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,
2024
2023
Assets
CURRENT ASSETS
Cash and cash equivalents
$
19,464
$
19,126
Other current assets
250
59
TOTAL CURRENT ASSETS
19,714
19,185
TOTAL ASSETS
$
19,714
$
19,185
Liabilities and Shareholders’ Equity
CURRENT LIABILITIES
Accounts payables
$
1,759
$
2,771
Accrued liabilities
486
415
Employee compensation and benefits
3,447
3,798
TOTAL CURRENT LIABILITIES
5,692
6,984
TOTAL LIABILITIES
5,692
6,984
COMMITMENTS AND CONTINGENCIES, see Note 3
SHAREHOLDERS’ EQUITY see Note 4
Common Shares, $ 0.00001 par value – 60,000,000 shares authorized as of March 31, 2024, and December 31, 2023, respectively, 18,356,060 , and 17,418,886 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively
*
*
Additional paid in capital
72,438
66,446
Accumulated deficit
( 58,416 )
( 54,245 )
TOTAL SHAREHOLDERS’ EQUITY
14,022
12,201
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$
19,714
$
19,185
*
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
2024
2023
OPERATING EXPENSES
Research and development
$
2,660
$
2,367
General and administrative
1,736
1,734
OPERATING LOSS
( 4,396 )
( 4,101 )
Finance income
225
52
NET LOSS
$
( 4,171 )
$
( 4,049 )
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS
$
( 4,171 )
$
( 4,049 )
BASIC AND DILUTED NET LOSS PER COMMON SHARES OUTSTANDING, see Note 6
$
( 0.25 )
$
( 0.27 )
Basic and diluted weighted average number of common shares outstanding
16,559,335
14,724,249
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)
Common Stock
Additional
Total
$0.00001 Par Value
Paid-In
Accumulated
Stockholders’
Shares
Amount
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 share 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 CHANGES IN STOCKHOLDERS’ EQUITY
(USD in thousands, except share amounts)
(unaudited)
Common Stock
Additional
Total
$0.00001 Par Value
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
BALANCES AT DECEMBER 31, 2023
17,418,886
*
$
66,446
$
( 54,245 )
$
12,201
Share based payments
—
—
1,296
—
1,296
Issuance of restricted share awards
434,527
—
—
—
—
Issuance of common shares, net of offering costs of $ 153 - At-the-market
502,647
*
4,696
—
4,696
Net loss for the period
—
—
—
( 4,171 )
( 4,171 )
BALANCES AT MARCH 31, 2024
18,356,060
*
$
72,438
$
( 58,416 )
$
14,022
*
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,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$
( 4,171 )
$
( 4,049 )
Adjustments to reconcile loss to net cash used in operating activities:
Cost of share-based payments
1,296
1,402
Changes in operating assets and liabilities:
Increase in other current assets
( 191 )
( 328 )
Decrease in accounts payable
( 1,012 )
( 814 )
Increase/(Decrease) in accrued liabilities
71
( 289 )
Decrease in accrued compensation and benefits
( 351 )
( 699 )
Net cash used in operating activities
$
( 4,358 )
$
( 4,777 )
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
$
4,849
$
—
Issuance costs related to At-the-market offering
( 153 )
—
Issuance costs related to initial public offering
—
( 341 )
Proceeds from exercise of warrants, options, and preferred investment option
—
702
Issuance costs related to private placement
—
( 109 )
Net cash provided by financing activities
$
4,696
$
252
INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS
$
338
$
( 4,525 )
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
$
19,126
$
19,993
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$
19,464
$
15,468
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. (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). 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).
c. In February 2022, the Company’s shares began trading on the NASDAQ under the symbol “NVCT”.
d. Liquidity and Capital Resources
The Company has incurred net operating losses since its inception and had an accumulated deficit of $ 58.4 million as of March 31, 2024. The Company had cash and cash equivalents of $ 19.5 million as of March 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 stock.
During the three months ended March 31, 2024, the Company sold a total of 502,647 common shares under its At-the-Market Program for aggregate total gross proceeds of approximately $ 4.8 million at an average selling price of $ 9.31 per share, resulting in net proceeds of approximately $ 4.7 million after deducting issuance costs.
Management believes that its existing cash and cash equivalents as of March 31, 2024 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, 2024 are not necessarily indicative of those expected for the year ending December 31, 2024 or for any future period. The condensed balance sheet as of December 31, 2023 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, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 5, 2024.
The significant accounting policies adopted and used in the preparation of the financial statements are consistent with those of the previous financial year.
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.
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NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
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 included in cash and cash equivalents are considered Level 1.
During the three months ended March 31, 2024 and 2023, 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.
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 position or results of operations. 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, as previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on March 5, 2024 (see Note 5a in the Notes to the Financial Statements in our Annual Report).
Any potential milestone or royalty payment amounts have not been accrued as of March 31, 2024 and December 31, 2023 due to the uncertainty related to the achievement of these events or milestones.
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, 2023 filed with the SEC on March 5, 2024 (see Note 5a in the Notes to the Financial Statements in our Annual Report).
Any potential future research support, milestone or royalty payment amounts have not been accrued as of March 31, 2024 and December 31, 2023 due to the uncertainty related to the achievement of these events, milestones or commitments to additional research. As of March 31, 2024, the Company has paid UoE $ 0.8 million of the total $ 3.0 million related to the fund-raising commitment.
10
NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
b. Related Party Transactions
There have been no related party transactions as previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on March 5, 2024 (see Note 10 in the Notes to the Financial Statements).
c. Contingencies
As of March 31, 2024, and December 31, 2023, there are no contingent liabilities, therefore, no provision was made.
NOTE 4 – SHAREHOLDERS’ EQUITY:
a. Private Placement in Public Entity
On July 29, 2022, the Company closed a private placement offering (the “July 2022 Private Placement”), pursuant to the terms and conditions of a Securities Purchase Agreement (the “Agreement”), dated July 27, 2022. In connection with the July 2022 Private Placement, the Company issued 1,015,598 shares of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 909,091 shares of common stock which were fully exercised as of December 31, 2022 and preferred investment options (the “Preferred Investment Options”) to purchase up to an aggregate of 1,924,689 shares of common stock. The Company agreed to pay the placement agent fee and management fee equal to 7.0 % and 1.0 %, respectively, of the aggregate gross proceeds from the July 2022 Private Placement including the exercise of the Preferred Investment Options. 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. As of March 31, 2024, 1,001,091 Preferred Investment Options were exercised for $ 8.9 million, net of fees. In addition, as part of the July 2022 Private Placement, the Company issued warrants to the placement agent to purchase up to 115,481 shares of common stock. The placement agent warrants are in substantially the same form as the Preferred Investment Options, except that the exercise price is $ 10.31 . As of March 31, 2024, 79,104 placement agent warrants were exercised for which the Company has received $ 0.8 million.
b. At-the-Market Program
During the three months ended March 31, 2024, the Company sold a total of 502,647 common shares under our At-the-Market Offering Agreement with H. C. Wainwright & Co. (the “ATM Program”) for aggregate total gross proceeds of approximately $ 4.8 million at an average selling price of $ 9.31 per share, resulting in net proceeds of approximately $ 4.7 million after deducting commissions and other transaction costs.
As of March 31, 2024, approximately $ 29.9 million of securities remain available under the ATM Program.
NOTE 5 – SHARE BASED PAYMENTS:
a. 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, 2024:
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NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
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 – March 31, 2024
348,281
4.59
7.69
1,257
Exercisable – March 31, 2024
222,086
4.39
7.71
Expected to vest – March 31, 2024
348,281
4.59
7.69
1,257
As of March 31, 2024, there was $ 0.1 million of unrecognized share-based compensation expense related to unvested stock options that is expected to be recognized over a weighted-average period of 0.49 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 share 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, 2024, 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, 2023
941,496
8.23
1.80
7,852
Granted
434,527
8.37
Vested
( 201,083 )
7.50
Outstanding – March 31, 2024
1,174,940
8.27
1.32
9,635
Expected to vest – March 31, 2024
1,174,940
8.27
1.32
9,635
There were 60,000,000 shares of common share authorized as of March 31, 2024. As of March 31, 2024, and December 31, 2023, 18,356,060 and 17,418,886 shares were issued and outstanding , respectively, which includes 1,174,940 and 941,496 of unvested RSAs as of March 31, 2024, and December 31, 2023, respectively.
As of March 31, 2024, there was $ 5.4 million of total unrecognized compensation cost related to RSAs expected to be recognized over a weighted average period of 1.32 years.
For the three months ended March 31, 2024, the Company issued 130,000 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 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 1/3 vesting on each anniversary of the date of the grant. On January 4, 2024, the vesting of the first 1/3 of the January 2023 Grants were extended to July 15, 2024.
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 1/3 vesting on each anniversary of the date of the grant. On January 4, 2024, the vesting of the first 2/3 of the April 2022 Grants were extended to July 15, 2024.
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NUVECTIS PHARMA, INC.
Notes to the Unaudited Condensed Financial Statements (continued)
On July 27, 2021, Mr. Bentsur, Dr. Poradosu, and Mr. 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. On January 4, 2024, the vesting of the July 2021 grant to Mr. Bentsur, Dr. Poradosu and Mr. Shemesh was extended to July 15, 2024.
Share Compensation Expense
For the three months ended March 31, 2024, the Company recognized expenses of $ 0.5 million as part of general and administrative expenses and $ 0.8 million as part of research and development expenses. For the three months ended March 31, 2023, the Company recognized expenses of $ 0.5 million as part of general and administrative expenses and $ 0.8 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 shareholders by the weighted average number of common share outstanding.
For the three months
For the three months
ended March 31, 2024
ended March 31, 2023
Loss attributable to common shareholders
$
( 4,171 )
$
( 4,049 )
Basic and diluted net loss per common share
( 0.25 )
( 0.27 )
Weighted average of common share outstanding
16,559,335
14,724,249
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 period.
For the three months ended March 31,
2024
2023
Weighted average of common shares
17,927,858
15,817,862
Unvested RSAs
( 1,368,523 )
( 1,093,613 )
Weighted average of common share outstanding
16,559,335
14,724,249
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,
2024
2023
Common shares issuable in relation to:
Warrants
159,870
238,974
Options
348,281
346,090
Unvested RSAs *
1,368,523
1,093,613
* includes 193,557 of RSAs granted outside of the Incentive Plan see explanation in note 5
NOTE 7 – RELATED PARTY TRANSACTIONS:
a. None
NOTE 8 – SUBSEQUENT EVENTS:
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.