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:
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).
If an emerging growth company, indicate by check
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standards provided pursuant to Section 13(a) of the Exchange Act.
On August 4, 2026, 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, 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.
(d) Exhibits.
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.
Exhibit 99.1
Nuvectis Pharma Reports Second Quarter
2026 Financial Results and Business Highlights
| · | Completed
in-licensing of ex-China rights to two potentially best-in-class compounds (NXP100 and NXP200)
from Haisco Pharmaceutical Group (“Haisco”), transforming the company into a
late-stage clinical development organization. |
| · | The
Company’s lead drug candidate, ciprocopan (NXP100), a Complement Factor B inhibitor
for once-daily, oral administration, was approved in China in July 2026 for the treatment
of patients with PNH previously untreated with complement inhibitors. |
| · | Completed
follow-on offering in July 2026, raising $115M in gross proceeds. Transaction anchored by
leading healthcare dedicated investors and extends cash runway into 1H 2029. |
August 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, today reported
its financial results for the second quarter of 2026 and provided an update on recent business progress.
Ron Bentsur,
Chairman and Chief Executive Officer of Nuvectis, commented, “The past several weeks mark a defining chapter for Nuvectis with
the in-licensing of our new lead drug candidate, ciprocopan (NXP100), a Complement Factor B Inhibitor for once-daily oral administration,
and the expansion of our oncology pipeline with the in-licensing of NXP200, an oral, brain-penetrant, paradox-breaker BRAF inhibitor.
Approximately two weeks ago, ciprocopan received its first marketing approval in China for the treatment of patients with paroxysmal
nocturnal hemoglobinuria (“PNH”) not previously treated with complement inhibitors. This approval marks the first global
approval of a once-daily, oral Complement Factor B inhibitor, bringing about a meaningful new treatment option for patients with PNH
in China, and also highlights ciprocopan’s compelling clinical profile and provides further validation of its therapeutic potential
as a treatment for a variety of complement-mediated diseases. We congratulate our partner Haisco on this significant achievement and
are excited about the opportunity to follow suit in the United States and in the other licensed territories.”
Mr. Bentsur
concluded, “As expected following an in-licensing transaction that involves a late-stage asset with a multi-billion-dollar market
potential, our main focus now is to advance ciprocopan toward a marketing application in the United States and other key territories,
with NXP200 and NXP900 driving potential longer-term upside in the oncology segment. The successful $115M follow-on offering recently
completed provides the resources necessary to advance our broad development strategy for NXP100 in PNH and other complement-mediated
diseases and execute the next stage of development across our oncology portfolio.”
Recent
Developments
| · | Completed
public offering in July 2026 for gross proceeds of $115 million, which includes the exercise
of the underwriters’ overallotment. Transaction was anchored by leading healthcare
investors and extends our cash runway into 1H 2029. |
| o | In
July 2026, our partner Haisco announced marketing approval of ciprocopan in China for the
treatment of patients with PNH previously untreated with complement inhibitors. The marketing
application in China for the treatment of PNH patients previously treated with anti C5 therapy
is under review. |
| o | U.S. regulatory efforts underway; a pre-investigation new drug
(“IND”) meeting with the Food and Drug Administration (“FDA”) followed by IND submission expected in 4Q2026. |
| o | Phase
1b in China in patients with BRAF-mutated solid tumors is ongoing. |
| o | Oral presentation of additional clinical data generated by Haisco
will be presented at the upcoming European Society for Medical Oncology (ESMO) conference (Madrid, Spain, October 23–27, 2026). |
| o | U.S. regulatory efforts underway; IND submission expected in
4Q2026. |
| o | With
the shift in corporate focus towards the development of ciprocopan, the NXP900 clinical development
will now continue with the promising, higher potential impact, combination opportunities: |
| § | Non-small cell lung cancer (NSCLC): the clinical trial evaluating the combination of NXP900 plus osimertinib (Tagrisso™) in
patients with NSCLC EGFR+ who initially responded to, and later progressed on, osimertinib, is ongoing, and we expect to provide
an update by the end of this year. The initiation of the combination study of NXP900 with lorlatinib (Lorbrena®) in patients with
NSCLC ALK+ who initially responded to, and later progressed on, an ALK inhibitor, is expected in 3Q2026. |
| § | Pancreatic cancer: Based on in-bound interest from two leading medical centers in the U.S., an investigator-sponsored trial
(IST) is planned to evaluate the combination of NXP900 plus daraxonrasib in patients with pancreatic cancer at these centers. Study initiation is
contingent on FDA approval and availability of daraxonrasib. |
Second Quarter 2026 Financial
Results
Cash, and cash equivalents were $22.2 million as of June 30, 2026,
compared to $31.6 million as of December 31, 2025. In July, the Company raised $115 million in gross proceeds in a follow-on offering
anchored by leading healthcare investors.
The Company's net loss was $7.0 million for the three months ended
June 30, 2026, compared to $6.3 million for the three months ended June 30, 2025, an increase in net loss of $0.7 million. Non-cash stock-based
compensation was $1.7 million for the three months ended June 30, 2026, compared to $1.7 million for the three months ended June 30, 2025.
Research and development expenses were
$4.7 million for the three months ended June 30, 2026, compared to $3.6 million for the three months ended June 30, 2025, an increase
of $1.1 million. The increase was primarily driven by a $0.4 million increase in manufacturing costs, a $0.4 million increase in clinical
trial expenses, and a $0.3 million increase in employee compensation and benefits.
General and administrative expenses
were $2.5 million for the three months ended June 30, 2026, compared to $3.0 million for the three months ended June 30, 2025, a decrease
of $0.5 million. The decrease was primarily driven by a $0.5 million decline in professional and consulting services related to public
company expenses.
Finance income was $0.2 million for
the three months ended June 30, 2026, and $0.3 million for the three months ended June 30, 2025.
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 Factor B inhibitor, with best-in-class potential, recently approved in China for the treatment of PNH patients previously
untreated with complement inhibitors. In PNH and other complement-mediated diseases, ciprocopan is expected to provide a meaningful convenience
advantage as a once-daily, oral treatment option for diseases requiring lifelong treatment.
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, including
central nervous system cancer, colorectal cancer, melanoma, and non-small cell lung cancer, with best-in-class potential.
NXP900 is an oral small molecule inhibitor
of the SRC Family of Kinases, including SRC and YES1 intended to inhibit the catalytic and scaffolding functions of the SRC kinase, providing
comprehensive shutdown of the SRC signaling pathway.
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, and estimates and projections regarding Nuvectis’ financial condition. 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’ second 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)
| | |
June 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| Assets | |
| | | |
| | |
| CURRENT ASSETS | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 22,160 | | |
$ | 31,634 | |
| Other current assets | |
| 216 | | |
| 75 | |
| TOTAL CURRENT ASSETS | |
| 22,376 | | |
| 31,709 | |
| | |
| | | |
| | |
| TOTAL ASSETS | |
$ | 22,376 | | |
$ | 31,709 | |
| | |
| | | |
| | |
| Liabilities and Shareholders’ Equity | |
| | | |
| | |
| | |
| | | |
| | |
| CURRENT LIABILITIES | |
| | | |
| | |
| Accounts payable | |
$ | 5,184 | | |
$ | 6,274 | |
| Deferred fundraising receipts | |
| 1,388 | | |
| — | |
| Accrued liabilities | |
| 92 | | |
| 115 | |
| Employee compensation
and benefits | |
| 6,630 | | |
| 6,907 | |
| TOTAL CURRENT LIABILITIES | |
| 13,294 | | |
| 13,296 | |
| TOTAL LIABILITIES | |
| 13,294 | | |
| 13,296 | |
| | |
| | | |
| | |
| COMMITMENTS AND CONTINGENCIES | |
| | | |
| | |
| | |
| | | |
| | |
| SHAREHOLDERS’ EQUITY | |
| | | |
| | |
| Common Shares, $0.00001 par value – 60,000,000 shares authorized
as of June 30, 2026, and December 31, 2025, 26,694,828, and 25,676,798 shares issued and outstanding as of June 30, 2026
and December 31, 2025, respectively | |
| * | | |
| * | |
| Additional paid in capital | |
| 121,839 | | |
| 118,100 | |
| Accumulated deficit | |
| (112,757 | ) | |
| (99,687 | ) |
| TOTAL SHAREHOLDERS’ EQUITY | |
| 9,082 | | |
| 18,413 | |
| TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY | |
$ | 22,376 | | |
$ | 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 June 30 | | |
Six Months
Ended June 30 | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| OPERATING EXPENSES | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 4,684 | | |
$ | 3,613 | | |
$ | 8,790 | | |
$ | 7,293 | |
| General and administrative | |
| 2,513 | | |
| 2,982 | | |
| 4,667 | | |
| 4,870 | |
| | |
| | | |
| | | |
| | | |
| | |
| OPERATING LOSS | |
| (7,197 | ) | |
| (6,595 | ) | |
| (13,457 | ) | |
| (12,163 | ) |
| Finance income | |
| 177 | | |
| 261 | | |
| 387 | | |
| 497 | |
| | |
| | | |
| | | |
| | | |
| | |
| NET LOSS | |
$ | (7,020 | ) | |
$ | (6,334 | ) | |
$ | (13,070 | ) | |
$ | (11,666 | ) |
| TOTAL NET LOSS ATTRIBUTABLE TO COMMON
SHAREHOLDERS | |
$ | (7,020 | ) | |
$ | (6,334 | ) | |
$ | (13,070 | ) | |
$ | (11,666 | ) |
| BASIC AND DILUTED NET LOSS PER
COMMON SHARE OUTSTANDING | |
$ | (0.30 | ) | |
$ | (0.30 | ) | |
$ | (0.56 | ) | |
$ | (0.56 | ) |
| Basic and diluted weighted average
number of common shares outstanding | |
| 23,475,989 | | |
| 21,366,268 | | |
| 23,445,397 | | |
| 20,655,856 | |