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, 2023

☐ 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.)

4546 El Camino Real, Suite B1
Los Altos, California		94022
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (650) 284-4433

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		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, 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, 2023, the registrant had 10,693,080 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents

PART I. FINANCIAL INFORMATION	1

Item 1. Financial Statements (unaudited)	1

Condensed Balance Sheets as of June 30, 2023, and December 31, 2022	1

Condensed Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2023, and 2022	2

Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity for the three and six months ended June 30, 2023, and 2022	3

Condensed Statements of Cash Flows for the six months ended June 30, 2023, and 2022	5

Notes to the Unaudited Condensed Interim Financial Statements	6

Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations	15

Item 3. Quantitative and Qualitative Disclosures About Market Risk	25

Item 4. Controls and Procedures	25

PART II. OTHER INFORMATION	27

Item 1. Legal Proceedings	27

Item 1A. Risk Factors	27

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	67

Item 3. Defaults Upon Senior Securities	67

Item 4. Mine Safety Disclosures	67

Item 5. Other Information	67

Item 6. Exhibits	68

SIGNATURES	69

Forward-Looking Statements

This Quarterly Report on Form 10-Q, or Quarterly Report, and the information incorporated herein by reference, 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, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or 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 risks and uncertainties, some of which cannot be predicted or quantified. All statements other than present and historical facts and conditions contained in this Quarterly Report, including statements regarding our future 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,” or “would,” 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 material 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 expenses, future revenue, anticipated capital requirements to fund our future operating expenses, and our need for additional financing;

	●	our 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 and future clinical trials, and the timing of reporting of data from those 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 and to include new indications;

	●	expectations relating to the timing of the provision of updates on, data readouts for, and completion of our clinical trials;

	●	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, and enrollment timing and projections for our clinical trials;

	●	our estimates of potential market opportunities and our ability to successfully realize these opportunities;

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

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

	●	our plans relating to the further development and manufacturing of our 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; and

	●	our expectations regarding the impact of the ongoing COVID-19 pandemic and geopolitical events on our business.

We have based the forward-looking statements contained in this Quarterly 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 Quarterly Report. These risks are not exhaustive. Other sections of this Quarterly 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 Quarterly 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 Quarterly 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 Quarterly 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 Quarterly 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.

iii

Part I – FINANCIAL INFORMATION

Item 1. Financial Statements

RenovoRx, Inc.

Condensed Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)

	June 30, 2023			December 31, 2022

Assets
Current assets:
Cash and cash equivalents	$	5,954		$	4,391
Short-term marketable securities		-			2,049
Prepaid expenses and other current assets		324			825
Deferred offering costs		36			-
Total assets	$	6,314		$	7,265

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	872		$	534
Accrued expenses		827			568
Total current liabilities		1,699			1,102
Common warrant liability		3,427			-
Total liabilities		5,126			1,102
Commitments and contingencies		-			-
Stockholders’ equity:
Convertible preferred stock, $0.0001 par value; 15,000,000 shares authorized as of June 30, 2023, and December 31, 2022, respectively; no shares issued and outstanding at June 30, 2023, and December 31, 2022		-			-
Common stock, $0.0001 par value, 250,000,000 shares authorized at June 30, 2023, and December 31, 2022; 10,693,080 and 9,097,701 shares issued and outstanding as of June 30, 2023, and December 31, 2022, respectively		1			1
Additional paid-in capital		37,944			37,318
Accumulated other comprehensive income		-			17
Accumulated deficit		(36,757	)		(31,173	)
Total stockholders’ equity		1,188			6,163
Total liabilities and stockholders’ equity	$	6,314		$	7,265

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

RenovoRx, Inc.

Condensed Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share amounts)

	2023			2022			2023			2022
	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2023			2022			2023			2022
Operating expenses:
Research and development	$	1,925		$	1,390		$	3,263		$	2,679
General and administrative		1,450			1,224			3,373			2,940
Total operating expenses		3,375			2,614			6,636			5,619
Loss from operations		(3,375	)		(2,614	)		(6,636	)		(5,619	)
Other income/(expenses), net:
Interest and dividend income		50			20			54			21
Other income, net		-			-			-			1
Change in fair value of common warrant liability		1,573			-			1,573			-
Transaction costs allocated to common warrant liability		(575	)		-			(575	)		-
Total other income/(expenses), net		1,048			20			1,052			22
Net loss		(2,327	)		(2,594	)		(5,584	)		(5,597	)
Other comprehensive loss:
Unrealized loss on marketable securities		-			(

SEC Form 10-Q filed by RenovoRx Inc.