Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of December 31, 2024, management carried out, under the supervision and with the participation of our principal executive officer and principal financial officer, an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our disclosure controls and procedures are designed to provide reasonable assurance that information we are required to disclose in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in applicable rules and forms. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of December 31, 2024, our disclosure controls and procedures were effective.
Management’s Annual Report on Internal Control Over Financial Reporting.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act). Our internal control system is designed to provide reasonable assurance to management and our board of directors regarding the preparation and fair presentation of published financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Under the supervision and with the participation of management, including our principal executive officer and principal financial officer, we have assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making our assessment of internal control over financial reporting, we used the criteria issued in the report Internal Control-Integrated Framework (2013) by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). We have concluded that our internal control over financial reporting was effective as of December 31, 2024 based on these criteria.
This annual report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our independent registered public accounting firm pursuant to the exemption from Section 404(b) of the Sarbanes-Oxley Act for non-accelerated filers provided by the Dodd-Frank Wall Street Reform and Consumer Protection Act.
Changes in Internal Control over Financial Reporting
During the fourth quarter of 2024, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls
Our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected.
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Item 9B. Other Information
Securities Trading Plans of Directors and Executive Officers
During the three months ended December 31, 2024, none of our directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2025 Annual Meeting of Stockholders.
Item 11. Executive Compensation
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2025 Annual Meeting of Stockholders.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2025 Annual Meeting of Stockholders.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2025 Annual Meeting of Stockholders.
Item 14. Principal Accountant Fees and Services
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2025 Annual Meeting of Stockholders.
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PART IV
Item 15. Exhibits and Financial Statement Schedules
(a)Financial Statements.
The following financial statements are filed as part of this report:
Report of Independent Registered Public Accounting Firm (PCAOB ID#1309)
F-2
Financial Statements:
Balance Sheets as of December 31, 2024 and 2023
F-3
Statements of Operations for the Years Ended December 31, 2024 and 2023
F-4
Statements of Changes in Shareholders’ equity for the Years Ended December 31, 2024 and 2023
F-5
Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-6
Notes to Financial Statements
F-7 - F-24
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NUVECTIS PHARMA INC.
INDEX TO FINANCIAL STATEMENTS
U.S. DOLLARS
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
( PCAOB name: Kesselman & Kesselman C.P.A.s and PCAOB ID: 1309 )
F-2
FINANCIAL STATEMENTS :
Balance Sheets
F-3
Statements of Operations
F-4
Statements of Changes in Shareholders’ equity
F-5
Statements of Cash Flows
F-6
Notes to the Financial Statements
F-7 - F-24
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
To the board of directors and shareholders of Nuvectis Pharma, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Nuvectis Pharma, Inc. (the "Company") as of December 31, 2024 and 2023, and the related statements of operations, changes in shareholders’ equity and cash flows for the years then ended, including the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the result of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Limited
Tel-Aviv, Israel
February 25, 2025
We have served as the Company’s auditor since 2021.
Kesselman & Kesselman, 146 Derech Menachem Begin St. Tel-Aviv 6492103, Israel,
P.O Box 7187 Tel-Aviv 6107120, Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
F-2
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NUVECTIS PHARMA, INC.
BALANCE SHEETS
(USD in thousands, except per share and share amounts)
December 31,
2024
2023
Assets
CURRENT ASSETS
Cash and cash equivalents
$
18,533
$
19,126
Other current assets
74
59
TOTAL CURRENT ASSETS
18,607
19,185
TOTAL ASSETS
$
18,607
$
19,185
Liabilities and Shareholders’ Equity
CURRENT LIABILITIES
Accounts payables
$
2,498
$
2,771
Accrued liabilities
840
415
Employee compensation and benefits
5,556
3,798
TOTAL CURRENT LIABILITIES
8,894
6,984
TOTAL LIABILITIES
8,894
6,984
COMMITMENTS AND CONTINGENCIES, see Note 5
SHAREHOLDERS’ EQUITY, see Note 6
Common Shares, $ 0.00001 par value – 60,000,000 shares authorized as of December 31, 2024, and December 31, 2023, 19,495,683 , and 17,418,886 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
*
*
Additional paid in capital
82,958
66,446
Accumulated deficit
( 73,245 )
( 54,245 )
TOTAL SHAREHOLDERS’ EQUITY
9,713
12,201
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$
18,607
$
19,185
* Represent amount lower than $1,000 USD.
The accompanying notes are an integral part of these financial statements.
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NUVECTIS PHARMA, INC.
STATEMENT OF OPERATIONS
(USD in thousands, except per share and share amounts)
For the year ended
For the year ended
December 31, 2024
December 31, 2023
OPERATING EXPENSES
Research and development
$
12,918
$
15,380
General and administrative
6,929
7,517
OPERATING LOSS
( 19,847 )
( 22,897 )
Finance income
847
637
NET LOSS
$
( 19,000 )
$
( 22,260 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$
( 19,000 )
$
( 22,260 )
BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING, see Note 8
$
( 1.11 )
$
( 1.43 )
Basic and diluted weighted average number of common shares outstanding
17,113,169
15,556,655
The accompanying notes are an integral part of these financial statements.
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NUVECTIS PHARMA, INC.
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(USD in thousands, except share amounts)
Common Shares
Additional
Total
$0.00001 Par Value
Paid-In
Accumulated
Shareholders’
Shares
Amount
Capital
Deficit
Equity
BALANCES AT DECEMBER 31, 2022
15,190,720
*
$
46,204
$
( 31,985 )
$
14,219
Issuance of restricted share awards
663,499
*
—
—
—
Exercise of preferred investment options, net of offering costs of $ 755
1,001,091
*
8,906
—
8,906
Exercise of warrants
185,024
*
1,479
1,479
Issuance of common shares, net of offering costs of $ 174 - At-the-market
371,743
*
5,114
5,114
Exercise of options
6,809
*
38
38
Share-based payments
*
4,705
4,705
Net loss
( 22,260 )
( 22,260 )
BALANCES AT DECEMBER 31, 2023
17,418,886
*
$
66,446
$
( 54,245 )
$
12,201
Issuance of restricted share awards
572,527
*
—
—
—
Issuance of common shares, net of offering costs of $ 382 - At-the-market
1,504,270
*
11,654
11,654
Share-based payments
*
4,858
4,858
Net loss
( 19,000 )
( 19,000 )
BALANCES AT DECEMBER 31, 2024
19,495,683
*
$
82,958
( 73,245 )
$
9,713
* Represent amount lower than $1,000 USD.
The accompanying notes are an integral part of these financial statements.
F-5
Table of Contents
NUVECTIS PHARMA, INC.
STATEMENTS OF CASH FLOWS
(USD in thousands, except per share and share amounts)
December 31,
December 31,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$
( 19,000 )
$
( 22,260 )
Adjustments to reconcile loss to net cash used in operating activities:
Cost of share-based payments
4,858
4,705
Changes in operating assets and liabilities:
(Increase)/decrease in other current assets
( 15 )
353
Decrease in accounts payable
( 273 )
( 139 )
Increase/(decrease) in accrued liabilities
425
( 30 )
Increase in accrued compensation and benefits
1,758
1,417
Net cash used in operating activities
( 12,247 )
( 15,954 )
CASH FLOWS FROM INVESTING ACTIVITIES
Net cash provided by (used in) investing activities
—
—
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of common shares - At-the market offering
12,036
5,289
Issuance costs related to At-the-market offering
( 382 )
( 174 )
Issuance costs related to initial public offering
—
( 341 )
Proceeds from exercise of warrants, options, and preferred investment options
—
11,192
Issuance costs related to the exercise of warrants, and preferred investment options
—
( 371 )
Issuance costs related to private placement
—
( 508 )
Net cash provided by financing activities
11,654
15,087
(DECREASE) IN CASH AND CASH EQUIVALENTS
( 593 )
( 867 )
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
$
19,126
$
19,993
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$
18,533
$
19,126
* Represent amount lower than $1,000 USD.
The accompanying notes are an integral part of these financial statements.
F-6
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements
NOTE 1 – GENERAL:
a.
Nuvectis Pharma Inc. (the “Company”) was incorporated under the laws of the State of Delaware on July 27, 2020 and commenced its principal operations in May 2021. The Company’s principal executive offices are located at Fort Lee in the state of New Jersey. The Company’s shares are traded on the NASDAQ under symbol “NVCT”.
The Company is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology.
b.
In May 2021, the Company entered into a worldwide, exclusive license agreement with the CRT Pioneer Fund (“CRT”) (see Note 5a). In August 2021, the Company entered into a worldwide, exclusive license agreement with the University of Edinburgh, Scotland for the Company’s second drug candidate (see Note 5a).
c. Liquidity
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred net operating losses since its inception and had an accumulated deficit of $ 73.2 million as of December 31, 2024. The Company had cash and cash equivalents of $ 18.5 million as of December 31, 2024 and has not generated positive cash flows from operations. To date, the Company has been able to fund its operations primarily through the issuance and sale of common shares and redeemable convertible preferred shares.
During the year ended December 31, 2024, the Company sold a total of 1,504,270 shares of common stock under the ATM for aggregate total gross proceeds of approximately $ 12.0 million at an average selling price of $ 8.00 per share, resulting in net proceeds of approximately $ 11.7 million after deducting commissions and other transaction costs. See Note 12.e for at-the-market activity subsequent to December 31, 2024.
On February 5, 2025, the Company sold 3,105,000 shares of common stock with aggregate gross proceeds of approximately $ 15.5 million at a sales price of $ 5.00 per share, resulting in approximate net proceeds of $ 13.9 million after deducting underwriter commissions and other transaction costs including a $ 0.4 million payment due to the UoE related to a fundraising event in the license agreement. See Note 12.f for events subsequent to December 31, 2024.
Based on management’s cash flow projections, the Company believes that the Company’s currently available cash and cash equivalents as of December 31, 2024 is sufficient to fund the Company’s planned operations for a period greater than 12 months from the issuance of these financial statements. The Company will need to raise additional capital in order to complete the clinical trials aimed at developing the product candidates until obtaining its regulation and marketing approvals. There can be no assurances that the Company will be able to secure such additional financing if at all, or at terms that are satisfactory to the Company, and that it will be sufficient to meet its needs. In the event the Company is not successful in obtaining sufficient funding, this could force the Company to delay, limit, or reduce our products’ development, clinical trials, commercialization efforts or other operations, or even close down or liquidate.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES:
a. Basis of Presentation
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“US GAAP”) and stated in U.S. dollars. The significant accounting policies used in the preparation of the financial statements are as follows:
b.
Use of Estimates in the Preparation of Financial Statements
The preparation of the Company’s financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses in the Company’s financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to accruals for research and development expenses, valuation of share based compensation awards, and valuation allowances for deferred tax assets. These estimates and assumptions are based on current facts, future expectations, and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates.
c.
Functional and Presentation Currency
The U.S. dollar (“dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted and expects to continue to operate in the foreseeable future. Accordingly, the functional currency of the Company is the dollar.
Adjustments arising from foreign currency transactions between the purchase and the settlement dates are reflected in the statements of operations as a component of financial income (expense). For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (i) for transactions — exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation) — historical exchange rates.
The Company did not recognize foreign currency transaction gains or losses in the years ended December 31, 2024 and December 31, 2023.
d.
Cash and Cash Equivalents
The Company considers as cash equivalents all highly liquid investments, which include short-term bank deposits that are not restricted as to withdrawal or use, with maturities of three months or less at the date acquired.
e.
Concentrations of Credit Risk
The Company is subject to credit risk from holding its cash and cash equivalents at one commercial bank. The Company limits its exposure to credit losses by investing in money market accounts which are included in cash and cash equivalents through a U.S. bank with high credit ratings. Cash may consist of deposits held with banks that may at times exceed federally insured limits, however, exposure to credit risk in the event of default by the financial institution is limited to the extent of amounts recorded on the balance sheets. The Company has not experienced any losses in such accounts and management
F-8
Table of Contents
NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held.
f.
Leases
In accordance with Accounting Standards Codification (“ASC”) 842, Leases, the Company defines a short-term lease if a lease has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. At the inception of the lease and as of December 31, 2024, the Company determined all leases were classified as short-term. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term in general and administrative. The operating lease costs for 2024 and 2023 were $ 14 thousand each year.
g.
Research and Development Expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including licensing fees, cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, subcontractors, materials used for research and development activities, and professional services. All costs associated with research and development are expensed as incurred.
h.
General and Administrative
General and administrative expenses consist primarily of personnel-related expenses, including employee salaries, bonuses, benefits, and share-based compensation, and recruiting costs for personnel in executive, finance, and other administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, professional fees for accounting, tax and consulting services, insurance costs, and travel expenses. General and administrative costs are expensed as incurred.
i.
Loss Contingencies
Certain conditions may exist as of the date of the financial statements, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company’s management assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment.
Management applies the guidance in ASC 450-20-25 when assessing losses resulting from contingencies. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability is recorded as accrued expenses in the Company’s financial statements. If the assessment indicates that a potential material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material are disclosed. As of December 31, 2024, and December 31, 2023, no contingent liabilities have been recognized.
j.
Share-Based Compensation
The Company accounts for employees’, directors’ and service providers’ share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment
F-9
Table of Contents
NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
transactions is recognized as an expense over the requisite service period. The equity awards could come in the form of options, warrants and RSAs.
The Company elected to recognize compensation costs for awards using the accelerated method based on the multiple-option award approach. Performance based awards are expensed over the vesting period only if the achievement of performance criteria is probable.
The Company has elected to recognize forfeitures as they occur.
For options containing a market condition, the market conditions are required to be considered when calculating the grant date fair value. ASC 718 requires selection of a valuation technique that best fits the circumstances of an award. (See Note 7). In order to reflect the substantive characteristics of the market condition option award, a Monte Carlo simulation valuation model was used to calculate the grant date fair value of such options. Expense for the market condition options is recognized over the derived service period as determined through the Monte Carlo simulation model.
k.
Comprehensive Loss
Comprehensive loss includes no items other than net loss.
l.
Income Taxes
1)
Deferred taxes
The Company accounts for income taxes in accordance with ASC 740, “Income Taxes” (hereafter – “ASC 740”). ASC 740 prescribes that Income taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future.
Given the Company’s losses, the Company concluded it is more likely than not the deferred tax assets will not be realized and has provided a full valuation allowance with respect to its deferred tax assets.
2)
Uncertainty in income taxes
The Company accounts for uncertain tax positions in accordance with ASC 740-10. The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. The Company does not have any provision for uncertain tax positions.
m.
Net Loss Per Share
The Company’s basic net loss per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted-average number of ordinary shares and vested ordinary shares issuable for
F-10
Table of Contents
NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
little or no further consideration outstanding during the period, without consideration of potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive shares of ordinary shares are anti-dilutive.
n.
Fair Value Measurement
The Company follows authoritative accounting guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value, and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The three levels of inputs that may be used to measure fair value include:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. The Company’s Level 1 assets consist of money market funds.
Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity. The fair value hierarchy gives the lowest priority to Level 3 inputs.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.
The money market accounts as of December 31, 2024 and 2023 totaling $ 18.2 million and $ 17.1 million, respectively, are included in cash and cash equivalents and are considered Level 1.
During the years ended December 31, 2024 and 2023, respectively, there were no transfers between fair value measure levels. The Company had no financial assets and liabilities measured at fair value as of December 31, 2024 and 2023, respectively. Other financial instruments consist mainly of cash and cash equivalents, other current assets, accounts payable and accrued liabilities. The fair value of these financial instruments approximates their carrying values.
o.
Warrants
The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, (“ASC 480-10”), and then in accordance with ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 480-10, warrants are considered liability-classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying
F-11
Table of Contents
NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares.
If the warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common shares and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability-classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded as a component of other income (expense), net in the statements of operations. Equity-classified warrants are accounted for at consideration received on the issuance date with no changes in fair value recognized after the issuance date. As of December 31, 2024 and 2023, respectively, all of the Company’s outstanding warrants are equity-classified warrants. (See Note 6d.)
p.
Recently Adopted Accounting Pronouncements
The Company qualifies as an emerging growth company (“EGC”) as defined under the Jumpstart Our Business Startups Act (the “JOBS Act”). Using exemptions provided under the JOBS Act for EGCs, the Company has elected to defer compliance with new or revised ASUs until it is required to comply with such updates, which is generally consistent with the adoption dates of private companies.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The key amendments include: (a) introduce a new requirement to disclose significant segment expenses regularly provided to the chief operating decision maker (“CODM”), (b) extend certain annual disclosures to interim periods, (c) clarify single reportable segment entities must apply ASC 280 in its entirety, (d) permit more than one measure of segment profit or loss to be reported under certain conditions, and (e) require disclosure of the title and position of the CODM. This ASU is effective for public entities with fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company adopted ASU 2023-07 on January 1, 2024 and such adoption did not impact the Company’s financial position, results of operations, cash flows or net loss per share (See Note 9).
q.
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40). The ASU improves the disclosures about a public business entity’s expenses and provides more detailed information about the types of expenses in commonly presented expense captions. The amendments require that at each interim and annual reporting period an entity will, inter alia, disclose amounts of purchases of inventory, employee compensation, depreciation and amortization included in each relevant expense caption (such as cost of sales, SG&A and research and development). The ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating this ASU to determine its impact on the Company's disclosures.
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Table of Contents
NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
In December 2023, FASB issued an Accounting Standard Update No. 2023-09 “Income Taxes (Topic 740)” to enhance the transparency and decision usefulness of income tax disclosure. The amendments in this Update mandate public entities to disclose specific categories in the rate reconciliation and additional information for reconciling items that meet quantitative threshold in the annual tax rate reconciliations. This update requires to present a table showing percentages and currency amounts, outlining tax related aspects such as state/local income tax, foreign tax effect, changes in tax law, credits, valuation allowances, nontaxable and nondeductible items, unrecognized tax benefits. Items that impact tax calculations by 5% and more are required to be disclosed separately, with certain categories required to be disaggregated by jurisdiction or nature. Reconciling items are categorized based on state/local, foreign, or federal/national tax levels. Some items can be presented on a net basis, while others need gross presentation. Entities must provide explanations of the major state/local jurisdictions affecting taxes and explain individual reconciling items. Additionally, the amendments in this Update require that all entities must disclose amount of income taxes paid disaggregated by federal(national) state and by individual jurisdictions in which income taxes paid if equal to or greater than 5% of total income taxes paid. The amendments also require entities to disclose income from continuing operations before income tax expense, and income tax expenses categorized by federal/national, state, and foreign levels. Moreover, certain previous disclosure requirements, like estimating changes in unrecognized tax benefits and cumulative temporary differences in deferred tax liabilities, are eliminated. The amendment in this Update also replaces the term "public entity" with "public business entity" in Topic 740 definitions.
The ASU will be effective for fiscal years beginning after December 15, 2025, and allows adoption on a prospective basis, with a retrospective option. The Company is in the process of assessing the impacts and method of adoption.
.
NOTE 3 – RESEARCH AND DEVELOPMENT EXPENSES:
Research and development expenses consisted of the following (in thousands):
For the year ended
For the year ended
December 31,
December 31,
2024
2023
Employee compensation and benefits
$
6,892
$
6,310
Clinical expense
4,330
4,296
Manufacturing
1,535
3,495
License fee
5
1,001
Professional services and other
156
278
Total research and development expenses
$
12,918
$
15,380
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
NOTE 4 – GENERAL AND ADMINISTRATIVE EXPENSES:
General and administrative expenses consisted of the following (in thousands):
For the year ended
For the year ended
December 31,
December 31,
2024
2023
Professional and consulting services
$
3,462
$
3,460
Employee compensation and benefits
2,091
2,298
Insurance
606
842
Travel
410
369
Other
360
548
Total general and administrative expenses
$
6,929
$
7,517
NOTE 5 – COMMITMENTS AND CONTINGENCIES:
a.
License agreement
CRT Pioneer Fund License Agreement
In May 2021, the Company entered into a worldwide, exclusive license agreement with the CRT Pioneer Fund for CP800 and any of its derivatives, (collectively, the “CP800 Program”). CP800 is a small molecule drug candidate that the Company believes can be applied to a broad range of cancers. Prior to licensing by the Company, CRT was the commercial owner of the CP800 Program, which it acquired from the Institute of Cancer Research in London, UK (“ICR”). The ICR is a world-renowned research institute focused on the discovery and preclinical development of cancer therapeutics pursuant to the license agreement, the Company has an obligation to pay success-based milestones and royalties to CRT, as follows: 1) pre-approval milestone payments of up to approximately $ 26.5 million including an upfront nonrefundable payment of $ 3.5 million and $ 1.0 million in patient recruitment milestones which has already been paid; 2) regulatory approval and commercial sales milestones of up to $ 178 million (in addition to the above $ 26.5 million); and 3) mid-single digit to 10 % royalties on a tiered basis on net sales.
On March 31, 2022, the Company and ICR revised the license agreement for research and development support to a total of $ 865,000 (to allow for additional research activities). As of December 31, 2024 and 2023, no expense and $ 0.6 million of research and development expenses were recognized, respectively. As of December 31, 2024, all research and development support had been expensed in prior years.
License Term
The license will remain in effect in each territory subject to the license and will continue until the Company’s obligation to pay royalties in such territory has expired. The royalty term for each licensed product in each country commences with the first commercial sale of the applicable licensed product in the applicable country and ends on the expiration of the last to expire of any patent specified by the license (with the key composition of matters patent expiring October 2034) or the expiration of any extended exclusivity period in the relevant country. CRT may earlier terminate the license if the Company, or any of our affiliates or sub-licensees, challenge or seek to challenge the validity of any of the licensed patents or upon a change of control in which the Company becomes controlled by a Tobacco Party, as such term is defined in the license. Either party may terminate the license upon material breach
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
by the other party, and upon the appointment of a receiver or upon a winding-up order or similar or equivalent action.
For the years ended December 31, 2024 and 2023, the Company paid no license fees associated with the achievement of certain milestones. These expenses would be recorded as research and development expenses. Any potential future research support, milestone or royalty payment amounts have not been accrued at December 31, 2024 and 2023 due to the uncertainty related to the achievement of these events, milestones or commitments to additional research.
University of Edinburgh License Agreement
In August 2021, the Company entered into a worldwide, exclusive license agreement with the University Court of the University of Edinburgh (“Edinburgh” or “University” or “Parties” or “UoE”) for the second drug candidate.
The Company is obligated to pay success-based milestones and royalties to the UoE, as follows: (1) pre-approval milestone payments of up to approximately $ 49.5 million including an upfront nonrefundable payment of $ 3.5 million which has already been paid and $ 0.5 million on the first anniversary of the effective date of this agreement. (2) regulatory approval and commercial sales milestones of up $ 279.5 million. (3) mid- single digit to 8 % royalties on a tiered basis on net sales; and 2.5 % of the gross amount of each of the Company’s future fund raisings up to a cumulative total of $ 3.0 million.
In collaboration with Edinburgh, the Company wishes to generate preclinical data to support Investigational New Drug (IND) submission and inform patient selection/enrichment strategies. The aim of the development collaboration formed between the Parties under this Agreement is to progress the development of the Licensed Technology, which is licensed under the License Agreement) according to the Work Plan. The Company has agreed to provide funding to Edinburgh to support such collaboration.
The Parties wish to enter into this Agreement to set out the terms for the provision of such funding by the company and the terms of the development collaboration formed between the Parties. In consideration of the obligations of Edinburgh, the Company shall pay the Project Costs in the amount of $ 772,000 , payable over 18 months. As of December 31, 2024, UoE’s research and development as described above has not yet begun and therefore no expenses were recorded in the financial statements.
License Term
The royalty term for each licensed product in each country is the period commencing with the first commercial sale of the applicable licensed product in the applicable country and ending on the expiration of the last to expire of any patent specified by the license (statutory expiration for the NXP900 patent family is April 2036), or the expiration of any extended exclusivity period in the relevant country. The Company may terminate the license if the Company determines that it is not scientifically or commercially viable to research, develop, or commercialize the licensed products which are the subject of the license agreement. UoE may terminate the agreement if the Company: (i) ceases to carry on the business regarding the treatment, prevention and/or diagnosis of human diseases; (ii) discontinues the development of the licensed products which are the subject of the license; (iii) disposes of our assets or business in whole or in material part; (iv) challenges the validity, ownership, or enforceability of the exclusively licensed technology; (v) contests the secret or substantial nature of certain know-how subject to the license; or (vi) breaches certain diligence obligations or fails to pay any amount due under the license within a specified time frame.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
For the year ended December 31, 2024, the Company did no t pay any fees related to the achievement of certain milestones or the private placement. For the year ended December 31, 2023, the Company paid $ 1.0 million related to the achievement of certain milestones and $ 0.4 million associated with the private placement. During the years ended December 31, 2024 and 2023, respectively, these expenses, if any, were recorded as research and development expenses. Through December 31, 2024, the Company has paid UoE $ 0.8 million of the total $ 3.0 million related to the fund-raising commitment, also see Note 12 for fund-raising activities after December 31, 2024. Any potential future research support, milestone or royalty payment amounts have not been accrued at December 31, 2024 and 2023 due to the uncertainty related to the achievement of these events, milestones or commitments to additional research.
b.
Contingencies
As of December 31, 2024, and 2023, no contingent liabilities have been recognized.
NOTE 6 – SHAREHOLDERS’ EQUITY:
a.
Private Placement in Public Entity
On July 29, 2022, the Company closed a private placement offering (the “July Private Placement”), pursuant to the terms and conditions of a Securities Purchase Agreement (the “Agreement”), dated July 27, 2022. In connection with the July Private Placement, the Company issued 1,015,598 shares of common shares (the “Shares”), pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 909,091 shares of common shares and preferred investment options (the “Preferred Investment Options”) to purchase up to an aggregate of 1,924,689 shares of common shares. The purchase price of each Share and each Pre-Funded Warrant was the $ 8.25 . The purchaser received one Preferred Investment Option for no consideration, with each Share or Pre-Funded Warrant purchased. The aggregate net cash proceeds to the Company from the July Private Placement were approximately $ 14.3 million, after deducting placement agent fees and other offering expenses. The Pre-Funded Warrants had an exercise price of $ 0.001 per share, were exercisable on or after August 24, 2022, and are exercisable until the Pre-Funded Warrants were exercised in full. The Preferred Investment Options became exercisable on January 23, 2023 and are exercisable at any time on or after January 23, 2023 through January 29, 2026, at an exercise price of $ 9.65 per share, subject to certain adjustments as defined in the Agreement. As of December 31, 2024, 1,001,091 Preferred Investment Options were exercised for $ 8.9 million, net of fees. As of December 31, 2024, 923,598 Preferred Investment Options are exercisable. The Company agreed to pay the placement agent a fee and management fee equal to 7.0 % and 1.0 %, respectively, of the aggregate gross proceeds from the July Private Placement. In addition, the Company issued warrants to the placement agent to purchase up to 115,481 shares of common shares. The placement agent warrants are in substantially the same form as the Preferred Investment Options, except that the exercise price is $ 10.31 . The Preferred Investment Options, the Pre-Funded Warrants, and the placement agent warrants are collectively referred to as the “Private Placement Warrants”. As of December 31, 2024, no additional placement warrants were exercised except for the 2023 exercises. As of December 31, 2023, 79,104 placement agent warrants were exercised for which the Company received $ 0.8 million. As of December 31, 2024, 36,377 placement agent warrants are exercisable.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
b.
At-the-Market Agreement
On March 17, 2023, the Company filed a shelf registration statement on Form S-3 (the “S-3”), which was declared effective on March 29, 2023. Under the S-3, the Company may sell up to a total of $ 150 million of its securities. In connection with the S-3, the Company entered into an At-the-Market agreement (“ATM”) with H.C. Wainwright & Co., LLC (“Agent”) relating to the sale of shares of common shares. Under the ATM, the Company pays the Agent a commission rate of up to 3.0 % of the gross proceeds from the sale of any common shares.
During the years ended December 31, 2024 and 2023, the Company sold a total of 1,504,270 and 371,743 shares of common shares under the ATM for aggregate total gross proceeds of approximately $ 12.0 million and $ 5.3 million at an average selling price of $ 8.00 and $ 14.23 per share, resulting in net proceeds of approximately $ 11.7 and $ 5.1 million after deducting commissions and other transaction costs, respectively.
c.
Rights of the Company’s common shares
Each ordinary share confers upon its holder the right to one vote and to receive dividends as declared by the Board of Directors of the Company. Since its inception, the Company has not declared any dividends.
In the event of our liquidation, dissolution or winding up, holders of the Company common shares will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities.
As of December 31, 2024, no dividends have been declared.
NOTE 7 – SHARE BASED PAYMENTS
a.
Share Based Payments
In January 2023, the Company granted 43,500 options with an exercise price of $ 7.51 per share, to a service provider, which will become exercisable between January 19, 2023, and January 18, 2025, into common shares based on the achievement of service condition, market condition or performance condition. As of December 31, 2024, 40,708 options were exercisable. Service condition options totaled 22,500 , had an estimated value based on Black-Scholes of approximately $ 74,000 and were exercisable as of December 31, 2024. Performance condition options totaled 12,000 , had an estimated value based on Black-Scholes of approximately $ 39,000 and were exercisable as of December 31, 2024. Market condition options totaling 9,000 options have a market condition which was achieved by December 31, 2024, and an estimated value of $ 20,000 based on a Monte Carlo model. During the year ended December 31, 2024, no options were exercised. During the year ended December 31, 2023, 2,792 options were exercised. The fair value of options was evaluated at the grant date using a Black-Scholes Option Pricing Model for various possible scenarios.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
The following table summarizes assumptions used for the Black-Scholes model at the grant date:
Risk-free interest rate
4.09
%
Common stock price
$
7.51
Expected dividend yield
—
Expected term (in years)
2
Expected volatility
75
%
In February 2022, the Company granted to the underwriter of the IPO 128,000 fully vested warrants upon the IPO, exercisable into common shares with an exercise price of $ 6.25 per share for 5 years after the grant date. The 128,000 fully vested warrants have an estimated value (based on Black-Scholes model) of approximately $ 458,000 and were recognized as a reduction from gross proceeds of the IPO. As of December 31, 2023, IPO warrants totaling 105,920 were exercised for $ 0.7 million. As of December 31, 2024, no additional IPO warrants were exercised.
In July 2022, the Company granted to the private placement agent of the July Private Placement, 115,481 warrants which become exercisable any time between January 23, 2023 and January 29, 2026, into common shares with an exercise price of $ 10.31 per share. The 115,481 warrants have an estimated value (based on Black-Scholes model) of approximately $ 618,000 . As of December 31, 2023, 79,104 placement agent warrants were exercised for which the Company has received $ 0.8 million. As of December 31, 2024, no additional placement agent warrants were exercised.
b.
2021 Incentive Plan
In May 2021, the Company’s board of directors approved an equity incentive plan (hereafter — “2021 Plan”), in which the Company has reserved a total amount of 408,486 common shares for issuance in connection with the Option Agreement. In February 2022, the Company’s board of directors approved an increase to total shares under the incentive plan to 1,500,000 . An amendment to the 2021 Plan was approved by holders of a majority of the voting power of the common shares of the Company in June 2023 to increase the total shares under the incentive plan to 2,500,000 . In addition, the amendment provides that on January 1 of each calendar year beginning in 2024 and ending in and including 2033, this authorization limit will automatically increase to the extent necessary so that the number of shares available for issuance pursuant to future awards granted after such date under the 2021 Plan is not less than (i) six percent ( 6 %) of the number of shares outstanding as of the last day of the immediately preceding calendar year or (ii) such lesser number of shares as may be determined by the Board.
The 2021 Plan provides for a variety of share-based compensation awards, including options, restricted share awards, or other shares. Under the 2021 Plan, the Company generally grants share-based awards with service-based vesting conditions only. Options and restricted share awards granted typically vest over a three-year period, but may be granted with different vesting terms.
Mr. Ron Bentsur, Dr. Enrique Poradosu and Mr. Shay Shemesh will be eligible for fully vested common shares equal to 1 %, 0.5 % and 0.5 %, respectively, of the then fully diluted share count when the Company reaches an average capitalization over a 30 -day period of $ 350 million or higher. As of December 31, 2024, the market capitalization has not been achieved.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
Options
The following table summarizes the Company’s option activity for the year ended December 31, 2024, for the 2021 Incentive Plan:
Weighted
Number of
Weighted average
average
Aggregated
shares under
exercise price per
remaining
intrinsic value
option
option
life
(in thousands)
Balance, December 31, 2023
348,281
$
4.59
7.94
$
1,317
Granted
—
-
Exercised
—
-
Forfeited
—
-
Outstanding – December 31, 2024
348,281
$
4.59
6.94
$
286
Exercisable – December 31, 2024
333,281
Expected to vest – December 31, 2024
348,281
$
4.59
6.94
$
286
As of December 31, 2024, there was $ 7 thousand of unrecognized share-based compensation expense related to unvested options that is expected to be recognized over a weighted-average period of 0.25 years.
The fair value of each option granted is estimated using the Black-Scholes option pricing method. The volatility is based on a combination of historical volatilities of companies in comparable stages as well as companies in the industry by statistical analysis of daily share pricing model. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted in dollar terms. The expected term of the options granted represents the period of time that the granted options are expected to remain outstanding based on common practice in the industry.
Restricted Share Awards
Restricted stock awards (RSAs) have been granted to employees and directors. The value of an RSA is based on the Company’s stock price on the date of grant. For grants prior to the IPO, the stock price was determined using a hybrid pricing model with a combination of the Black-Scholes Option Pricing Model (OPM) and the P-WERM model for various possible scenarios. For grants subsequent to the IPO, the Company’s closing stock price on the date of grant was used to determine the fair value. The shares underlying the RSAs are issued on the grant date. The Company has granted RSAs pursuant to the 2021 plan.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
The following table summarizes the Company’s RSA activity for the year ended December 31, 2024, as described above from the 2021 Incentive Plan:
Weighted
Weighted average
Aggregated
Number of
average grant
contractual term
intrinsic value
shares
date fair value
(in years)
(in thousands)
Balance, December 31, 2023
941,496
$
8.23
1.80
$
7,852
Granted
572,527
8.09
Forfeited
( 23,850 )
7.70
Vested
( 124,404 )
6.83
Outstanding – December 31, 2024
1,365,769
$
8.21
1.27
$
7,389
Expected to vest – December 31, 2024
1,365,769
$
8.21
1.27
$
7,389
As of December 31, 2024, there was $ 2.7 million of total unrecognized compensation cost related to RSAs that is expected to be recognized over a weighted average period of 1.3 years.
The total fair value of RSAs vested for the year ended December 31, 2024, was $ 0.8 million.
On January 4, 2024, the Company issued 130,000 RSAs to each of Dr. Enrique Poradosu and Mr. Shay Shemesh (the “January 2024 Grants”). These RSAs vest over three years with one -third vesting on each anniversary of the date of the grant.
On January 12, 2023, the Company issued 210,000 RSAs to Mr. Ron Bentsur and 115,000 RSAs to each of Dr. Enrique Poradosu and Mr. Shay Shemesh (the “January 2023 Grants”). These RSAs vest over three years with one -third vesting on each anniversary of the date of the grant. On January 4, 2024, the vesting of the first one -third of the January 2023 Grants were extended to July 15, 2024. On July 12, 2024, the vesting of the first one -third of the January 2023 Grants were extended to January 3, 2025.
On April 1, 2022, the Company issued 120,000 RSAs to Mr. Bentsur and 60,000 RSAs to each of Dr. Poradosu and Mr. Shemesh (the “April 2022 Grants”). These RSAs vest over three years with one -third vesting on each anniversary of the date of the grant. On January 4, 2024, the vesting of the first two -thirds of the April 2022 Grants were extended to July 15, 2024. On July 12, 2024, the vesting of the first two -thirds of the April 2022 Grants were extended to January 3, 2025.
On July 27, 2021, Mr. Ron Bentsur, Dr. Enrique Poradosu, and Mr. Shay Shemesh were granted 96,759 RSAs, 48,399 RSAs and 48,399 RSAs, respectively, which were not part of the Incentive Plan and excluded from the table above (the “July 2021 Grants”). On July 12, 2024, January 4, 2024, March 29, 2023, January 1, 2023, July 1, 2022 and December 13, 2022, the vesting of these grants was extended to January 3, 2025, July 15, 2024, April 1, 2023, January 1, 2023 and June 30, 2022, respectively.
Also see Note 12 for subsequent vesting extensions.
c.
Share compensation expense
For the period ended December 31, 2024, the Company recognized expenses of $ 1.9 million as part of the general and administrative expenses and $ 3.0 million as part of the research and development expenses.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
For the period ended December 31, 2023, the Company recognized expenses of $ 2.1 million as part of the general and administrative expenses and $ 2.6 million as part of the research and development expenses.
NOTE 8 – NET LOSS PER SHARE:
a.
Basic
Basic net loss per share is calculated by dividing the net loss attributable to the Company’s shareholders by the weighted average number of common shares outstanding.
For the year ended
For the year ended
December 31, 2024
December 31, 2023
(in thousand U.S. dollars except per share and share amounts)
Loss attributable to common stockholders
( 19,000 )
( 22,260 )
Basic and diluted net loss per common share
( 1.11 )
( 1.43 )
Weighted average of common shares outstanding
17,113,169
15,556,655
Basic loss per share is calculated by dividing the result attributable to equity holders of the Company by the weighted average number of Ordinary Shares in issue during the year.
For the year ended
December 31, 2024
December 31, 2023
Weighted average of common shares
18,525,902
16,691,708
Average unvested RSAs
( 1,412,733 )
( 1,135,053 )
Weighted average of common shares outstanding
17,113,169
15,556,655
b.
Diluted
As of December 31, 2024 and 2023, respectively, the Company excluded potentially dilutive securities from the calculation of diluted net loss per Ordinary Share because their effects would have been anti-dilutive.
The following potentially dilutive securities were excluded from the calculation of diluted net loss per Ordinary Share because their effect would have been anti-dilutive for the years presented:
For the year ended
For the year ended
December 31,
December 31,
2024
2023
Common shares issuable in relation to:
Warrants
159,870
159,870
Options
348,281
348,281
Unvested RSA *
1,559,326
1,145,726
* Includes 193,557 of RSAs granted outside of the Incentive Plan see explanation in Note 7.
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
NOTE 9 – SEGMENT REPORTING:
a. The Company operates in one reportable segment: clinical development. The clinical development segment facilitates the development of potential new drug compounds, and its business is unified for the purposes of valuation of its performance.
Management does not segregate its business for internal reporting. The Company's Chief Operating Decision Maker (“CODM”), who is the CEO evaluates the Company's performance based on its unified internal reporting which is consistent with the presentation in the Company’s financial statements.
Net loss is used to monitor budget versus actual results.
The CODM uses many quantitative and qualitative factors including net loss, and quarterly cash burn in benchmarking the Company to its competitors. The competitive analysis along with the monitoring of budgeted versus actual results are used in assessing performance of the segment and in establishing management’s compensation.
Significant segment expenses are presented in the Company’s statements of operations. Additional disaggregated significant segment expenses on a functional basis, that are not separately presented on the Company’s statements of operations, are presented below:
For the Year Ended December 31,
2024
2023
Employee Expenses
$
8,983
$
8,608
Clinical Trial Expenses
4,330
4,296
Professional Fees
3,618
3,738
Manufacturing
1,535
3,495
License Fees
5
1,001
Insurance
606
842
Other Segment Items *
( 77 )
280
Segment Loss
$
19,000
$
22,260
* - Other Segment Items included in net loss includes interest income, travel and entertainment expenses, printing and information technology expenses.
NOTE 10 – INCOME TAXES:
a.
The Company has not recorded an income tax benefit for the years ended December 31, 2024 and 2023, respectively. The Company has incurred net pre-tax losses in the United States only for all periods presented. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the carrying amounts of existing assets and liabilities in the financial statements and their respective tax bases using tax rates expected to be in effect during the years in which the basis differences reverse.
b.
Tax Rates:
Income of the Company is taxed according to the federal tax laws in the US and the relevant state laws. The U.S tax rate in 2024 and 2023 is 26.9 % comprising U.S statutory tax rates of 21 % and state tax rate
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
of 5.9 %. For the years ended years ended December 31, 2024 and 2023, the Company’s effective tax rate is below the federal statutory income tax rate of 21 % primarily due to state income taxes, net of federal benefit and the Company’s position to establish a full valuation allowance on its deferred tax assets.
c.
Corporate Taxation in the U.S.
The applicable corporate tax rate for the Company is 21 %.
As of December 31, 2024, the Company has an accumulated tax loss carryforward of approximately $ 43.0 million (as of December 31, 2023, $ 35.0 million). Under U.S. tax laws, subject to certain limitations, carryforward tax losses originating in tax year have no expiration date, but they are limited to 80% of the company’s taxable income in any given tax year.
A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows:
For the year-ended
Percentage of pre-tax income
2024
2023
Statutory federal income tax rate
21 %
21 %
State taxes, net of federal tax benefit
6 %
6 %
R&D Tax Credit
( 5 )%
( 5 )%
Change in valuation allowance
( 22 )%
( 22 )%
Income taxes provision (benefit)
—%
—%
d.
Tax Assessments
The Company has not been taxed since its inception.
e.
Deferred Taxes
The tax effect of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets and liabilities are presented below:
As of
As of
December 31, 2024
December 31, 2023
(in thousands USD)
(in thousands USD)
Deferred tax asset:
Net operating loss carry forward
11,616
9,625
Share Compensation
3,542
2,236
Research and Development credits
52
52
Accruals and reserves
4,318
2,578
Total deferred tax assets
19,528
14,491
Valuation allowance
( 19,528 )
( 14,491 )
Deferred tax assets recognized
—
—
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NUVECTIS PHARMA, INC.
Notes to the Financial Statements (continued)
As the achievement of required future taxable income is not likely, the Company recorded a full valuation allowance. The following table presents a reconciliation of the beginning and ending valuation allowance:
As of
As of
December 31, 2024
December 31, 2023
(in thousands USD)
(in thousands USD)
Balance at beginning of the year
14,491
8,573
Additions to valuation allowance
5,037
5,918
Release of valuation allowance
—
—
Balance at end of the year
19,528
14,491
NOTE 11 – RELATED PARTY TRANSACTIONS:
a.
As for related party transactions regarding equity grants, see Note 7 and Note 12.
NOTE 12 – SUBSEQUENT EVENTS:
a. On January 2, 2025, the Company issued 250,000 RSAs to Mr. Ron Bentsur, and 150,000 RSAs to Dr. Enrique Poradosu and Mr. Shay Shemesh each
b. On January 2, 2025, the vesting of the January 2024 Grants to Dr. Enrique Poradosu and Mr. Shay Shemesh first 1/3 vesting of the grant was extended to July 15, 2025, the second remained at January 12, 2025 and the third vesting remained at January 12, 2026.
c. On January 2, 2025, the vesting of the July 2021 Grants and April 2022 Grants to Mr. Ron Bentsur, Dr. Enrique Poradosu and Mr. Shay Shemesh was extended to July 15, 2025
d. On January 2, 2025, the vesting of the January 2023 Grants to Mr. Ron Bentsur, Dr. Enrique Poradosu and Mr. Shay Shemesh first 1/3 vesting of the grant was extended to July 15, 2025, the second remained at July 15, 2025 and the third vesting remained at January 12, 2026.
e. Through the completion of the subsequent events review, the Company sold a total of 189,816 shares of common stock under the ATM for aggregate total gross proceeds of approximately $ 1.3 million at an average selling price of $ 6.70 per share, resulting in net proceeds of approximately $ 1.2 million after deducting commissions and other transaction costs.
f. On February 5, 2025, the Company entered into an underwriter agreement (the “Underwriter Agreement”) in connection with sale of 3,105,000 shares of common stock of the Company with aggregate gross proceeds of approximately $ 15.5 million at a sales price of $ 5.00 per share, resulting in approximate net proceeds of $ 13.9 million after deducting underwriter commissions and other transaction costs including $ 0.4 million payment to the UoE related to a fundraising event in the license agreement.
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(b)Exhibits.
Exhibit No.
Description
3.1
Second Amended and Restated Certificate of Incorporation of Nuvectis Pharma, Inc., filed as exhibit 3.1 to the Form 8-K filed on February 4, 2022 and incorporated herein by reference.
3.2
Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation of Nuvectis Pharma, Inc., filed as exhibit 3.3 to the Form 8-K filed on February 4, 2022 and incorporated herein by reference.
3.3
Amended and Restated Bylaws of Nuvectis Pharma, Inc., filed as exhibit 3.2 to the Form 8-K filed on February 4, 2022 and incorporated herein by reference.
4.1
Form of Common Stock Certificate, filed as exhibit 4.1 to the Form S-1/A, filed on October 21, 2021 and incorporated herein by reference.
4.2
Form of Warrant, filed as exhibit 4.2 to the Form S-1/A filed on October 28, 2021 and incorporated herein by reference.
4.3
Form of Underwriter’s Warrant, filed as exhibit 4.2 to the Form S-1/A filed on January 18, 2022 and incorporated herein by reference.
4.4
Form of Preferred Investment Option, filed as exhibit 10.2 to the Form 8-K filed on July 29, 2022 and incorporated herein by reference.
4.5
Form of Pre-Funded Warrant, filed as exhibit 10.3 to the Form 8-K filed on July 29, 2022 and incorporated herein by reference.
4.6
Description of Securities of Nuvectis Pharma, Inc. *
10.1
2021 Global Equity Incentive Plan, filed as exhibit 10.1 to the Form S-1 filed on October 6, 2021 and incorporated herein by reference.
10.2
Executive Employment Agreement with Ron Bentsur, filed as exhibit 10.2 to the Form S-1 filed on October 6, 2021 and incorporated herein by reference. #
10.3
Executive Employment Agreement with Enrique Poradosu, filed as exhibit 10.3 to the Form S-1 filed on October 6, 2021 and incorporated herein by reference. #
10.4
Executive Employment Agreement with Shay Shemesh, filed as exhibit 10.4 to the Form S-1 filed on October 6, 2021 and incorporated herein by reference. #
10.5
License Agreement between Nuvectis Pharma, Inc. and CRT Pioneer Fund LP dated May 19, 2021, filed as exhibit 10.5 to the Form S-1 filed on October 6, 2021 and incorporated herein by reference. **
10.6
License Agreement between Nuvectis Pharma, Inc. and The University Court of the University of Edinburgh, dated August 26, 2021, filed as exhibit 10.6 to the Form S-1 filed on October 6, 2021 and incorporated herein by reference. **
19.1
Nuvectis Pharma, Inc. Insider Trading Policy, filed as exhibit 19.1 to the Form 10-K filed on March 5, 2024 and incorporated herein by reference.
21.1
List of subsidiaries of Nuvectis Pharma, Inc. *
23.1
Consent of Independent Registered Public Accounting Firm *
24.1
Power of Attorney (included on signature page). *
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *
31.2
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *
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32.1
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
32.2
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
97.1
Nuvectis Pharma, Inc. Incentive Compensation Recovery Policy, filed as exhibit 97.1 to the Form 10-K filed on March 5, 2024 and incorporated herein by reference.
101.INS*
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document *
101.SCH*
Inline XBRL Taxonomy Schema Linkbase Document *
101.CAL*
Inline XBRL Taxonomy Calculation Linkbase Document *
101.DEF*
Inline XBRL Taxonomy Definition Linkbase Document *
101.LAB*
Inline XBRL Taxonomy Labels Linkbase Document *
101.PRE*
Inline XBRL Taxonomy Presentation Linkbase Document *
104
Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
*
Filed herewith.
**
Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K.
#
Management Compensation Arrangement.
Item 16. Form 10-K Summary
The Company has elected not to provide summary information.
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Signatures
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Fort Lee, State of New Jersey, on this 25th day of February 2025.
Nuvectis Pharma, Inc.
By:
/s/ Ron Bentsur
Name: Ron Bentsur
Title: Chairman, Chief Executive Officer and President
POWER OF ATTORNEY
We, the undersigned directors and/or executive officers of Nuvectis Pharma, Inc., hereby severally constitute and appoint Ron Bentsur, acting singly, his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her in any and all capacities, to sign this report and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing necessary or appropriate to be done in connection therewith, as fully for all intents and purposes as he or she might or could do in person, hereby approving, ratifying and confirming all that said attorney-in-fact and agent, or his substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Ron Bentsur
Chairman, Chief Executive Officer and President
Ron Bentsur
(Principal Executive Officer)
February 25, 2025
/s/ Michael J Carson
Vice President of Finance
Michael J Carson
(Principal Financial and Accounting Officer)
February 25, 2025
/s/ Kenneth Hoberman
Kenneth Hoberman
Director
February 25, 2025
/s/ James F. Olivero III
James F. Oliviero III
Director
February 25, 2025
/s/ Matthew L. Kaplan
Matthew L. Kaplan
Director
February 25, 2025
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