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): May 7, 2024

 

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 May 7, 2024, Nuvectis Pharma, Inc. issued a press release to provide a corporate update and to announce its financial results for the first quarter ended March 31, 2024. 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 May 7, 2024.
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: May 7, 2024
	By:	/s/ Ron Bentsur
		Ron Bentsur
		Chairman, Chief Executive Officer and President

 

 

Exhibit 99.1

 

 

 

Nuvectis Pharma, Inc. Reports First Quarter 2024 Financial Results and Business Highlights

 

·

Encouraging preliminary data announced from the NXP800 Phase 1b study in platinum resistant, ARID1a-mutated ovarian cancer, a program granted Fast Track Designation by the US FDA

 

·

Data presented at the 2024 AACR demonstrate NXP900's robust activity in non-small cell cancer cell lines

 

·

Several clinical data updates expected in 2H 2024

 

May 7, 2024, 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 first quarter 2024 and provided an update on recent business progress.

 

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "Our clinical development programs for NXP800 and NXP900 continued to advance nicely in the first quarter of 2024. For NXP800, we announced encouraging preliminary data from the Phase 1b study in platinum resistant, ARID1a-mutated ovarian cancer. We believe these data provide early evidence for the potential activity of NXP800 in this deadly disease. We are also pleased with the recent increase in patient enrollment into the study as more clinical sites are now fully activated. In addition, our collaboration with the Mayo Clinic investigating NXP800 as a treatment option for patients with cholangiocarcinoma is also advancing, providing a second potential opportunity for NXP800 in another disease representing a severe unmet medical need."

 

Mr. Bentsur continued, "With respect to NXP900, the Phase 1a dose-escalation study continues as planned, and we recently presented new preclinical data at the 2024 AACR conference confirming the report by AstraZeneca researchers previously published in Nature Communications that adding NXP900 to osimertinib, the active ingredient in TAGRISSO®, an epidermal growth factor receptor (EGFR) inhibitor, re-sensitizes resistant non-small cell lung cancer (NSCLC) cells to osimertinib. In addition, we presented new preclinical data demonstrating the potential synergy between NXP900 and alectinib, the active ingredient in ALECENSA®, in anaplastic lymphoma kinase (ALK)-mutated NSCLC cells. EGFR and ALK inhibitors are important therapies against NSCLC and these preclinical data for NXP900 demonstrate its potential in reversing resistance to EGFR and ALK targeted agents."

 

Mr. Bentsur concluded, "2024 is shaping up to be a potentially transformational year for Nuvectis with several clinical data updates expected in the second half of the year. Importantly, we remain cash flow efficient and ended the quarter with approximately $19.5 million in cash, which we believe provides runway into 2H 2025."

 

 

 

 

First Quarter 2024 Financial Results

 

Cash, and cash equivalents were $19.5 million as of March 31, 2024, compared to $19.1 million as of December 31, 2023. The increase of $0.4 million in the cash balance in the first quarter of 2024 is a result of the utilization of the at-the-market facility, partially offset by the operating expenses for the quarter.

 

The Company's net loss was $4.2 million for the three months ended March 31, 2024, compared to $4.0 million for the three months ended March 31, 2023, an increase in net loss of $0.2 million. Net loss for the first quarter of 2024 fiscal year included $1.3 million in non-cash stock-based compensation.

 

Research and development expenses, including non-cash stock-based compensation, were $2.7 million for the three months ended March 31, 2024, compared to $2.4 million for the three months ended March 31, 2023, an increase of $0.3 million.

 

General and administrative expenses, including non-cash stock-based compensation, were $1.7 million for the three months ended March 31, 2024, compared to $1.7 million for the three months ended March 31, 2023.

 

Interest income was $0.2 million for the three months ended March 31, 2024, compared to $0.1 million for the three months ended March 31, 2023, an increase of $0.1 million.

 

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 clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action in that it inhibits both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.

 

 

 

 

Forward Looking Statements

 

Certain statements in this press release constitute "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”, 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 of operations, 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 conclusions and interpretation of preclinical data generated to date for NXP800 and NXP900, including preclinical experiments highlighting NXP900's potential to become a viable therapeutic option as a single-agent or in combination with other approved drugs for the treatment of non-small cell lung cancer and other diseases, the conclusions and interpretation of the Phase 1a data generated for NXP800 and the timing and clinical expectations for 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, cholangiocarcinoma and potentially other cancer indications, and the timing of and expectations for 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 2023 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.

 

BALANCE SHEET

 

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

 

		March 31,				December 31,
		2024				2023
Assets
CURRENT ASSETS:
Cash and cash equivalents		$	19,464			$	19,126
Other current assets			250				59
TOTAL CURRENT ASSETS			19,714				19,185
TOTAL ASSETS		$	19,714			$	19,185
Liabilities and Shareholders’ Equity
CURRENT LIABILITIES
Accounts payables		$	1,759			$	2,771
Accrued liabilities			486				415
Employee compensation and benefits			3,447				3,798
TOTAL CURRENT LIABILITIES			5,692				6,984
TOTAL LIABILITIES			5,692				6,984
COMMITMENTS AND CONTINGENCIES,
SHAREHOLDERS’ EQUITY:
Common Shares, $0.00001 par value – 60,000,000 shares authorized as of March 31, 2024, and December 31, 2023, respectively, 18,356,060, and 17,418,886 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively			*				*
Additional paid in capital			72,438				66,446
Accumulated deficit			(58,416	)			(54,245	)
TOTAL SHAREHOLDERS’ EQUITY			14,022				12,201
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	19,714			$	19,185

 

*

Represents an amount lower than $1,000 USD.

 

 

 

 

NUVECTIS PHARMA, INC.

 

STATEMENT OF OPERATIONS

 

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

 

		Three Months Ended March 31,
		2024				2023
OPERATING EXPENSES:
Research and development		$	2,660			$	2,367
General and administrative			1,736				1,734
OPERATING LOSS			(4,396	)			(4,101	)
Finance income			225				52
NET LOSS		$	(4,171	)		$	(4,049	)
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS		$	(4,171	)		$	(4,049	)
BASIC AND DILUTED NET LOSS PER COMMON SHARES OUTSTANDING		$	(0.25	)		$	(0.27	)
Basic and diluted weighted average number of common shares outstanding			16,559,335				14,724,249

 

 

 

v3.24.1.u1

Cover	May 07, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 07, 2024
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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