IAG and our platform technology by continuing to enroll patients in our ongoing Phase III TIGeR-PaC clinical trial, expand the number of clinical trials, and advance IAG through other preclinical and clinical pipeline indication opportunities beyond LAPC;

•

Make investments as we deem necessary to expand our commercial sales operation for RenovoCath;

•

Hire additional research, development, sales and marketing, and selling, general and administrative personnel;

•

Pursue collaborations, licensing arrangements or other strategic or commercial activities relating to our technology;

•

Maintain, expand, enforce, defend, and protect our intellectual property portfolio; and

•

Expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts.

In addition to the variables described above, if and when IAG or any of our other potential future product candidates successfully complete development and receive regulatory approval, we will incur substantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure to commercialize

products for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, and other commercial costs. We cannot reasonably estimate these costs at this time.

Due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, there is a risk that we will be required to raise additional capital at some point to continue the commercialization of RenovoCath and complete the development of and gain regulatory approval for IAG or any other of our future potential product candidates. We have historically financed our operations primarily through private and public sales of our equity (including warrants to purchase common stock). To raise additional capital, we may seek to sell additional equity and/or debt securities, obtain a credit facility or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do on favorable terms, or at all.

Our ability to obtain additional financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by 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.

Our condensed interim financial statements as of June 30, 2026, have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. Based on our operating plans, we expect that our current cash and cash equivalents as of the date of this Report will be sufficient to fund our operating, investing and financing cash flow needs at least the next 12 months from the date of issuance of this report (i.e., into the second half of 2027), assuming our commercial strategy and our development programs advance as currently contemplated.

As a result, while raising capital is not our current focus, we may require additional funding in the future to support our strategy. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through private or public equity financings, debt financings and collaborations, licensing agreements or other similar arrangements. We currently have no credit facility or committed sources of capital. To the extent that we raise additional capital through equity or debt, the ownership interests of our stockholders will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that could restrict our operations. We may require additional capital beyond our currently anticipated amounts and additional capital may not be available on reasonable terms, or at all. If we raise additional funds through collaboration arrangements or other strategic transactions in the future, we may have to relinquish valuable rights to our technologies or future revenue streams or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through private or public equity financings or debt financings when needed, we may be required to delay, limit, reduce or terminate development or future commercialization efforts, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the value we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our condensed interim financial statements, and our shareholders may lose their entire investment in our common stock.

Components of Our Results of Operations

Revenue

In the fourth quarter of 2024, we began generating revenue through the sale of our RenovoCath device on a standalone basis directly to end user customers (i.e., hospitals and cancer treatment centers), and revenue generation from such activity continued for the entire year ended December 31, 2025 and accelerated in the first and second quarters of 2026, with the second quarter of 2026 being a record revenue quarter for us. We consider customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. Our contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath device. We recognize revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, we evaluate whether the price is subject to refund or adjustment to determine the net consideration to which we expect to be entitled. The only type of variable consideration we offer is limited return rights relating primarily to product damage or defects

identified upon receipt, and therefore we expect minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. As of June 30, 2026 and December 31, 2025, we recorded nil of allowance for returns.

Cost of Revenue

Cost of revenue consists of costs associated with the sales of RenovoCath devices primarily from Medical Murray, our third-party RenovoCath manufacturer. Prior to the commercialization of RenovoCath, all costs of manufacturing to produce the RenovoCath devices were allocated to our TIGeR-PaC Phase III clinical trial study in prior periods and expensed as research and development. The cost for RenovoCath devices not associated with the TIGeR-PaC study represents primarily third-party manufacturing costs and shipping and handling costs when applicable.

Operating Expenses

Research and Development

Research and development expenses consist of costs related to the research and development of our TAMP technology and our ongoing clinical trial. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors and consultants. We outsource a substantial portion of our clinical trial activities, having utilized the services of third-party clinical trial sites and contract research organizations to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for the RenovoCath delivery device, which comprises part of our IAG product candidate. Accordingly, we are able to charge our clinical trial sites for the RenovoCath delivery device. To date, payments from clinical trial sites in consideration for RenovoCath delivery devices have been adequate to cover our direct manufacturing costs. Any payments we receive from clinical trial sites as consideration for use of RenovoCath delivery devices offset our research and development expenses. We expect our research and development expenses to increase for the foreseeable future as we continue the development of our product candidates and enroll subjects in our ongoing Phase III clinical trial, initiate other new clinical trials, post marketing study (what we call our RR5 study), and pursue regulatory approval of our product candidates. It is difficult to predict with any certainty the duration and costs of completing our current or future clinical trials of our product candidates or if, when or to what extent we will achieve regulatory approval and generate revenue from the commercialization and sale of our product candidates. The duration, costs and timing of clinical trials and other development of our product candidates will depend on a variety of factors, including uncertainties in clinical trial enrollment, timing and extent of future clinical trials, development of new product candidates and significant and changing government regulation. We may never succeed in achieving regulatory approval for any of our product candidates.

Our research and development expenses include:

•

expenses incurred under agreements with clinical trial sites, contract research organizations, and consultants that are involved in conducting our clinical trials;

•

costs of acquiring and developing clinical trial materials;

•

personnel costs, including salaries, benefits, bonuses, and stock-based compensation for employees engaged in preclinical and clinical research and development;

•

costs related to compliance with regulatory requirements;

•

third-party vendor costs related to manufacturing materials and testing to develop the next generation of our delivery device, RenovoCath, including additional non-recurring engineering costs;

•

costs related to preclinical studies and pilot testing;

•

travel expenses; and

•

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 are expensed as incurred. Costs for certain development activities, such as clinical trials and animal studies, are recognized based on evaluation of progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to us by third party vendors.

Selling, General and Administrative

Selling, general and administrative expenses consist of salaries, benefits, and stock-based compensation for personnel in executive, finance and administrative functions, professional services and associated costs related to accounting, tax, audit, legal, intellectual property and other matters, consulting costs, marketing, conferences, travel and allocated expenses for rent, insurance and other general overhead costs. We expect to continue to incur additional expenses as a result of operating as a public company, including costs to comply with the rules and regulations of the SEC, and Nasdaq continued listing standards and increased expenses in the areas of insurance, professional services and investor relations. As a result, we expect our selling, general and administrative expenses to increase in the foreseeable future. Selling, general and administrative expenses are expensed as incurred.

Other Income (Expense), Net

Interest Income, Net

Interest expense consists of expense for the amortization of directors and officers liability insurance premiums.

Interest income is earned from cash deposited in our short-term marketable securities and money market account.

Change in Fair Value of Warrant Liability

Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the common stock warrant liability for warrants issued under the registered direct offering. On April 3, 2023, we completed a registered direct offering financing issuing shares of common stock and common stock warrants. The fair value of the common stock warrant per share was $0.18 and $0.66 on June 30, 2026, and 2025, respectively. The decrease in the fair value was primarily due to the decrease in our stock price combined with a shorter number of years remaining to the warrant expiration date.

Income Tax Expense

We account for income taxes using the asset and liability method. Under this method, deferred income tax assets and liabilities are recorded based on the estimated future tax effects of differences between the financial statement and income tax basis of existing assets and liabilities. Deferred income tax assets and liabilities are recorded net and classified as noncurrent on the balance sheets. A valuation allowance is provided against our deferred income tax assets when their realization is more likely than not.

We are subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting for uncertainty in income taxes, we recognize tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is more-likely-than-not (greater than 50%) of being realized upon settlement. Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense.

Results of Operations

Comparison of the Three Months Ended June 30, 2026 and 2025

The following table summarizes the significant components of our results of operations for the periods presented (in thousands, except percentages):


	Three Months Ended June 30,						Increase / (Decrease)
	2026			2025			$			%
	(unaudited)
Revenues	$	909		$	422		$	487			115
Cost of revenues		143			152			(9	)		(6	)
Gross profit		766			270			496			184

Operating expenses:
Research and development	$	1,200		$	1,426		$	(226	)		(16	)
Selling, general and administrative		2,915			1,522			1,393			92
Total operating expenses		4,115			2,948			1,167			40
Loss from operations		(3,349	)		(2,678	)		(671	)		(25	)
Other income (expense), net
Interest and dividend income		90			133			(43	)		(32	)
Loss on disposition of asset		(2	)		-			(2	)		(100	)
Change in fair value of common warrant liability		350			(350	)		700			200
Total other income (expense), net		438			(217	)		655			302
Net loss	$	(2,911	)	$	(2,895	)	$	(16	)		(1	)

Revenue

We recognized record quarterly revenue of approximately $0.9 million from sales of RenovoCath for the three months ended June 30, 2026, compared to $0.4 million for the same period last year, representing a $0.5 million increase in sales volume. The growth was driven by continued expansion of active commercial cancer centers and repeat ordering from our existing commercial cancer center base. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2026.

Cost of Revenue

Cost of revenue was approximately $0.1 million for the three months ended June 30, 2026, compared to approximately $0.2 million cost of revenue for the same period last year, remaining relatively flat from the prior period last year. Prior to the Medical Murray supply agreement, devices sold for the same period as last year were manufactured based on time and materials which resulted in higher manufacturing costs per device. We expect costs of revenue to increase as we increase our revenue from RenovoCath sales.

Research and Development

Research and development expenses were approximately $1.2 million for the three months ended June 30, 2026, compared to $1.4 million for the same period last year, a decrease of $0.2 million. The period-over-period decrease in research and development expenses is primarily driven by a decrease in regulatory and clinical development of $0.1 million due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC, including a decrease of $0.2 million in selling, general, and administrative expenses allocated to research and development expense. This decrease was off-set by an increase in employee and related benefit costs of $0.1 million. We anticipate research and development expenses to increase in the second half of 2026 as we advance our clinical development of IAG and the development of our next generation RenovoCath device including incurring expenses for the filing of a 510(k) with the FDA next year at least 90 days before the device is offered for sale.

Selling, General and Administrative

Selling, general and administrative expenses were approximately $2.9 million for the three months ended June 30, 2026, compared to $1.5 million for the same period last year, an increase of approximately $1.4 million. The period-over-period increase in selling, general and administrative expenses is primarily driven by an increase in head count

and employee and related benefit costs of $0.8 million as we made targeted investments in expanding our RenovoCath commercialization program, resulting in an increased commercial pipeline, additional active cancer center customers and a resulting increase in revenue. Professional, and other expenses to include travel and marketing expenses increased by $0.4 million primarily due to supporting our RenovoCath commercialization strategy, including the decreased in selling, general, and administrative expenses allocated to research of $0.2 million. We anticipate selling, general and administrative expenses to increase during the second half of 2026 as we progress with our commercialization activities for RenovoCath.

Other Income (Expense), Net

Other Income was approximately $0.4 million for the three months ended June 30, 2026, compared to other expense of approximately $0.2 million for the same period last year. The increase in other income was primarily due to a $0.7 million change in the fair value of common warrant liability, primarily due to a decrease in our stock price.

Comparison of the Six Months Ended June 30, 2026 and 2025


	Six Months Ended June 30,						Increase / (Decrease)
	2026			2025			$			%
	(unaudited)
Revenues	$	1,472		$	619		$	853			138	%
Cost of revenues		227			246			(19	)		-8	%
Gross profit		1,245			373			872			234	%

Operating expenses:
Research and development	$	2,428		$	3,068		$	(640	)		-21	%
Selling, general and administrative		5,635			3,093			2,542			82	%
Total operating expenses		8,063			6,161			1,902			31	%
Loss from operations		(6,818	)		(5,788	)		(1,030	)		-18	%
Other income (expense), net
Interest and dividend income		134			239			(105	)		-44	%
Loss on disposition of asset		(2	)		-			(2	)		-100	%
Change in fair value of common warrant liability		254			234			20			9	%
Total other income (expense), net		386			473			(87	)		-18	%
Net loss	$	(6,432	)	$	(5,315	)	$	(1,117	)		-21	%

Revenue

We recognized approximately $1.5 million of revenue from sales of RenovoCath for the six months ended June 30, 2026, compared to $0.6 million for the same period last year, representing a $0.9 million increase in sales volume. The significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across our active commercial cancer centers. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2026.

Cost of Revenue

Cost of revenue was approximately $0.2 million for the six months ended June 30, 2026, compared to approximately $0.2 million, remaining relatively flat for the same period last year. Prior to the Medical Murray supply agreement, devices sold for the same period as last year were manufactured based on time and materials which resulted in higher manufacturing costs per device. We expect costs of revenue to increase as we increase our revenue from RenovoCath sales.

Research and Development

Research and development expenses were approximately $2.4 million for the six months ended June 30, 2026, compared to $3.1 million for the same period last year, a decrease of $0.7 million. The period-over-period decrease in research and development expenses is primarily driven by a decrease in regulatory and clinical development of $0.4 million due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC, including a decrease in non-recurring engineering costs for the development of the next generation of our RenovoCath delivery system of $0.2 million, and selling, general, and administrative expenses allocated to research and development costs of $0.4 million. The decrease was off-set by an increase in employee and related benefit costs of $0.4 million primarily due to an increase in employees and salary changes associated with cost-of-living adjustments. We anticipate research and development expenses to increase in the second half of 2026 as we advance our clinical development of IAG and the development of our next generation RenovoCath device including incurring expenses for the filing of a 510(k) with the FDA next year at least 90 days before the device is offered for sale.

Selling, General and Administrative

Selling, general and administrative expenses were approximately $5.6 million for the six months ended June 30, 2026, compared to $3.1 million for the same period last year, an increase of approximately $2.5 million. The period-over-period increase in selling, general and administrative expenses is primarily driven by an increase in head count and employee and related benefit costs of $1.3 million as we made targeted investments in expanding our RenovoCath commercialization program, resulting in an increased commercial pipeline, additional active cancer center customers and a resulting increase in revenue. Professional, and other expenses to include travel and marketing expenses increased by $0.7 million primarily due to supporting our RenovoCath commercialization strategy. Legal expenses increased $0.1 million, including a decrease in selling, general, and administrative expenses of $0.4 million. We anticipate selling, general and administrative expenses to increase during the second half of 2026 as we progress with our commercialization activities for our RenovoCath delivery system.

Other Income (Expense), Net

Other Income (expense), net was approximately $0.4 million for the six months ended June 30, 2026, compared to approximately $0.5 million for the same period last year. The decrease in other income was primarily due to a decrease in interest income of approximately $0.1 million.

Liquidity and Capital Resources

From our inception through June 30, 2026, we had raised an aggregate of $81.4 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in registered and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $72.5 million. As of June 30, 2026, we had cash and cash equivalents of $9.5 million.

We have incurred significant losses and negative cash flows from operations since our inception. For the six months ended June 30, 2026, we recorded a net loss of $6.4 million and an accumulated deficit of $67.8 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations in the near future, although that is an important goal for our commercial efforts. We also expect to incur losses from our clinical activities until revenues from RenovoCath sales grow and outpace cash and non-cash expenses. Losses may also continue until regulatory approval is granted for our lead product candidate, IAG, and until IAG is commercially launched and revenues are generated from sales of IAG, all of which, with respect to IAG, will not occur for several years. We face the risk that commercial sales of RenovoCath will not grow as anticipated, and regulatory approval of IAG is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements. No assurances can be made that we will pursue these strategies, and even if we do, there is a risk that we will be unable to generate revenue from such activities.

We believe we will be able to continue to raise additional required capital as needed through debt financings, private or public equity financings (including our at the market offering program), potential exercises of outstanding warrants, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available as and when needed or will be at terms acceptable to us. The inability to raise capital as and when needed would have a negative impact on our liquidity, financial condition and our ability to pursue our business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve cashflow positive operations or profitability, and we may

never do so. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials or other operations. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section of this Report and our 2025 Annual Report titled “Risk Factors.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

On March 20, 2026, we closed on a private placement offering to 15 accredited investors, of which 5 were insider investors, and issued 8,438,790 shares of common stock, 2,200,000 pre-funded warrants, and 5,319,392 revenue milestone warrants, representing 50% warrant coverage. The revenue milestone warrants have an exercise price equal to two times (2x) the purchase price paid for the shares of common stock in the offer, and they expire on the earlier of: (i) 30 days of our reporting $1.5 million in gross product sales in any fiscal quarter and (ii) March 30, 2029. We raised aggregate gross proceeds of $10.0 million in this financing, before deducting placement agent fees and other legal and professional fees of approximately $0.7 million. In addition, we incurred approximately $0.3 million of issuance costs.

As of the date of this Report, we believe that we have sufficient cash resources, including our private placement closing in March 2026 described above, to allow us to fund our operating, investing and financing cash flow needs through at least the next 12 months (i.e., into the second half of 2027). The accompanying unaudited condensed interim financial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying unaudited condensed interim financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if we are unable to continue as a going concern.

Sources of Liquidity

Since our inception, we have been primarily a clinical stage company on IAG, our clinical development stage lead product candidate, a novel drug-device combination product for the treatment of LAPC. In 2024, we made the decision to launch an effort to commercialize our RenovoCath device as a standalone product within its FDA-cleared fields of use and upon our initial commercialization launch of RenovoCath, we generated revenue in the fourth quarter of 2024. We have since grown our RenovoCath revenues, and our goal is to grow revenues from our RenovoCath commercialization efforts in the second half of 2026 and beyond. However, we have incurred significant operating losses and negative cash flows from operations and we anticipate that we will continue to incur net losses until our RenovoCath commercial efforts generate meaningful revenues, of which no assurances can be given.

Cash Flows

Our primary uses of cash are to fund our operations including research and development, commercialization of our RenovoCath as a standalone device and selling, general and administrative expenses. We will continue to incur operating losses in the future and expect that our research and development and selling, general and administrative expenses will continue to increase as we continue our research and development efforts with respect to clinical development of IAG and further develop our technology platform, commercializing RenovoCath and ensuring we are complying with the requirements of being a public company. The cash used to fund operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

The following table summarizes our cash flows for the periods indicated (in thousands):


	Six Months Ended June 30,
	2026			2025
Net cash provided by (used in):
Operating activities	$	(6,576	)	$	(5,683	)
Investing activities		(71	)		(2	)
Financing activities		9,102			10,845
Net increase in cash and cash equivalents	$	2,455		$	5,160

Net Cash Used in Operating Activities

Cash used in operating activities for the six months ended June 30, 2026, reflected a net loss of $6.4 million, offset by non-cash charges of approximately $0.7 million, and a net change in our operating assets and liabilities of $0.8 million.

Cash used in operating activities for the six months ended June 30, 2025, reflected a net loss of $5.3 million, offset by non-cash charges of $0.4 million, and a net change in our operating assets and liabilities of $0.8 million.

Cash Used in Investing Activities

Cash used in investing activities for the six months ended June 30, 2026, consisted of $71,000 for the purchase of property and equipment.

Cash used in investing activities for the six months ended June 30, 2025, consisted of $2,000 for the purchase of property and equipment.

Cash Provided by Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2026 was $9.1 million, consisting primarily of net proceeds from the March 2026 private placement.

Net cash provided by financing activities for the six months ended June 30, 2025 was $10.8 million, consisting primarily of net proceeds from the public equity offering.

Contractual Obligations and Other Commitments

In April 2026, we terminated our existing lease agreement for our administrative corporate headquarters without penalty, and entered into a new 33-month non-cancelable operating lease within the same office building, commencing on April 1, 2026 and ending on December 31, 2028. The lease has a one-time option to renew the term for an extension period of 36 months.

In June 2026, we entered into a new non-cancelable purchase commitment of $1.5 million with Medical Murray, our third-party manufacturer, for our RenovoCath device. The purchase commitment will provide commercially available RenovoCath devices for our cancer centers into the second half of 2027.

Critical Accounting Policies and Significant Judgments and Estimates

The accompanying management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed interim financial statements and the related disclosures, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed interim financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our unaudited condensed interim financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. Our critical accounting policies and estimates are detailed in our 2025 Annual Report.

There have been no significant changes to our critical accounting policies or significant judgments and estimates for the six months ended June 30, 2026, from those previously disclosed in our 2025 Annual Report.

Convertible Instruments and Embedded Derivatives

We evaluate all of our agreements to determine whether such instruments have derivatives or contain features that qualify as embedded derivatives. We account for certain redemption features that are associated with the terms of convertible notes as liabilities at fair value and adjust the instruments to their fair value at the end of each reporting period. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially

recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in other income (expenses), net in the statements of operations. Derivative instrument liabilities are classified in the balance sheets as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.

Pre-Funded Common Stock Warrants and Common Stock Warrants

We evaluate pre-funded common stock warrants and common stock warrants issued in connection direct financing to determine whether such warrants qualify for equity classification, or meet the definition of a derivative instrument, classified as a liability on the Balance Sheets and measured at fair value at inception and at each reporting date with changes in fair value recognized in the Statements of Operations and Comprehensive Loss in the period of change.

Direct Offering Costs

Direct offering costs consist principally of commissions, placement fees and other expenses, including other professional expenses incurred. We evaluate the terms under the financing agreement to determine the classification of direct costs in the accompanying Balance Sheets or accompanying Statements of Operations and Comprehensive Loss or some combinations of both.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company” as defined in the JOBS Act. Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected this exemption to delay adopting new or revised accounting standards. We will remain an emerging growth company until the earlier of (1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.235 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. Based on these variables, we will cease being an emerging growth company as of December 31, 2026.

An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company:

•

we may present only two years of audited financial statements, plus unaudited interim condensed financial statements for any interim period, and related Management’s Discussion and Analysis of Financial Condition and Results of Operations;

•

we may avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act;

•

we may provide reduced disclosure about our executive compensation arrangements; and

•

we do not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

We have elected to take advantage of certain of the reduced disclosure obligations in this Report on Form 10-Q and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may differ from the information provided by other public reporting companies in which they hold equity interests.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (1) the market value of our stock held by nonaffiliates is less than $250.0 million or (2) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by

non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, like emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Recently Issued and Adopted Accounting Pronouncements

There were no new accounting pronouncements that were issued or became effective since the issuance of our 2025 Annual Report that had, or are expected to have, a material impact on our unaudited condensed balance sheets, unaudited condensed statement of operations or unaudited condensed statement of cash flows.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

The disclosures in this Item are not required because we qualify as a smaller reporting company under federal securities laws.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2026. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be disclosed in our periodic reports filed with the SEC (such as this Quarterly Report on Form 10-Q) has been appropriately recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Based on their evaluation of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of June 30, 2026.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the three months ended June 30, 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Part II – OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may be involved in various legal actions, including claims and proceedings arising in the ordinary course of business. We are currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our results of operations or financial position, and, to the best of management’s knowledge, no such litigation is currently pending or threatened.

Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

Item 1A. Risk Factors

An investment in our securities is speculative and involves a high degree of risk. You should carefully consider the risk factors below, as well as the other information in this Report, including our unaudited interim condensed financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other public filings in evaluating our business, including those risk factors included in our 2025 Annual Report. The occurrence of any of the events or developments described in our 2025 Annual Report, or summarized below or described elsewhere in this Report could harm our business, financial

condition, results of operations, growth prospects or stock price. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.

Risk Factors Summary

The following is a summary of principal factors and uncertainties that make investing in shares of our common stock risky and impact our ability to execute on our business strategy include risks regarding the following. This summary is not exhaustive, and readers are therefore encouraged to review the “Risk Factors” section herein and the “Risk Factors” section in our 2025 Annual Report in their entirety:

•

We have no drug/device combination products approved for commercial sale, only limited experience as a company in the commercialization of standalone medical devices and no extended operating history as a revenue generating company. These factors make it difficult to evaluate our current business and predict our future success and viability.

•

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.

•

We are executing on a commercial strategy for selling our RenovoCath device on a standalone basis, which is a relatively new activity for our company and subject to significant inherent risks.

•

Our estimates of our serviceable addressable market (SAM), 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.

•

Revenue recognition from our RenovoCath commercialization activities could be complex and uncertain. We may also be required to defer recognition of revenues under policies which we develop. Our inability to properly recognize revenue could have a material adverse effect on our estimates of our future revenue performance and on our actual financial results.

•

Our revenues and results of operations, particularly as they relate to RenovoCath sales, are difficult to predict and may fluctuate from quarter to quarter, which could adversely affect our business and the market price of our common stock.

•

We face the risk that we may need to raise additional capital over the longer term to both develop and commercialize IAG (assuming FDA approval) and to separately engage in sales and marketing activities for RenovoCath as a standalone device. Our failure to obtain funding when needed (even following this offering) may force us to delay, reduce or eliminate our product development programs, commercial efforts or collaboration efforts. Moreover, if we do not obtain adequate and timely funding, we may not be able to continue as a going concern.

•

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.

•

The commercial viability of IAG or other product candidates remains subject to current and future preclinical studies, clinical trials (notably our Phase III TIGeR-PaC study), regulatory approvals, and the risks generally inherent in the development of a drug-device product candidate. If we are unable to successfully advance or develop IAG or any other product candidate, our business will be materially harmed.

•

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.

•

If we do not achieve our projected commercial or development goals in the timeframes we announce and expect, our stock price may decline.

•

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.

•

If the results of preclinical studies or clinical trials for our product candidates are negative, we could be delayed or precluded from the further development or commercialization of our product candidates, which could materially harm our business.

•

If we are unable to satisfy regulatory requirements, we may not be able to commercialize 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.

•

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.

•

Our future success depends on our ability to retain our key personnel and to attract, retain, and motivate qualified personnel, especially in light of an acute workforce shortage and hyper-competitive compensation environment.

•

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.

•

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.

•

We are not currently in compliance with the “minimum bid price” continued listing requirement for The Nasdaq Stock Market. If we do not regain compliance and continue to meet such requirement or any other continued listing requirements, our common stock may be delisted, which could affect the market price and liquidity for our common stock and reduce our ability to raise additional capital and otherwise properly function as a public company.

We are also providing the following updated risk factor on a voluntary basis:

We are not currently in compliance with the “minimum bid price” continued listing requirement for The Nasdaq Stock Market. If we do not regain compliance by the end of 2026 and continue to meet such requirement or any other continued listing requirements, our common stock may be delisted, which could affect the market price and liquidity for our common stock and reduce our ability to raise additional capital and otherwise properly function as a public company.

On December 31, 2025, we received a letter from the Listing Qualifications Staff of the Nasdaq Stock Market, LLC (“Nasdaq”) indicating that we are not in compliance with the requirement to maintain a minimum bid price of $1.00 per share required for continued listing on Nasdaq, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”) for 32 consecutive trading days.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we were initially provided 180 calendar days, or until June 30, 2026, to regain compliance. On July 1, 2026, we received a notification letter from Nasdaq informing us that, while we have not yet regained compliance with the Minimum Bid Price Requirement, Nasdaq has determined that we are eligible for an additional 180 calendar day period, or until December 28, 2026 (the “Second Compliance Period”), to regain compliance. If at any time during the Second Compliance Period, the bid price of our common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, Nasdaq will provide us with written confirmation of

compliance with the Minimum Bid Price Requirement and the matter will be closed. In the event we do not regain compliance with the Minimum Bid Price Requirement by the end of the Compliance Period, the Listing Qualifications Department of Nasdaq will issue a Staff Delisting Determination under Nasdaq Listing Rule 5810 with respect to that security (the “Low Priced Stocks Rule”). If a company receives such delisting notice, the company can request a hearing before a Nasdaq hearings panel (the “Panel”). If our common stock closes at or below $0.10 for ten consecutive days during the Second Compliance Period, we could receive a Staff Delisting Determination during the Second Compliance Period or, if we receive such Staff Delisting Determination, Nasdaq may not grant our request for a hearing, or if Nasdaq grants our request for a hearing, the Panel may not grant our request for continued listing of our common stock on The Nasdaq Capital Market pending our compliance with all applicable listing criteria, including the Minimum Bid Price Requirement, or we may be unable to timely satisfy the terms of any extension that may be granted by the Panel.

We will continue to monitor the closing bid price of our common stock and seek to regain compliance with all applicable Nasdaq requirements within the allotted compliance periods and may, if appropriate, consider available options, including implementation of a reverse stock split, to regain compliance with the Minimum Bid Price Requirement or the Low Priced Stocks Rule, as applicable. A reverse stock split, would require approval of our stockholders, which may not be obtained, and if we are unable to otherwise regain compliance with the Minimum Bid Price Requirement, we will be subject to delisting from Nasdaq as described above. Even if we are able to implement, such split could have a material adverse effect on our stock price and valuation, including as public stock prices often decrease following the occurrence of a reverse stock split.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

Item 6. Exhibits


		Incorporated by Reference
Exhibit Number	Exhibit Description	Form	File No.	Exhibit	Filing Date
3.1	Sixth Amended and Restated Certificate of Incorporation of RenovoRx, Inc.	8-K	001-40738	3.1	August 31, 2021
3.2	Amended and Restated Bylaws of RenovoRx, Inc.	8-K	001-40738	3.1	September 11, 2023
4.1	Form of Private Common Stock Warrant (related to the 2020 Convertible Notes and 2021 Convertible Notes)	10-Q	001-40738	4.1	November 15, 2021
4.2	Form of Underwriter’s Warrant	S-1	333-258071	4.1	August 25, 2021
4.3	Form of Warrant Agent Agreement (including the terms of the Warrants)	S-1	333-258071	4.2	August 25, 2021
4.4	Specimen Stock Certificate evidencing the Shares of Common Stock	S-1	333-258071	4.4	August 25, 2021
4.5	Form of Warrant Certificate	S-1	333-258071	4.5	August 25, 2021
4.6	Form of Pre-Funded Common Stock Purchase Warrant	8-K	001-40738	4.1	April 3, 2023
4.7	Form of Common Stock Purchase Warrant	8-K	001-40738	4.2	April 3, 2023
4.8	Warrant to Purchase Common Stock of RenovoRx, Inc.	8-K	001-40738	10.3	January 29, 2024
4.9	RenovoRx Placement Agent Warrant	8-K	001-40738	10.5	January 29, 2024
4.10	Form of Pre-Funded Common Stock Purchase Warrant of RenovoRx, Inc.	8-K	001-40738	10.2	April 15, 2024
4.11	Form of Series A Warrant to Purchase Common Stock of RenovoRx, Inc.	8-K	001-40738	10.3	April 15, 2024
4.12	Form of Series B Warrant to Purchase Common Stock of RenovoRx, Inc.	8-K	001-40738	10.4	April 15, 2024
4.13	Form of Placement Agent Warrant to Purchase Common Stock of RenovoRx, Inc.	8-K	001-40738	10.5	April 15, 2024
4.14	Common Stock Purchase Warrant Issued to Medical Murray, Inc., dated September 25, 2024	10-Q	001-40738	4.14	November 13, 2024
4.15	Form of Underwriter Warrant issued in February 2025 Public Offering	8-K	001-40738	4.1	February 10, 2025
4.16	Form of Pre-Funded Warrant Issued to Investors in the March 2026 Private Placement	8-K	001-40738	4.1	March 23, 2026
4.17	Form of Milestone Warrant Issued to Investors in the March 2026 Private Placement	8-K	001-40738	4.2	March 23, 2026
10.1	Amended and Restated 2021 Omnibus Equity Incentive Plan	8-K	001-40738	10.1	June 30, 2026
31.1	Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	Filed herewith
31.2	Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.	Filed herewith
32.1†	Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	Furnished herewith


32.2†	Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	Furnished herewith
101.INS	Inline XBRL Instance Document-the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document	Filed herewith
101.SCH	Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents	Filed herewith
104	Cover Page formatted as Inline XBRL and contained in Exhibit 101	Filed herewith

† The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	RenovoRx, Inc.

Date: August 13, 2026	By:	/s/ Shaun R. Bagai
		Shaun R. Bagai
		Chief Executive Officer
		(Principal Executive Officer)

Date: August 13, 2026	By:	/s/ Mark Voll
		Mark Voll
		Chief Financial Officer
		(Principal Financial Officer)