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RenovoRx, Inc.

For the period ended Jun 30, 2025. Filed Aug 14, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 14, 2025

RNXT$1.13-5.0%Stored close · as of Nov 6, 2026
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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 30,2025

OR

☐** 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)

Delaware27-1448452
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
Mountain View, California94040
(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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.0001 per shareRNXTThe 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 11, 2025, the registrant had 36,645,884 shares of common stock, $0.0001 par value per share, outstanding.

TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION1
Item 1. Financial Statements1
Condensed Balance Sheets as of June 30, 2025, and December 31, 20241
Condensed Statements of Operations for the three and six months ended June 30, 2025, and 20242
Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2025, and 20243
Condensed Statements of Cash Flows for the six months ended June 30, 2025, and 20245
Notes to the Unaudited Condensed Interim Financial Statements6
Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations18
Item 3. Quantitative and Qualitative Disclosures About Market Risk30
Item 4. Controls and Procedures30
PART II. OTHER INFORMATION32
Item 1. Legal Proceedings32
Item 1A. Risk Factors32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds34
Item 3. Defaults Upon Senior Securities34
Item 4. Mine Safety Disclosures34
Item 5. Other Information34
Item 6. Exhibits35
SIGNATURES36

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 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,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” “in the future” or the negative of these terms or other comparable 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 regarding future revenue, expenses, anticipated capital requirements to fund our future operating expenses, and our need for additional financing;
●our future financial 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 results;
●the progress and focus of our current pivotal Phase III TIGeR-PaC trial, our PanTheR multi-center post-marketing registry trial, and potential future clinical trials;
●projections for the timing 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 our clinical trials (notably our ongoing Phase III TIGeR-PaC trial);
●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 technology, devices and 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 such market opportunities;
●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 LLC (“Nasdaq”); 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 significant risks, uncertainties, assumptions and other factors described in the section titled “Risk Factors” and elsewhere in this Report, in our Annual Report on Form 10-K for the year ended December 31, 2024 and our other SEC filings and public statements. 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.

Unless the context otherwise indicates, “RenovoRx,” the “Company,” “we,” “our,” and “us” refer to RenovoRx, Inc., a Delaware corporation. All information presented herein is based on our fiscal calendar. Unless otherwise stated, references to particular years, quarters, months or periods refer to the Company’s fiscal years ended in December and the associated quarters, months and periods of those fiscal years.

ContentsView on SEC.gov

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