NVCT Nuvectis Pharma Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

  

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): August 9, 2023

 

Nuvectis Pharma, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware (State or Other Jurisdiction of Incorporation)

001-41264 (Commission File Number)

86-2405608 (IRS Employer Identification No.)

 

1 Bridge Plaza Suite 275

Fort Lee, NJ 07024

(Address of Principal Executive Offices)

 

(201) 614-3150

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

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

 

Title of Class	Trading Symbol(s)	Exchange Name
Common Stock	NVCT	Nasdaq Capital Market

 

¨	Written communications pursuant to Rule 425 under the Securities Act.
¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act.
¨	Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.
¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

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. ¨

 

 

 

Item 2.02.

Results of Operations and Financial Condition.

 

On August 9, 2023, Nuvectis Pharma, Inc. issued a press release to provide a corporate update and to announce its financial results for the second quarter ended June 30, 2023. A copy of such press release is being furnished as Exhibit 99.1 to this report.

 

The information, including Exhibit 99.1, in this Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall otherwise be expressly set forth by specific reference in such filing.

 

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

The following exhibit is furnished herewith:

 

Exhibit
Number		Description
99.1		Press release issued by Nuvectis Pharma, Inc., dated August 9, 2023.
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

 

SIGNATURES

 

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

  

	Nuvectis Pharma, Inc.
	(Registrant)
Date: August 9, 2023
	By:	/s/ Ron Bentsur
		Ron Bentsur
		Chairman, Chief Executive Officer and President

 

 

Exhibit 99.1

 

 

Nuvectis Pharma, Inc. Reports Second Quarter 2023 Financial Results and Business Highlights

 

·

The Phase 1b study of NXP800 in patients with platinum resistant, ARID1a-mutated ovarian carcinoma is ongoing

 

·

NXP900 IND cleared by the US FDA, start of Phase 1a study expected in Q3 2023

 

August 9, 2023, Fort Lee, NJ - Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported its financial results for the second quarter 2023 and provided an update on recent pipeline progress.

 

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "During the second quarter, we made significant progress on our NXP800 and NXP900 development programs. For NXP800, we initiated our single-arm, open-label, Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian carcinoma and the study is ongoing. We expect to have a preliminary data update from the Phase 1b in the first quarter of 2024." Mr. Bentsur continued, "Moreover, data generated in several preclinical cancer models support the expansion of the NXP800 clinical program into additional potential target indications, such as cholangiocarcinoma."

 

With respect to the NXP900 program, Mr. Bentsur added, "For NXP900, the Investigational New Drug ("IND") application was cleared by the US Food and Drug Administration ("FDA"), and we expect to initiate the Phase 1a dose escalation study this quarter." Mr. Bentsur concluded, "Finally, we have significantly strengthened our financial position, ending the quarter with approximately $24.6 million in cash. We expect this will enable us to support planned operations into H1 2025."

 

Second Quarter 2023 Financial Results

 

Cash, cash equivalents, and short-term investments were $24.6 million as of June 30, 2023, compared to $20.0 million as of December 31, 2022. The increase of $4.6 million was primarily a result of the exercise of warrants from the July 2022 private investment in public equity (“PIPE”) transaction.

 

Research and Development (R&D) expenses were $4.3 million for the three months ended June 30, 2023, compared to $2.5 million for the three months ended June 30, 2022. The increase of $1.8 million in R&D expenses was primarily attributed to non-cash expenses related to stock-based compensation and manufacturing costs. R&D expenses for the three months ended June 30, 2023 included $0.6 million in non-cash expenses related to stock-based compensation and $0.9 million in one-time research support and milestone payments in connection with the NXP800 and NXP900 license agreements.

 

General and Administrative (G&A) expenses were $1.5 million for the three months ended June 30, 2023, compared to $1.1 million for the three months ended June 30, 2022, an increase of $0.4 million. G&A expenses for the three months ended June 30, 2023 included $0.4 million in non-cash expenses related to stock-based compensation.

 

 

 

 

The Company's net loss was $5.7 million for the three months ended June 30, 2023, compared to $3.6 million for the three months ended June 30, 2022, an increase of $2.1 million. The net loss for the three months ended June 30, 2023 included $1.0 million in non-cash expenses related to stock-based compensation and $0.9 million in one-time payments in connection with the NXP800 and NXP900 license agreements.

 

About Nuvectis Pharma, Inc.

 

Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule in a Phase 1b clinical trial for the treatment of platinum resistant, ARID1a-mutated ovarian carcinoma, a development program that was granted Fast Track Designation by the US FDA. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor. The IND has been cleared by the FDA and a Phase 1a dose escalation study is expected to begin in Q3 2023.

 

Forward Looking Statements

 

This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," "set to," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results and timing of operations, including clinical trials, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the preclinical data generated to date for NXP800 and NXP900, the Phase 1a data generated and the Phase 1b clinical expectations for NXP800, including the safety, tolerability and other observations from the NXP800 Phase 1a study and timing, and safety, tolerability and efficacy data from the NXP800 Phase 1b study, including statements regarding NXP800's potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma and potentially other cancer indications, and timing for the commencement of the Phase 1a study for NXP900. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in our 2022 Form 10-K filed with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and 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 press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

 

 

 

Company Contact

 

Ron Bentsur

Chairman, Chief Executive Officer and President

201-614-3151

rbentsur@nuvectis.com

 

 

Media Relations Contact

 

Christopher M. Calabrese

LifeSci Advisors

Tel: 917-680-5608

ccalabrese@lifesciadvisors.com

 

 

 

 

NUVECTIS PHARMA, INC.

 

CONDENSED BALANCE SHEETS

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

(unaudited)

 

		June 30,				December 31,
		2023				2022
Assets
CURRENT ASSETS:
Cash and cash equivalents		$	24,600			$	19,993
Other current assets			341				412
TOTAL CURRENT ASSETS			24,941				20,405
TOTAL ASSETS		$	24,941			$	20,405
Liabilities and Stockholders’ Equity
CURRENT LIABILITIES
Accounts payables		$	1,803			$	2,910
Payable offering costs			399				450
Accrued liabilities			571				445
Employee compensation and benefits			1,836				2,381
TOTAL CURRENT LIABILITIES			4,609				6,186
TOTAL LIABILITIES			4,609				6,186
COMMITMENTS AND CONTINGENCIES,
STOCKHOLDERS’ EQUITY: see Note 4
Common Stock, $0.00001 par value – 60,000,000 shares authorized as of June 30, 2023, and December 31, 2022, 17,221,113, and 15,190,720 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively			*				*
Additional paid in capital			62,074				46,204
Accumulated deficit			(41,742	)			(31,985	)
TOTAL STOCKHOLDERS’ EQUITY			20,332				14,219
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	24,941			$	20,405

 

*

Represents an amount lower than $1,000 USD.

 

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

 

 

 

 

NUVECTIS PHARMA, INC.

 

CONDENSED STATEMENTS OF OPERATIONS

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

(unaudited)

 

		Three Months Ended June 30								Six Months Ended June 30
		2023				2022				2023				2022
OPERATING EXPENSES:
Research and development		$	4,262			$	2,505			$	6,629			$	4,310
General and administrative			1,510				1,068				3,244				2,208
OPERATING LOSS			(5,772	)			(3,573	)			(9,873	)			(6,518	)
Finance income			64				4				116				6
NET LOSS		$	(5,708	)		$	(3,569	)		$	(9,757	)		$	(6,512	)
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS		$	(5,708	)		$	(3,569	)		$	(9,757	)		$	(6,512	)
BASIC AND DILUTED NET LOSS PER COMMON STOCK OUTSTANDING		$	(0.38	)		$	(0.28	)		$	(0.65	)		$	(0.59	)
Basic and diluted weighted average number of common stock outstanding			15,178,035				12,717,794				14,951,881				10,984,297

 

 

v3.23.2

Cover	Aug. 09, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 09, 2023
Entity File Number	001-41264
Entity Registrant Name	Nuvectis Pharma, Inc.
Entity Central Index Key	0001875558
Entity Tax Identification Number	86-2405608
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1 Bridge Plaza Suite 275
Entity Address, City or Town	Fort Lee
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07024
City Area Code	201
Local Phone Number	614-3150
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	NVCT
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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