8-K
Nuvectis Pharma, Inc. (NVCT)
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 8, 2022
Nuvectis Pharma, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware<br><br>(State or Other Jurisdiction<br><br>of Incorporation) | 001-41264<br><br>(Commission File Number) | 86-2405608<br><br>(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 8, 2022, 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, 2022. 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 8, 2022. |
| 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 8, 2022 | ||
| By: | /s/ Ron Bentsur | |
| Ron Bentsur | ||
| Chairman, Chief Executive Officer and President |
Exhibit 99.1
Nuvectis Pharma, Inc. Reports Third Quarter 2022 FinancialResults and Business Highlights
| • | The dose escalation portion of the Phase 1 clinical trial of NXP800is ongoing, and the Phase 1b dose expansion portion is expected to begin in Q1 2023 |
|---|---|
| • | Investigational New Drug Application(“IND”)-enabling studiesfor NXP900 are ongoing, submission of IND or equivalent expected in Q1 2023 |
| --- | --- |
| • | Positive preclinical data for NXP800 in an ARID1a-mutated gastric cancermodel |
| --- | --- |
| • | NXP800 poster presented at the 2022 ENA Conference on the validationof biomarkers supporting the clinical development of NXP800 |
| --- | --- |
| • | NXP900 poster presented at the 2022 ENA Conference on the distinctionbetween NXP900 and dasatinib activity profiles, and the connection between NXP900 activity and certain alterations in the HIPPO signalingpathway |
| --- | --- |
| • | Formation of Scientific Advisory Board |
| --- | --- |
November 8, 2022, Fort Lee, NJ - Nuvectis Pharma, Inc (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a 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 third quarter of 2022 and provided an update on recent business progress.
"In the third quarter of 2022, we continued to advance both of our pipeline products, NXP800 and NXP900, toward the next phase in their respective development programs. The NXP800 Phase 1a dose-escalation study is proceeding as planned, with the start of the Phase 1b expansion phase expected in Q1 2023. The recently reported positive preclinical data in an ARID1a-mutated gastric carcinoma model provides another possible development opportunity for NXP800, as ARID1a is mutated in approximately 20-25% of the roughly 26,000 new cases reported in the US annually," commented Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, "We believe that NXP900 is uniquely positioned to become the first SRC/YES1 kinase inhibitor for the treatment of certain solid tumors. In this regard, the recent discovery of increased sensitivity to NXP900 in cancer cells harboring alterations in the HIPPO signaling pathway is very important, as it provides additional potential criteria for patient selection. We anticipate completing the NXP900 IND-enabling studies by the end of this year and to submit an IND or an equivalent application in Q1 2023." Mr. Bentsur concluded, "We continue to operate efficiently with an expected cash runway into the second half of 2024."
Third Quarter Highlights
NXP800
| • | The Phase 1a dose escalation portion of the Phase 1 clinical program of NXP800 is ongoing, and the Phase<br>1b dose expansion study is expected to begin in Q1 2023. |
|---|---|
| • | Positive preclinical data in a xenograft model of ARID1a-mutated gastric cancer provides another possible<br>development opportunity for NXP800. According to the American Cancer Society, approximately 26,000 new cases of gastric cancer are expected<br>in 2022, of which approximately 25% will carry an ARID1a mutation. |
| --- | --- |
| • | Biomarker data supporting the clinical development of NXP800 were presented at the 2022 EORTC-NCI-AACR<br>("ENA") Symposium. |
| --- | --- |
NXP900
| • | NXP900 preclinical data was presented at the 2022 ENA Symposium. The presentation provided new data on<br>the differential activity profile of NXP900 versus dasatinib, and on the increased<br>sensitivity to NXP900 in cancer cells harboring alterations in the HIPPO signaling pathway. |
|---|
Third Quarter 2022 Financial Results
Cash, cash equivalents, and short-term investments were $23.6 million as of September 30, 2022, compared to $5.7 million as of December 31, 2021. The increase of $17.9 million was primarily a result of the Company's initial public offering in February 2022 and the private placement in July 2022.
The Company’s net loss was $5.9 million for the three months ended September 30, 2022, compared to $4.7 million for the three months ended September 30, 2021, an increase of $1.2 million. Net loss for the third quarter of 2022 included $0.5 million in non-cash expenses and $3.4 million in one-time expenses, primarily related to milestone and fee payments in connection with the NXP800 and NXP900 license agreements.
Research and development expenses were $4.5 million for the three months ended September 30, 2022, compared to $4.2 million for the three months ended September 30, 2021, an increase of $0.4 million. The increase in research and development expenses is primarily attributed to one-time expenses related to milestone and fee payments in connection with the license agreements, and an increase in preclinical and clinical development costs. Research and development expenses for the third quarter of 2022 included $0.3 million in non-cash expenses.
General and administrative expenses were $1.4 million for the three months ended September 30, 2022, compared to $0.5 million for the three months ended September 30, 2021, an increase of $0.9 million. The increase in general and administrative expenses is primarily attributed to the 2022 initial public offering. General and administrative expenses for the third quarter of 2022 also included $0.2 million in non-cash expenses.
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates: NXP800, a clinical-stage HSF1 pathway inhibitor currently in a Phase 1 study in patients with advanced solid tumors, and NXP900, a novel SRC/YES1 kinase inhibitor currently in preclinical development with IND-enabling studies ongoing.
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," 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 preclinical data generated to date and the preclinical and clinical expectations for NXP800 and NXP900, including the results and completion of the Phase 1a dose-escalation study of NXP800 and the expected commencement of the Phase 1b study, as well as the expected submission of an IND, or an equivalent application, 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 the 2021 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 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.
CONDENSEDBALANCE SHEETS
(USD in thousands, except per share and share amounts)
(unaudited)
| December 31, | |||||
|---|---|---|---|---|---|
| 2021 | |||||
| Assets | |||||
| CURRENT ASSETS: | |||||
| Cash and cash equivalents | 23,640 | $ | 5,742 | ||
| Other current assets | 1,226 | 91 | |||
| TOTAL CURRENT ASSETS | 24,866 | 5,833 | |||
| Deferred offering costs | — | 824 | |||
| TOTAL ASSETS | 24,866 | $ | 6,657 | ||
| Liabilities, Redeemable Convertible Preferred Shares and Stockholders’ Equity (Deficit) | |||||
| CURRENT LIABILITIES: | |||||
| Accounts payables | 2,251 | $ | 1,058 | ||
| Payable offering costs | 640 | 824 | |||
| Accrued liabilities | 738 | 395 | |||
| Employee compensation and benefits | 863 | 142 | |||
| TOTAL CURRENT LIABILITIES | 4,492 | 2,419 | |||
| TOTAL LIABILITIES | 4,492 | 2,419 | |||
| COMMITMENTS AND CONTINGENCIES, see Note 3 | |||||
| REDEEMABLE CONVERTIBLE PREFERRED SHARES: | |||||
| Convertible preferred A stock, 0.00001 par value – Zero and 6,630,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively. As of September 30, 2022 all issued and outstanding preferred A stock was converted to common stock. As of December 31, 2021, 5,012,280 preferred A stock shares were issued and outstanding. | — | 15,246 | |||
| STOCKHOLDERS’ EQUITY (DEFICIT), see Note 4: | |||||
| Common Stock, 0.00001 par value – 60,000,000 and 12,870,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively 14,642,483 and 4,505,514 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | * | * | |||
| Additional paid in capital | 45,663 | 1,892 | |||
| Notes received for common shares | — | * | |||
| Accumulated deficit | (25,289 | ) | (12,900 | ) | |
| TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | 20,374 | (11,008 | ) | ||
| TOTAL LIABILITIES, REDEEMABLE COVERTIBLE PREFERRED SHARES AND STOCKHOLDERS’ EQUITY (DEFICIT) | 24,866 | $ | 6,657 |
All values are in US Dollars.
| * | Represents an amount lower than $1,000 USD. |
|---|
NUVECTIS PHARMA, INC.
CONDENSED STATEMENTS OF OPERATIONS
(USD in thousands, except per share and share amounts)
(unaudited)
| Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| OPERATING EXPENSES: | ||||||||||||
| Research and Development | $ | 4,520 | $ | 4,156 | $ | 8,830 | $ | 8,401 | ||||
| General and Administrative | 1,418 | 512 | 3,626 | 2,228 | ||||||||
| OPERATING LOSS | (5,938 | ) | (4,668 | ) | (12,456 | ) | (10,629 | ) | ||||
| Finance Income | 61 | — | 67 | — | ||||||||
| NET LOSS | $ | (5,877 | ) | $ | (4,668 | ) | $ | (12,389 | ) | $ | (10,629 | ) |
| NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS | $ | (5,877 | ) | $ | (4,668 | ) | $ | (12,389 | ) | $ | (10,629 | ) |
| BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING, see Note 6 | $ | (0.42 | ) | $ | (1.04 | ) | $ | (1.03 | ) | $ | (2.54 | ) |
| Basic and Diluted Weighted Average Number of Common Shares Outstanding | 14,050,271 | 4,505,514 | 11,988,770 | 4,188,340 |