NUVECTIS PHARMA, INC._March 31, 2025

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the Quarterly Period Ended March 31, 2025

☐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 001-41264

NUVECTIS PHARMA, INC.

(Exact name of registrant as specified in its charter)


Delaware		86-2405608
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

1 Bridge Plaza, Suite 275
Fort Lee, NJ 07024		07024
(Address of Principal Executive Offices)		(Zip Code)

(201) 614-3150

(Registrant’s telephone number, including area code)

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 $0.00001 per share	NVCT	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 Act). Yes ☐ No ☒

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.



Class of Common Stock		Outstanding Shares as of May 1, 2025
Common Stock, $0.00001 par value		23,634,586

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NUVECTIS PHARMA, INC.

FORM 10-Q

FOR THE QUARTER ENDED March 31, 2025

TABLE OF CONTENTS


		Page
PART I	FINANCIAL INFORMATION	5
Item 1	Financial Statements	5
	Unaudited Condensed Balance Sheets as of March 31, 2025 and December 31, 2024	5
	Unaudited Condensed Statements of Operations for the Three Months Ended March 31, 2025 and 2024	6
	Unaudited Condensed Statements of Changes in Shareholders’ Equity for the Three Months Ended March 31, 2025 and 2024	7
	Unaudited Condensed Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024	8
	Notes to Unaudited Condensed Financial Statements	9
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3	Quantitative and Qualitative Disclosures About Market Risk	23
Item 4	Controls and Procedures	23

PART II	OTHER INFORMATION	24
Item 1	Legal Proceedings	24
Item 1A	Risk Factors	24
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	51
Item 3	Defaults Upon Senior Securities	52
Item 4	Mine Safety Disclosures	52
Item 5	Other Information	52
Item 6	Exhibits	53
	Signatures	54

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SUMMARY OF RISK FACTORS

An investment in our common stock is subject to a broad range of risks and should only be made after a careful consideration of such risks. For a discussion of some of the risks you should consider before purchasing our common stock, you are urged to carefully review and consider the section entitled “Item 1A. Risk Factors.”

Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our common stock. These risks are discussed more fully in the section titled “Risk factors” beginning on page 26 of this report, and include the following:

Risks Related to our Financial Condition and Capital Requirements

●

We have a limited operating history, have only initiated a limited number of clinical trials, and have only a limited number of patients currently enrolled in our ongoing trials and have not completed any clinical trials to date. We do not have any products approved for commercial sale and have not generated any revenue, which may make it difficult for investors to evaluate our current business and likelihood of success and viability.

●

We have incurred losses since our inception and have not generated any revenue. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability.

●

Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery or identification, preclinical and clinical development, regulatory approval and commercialization of our current or future product candidates.

●

Tariffs and other trade measures could adversely affect our business, results of operations, financial position and cash flows.

●

We will require substantial additional capital to finance our operations and achieve our goals. If we are unable to raise capital when needed or on terms acceptable to us, we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations.

●

Policies implemented during the COVID 19 pandemic, which remain in place today, could adversely impact our business, including our preclinical development, clinical trials and clinical trial operations.

Risks Related to the Development of our Product Candidates

●

We are substantially dependent on the success of our product candidates, NXP800, and NXP900.

●

Clinical trials are very expensive, time consuming and difficult to design and implement, and involve uncertain safety, tolerability and efficacy outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials. Our current or future product candidates may not have favorable results in early or later clinical trials, if any, or receive regulatory approval.

●

If we fail to demonstrate safety and/or efficacy for any or all of our product candidates, we may need to terminate development programs, which may harm our reputation and the business.

●

The development and commercialization of pharmaceutical products are subject to extensive regulation, and we may not obtain regulatory approvals for NXP800, NXP900, or any future product candidate.

●

If we are unable to obtain or maintain regulatory approval for our product candidates and ultimately cannot commercialize one or more of them, or experience significant delays in doing so, our business will be materially harmed.

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Risks Related to Government Regulation

●

Denial of or delay in our receipt of required regulatory approvals may prevent or delay commercialization of our current or future product candidates and our ability to generate revenue may be materially impaired.

●

Even if we receive regulatory approval of our current or future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our current or future product candidates.

Risks Related to our Intellectual Property

●

If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products and technology may be adversely affected.

Risks Related to our Reliance on Third Parties

●

The manufacturing of our current and any future product candidates is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to supply any of our current or future product candidates for clinical trials or, if approved, for commercial sale.

Risks Related to Managing Growth and Employee Matters

●

Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital.

●

We currently have 13 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

Risks Related to Commercial Activities

●

If any of our current or future product candidates do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues from any such current or future product candidate may be limited.

●

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates.

Risks Related to Ownership of our Common Stock

●

We do not know whether an active, liquid and orderly trading market will be maintained for our Common Stock or what the market price of our Common Stock will be and, as a result, it may be difficult for you to sell your shares of our Common Stock.

●

We do not intend to pay dividends on our Common Stock in the foreseeable future, so any returns will be limited to the value of our stock, which may be volatile.

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

NUVECTIS PHARMA, INC.

CONDENSED BALANCE SHEETS

(USD in thousands, except per share and share amounts)

(unaudited)


	March 31,		December 31,
	2025		2024
Assets
CURRENT ASSETS
Cash and cash equivalents	$	29,864	$	18,533
Other current assets		284		74
TOTAL CURRENT ASSETS		30,148		18,607

TOTAL ASSETS	$	30,148	$	18,607

Liabilities and Shareholders’ Equity

CURRENT LIABILITIES
Accounts payables	$	2,992	$	2,498
Payable offering costs		300		—
Accrued liabilities		865		840
Employee compensation and benefits		5,037		5,556
TOTAL CURRENT LIABILITIES		9,194		8,894
TOTAL LIABILITIES		9,194		8,894

COMMITMENTS AND CONTINGENCIES, see Note 3

SHAREHOLDERS’ EQUITY, see Note 4
Common Shares, $0.00001 par value – 60,000,000 shares authorized as of March 31, 2025, and December 31, 2024, 23,634,586, and 19,495,683 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively		*		*
Additional paid in capital		99,531		82,958
Accumulated deficit		(78,577)		(73,245)
TOTAL SHAREHOLDERS’ EQUITY		20,954		9,713
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$	30,148	$	18,607

*	Represents an amount lower than $1 USD.

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

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NUVECTIS PHARMA, INC.

CONDENSED STATEMENTS OF OPERATIONS

(USD in thousands, except per share and share amounts)

(unaudited)



	Three Months Ended March 31
	2025		2024
OPERATING EXPENSES
Research and development	$	3,680	$	2,660
General and administrative		1,888		1,736

OPERATING LOSS		(5,568)		(4,396)
Finance income		236		225

NET LOSS	$	(5,332)	$	(4,171)
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS	$	(5,332)	$	(4,171)
BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING, see Note 6	$	(0.27)	$	(0.25)
Basic and diluted weighted average number of common shares outstanding		19,937,507		16,559,335

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

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NUVECTIS PHARMA, INC.

CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(USD in thousands, except share amounts)

(unaudited)




	Common shares		Additional					Total
	$0.00001 Par Value		Paid-In		Accumulated			Shareholders’
	Shares	Amount	Capital		Deficit		Equity
BALANCES AT DECEMBER 31, 2023	17,418,886	*	$	66,446	$	(54,245)	$	12,201
Share-based payments	—	—		1,296		—		1,296
Issuance of restricted share awards	434,527	—		—		—		—
Issuance of common shares, net of offering costs of $153 - At-the-market	502,647	*		4,696		—		4,696
Net loss for the period	—	—		-		(4,171)		(4,171)
BALANCES AT MARCH 31, 2024	18,356,060	*	$	72,438	$	(58,416)	$	14,022




	Common Shares		Additional				Total
	$0.00001 Par Value		Paid-In		Accumulated		Shareholders’
	Shares	Amount	Capital		Deficit		Equity
BALANCES AT DECEMBER 31, 2024	19,495,683	*	$	82,958	$	(73,245)	$	9,713
Share-based payments	—	—		1,368		—		1,368
Issuance of restricted share awards	844,087	—		—		—		—
Issuance of common shares, net of offering costs of $1,552 - Public offering	3,105,000	*		13,973				13,973
Issuance of common shares, net of offering costs of $41 - At-the-market	189,816	*		1,232		—		1,232
Net loss for the period	—	—		—		(5,332)		(5,332)
BALANCES AT MARCH 31, 2025	23,634,586	*	$	99,531	$	(78,577)	$	20,954

*	Represents an amount lower than $1 USD.

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

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NUVECTIS PHARMA, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(USD in thousands, except per share and share amounts)

(unaudited)


	Three Months Ended March 31,
	2025		2024
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(5,332)	$	(4,171)
Adjustments to reconcile loss to net cash used in operating activities: Cost of share-based payments		1,368		1,296
Changes in operating assets and liabilities:
Increase in other current assets		(210)		(191)
Increase/(decrease) in accounts payable		494		(1,012)
Increase in accrued liabilities		25

SEC Form 10-Q filed by Nuvectis Pharma Inc.