Item 1. Financial Statements
Item 1. Financial Statements
NUVECTIS PHARMA, INC.
CONDENSED BALANCE SHEETS
(USD in thousands, except per share and share amounts)
(unaudited)
March 31,
December 31,
2023
2022
Assets
CURRENT ASSETS:
Cash and cash equivalents
$
15,468
$
19,993
Other current assets
740
412
TOTAL CURRENT ASSETS
16,208
20,405
TOTAL ASSETS
$
16,208
$
20,405
Liabilities and Stockholders’ Equity
CURRENT LIABILITIES
Accounts payables
$
2,096
$
2,910
Payable offering costs
—
450
Accrued liabilities
156
445
Employee compensation and benefits
1,682
2,381
TOTAL CURRENT LIABILITIES
3,934
6,186
TOTAL LIABILITIES
3,934
6,186
COMMITMENTS AND CONTINGENCIES, see Note 3
STOCKHOLDERS’ EQUITY: see Note 4
Common Stock, $ 0.00001 par value – 60,000,000 shares authorized as of March 31, 2023, and December 31, 2022, 15,886,139 , and 15,190,720 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively
*
*
Additional paid in capital
48,308
46,204
Accumulated deficit
( 36,034 )
( 31,985 )
TOTAL STOCKHOLDERS’ EQUITY
12,274
14,219
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
16,208
$
20,405
*
Represents an amount lower than $1,000 USD.
The accompanying notes are an integral part of these unaudited condensed financial statements.
3
NUVECTIS PHARMA, INC.
CONDENSED STATEMENTS OF OPERATIONS
(USD in thousands, except per share and share amounts)
(unaudited)
Three Months Ended March 31
2023
2022
OPERATING EXPENSES:
Research and development
$
2,367
$
1,805
General and administrative
1,734
1,140
OPERATING LOSS
( 4,101 )
( 2,945 )
Finance income
52
2
NET LOSS
$
( 4,049 )
$
( 2,943 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$
( 4,049 )
$
( 2,943 )
BASIC AND DILUTED NET LOSS PER COMMON STOCK OUTSTANDING, see Note 6
$
( 0.27 )
$
( 0.32 )
Basic and diluted weighted average number of common stock outstanding
14,724,249
9,159,139
The accompanying notes are an integral part of these unaudited condensed financial statements.
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NUVECTIS PHARMA, INC.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(USD in thousands, except share amounts)
(unaudited)
Notes
Redeemable Convertible
received
Preferred Stock
Common Stock
from
Additional
Total
$0.00001 Par Value
$0.00001 Par Value
Common
Paid-In
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
stock
Capital
Deficit
Equity/(Deficit)
BALANCES AT DECEMBER 31, 2021
5,012,280
15,246
4,505,514
*
*
1,892
$
( 12,900 )
$
( 11,008 )
Conversion of Series A redeemable convertible preferred shares
( 5,012,280 )
( 15,246 )
5,012,280
*
—
15,246
—
15,246
Issuance of common stock upon initial public offering, net of offering costs of $ 2,892
3,200,000
*
13,108
13,108
Share based payments
156
Net loss for the period
( 2,943 )
( 2,943 )
BALANCES AT MARCH 31, 2022
—
—
12,717,794
*
*
30,402
$
( 15,843 )
$
14,559
Notes
Redeemable Convertible
received
Preferred Stock
Common Stock
from
Additional
Total
$0.00001 Par Value
$0.00001 Par Value
Common
Paid-In
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
stock
Capital
Deficit
Equity
BALANCES AT DECEMBER 31, 2022
—
$
-
15,190,720
*
—
$
46,204
$
( 31,985 )
$
14,219
Share based payments
1,402
1,402
Issuance of restricted stock awards
585,499
—
—
Exercise of preferred investment options
4,000
*
39
39
Exercise of warrants
105,920
*
663
663
Net loss for the period
—
—
—
—
( 4,049 )
( 4,049 )
BALANCES AT MARCH 31, 2023
—
—
15,886,139
*
—
$
48,308
$
( 36,034 )
$
12,274
*
Represents an amount lower than $1,000 USD.
The accompanying notes are an integral part of these unaudited condensed financial statements.
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NUVECTIS PHARMA, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(USD in thousands, except per share and share amounts)
(unaudited)
Three Months Ended March 31,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 4,049 )
$
( 2,943 )
Adjustments to reconcile loss to net cash used in operating activities:
Cost of stock-based payments
1,402
156
Changes in operating assets and liabilities:
Increase in other current assets
( 328 )
( 831 )
(Decrease)/increase in accounts payable, accrued compensation and benefits, and accrued liabilities
( 1,802 )
542
Net cash used in operating activities
$
( 4,777 )
$
( 3,076 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Net cash provided by (used in) investing activities
—
—
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock upon initial public offering
$
—
$
16,000
Issuance costs related to initial public offering
( 341 )
( 1,973 )
Proceeds from exercise of warrants/preferred investment option
702
—
Issuance costs related to private placement
( 109 )
—
Net cash provided by financing activities
$
252
$
14,027
(DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS
$
( 4,525 )
$
10,951
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
$
19,993
$
5,742
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$
15,468
$
16,693
Supplemental noncash disclosure of investing and financing activities:
Unpaid deferred offering costs
—
97
The accompanying notes are an integral part of these unaudited condensed financial statements.
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NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements
NOTE 1 – GENERAL:
a. Nuvectis Pharma, Inc. (formerly Centry Pharma Inc.) (hereafter – 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 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 3a).
c. 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 3a).
d. In February 2022, the Company’s shares began trading on the NASDAQ under the symbol “NVCT”.
e. Liquidity and Capital Resources
The Company has incurred net operating losses since its inception and had an accumulated deficit of $ 36 million as of March 31, 2023. The Company had cash and cash equivalents of $ 15.5 million as of March 31, 2023 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 stock and redeemable convertible preferred shares.
Management believes that its existing cash, and cash equivalents as of March 31, 2023 enable the Company to fund planned operations for at least 12 months following the issuance date of these condensed 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 regulatory and marketing approvals. There can be no assurances that the Company will be able to secure such additional financing, 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 its 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 Unaudited Condensed Financial Statements (continued)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES :
a. Basis of Presentation
The accompanying condensed financial statements are unaudited. The unaudited condensed financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”), are stated in U.S. dollars and follow the requirements of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements as certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. The unaudited condensed financial statements have been prepared on the same basis as the audited financial statements. The unaudited condensed financial statements include the accounts of the Company. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
In the opinion of management, the unaudited condensed financial statements include all normal and recurring adjustments that are considered necessary for the fair statement of results for the interim periods. The results for the period ended March 31, 2023 are not necessarily indicative of those expected for the year ending December 31, 2023 or for any future period. The condensed balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date but does not include all disclosures required by U.S. GAAP. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the related notes thereto for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2023.
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 equity 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.
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.
8
NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
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 included in cash and cash equivalents are considered Level 1.
During the three months ended March 31, 2023 and 2022, there were no transfers between fair value measure levels. 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.
d.
Stock 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 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 stock 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 5). 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 stock options. Expense for the market condition stock options is recognized over the derived service period as determined through the Monte Carlo simulation model.
e. Recently Issued Accounting Pronouncements Not Yet Adopted
Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial statements. No new accounting standards were adopted during the period .
NOTE 3 – COMMITMENTS AND CONTINGENCIES:
a. License Agreements
CRT Pioneer Fund License Agreement
There have been no material changes to the CRT Pioneer Fund License Agreement (the “License Agreement”) as previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Securities and Exchange Commission on March 8, 2023 (see Note 5a in the Notes to the Financial Statements).
Any potential milestone or royalty payment amounts have not been accrued as of March 31, 2023 and December 31, 2022 due to the uncertainty related to the achievement of these events or milestones.
9
NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
University of Edinburgh License Agreement
There have been no material changes to the University of Edinburgh (“UoE”) License Agreement as previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the Securities and Exchange Commission on March 8, 2023 (see Note 5a in the Notes to the Financial Statements).
Any potential future research support, milestone or royalty payment amounts have not been accrued as of March 31, 2023 and December 31, 2022 due to the uncertainty related to the achievement of these events, milestones or commitments to additional research.
b. Related Party Transactions
As for related party transactions, see Note 5.
c. Contingencies
As of March 31, 2023, and as of December 31, 2022, there are no contingent liabilities, therefore, no provision was made.
NOTE 4 – STOCKHOLDERS’ 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 stock (the “Shares”), pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 909,091 shares of common stock and preferred investment options (the “Preferred Investment Options”) to purchase up to an aggregate of 1,924,689 shares of common stock. The Preferred Investment Options became exercisable on January 23, 2023 and are exercisable through January 29, 2026, at an exercise price of $ 9.65 per share, subject to certain adjustments as defined in the Agreement. 4,000 Preferred Investment Options were exercised and $ 39,000 was received as of March 31, 2023.
NOTE 5 – SHARE BASED PAYMENTS:
a. Share Based Payments
In January 2023, the Company granted to a service provider 43,500 options which become exercisable between January 19, 2023, and January 18, 2025, into common stock with an exercise price of $ 7.51 per share based on the achievement of service condition, market condition or performance condition. As of March 31, 2023, 12,000 options were exercisable. Service condition options totaled 22,500 , had an estimated value based on Black-Scholes of approximately $ 74,000 and were not exercisable as of March 31, 2023. Performance condition options totaled 12,000 , had an estimated value based on Black-Scholes of approximately $ 39,000 and were exercisable as of March 31, 2023. Market condition options totaling 9,000 options have a market condition which was not achieved by March 31, 2023, and an estimated value of $ 20,000 based on a Monte Carlo model. No options have been exercised as of March 31, 2023. The fair value of options was evaluated at the grant date using a Black-Scholes Option Pricing Model for various possible scenarios.
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
10
NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
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 stock 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. IPO warrants totaling 105,920 were exercised and the Company received $ 0.7 million as of March 31, 2023.
b. 2021 Global Equity Incentive Plan (“Incentive Plan”)
The following table summarizes the Company’s stock option activity in the Incentive Plan for the three months ended March 31, 2023:
Weighted
Number of
Weighted average
average
Aggregated
shares under
Exercise price per
remaining
Intrinsic value
option
Option
Life
(in thousands)
Balance, December 31, 2022
311,590
4.20
8.79
1,042
Granted
34,500
7.51
Exercised
—
—
Forfeited
—
—
Outstanding – March 31, 2023
346,090
4.53
8.67
2,969
Exercisable – March 31, 2023
87,582
3.66
8.55
Expected to vest – March 31, 2023
346,090
4.53
8.67
2,969
As of March 31, 2023, there was $ 0.7 million of unrecognized stock-based compensation expense related to unvested stock options that is expected to be recognized over a weighted-average period of 1.92 years.
Restricted Stock Awards
Restricted stock awards (“RSAs”) have been granted to employees. The value of an RSA award is based on the Company’s stock price on the date of grant. The Company granted RSAs pursuant to the Incentive Plan.
The following table summarizes the Company’s RSA activity for the three months ended March 31, 2023, as described above from the 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, 2022
338,807
7.15
2.22
2,541
Granted
585,499
7.56
Vested
( 24,250 )
8.98
Outstanding – March 31, 2023
900,056
7.44
2.51
11,800
Expected to vest – March 31, 2023
900,056
7.44
2.51
11,800
As of March 31, 2023, there was $ 4.6 million of total unrecognized compensation cost related to RSAs expected to be recognized over a weighted average period of 2.51 years.
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NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
On January 3, 2023, the Company issued 145,499 RSAs to employees and other service providers with a determined fair value of $ 1.1 million. These RSAs vest over three years with 1/3 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. These RSAs vest over three years with 1/3 vesting on each anniversary of the date of the grant. The fair value of these RSAs was determined to be $ 3.3 million.
On April 1, 2022, the Company issued 120,000 RSAs to Mr. Ron Bentsur and 60,000 RSAs to each of Dr. Enrique Poradosu and Mr. Shay Shemesh. These RSAs vest over three years with 1/3 vesting on each anniversary of the date of the grant. On March 29, 2023, the vesting of the first 1/3 of the grant was extended to January 11, 2024, the second vesting extended to April 2, 2024 and the third vesting extended to April 2, 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 Company’s Incentive Plan and excluded from the table above. On March 29, 2023, the vesting of these grants was extended to January 11, 2024.
Share Compensation Expense
For the three months ended March 31, 2023, the Company recognized expenses of $ 0.7 million as part of general and administrative expenses and $ 0.7 million as part of research and development expenses. For the three months ended March 31, 2022, the Company recognized expenses of $ 0.1 million as part of general and administrative expenses and $ 0.1 million as part of research and development expenses.
NOTE 6 – NET LOSS PER SHARE:
a. Basic
Basic net loss per share is calculated by dividing the net loss attributable to the Company’s stockholders by the weighted average number of common stock outstanding.
For the three months
For the three months
ended March 31, 2023
ended March 31, 2022
Loss attributable to common stockholders
$
( 4,049 )
$
( 2,943 )
Basic and diluted net loss per common share
( 0.27 )
( 0.32 )
Weighted average of common share outstanding
14,724,249
9,159,139
Basic loss per share is calculated by dividing the result attributable to equity holders of the Company by the weighted average number of shares of common stock in issue during the year.
The calculation of the loss per share includes 1,924,689 pre-funded warrants/shares issued as part of the private placement, as the Company considers these shares to be exercised for no additional consideration. As of March 31, 2023 the amount of pre-funded warrants/shares issued were 1,924,689 , and as of March 31, 2022, zero .
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NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
b. Diluted
The following potentially dilutive securities were excluded from the calculation of diluted net loss per common share because their effect would have been anti-dilutive for the years presented:
March 31,
2023
2022
Common stock issuable in relation to:
Warrants
238,974
228,893
Options
346,090
226,590
Unvested RSAs *
1,093,613
270,137
* includes 193,557 of RSAs granted outside of the Incentive Plan
NOTE 7 – RELATED PARTY TRANSACTIONS:
a. See note 5
NOTE 8 – SUBSEQUENT EVENTS:
a. During April and May 2023, a certain investor exercised 34,000 Preferred Investment Options granted in July 2022 in association with the Securities Purchase Agreement. Gross proceeds from the exercise of these options were approximately $ 0.3 million.
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