Form 8-K

8-K — Nuvectis Pharma, Inc.

Accession: 0001104659-26-122360

Filed: 2026-11-04

Period: 2026-11-04

CIK: 0001875558

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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):

November 4, 2026

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 November 4, 2026, Nuvectis

Pharma, Inc. issued a press release to provide a corporate update and to announce its financial results for the third quarter ended September

30, 2026. 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 November 4, 2026.

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: November 4, 2026

By:

/s/ Ron Bentsur

Ron Bentsur

Chairman, Chief Executive Officer and President

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2628939d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Nuvectis

Pharma Reports Third Quarter 2026 Financial Results and Business Highlights

· In-licensing

of ex-China rights to two potentially best-in-class compounds (NXP100 and NXP200) from Haisco

Pharmaceutical Group transformed Nuvectis into a late-stage clinical development company.

· The

Company’s lead drug candidate, ciprocopan (NXP100), a Complement Factor B inhibitor

(CFBi) for once-daily oral administration, was approved in China in July 2026 for the

treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) previously untreated

with complement inhibitors.

FDA

discussions ongoing regarding the U.S. regulatory path forward for ciprocopan in patients with PNH; An update is expected before year-end.

· Cash

position of approximately $140 million extends the Company’s runway into 2H 2029.

Nuvectis

will hold a conference call today at 8:00 AM ET to discuss business highlights and its third quarter 2026 financial results.

November 4,

2026, Fort Lee, NJ - Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical

company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, announced

today its financial results for the third quarter of 2026 and provided an update on recent business progress.

"The

last few months have been truly transformational for Nuvectis," said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis.

"The strategic in-licensing of ciprocopan (NXP100, our CFBi) and NXP200 (our paradox-breaker BRAF inhibitor) firmly establishes

Nuvectis as a late-stage clinical development company with potential best-in-class assets. Our immediate priority is to advance ciprocopan

toward a U.S. marketing application in PNH, as well as in additional indications. Our discussions with the FDA regarding the next steps

for PNH are well underway, and we expect to provide an update before year-end. We plan to submit a U.S. IND for NXP100 by year-end. In

parallel, we are building out our internal complement expertise to support a broad development program. Recently, we strengthened our

team with the hiring of Dustin Little, M.D., a SVP Clinical Development and head of our Complement program. Dr. Little is a physician-scientist

and board-certified nephrologist and brings the ideal combination of relevant industry experience, having worked in clinical development

at AstraZeneca for a decade, and as a physician. We are excited to have him join the team."

Mr. Bentsur

continued, "With its potential for a clear dosing convenience compared to injectable treatments and Fabhalta—the twice-daily

oral CFBi—and supported by robust clinical data in PNH and IgAN as well as validating clinical data from the Fabhalta clinical

trials, we believe ciprocopan has the potential to redefine the standard of care for patients in targeted settings.”

“For

NXP200, updated Phase 1b results in BRAF V600-mutated recurrent or progressive glioma were presented at the recent ESMO annual meeting.

Single-agent NXP200 demonstrated durable responses, including complete responses, with activity also seen in patients previously treated

with a BRAF inhibitor. The data are encouraging and underscore the potential of NXP200 to become a differentiated, best-in-class, second-generation,

paradox-breaker BRAF inhibitor. We expect to submit a U.S. IND for NXP200 by year-end, and we look forward to providing additional NXP200

Phase 1b data from China, alongside a Phase 1b data update for NXP900, our SRC-Yes1 kinase inhibitor,in the coming months."

"We

ended the quarter with approximately $140 million in cash, representing the strongest financial position in Nuvectis’ history,"

Mr. Bentsur concluded. "We expect this funding to support our operations into the second half of 2029, providing a runway that

extends well beyond multiple potential value-creating clinical and regulatory milestones."

Recent

Developments

· Completed

in licensing of two potentially best-in-class drug candidates from Haisco Pharmaceutical

Group and follow-on public offering anchored by leading healthcare investors.

Ciprocopan

(NXP100)

· In

July 2026, ciprocopan achieved its first global approval (in China), for the treatment

of patients with PNH previously untreated with complement inhibitors. A second marketing

application for ciprocopan in China is currently under review, for the treatment of PNH patients

previously treated with anti C5 therapy, with approval expected in 1Q27; additional ongoing

clinical trials for ciprocopan in China include a Phase 3 in IgAN and a Phase 2 study in

lupus nephritis.

· Communications

with the U.S. FDA about the potential of the clinical data package that led to the approval

of ciprocopan in China for the treatment of PNH to support a marketing application for NXP100

in the U.S. are well underway and an update is expected by year-end; Nuvectis continues to

explore additional opportunities and an IND submission, for an indication beyond PNH, is

expected by year-end.

· Phase

3 results from a study conducted in China of a head-to-head comparison of NXP100 versus eculizumab

(Soliris) in patients with PNH naïve to complement inhibition was presented at the (European

Hematology Association 2026 conference), demonstrating a robust efficacy advantage of ciprocopan

versus Soliris.

NXP200

· In

September, NXP200 was granted Breakthrough Therapy Designation for the treatment of patients

with BRAF V600-mutant, recurrent or progressive high-grade glioma by China’s Center

for Drug Evaluation (CDE). In April, the project was selected as a pilot project under the

“Pediatric Anti-tumor Drug R&D Encouragement Pilot Scheme (Starlight Program)”

for the indication of pediatric BRAF V600-mutated recurrent or progressive glioma by CDE.

· In

October, expanded NXP200 Phase 1b data in patients with recurrent or progressive BRAF V600-mutated

gliomas were presented at the 2026 ESMO Congress. As of the May 4, 2026 cutoff, 27 efficacy-evaluable

patients with recurrent or progressive BRAF V600 glioma were treated with NXP200 monotherapy,

including 20 patients with high-grade glioma and 7 with low-grade glioma.

o Treatment

with NXP200 resulted in an ORR of 40.0% in the high-grade glioma cohort, including 3 CRs

(two confirmed and one preliminary) and 42.9% in the low-grade glioma cohort, including one

confirmed CR. All response assessments were based on RANO 2.0 criteria. Notably, among the

three patients previously treated with a BRAF inhibitor, two achieved a partial response

and one had stable disease.

o Deep

responses (>80% tumor burden reduction) were achieved in 87.5% of responders with high-grade

glioma and 66.7% of responders with low-grade glioma. 81.5% of the patients in the study

achieved a tumor reduction.

· A

U.S. IND submission is expected by year-end.

· Updates

from the ongoing Phase 1b study in China, including in additional tumor types, are expected

in early 2027.

NXP900

· NXP900

Phase 1b clinical development continues to focus on combination opportunities:

o Non-small

cell lung cancer (NSCLC): the clinical trials evaluating the combination of NXP900 plus osimertinib

(Tagrisso™) in patients with NSCLC EGFR+ and the combination with lorlatinib

(Lorbrena®) in patients with NSCLC ALK+ are ongoing. Update from Phase 1b

expected during the first half of 2027.

o Pancreatic

cancer: An investigator-sponsored trial to evaluate the combination of NXP900 plus the recently

approved daraxonrasib in patients with pancreatic cancer is planned at two leading medical

centers in the U.S.

Corporate

Updates: Recent Hire Strenthens Our Clinical Development Team

Dustin

Little, MD, joined Nuvectis as Senior Vice President, Head of the Complement program, in September 2026. Dr. Little is a physician-scientist

and board-certified nephrologist with a decade of pharmaceutical industry experience driving drug development from asset acquisition

through program design, regulatory submission and approval. From 2016-2026, Dr. Little worked at Astra Zeneca and most recently

served as Global Clinical Head, Late Cardiovascular, Renal, and Metabolism (CVRM), providing clinical leadership for renal disease area

strategy at AstraZeneca as well as multiple first-in-class/potential first-in-class treatments for people living with kidney, cardiovascular,

or hematologic diseases. Dr. Little also represented AstraZeneca externally in regulatory interactions and on major industry, academic

and drug development advisory bodies.

Dr. Little

earned his doctorate degree from the University of Washington School of Medicine in 2007. Between 2007-2016 Dr. Little served in

the US military during which time he completed his internal medicine residency at the Madigan Army Medical Center and nephrology fellowship

at the Walter Reed National Medical Center. In 2013, Dr. Little deployed to Afghanistan as a squadron physician. Dr. Little

continues to treat patients as a volunteer at a Washington, DC-area nephrology clinic.

Mr. Bentsur

said, “We welcome Dustin to Nuvectis. Dustin has had an immediate impact on the NXP100 program including involvement in the FDA

discussions for PNH, conducting prioritization assessments of other indications, protocol writing and interactions with top key opinion

leaders. Dustin’s knowledge and understanding of the complement inhibition in nephrology and hematology diseases are exceptional

and we look forward to harnessing his expertise as we set out to establish NXP100 as a potential best-in-class compound across several

indications.”

Dr. Little

commented, “It’s exciting to join Nuvectis at such a transformative time. The company has built a strong foundation and NXP100,

as a late-stage once-a-day oral CFBi, represents a unique opportunity for significant impact across several indications. Leveraging my

industry experience and medical knowledge, I look forward to helping spearhead this program forward while utilizing the compelling

NXP100 Chinese and other CFBi data as a roadmap for our development plans.”

Third

Quarter 2026 Financial Results

Cash

and cash equivalents were $140.7 million as of September 30, 2026, compared to $31.6 million as of December 31, 2025. In July,

the Company raised $115.0 million in gross proceeds in a follow-on offering and additional $39.5 million of cash was raised via the existing

ATM of which $37.0 million placed with a single healthcare dedicated fund.

The

Company's net loss was $30.1 million for the three months ended September 30, 2026, compared to $7.5 million for the three months

ended September 30, 2025, an increase in net loss of $22.6 million, which includes a one-time upfront payment associated with the

NXP100 and NXP200 license agreement of $20.0 million, and $1.8 million in milestones associated with NXP900. Non-cash stock-based compensation

was $2.4 million for the three months ended September 30, 2026, compared to $1.5 million for the three months ended September 30,

2025. Net of the up-front license payment, the one-time milestone associated with NXP900 and non-cash stock-based compensation, the net

loss for the third quarter 2026 was $5.8 million.

Research

and development expenses were $27.4 million for the three months ended September 30, 2026, compared to $5.8 million for the three

months ended September 30, 2025, an increase of $21.6 million. The increase was primarily driven by the $20.0 million upfront payment

for the NXP100 and NXP200 license agreement, $1.8 million in milestones associated with NXP900, a $1.2 million increase in employee compensation

and benefits, $0.5 million increase in clinical trial expenses and a $0.1 million increase in manufacturing costs, partially offset by

$2.0 million in license fees paid in 2025. Non-cash stock-based compensation was $1.5 million for the three months ended September 30,

2026, compared to $0.9 million for the three months ended September 30, 2025.

General

and administrative expenses were $3.7 million for the three months ended September 30, 2026, compared to $2.0 million for the three

months ended September 30, 2025, an increase of $1.7 million. The increase was primarily driven by a $1.2 million increase in professional

and consulting services and a $0.4 million increase in employee compensation and benefits. Non-cash stock-based compensation was $0.9

million for the three months ended September 30, 2026, compared to $0.6 million for the three months ended September 30, 2025.

Finance

income was $1.0 million for the three months ended September 30, 2026, and $0.3 million for the three months ended September 30,

2025.

Conference

Call and Webcast Information:

Time:

8:00 AM ET

Date:

Wednesday, November 4, 2026

Participant

Dial-In (U.S.): 1-877-407-0752

Participant

Dial-In (International): 1-201-389-0912

Conference

ID: 13763643

Webcast

Access: Please click here

The

live and archived webcast can also be accessed by visiting the Nuvectis Pharma website on the Events and Presentations section of the

Investor Relations page. A replay of the webcast will be archived for at least 30 days following the presentation.

About

Nuvectis Pharma, Inc.

Nuvectis

Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment

of immune complement-related conditions and oncology. The Company’s pipeline includes ciprocopan (NXP100), a complement Factor

B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in

development for the treatment of advanced cancers.

The

company’s lead drug candidate is ciprocopan, a once-a-day Factor B inhibitor, with best-in-class potential, recently approved in

China for the treatment of PNH patients previously untreated with complement inhibitors.

NXP200

is an oral, brain-penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated

solid tumor malignancies, with best-in-class potential.

NXP900

is an oral small molecule inhibitor of the SRC family kinases, including SRC and YES1.

Forward

Looking Statements

This

press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which 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. These forward-looking statements include, but are

not limited to, statements regarding future events, including statements about the use of proceeds from the public offering and the approvability

and market potential of our pipeline products. Forward looking statements are based on Nuvectis’ current expectations, estimates

and projections and past interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics,

pharmacodynamics, and efficacy data generated to date for its pipeline products NXP100, NXP200, and NXP900, estimates and projections

regarding Nuvectis’ financial condition and IND submissions and future clinical trials for NXP100 and NXP200. The outcomes 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. 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 may also be subject to market and other conditions and described

more fully in the section titled "Risk Factors" in Nuvectis’ third quarter 2026 Form 10-Q and Nuvectis’ other

public filings with the U.S. 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 Nuvectis’ 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

rbentsur@nuvectis.com

Media

Relations Contact

Kevin

Gardner

LifeSci

Advisors

kgardner@lifesciadvisors.com

NUVECTIS

PHARMA, INC.

BALANCE

SHEET

(USD

in thousands, except per share and share amounts)

September 30,

December 31,

2026

2025

Assets

CURRENT ASSETS

Cash and cash equivalents

$ 140,707

$ 31,634

Other current assets

132

TOTAL CURRENT ASSETS

140,839

31,709

TOTAL ASSETS

$ 140,839

$ 31,709

Liabilities and Shareholders’ Equity

CURRENT LIABILITIES

Accounts payable

$ 5,761

$ 6,274

Accrued liabilities

2,109

115

Employee compensation and benefits

6,323

6,907

TOTAL CURRENT LIABILITIES

14,193

13,296

TOTAL LIABILITIES

14,193

13,296

COMMITMENTS AND CONTINGENCIES,

SHAREHOLDERS’ EQUITY,

Common Shares, $0.00001 par value – 60,000,000 shares authorized as of September 30, 2026, and December 31, 2025, 35,031,982, and 25,676,798 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively

Additional paid in capital

269,473

118,100

Accumulated deficit

(142,827 )

(99,687 )

TOTAL SHAREHOLDERS’ EQUITY

126,646

18,413

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

$ 140,839

$ 31,709

* 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 September 30

Nine Months Ended September 30

2026

2025

2026

2025

OPERATING EXPENSES

Research and development

$ 27,370

$ 5,774

$ 36,160

$ 13,067

General and administrative

3,679

2,020

8,346

6,890

OPERATING LOSS

(31,049 )

(7,794 )

(44,506 )

(19,957 )

Finance income

979

332

1,366

829

NET LOSS

$ (30,070 )

$ (7,462 )

$ (43,140 )

$ (19,128 )

NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS

$ (30,070 )

$ (7,462 )

$ (43,140 )

$ (19,128 )

EFFECT OF WARRANTS MODIFICATION,

—

(2,429 )

—

(2,429 )

TOTAL NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS

$ (30,070 )

$ (9,891 )

$ (43,140 )

$ (21,557 )

BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING

$ (1.02 )

$ (0.44 )

$ (1.69 )

$ (1.01 )

Basic and diluted weighted average number of common shares outstanding

29,466,698

22,719,057

25,474,553

21,351,228

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- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

Local phone number for entity.

+ References

No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

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- Definition

Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

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- Definition

Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

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No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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