10-Q 1 tmb-20230930x10q.htm 10-Q
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315603

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended September 30, 2023

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Transition Period from                     to                   .

Commission File Number 001-41264

NUVECTIS PHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware

    

86-2405608

(State or Other Jurisdiction of Incorporation or Organization)

(I.R.S. Employer Identification No.)

1 Bridge Plaza, Suite 275

Fort Lee, NJ 07024

07024

(Address of Principal Executive Offices)

(Zip Code)

(201614-3150

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.00001 per share

 

NVCT

 

NASDAQ Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes      No     

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes      No    

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer

Accelerated filer

 

Non-accelerated filer

Smaller reporting company

 

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes    No  

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.

 

 

 

Class of Common Stock

 

Outstanding Shares as of November 07, 2023

Common Stock, $0.00001 par value

 

17,326,594

1

NUVECTIS PHARMA, INC.

FORM 10-Q

FOR THE QUARTER ENDED September 30, 2023

TABLE OF CONTENTS

Page

PART I

FINANCIAL INFORMATION

3

Item 1

Financial Statements

3

Unaudited Condensed Balance Sheets as of September 30, 2023 and December 31, 2022

3

Unaudited Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2023 and 2022

4

Unaudited Condensed Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2023 and 2022

5

Unaudited Condensed Statements of Cash Flows for the Three and Nine Months Ended September 30, 2023 and 2022

7

Notes to Unaudited Condensed Financial Statements

8

Item 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

15

Item 3

Quantitative and Qualitative Disclosures About Market Risk

23

Item 4

Controls and Procedures

23

PART II

OTHER INFORMATION

24

Item 1

Legal Proceedings

24

Item 1A

Risk Factors

24

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

24

Item 3

Defaults Upon Senior Securities

25

Item 4

Mine Safety Disclosures

25

Item 5

Other Information

25

Item 6

Exhibits

26

Signatures

27

2

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

NUVECTIS PHARMA, INC.

CONDENSED BALANCE SHEETS

(USD in thousands, except per share and share amounts)

(unaudited)

    

September 30, 

    

December 31, 

2023

2022

    

Assets

 

  

 

  

CURRENT ASSETS:

 

  

 

  

 

Cash and cash equivalents

 

$

22,059

 

$

19,993

 

Other current assets

 

203

 

412

 

TOTAL CURRENT ASSETS

 

22,262

 

20,405

 

TOTAL ASSETS

 

$

22,262

 

$

20,405

 

Liabilities and Stockholders’ Equity

 

  

 

  

 

CURRENT LIABILITIES

Accounts payables

 

$

3,492

 

$

2,910

 

Payable offering costs

 

 

450

 

Accrued liabilities

 

158

 

445

 

Employee compensation and benefits

 

1,926

 

2,381

 

TOTAL CURRENT LIABILITIES

 

5,576

 

6,186

 

TOTAL LIABILITIES

 

5,576

 

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 September 30, 2023, and December 31, 2022, 17,309,911, and 15,190,720 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

*

 

*

Additional paid in capital

 

64,309

 

46,204

 

Accumulated deficit

 

(47,623)

 

(31,985)

 

TOTAL STOCKHOLDERS’ EQUITY

 

16,686

 

14,219

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

22,262

 

$

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 September 30

Nine Months Ended September 30

    

2023

    

2022

    

2023

    

2022

OPERATING EXPENSES:

 

 

 

Research and development

 

$

4,486

 

$

4,520

 

$

11,115

 

$

8,830

 

General and administrative

1,672

 

1,418

4,916

 

3,626

 

 

 

OPERATING LOSS

 

(6,158)

 

(5,938)

 

(16,031)

 

(12,456)

 

Finance income

277

 

61

393

 

67

 

 

 

NET LOSS

 

$

(5,881)

 

$

(5,877)

 

$

(15,638)

 

$

(12,389)

 

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

$

(5,881)

 

$

(5,877)

$

(15,638)

 

$

(12,389)

 

BASIC AND DILUTED NET LOSS PER COMMON STOCK OUTSTANDING, see Note 6

$

(0.37)

 

$

(0.42)

$

(1.02)

 

$

(1.03)

 

Basic and diluted weighted average number of common stock outstanding

16,104,446

 

14,050,271

15,341,685

 

11,988,770

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

4

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

156

Net loss for the period

 

 

 

 

 

 

 

(2,943)

 

(2,943)

BALANCES AT MARCH 31, 2022

 

 

 

12,717,794

 

*

 

*

 

$ 30,402

 

$

(15,843)

 

$

14,559

Share-based payments

*

510

 

510

Net loss for the period

 

 

 

 

 

 

 

(3,569)

 

(3,569)

BALANCES AT JUNE 30, 2022

 

 

$

 

12,717,794

 

*

 

*

 

$ 30,912

 

$

(19,412)

 

$

11,500

Issuance of common stock, unexercised prefunded warrants and warrants in private placement, net of offering costs of $1,687

1,214,689

*

14,192

Exercise of prefunded warrants

710,000

*

 

Share based payments

*

559

559

Net loss for the period

 

 

 

 

 

 

 

(5,877)

 

(5,877)

BALANCES AT SEPTEMBER 30, 2022

 

 

$

-

 

14,642,483

 

*

 

*

 

$ 45,663

 

$

(25,289)

 

$

20,374

*

Represents an amount lower than $1,000 USD.

The accompanying notes are an integral part of these unaudited condensed financial statements.

5

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

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

Share based payments

 

 

 

  

 

  

 

  

 

950

 

  

 

950

Issuance of restricted stock awards

63,000

Exercise of preferred investment options, net of offering costs of $770

997,091

*

8,852

8,852

Exercise of warrants

79,104

*

816

816

Issuance of common stock, net of offering costs of $152 - At-the-market

188,970

*

3,110

3,110

Exercise of stock options

6,809

*

38

38

Net loss for the period

 

 

 

 

 

 

 

(5,708)

 

(5,708)

BALANCES AT JUNE 30, 2023

 

 

$

 

17,221,113

 

*

 

 

$

62,074

 

$

(41,742)

 

$

20,332

Share based payments

 

 

 

 

*

 

  

 

1,134

 

  

 

1,134

Issuance of restricted stock awards

15,000

*

Issuance of common stock, net of offering costs of $39 - At-the-market

73,798

*

1,101

1,101

Net loss for the period

 

 

 

 

 

 

 

(5,881)

 

(5,881)

BALANCES AT SEPTEMBER 30, 2023

 

 

 

17,309,911

 

*

 

 

$

64,309

 

$

(47,623)

 

$

16,686

*

Represents an amount lower than $1,000 USD.

The accompanying notes are an integral part of these unaudited condensed financial statements.

6

NUVECTIS PHARMA, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(USD in thousands, except per share and share amounts)

(unaudited)

Nine Months Ended September 30, 

    

2023

    

2022

CASH FLOWS FROM OPERATING ACTIVITIES:

 

  

 

  

 

Net loss

 

$

(15,638)

 

$

(12,389)

 

Adjustments to reconcile loss to net cash used in operating activities:
Cost of stock-based payments

 

3,485

 

1,225

 

Changes in operating assets and liabilities:

 

  

 

  

 

(Increase)/decrease in other current assets

 

209

 

(1,135)

 

(Decrease)/increase in accounts payable, accrued compensation and benefits, and accrued liabilities

 

(160)

 

2,256

 

Net cash used in operating activities

 

$

(12,104)

 

$

(10,043)

 

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

 

$

4,388

 

$

 

Issuance costs related to At-the-market offering

(190)

Proceeds from issuance of common stock upon initial public offering

16,000

Issuance costs related to initial public offering

(341)

(2,551)

Proceeds from issuance of common stock and pre-funded warrants in private placement

15,879

Proceeds from exercise of warrants/options/preferred investment option

11,192

Issuance costs related to the exercise of warrants/preferred investment option

(371)

Issuance costs related to private placement

(508)

(1,387)

Net cash provided by financing activities

 

$

14,170

 

$

27,941

 

INCREASE IN CASH AND CASH EQUIVALENTS

 

$

2,066

 

$

17,898

 

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD

 

$

19,993

 

$

5,742

 

CASH AND CASH EQUIVALENTS AT END OF PERIOD

 

$

22,059

 

$

23,640

 

Supplemental noncash disclosure of investing and financing activities:

 

  

 

  

 

Unpaid issuance costs related to the private placement

 

 

300

The accompanying notes are an integral part of these unaudited condensed financial statements.

7

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).
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 $47.6 million as of September 30, 2023. The Company had cash and cash equivalents of $22.1 million as of September 30, 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, all of which was converted into common stock at the February 2022 initial public offering.

Management believes that its existing cash, and cash equivalents as of September 30, 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.

8

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 September 30, 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 adopted and used in the preparation of the financial statements are consistent with those of the previous financial year except as described below.

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.

9

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 and nine months ended September 30, 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 restricted stock awards.

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, as revised on March 31, 2022, (the “License Agreement”) as previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year

10

NUVECTIS PHARMA, INC.

Notes to the Unaudited Condensed Financial Statements (continued)

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) except noted below.

In connection with the License Agreement described in the annual report, the Company agreed to provide Institute of Cancer Research in London, UK ("ICR”) with up to an additional $865,000 in research and development support to conduct additional scientific research and preclinical testing for certain indications that the Company selects in connection with the NXP800 Program. The Company recognized zero and $0.4 million in research and development expense during the three months and nine months ended September 30, 2023, respectively.  The Company expects to expense the remaining $0.2 million related to this research and development support in the fourth quarter 2023.

Any potential milestone or royalty payment amounts have not been accrued as of September 30, 2023 and December 31, 2022 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, 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 September 30, 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

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, 2022 filed with the Securities and Exchange Commission on March 8, 2023 (see Note 10 in the Notes to the Financial Statements).

c.Contingencies

As of September 30, 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 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. 1,001,091 Preferred Investment Options were exercised for $8.9 million, net of fees, as of September 30, 2023. 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

11

NUVECTIS PHARMA, INC.

Notes to the Unaudited Condensed Financial Statements (continued)

$10.31. 79,104 placement agent warrants were exercised for which the Company has received $0.8 million as of September 30, 2023.

NOTE 5 – 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 stock based on the achievement of service condition, market condition or performance condition. As of September 30, 2023, 21,000 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 September 30, 2023.  Performance condition options totaled 12,000, had an estimated value based on Black-Scholes of approximately $39,000 and were exercisable as of September 30, 2023.  Market condition options totaling 9,000 options have a market condition which was achieved by September 30, 2023, and an estimated value of $20,000 based on a Monte Carlo model. 2,792 options have been exercised as of September 30, 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

Expected volatility

 

75

%

In February 2022, the Company granted to the underwriter of our initial public offering of common stock (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 for $0.7 million as of September 30, 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 nine months ended September 30, 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

 

43,500

 

7.51

 

  

 

  

Exercised

 

(6,809)

 

5.91

 

  

 

  

Forfeited

 

 

 

  

 

  

Outstanding – September 30, 2023

 

348,281

 

4.59

 

8.19

 

2,912

Exercisable – September 30, 2023

 

210,836

 

4.22

 

8.15

 

  

Expected to vest – September 30, 2023

 

348,281

 

4.59

 

8.19

 

2,912

As of September 30, 2023, there was $0.3 million of unrecognized stock-based compensation expense related to unvested stock options that is expected to be recognized over a weighted-average period of 1.42 years.

12

NUVECTIS PHARMA, INC.

Notes to the Unaudited Condensed Financial Statements (continued)

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 nine months ended September 30, 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

 

663,499

 

8.76

 

  

 

  

Vested

 

(50,137)

 

9.44

 

  

 

  

Outstanding – September 30, 2023

 

952,169

 

8.07

 

2.16

 

12,273

Expected to vest – September 30, 2023

 

952,169

 

8.07

 

2.16

 

12,273

There were 60,000,000 shares of common stock authorized as of September 30, 2023. As of September 30, 2023 and December 31, 2022, 17,309,911 and 15,190,720 shares were issued and outstanding, respectively, which includes 952,169 and 338,807 of unvested RSAs as of September 30, 2023, and December 31, 2022, respectively.

As of September 30, 2023, there was $4.09 million of total unrecognized compensation cost related to RSAs expected to be recognized over a weighted average period of 2.13 years.

For the nine months ended September 30, 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, along with 18,000 RSAs issued to its independent directors. These RSAs vest over three years with 1/3 vesting on each anniversary of the date of the grant.

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 September 30, 2023, the Company recognized expenses of $0.5 million as part of general and administrative expenses and $0.6 million as part of research and development expenses. For the three months ended September 30, 2022, the Company recognized expenses of $0.2 million as part of general and administrative expenses and $0.3 million as part of research and development expenses.

For the nine months ended September 30, 2023, the Company recognized expenses of $1.6 million as part of general and administrative expenses and $1.9 million as part of research and development expenses. For the nine months ended September 30, 2022, the Company recognized expenses of $0.6 million as part of general and administrative expenses and $0.6 million as part of research and development expenses.

13

NUVECTIS PHARMA, INC.

Notes to the Unaudited Condensed Financial Statements (continued)

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

For the nine ended

For the nine ended

ended September 30, 2023

    

ended September 30, 2022

ended September 30, 2023

    

ended September 30, 2022

in thousand U.S. dollars except per share and share amounts

Loss attributable to common stockholders

$

(5,881)

 

$

(5,877)

$

(15,638)

 

$

(12,389)

 

Basic and diluted net loss per common share

(0.37)

 

(0.42)

(1.02)

 

(1.03)

 

Weighted average of common share outstanding

16,104,446

 

14,050,271

15,341,685

 

11,988,770

 

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.

For the three months

For the nine ended

ended September 30, 2023

    

ended September 30, 2023

    

Weighted average of common stock

17,250,172

 

16,487,411

 

Unvested RSAs

(1,145,726)

 

(1,145,726)

 

Weighted average of common share outstanding

16,104,446

 

15,341,685

 

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:

September 30, 

    

2023

    

2022

Common stock issuable in relation to:

 

  

 

  

Warrants

 

159,870

 

344,374

Options

 

348,281

 

311,590

Unvested RSAs *

 

1,145,726

 

548,237

*includes 193,557 of RSAs granted outside of the Incentive Plan

NOTE 7 – RELATED PARTY TRANSACTIONS:

a.None

NOTE 8 – SUBSEQUENT EVENTS:

14

Item 2.Management’s Discussion and Analysis of the Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this report. The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words “expect,” “anticipate,” “intend,” “believe,” “may,” “plan,” “seek” or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof and we assume no obligation to update any such forward-looking statements. For such forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Our business and financial performance are subject to substantial risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider the information set forth under the heading “Risk Factors” herein and in our Annual Report on Form 10-K for the year ended December 31, 2022. As used below, the words “we,” “us” and “our” may refer to Nuvectis Pharma, Inc.

Overview

We are a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. We seek to develop drug candidates in the precision medicine space, and our processes for selection and clinical development of drug candidates is based on scientific insights into cancer-promoting factors, as well as on our understanding of the clinical landscape and regulatory requirements.

NXP800 (Integrated Stress Response Activator) 

We have licensed exclusive world-wide development and commercial rights to NXP800, a novel Integrated Stress Response (“ISR”) pathway activator, which was discovered at the Institute of Cancer Research (“ICR”) in London, England.

NXP800 is an oral, small molecule discovered in a phenotypic screen for inhibitors of the heat shock factor 1 stress response. In a panel of human carcinoma cell lines NXP800 induced the genes associated with activation of the integrated ISR via activation of the general control non-derepressible 2 ("GCN2”) kinase. Consistent with activation of the ISR, NXP800 increased the expression of the following downstream ISR markers/effectors: activating transcription factor 4 (“ATF4”), ChaC glutathione specific gamma-glutamylcyclotransferase 1 (“CHAC1”) and C/EBP homologous protein (“CHOP”) both in human ovarian cells in vitro and corresponding tumor xenograft models in vivo.

NXP800 acts on cancer cells to stimulate the GCN2 kinase, which activates the ISR pathway, leading to inhibition of cap-dependent protein translation, including heat shock factor 1 (“HSF1”) regulated proteins. In preclinical studies, treatment with NXP800 inhibited tumor growth in xenografts models of human ovarian and gastric cancers, in which, a genetic mutation in the AT-rich interactive domain-containing protein 1A (“ARID1a”) gene was present, potentially rendering ARID1a a biomarker for treatment sensitivity, offering potential strategies for enrichment. Based on this work, we have begun to clinically investigate NXP800 in platinum-resistant ARID1a-mutated ovarian carcinoma, a type of cancer which is primarily comprised of two histologies, Ovarian Clear Cell Carcinoma (“OCCC”) and ovarian endometrioid carcinoma (“OEC”), and to investigate the utility of ARID1a deficiency as a patient selection marker in additional tumor types. The genetic screening for the ARID1a mutation is performed using commercially available next generation sequencing-based in vitro diagnostic test, which is routinely utilized in the clinic for cancer patients.

The Phase 1 study was initiated in December 2021 and is comprised of two parts: dose-escalation (Phase 1a), followed by an expansion phase (Phase 1b). In the Phase 1a, the safety, tolerability and pharmacokinetic properties of NXP800 were evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for Phase 1b. The Phase 1b portion of the study, which was initiated in the second quarter of 2023, is evaluating the safety and preliminary anti-tumor activity of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian carcinoma. Additional studies to evaluate the safety and preliminary anti-tumor activity of NXP800 in additional tumor types are planned.

In June 2022, the Investigational New Drug Application (“IND”) for NXP800, which was previously submitted to the U.S. Food and Drug Administration (the “FDA”), was cleared, which included the Phase 1 clinical trial protocol. Preclinical studies were conducted, and additional preclinical studies are being conducted to identify development opportunities for NXP800 in additional solid tumor types. In December 2022, we announced that the FDA granted Fast Track Designation status to the development program of NXP800 for the

15

treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma. In August 2023, we announced that NXP800 received Orphan Drug Designation for the treatment of cholangiocarcinoma.

NXP900 (SRC/YES1 Kinase Inhibitor)

NXP900 is a SRC Family Kinase (“SFK”) inhibitor that potently inhibits the proto-oncogenes c-Src (“SRC”) and YES1 kinases. NXP900 was discovered at the University of Edinburgh, Scotland. SRC is aberrantly activated in many cancer types, including solid tumors such as breast, colon, prostate, pancreatic and ovarian, while remaining predominantly inactive in non-cancerous cells. Increased SRC activity is generally associated with late-stage cancers, metastatic potential and resistance to therapy, and correlates with poor clinical prognosis. YES1 gene amplification has been reported to be implicated in several tumors including lung, head and neck, bladder and esophageal cancers. In addition, YES1 directly phosphorylates and activates the Yes-associated protein (“YAP1”), the main effector of the Hippo pathway, which has been identified as a promoter of drug resistance, cancer progression, and metastasis in several cancer types, including squamous cell, mesothelioma and papillary kidney cancers.

In vivo, treatment with NXP900 inhibited primary and metastatic tumor growth in xenograft models of breast, cervical, esophageal, head and neck and medulloblastoma cancers, and demonstrated on-target pharmacodynamic effects. Furthermore, it has been found that YES1 gene amplification is a key mechanism of resistance to Epidermal Growth Factor Receptor (“EGFR”) or (Human Epidermal Growth Factor Receptor 2 and anaplastic lymphoma kinase, commonly referred to as ALK, inhibitors. A peer reviewed study published in Nature Communication (not sponsored by the Company) published in April 2022 demonstrated that NXP900 was able to re-sensitize resistant non-small cell lung cancer (“NSCLC”) cells to osimertinib (active ingredient in Tagrisso®), the leading EFGR inhibitor used for the treatment of EGFR mutation-positive NSCLC, when used in combination with osimertinib.  

In May 2023, the U.S. Food and Drug Administration (“FDA”) cleared the Company's Investigational New Drug Application (“IND”) for NXP900, which includes the Phase 1 clinical trial protocol.

The Phase 1 study was initiated in September 2023 and is comprised of two parts: dose-escalation (Phase 1a), to be followed by an expansion phase (Phase 1b). In the ongoing Phase 1a, the safety, tolerability and pharmacokinetic properties of NXP900 in patients with advanced solid tumors will be assessed in order to identify a dose and dosing schedule for Phase 1b.

Since our inception in 2020, we have devoted all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, acquiring product candidates and securing related intellectual property rights and conducting research and development activities. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have not yet successfully completed any pivotal clinical trials, obtained any regulatory approvals, manufactured a commercial-scale drug, or conducted sales and marketing activities.

Results of Operations

From our inception on July 27, 2020, through September 30, 2023, we did not generate any revenue. Our main activities through September 30, 2023, have been organizational and capital raising activities, the completion of the in-license agreements for our two drug candidates, NXP800 and NXP900, our Clinical Trial Application by the Medicines and Healthcare Regulatory Agency, preparation for the Phase 1a and Phase 1b clinical trials for NXP800, which commenced in December 2021 and April 2023, respectively, and beginning our IND-enabling studies, which commenced in late 2021, along with preparation for the Phase 1a clinical trial for NXP900. In May 2023, NXP900 received FDA clearance, and the Phase 1a study was initiated in September 2023. Additionally, we completed our initial public offering in February 2022, a private placement offering in July 2022 and a shelf registration in March 2023.

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, and materials and service used for research and development activities, including clinical trials, manufacturing costs, and professional services. All costs associated with research and development are expensed as incurred.

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidates is highly uncertain. At this time, we cannot accurately

16

estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates and we may never succeed in obtaining regulatory approval for any of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, for our personnel in executive, finance and accounting, and other administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees paid for accounting, auditing, consulting, and tax services; insurance costs; investor relations activities; travel expenses; and facility costs not otherwise included in research and development expenses.

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research and development activities.

The following table summarizes our results of operations expenses for the three months ended September 30, 2023 and 2022: (in thousands)

Three Months Ended September 30

    

2023

    

2022

    

Change

OPERATING EXPENSES:

 

  

 

  

 

  

Research and Development

 

$

4,486

 

$

4,520

 

$

(34)

General and Administrative

 

1,672

 

1,418

 

254

OPERATING LOSS

 

(6,158)

 

(5,938)

 

(220)

Finance Income

 

277

 

61

 

216

NET LOSS

 

$

(5,881)

 

$

(5,877)

 

$

(4)

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended September 30, 2023 and 2022: (in thousands)

    

For the three months ended September 30

    

Increase/

    

2023

    

2022

    

(Decrease)

Clinical Expenses

$

1,209

 

$

590

$

618

Employee Compensation and Benefits

1,219

 

1,452

(233)

Manufacturing

1,494

 

482

1,012

License Fee

500

 

1,897

(1,397)

Professional services and other

65

 

99

(34)

Total research and development expenses

$

4,486

 

$

4,520

$

(34)

Research and development expenses remained flat during the three months ended September 30, 2023, compared to the same period in 2022. Research and development expense during the three months ended September 30, 2023, was primarily driven by a $1.0 million increase in manufacturing development to support the planned clinical trials for NXP800 and NXP900 and $0.6 million for the ongoing NXP800 clinical trial and initiation of the NXP900 clinical trial which was offset by a $1.4 million decrease in related license fees which was expensed in 2022 and a $0.2 million decrease in employee compensation related to bonuses awarded in 2022 which included a $0.3 million increase related to employee stock compensation.

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The following table summarizes our general and administrative expenses for the three months ended September 30, 2023 and 2022: (in thousands)

For the three months ended September 30

    

Increase/

    

2023

2022

    

(Decrease)

Professional and consulting services

 

$

831

 

$

411

$

420

Employee Compensation and Benefits

 

410

 

566

(156)

Insurance and Other

 

431

 

441

(10)

Total general and administrative expenses

 

$

1,672

 

$

1,418

$

254

General and administrative expenses increased by $0.3 million, or 18%, during the three months ended September 30, 2023, compared to the same period in 2022. The increase in general and administrative expense during the three months ended September 30, 2023, was primarily driven by the $0.4 million increase in professional and consulting services related to public company related expenses, partially offset by a $0.2 million decrease related to employee compensation and benefits related bonuses award in 2022 and includes a $0.3 million increase in employee stock-based compensation.

As a result of the foregoing, our loss from operations for the three months ended September 30, 2023, remained consistent compared to the same period in 2022.

The following table summarizes our results of operations expenses for the nine months ended September 30, 2023 and 2022: (in thousands)

Nine Months Ended September 30

    

2023

    

2022

    

Change

OPERATING EXPENSES:

 

  

 

  

 

  

Research and Development

 

$

11,115

 

$

8,830

 

$

2,285

General and Administrative

 

4,916

 

3,626

 

1,290

OPERATING LOSS

 

(16,031)

 

(12,456)

 

(3,575)

Finance Income

 

393

 

67

 

326

NET LOSS

 

$

(15,638)

 

$

(12,389)

 

$

(3,249)

Research and Development Expenses

The following table summarizes our research and development expenses for the nine months ended September 30, 2023 and 2022: (in thousands)

    

For the nine months ended September 30

    

Increase/

    

2023

    

2022

    

(Decrease)

Employee Compensation and Benefits

$

3,805

 

$

2,178

1,627

Clinical Expenses

3,085

2,763

322

Manufacturing

3,094

 

1,239

1,855

License Fee

1,001

 

2,297

(1,296)

Professional services and other

131

 

353

(222)

Total research and development expenses

$

11,115

 

$

8,830

$

2,285

Research and development expenses increased by $2.3 million during the nine months ended September 30, 2023 compared to the same period in 2022.  The increase in research and development expense during the nine months ended September 30, 2023 was primarily driven by a $1.9 million increase in manufacturing related costs of NXP800 for the ongoing Phase 1 study and planned Phase 1 clinical trials of NXP900, $1.6 million increase in employee compensation and benefits, including $1.2 million increase in stock based compensation, $0.3 million in clinical expenses paid out in connection with our product candidates NXP800 and NXP900, partially

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offset by a $1.3 million decrease in license fees which was expensed in 2022 and a $0.2 million decrease in professional services and other expenses associated with our drug product programs.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2023 and 2022: (in thousands)

For the nine months ended September 30

    

Increase/

    

2023

2022

    

(Decrease)

Professional and consulting services

 

$

2,272

 

$

1,413

$

859

Employee Compensation and Benefits

 

1,405

 

1,026

379

Insurance and Other

 

1,239

 

1,187

52

Total general and administrative expenses

 

$

4,916

 

$

3,626

$

1,290

General and administrative expenses increased by $1.3 million, during the nine months ended September 30, 2023 compared to the same period in 2022. The increase in general and administrative expenses for the nine months ended September 30, 2023, was primarily driven by $0.4 million in employee compensation including $0.4 million increase in stock compensation expense, an increase of $0.9 million in professional and consulting fees paid to third-party providers including $0.6 million in increase stock compensation expense and $0.1 million in insurance and other due to public company expenses.

As a result of the foregoing, our loss from operations for the nine months ended September 30, 2023, increased $3.2 million, compared to the same period in 2022, which was primarily driven by employee compensation and benefits, clinical trial expenses, and manufacturing expenses.

Liquidity and Capital Resources

As of September 30, 2023, we had $22.1 million of cash and cash equivalents. For the three months ended September 30, 2023, and 2022, we had net losses of $5.9 million and $5.9 million, respectively. For the nine months ended September 30, 2023, and 2022, we had net losses of $15.6 million and $12.4 million, respectively. As of September 30, 2023, we had an accumulated deficit of $47.6 million.

On February 4, 2022, we announced the pricing of our initial public offering of common stock (the “IPO”) of 3,200,000 shares of common stock for a price of $5.00 per share, less certain underwriting discounts and commissions. As part of the UoE license agreement, we are required to pay UoE 2.5% of the gross amount of each of our future fund raisings up to a cumulative total of $3.0 million. Pursuant to the IPO, we paid UoE $0.4 million associated with this fundraising.

The IPO closed on February 8, 2022, with gross proceeds of $16.0 million, before deducting underwriting discounts and expenses (for net proceeds of $12.6 million).

In addition, on July 29, 2022, we completed the July 2022 Private Placement in which we received gross proceeds of $15.9 million before deducting fees and expenses (for net proceeds of $14.2 million) excluding payments required by our license agreements. As part of this transaction, we issued Preferred Investment Options which 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 securities purchase agreement. For the nine months ended September 30, 2023, 1,001,091 Preferred Investment Options were exercised, and $8.9 million, net of fees, was received as of  September 30, 2023. In addition, as part of the July 2022 Private Placement, we 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 September 30, 2023, 79,104 placement agent warrants were exercised, and $0.8 million, net of fees, was received.

On March 17, 2023, we filed a shelf registration statement on Form S-3 (the “Registration Statement”). Pursuant to the Registration Statement, we may offer and sell securities having an aggregate public offering price of up to $150.0 million. In connection with the filing of the Registration Statement, we also entered into a sales agreement with H. C. Wainwright & Co. (the “Sales Agent”), pursuant to which we may issue and sell shares of our common stock for an aggregate offering price of up to $40.0 million under an at-the-market offering program (the “ATM”), which is included in the $150.0 million of securities that may be offered pursuant to the Registration

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Statement. Pursuant to the ATM, we will pay the Sales Agent a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of our common stock. We are not obligated to make any sales of shares of our common stock under the ATM. As of September 30, 2023, we have sold 266,650 shares of our common stock and received $4.2 million in net proceeds under the ATM.

We believe that the proceeds from our IPO, private placement and ATM will enable us to fund our operating expenses and capital expenditures through at least the next 12 months from the issuance of our financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Our future viability in the long term is dependent on our ability to raise additional capital to finance our operations.

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our current or future product candidates, including payments of milestones and sponsored research commitments associated with our license agreements for NXP800 and NXP900. In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, and other expenses that we did not incur as a private company. The timing and amount of our operating expenditures will depend largely on our ability to:

advance development of our clinical and preclinical programs;
manufacture, or procure the manufacturing of, our preclinical and clinical drug material and develop processes for late stage and commercial manufacturing;
seek regulatory approvals for any current or future product candidates that successfully complete clinical trials;
achieve milestones in accordance with our license agreements;
establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any current or future product candidates for which we may obtain marketing approval;
hire additional clinical, quality control and scientific personnel;
expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts and our operations as a public company;
obtain, maintain, expand and protect our intellectual property portfolio; and
acquire additional product candidates.

We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for our other future product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Because of the numerous risks and uncertainties associated with research, development and commercialization of our product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:

the scope, progress and costs of researching and developing our current or future product candidates, including the timing and safety, tolerability and efficacy results from our preclinical and clinical trials;
the costs, timing and outcome of regulatory review of our current or future product candidates;
the costs, timing and ability to manufacture our current or future product candidates to supply our preclinical development efforts and our clinical trials;
the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our current or future product candidates for which we receive marketing approval;

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the costs of manufacturing commercial-grade products and necessary inventory to support commercial launch;
the ability to receive additional non-dilutive funding, including grants from organizations and foundations;
the revenue, if any, received from commercial sale of our products, should any of our current or future product candidates receive marketing approval;
the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual property rights and defending intellectual property-related claims;
our ability to establish and maintain collaborations on favorable terms, if at all; and
the extent to which we acquire or in-license other product candidates and technologies.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of public or private equity offerings, debt financings, governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in fixed payment obligations.

If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Cash Flows

The following table provides information regarding our cash flows for the periods presented: (in thousands)

For the nine months ended September 30

    

2023

    

2022

Net cash used in operating activities

 

$

(12,104)

 

$

(10,043)

Net cash used in investing activities

 

 

Net cash provided by financing activities

 

14,170

 

27,941

Operating Activities

During the nine months ended September 30, 2023, $12.1 million of cash was used in operating activities. This was primarily attributable to our net loss of $15.6 million, partially offset by non-cash charges of $3.5 million. The change in our operating assets and liabilities was primarily due to $0.7 million payment of employee compensation and benefits, $0.5 million payment for our director and officer insurance of deferred offering costs, and $0.5 million payments related to public company operations.

During the nine months ended September 30, 2022, $10.0 million of cash was used in operating activities. This was primarily attributable to our net loss of $12.4 million, partially offset by non-cash charges of $1.2 million. The change in our operating assets and liabilities was primarily due to an increase of $1.1 million in prepaid and other assets, which was primarily due to $1.1 million payment for our director and officer insurance, partially offset by $2.2 million increase in accounts payable and accrued expense, due to growth in our business, the advancement of our research programs, and the timing of vendor invoicing and payments.

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Financing activities

During the nine months ended September 30, 2023, net cash provided by financing activities was $14.2 million, consisting primarily of $10.7 million net proceeds from the exercise of warrants associated with our IPO and private placement along with $4.2 million net proceeds from the sale of common stock through the ATM, offset by $0.4 million of deferred offering costs paid.

During the nine months ended September 30, 2022, net cash provided by financing activities was $27.9 million, consisting primarily of proceeds from the sale of our common stock, offset by $3.9 million of commission and deferred offering costs paid.

Contractual Obligations and Other Commitments

We enter into contracts in the normal course of business with clinical research organizations, contract manufacturing organizations, and other third parties for clinical trials, preclinical research studies, and testing and manufacturing services. These contracts are cancelable by us upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. The amount and timing of such payments are not known.

We have also entered into license and collaboration agreements with third parties, which are in the normal course of business. We have not included future payments under these agreements since obligations under these agreements are contingent upon future events such as our achievement of specified development, regulatory, and commercial milestones, or royalties on net product sales.

Pursuant to the NXP800 License Agreement, we are required to make payments to the ICR for certain development and regulatory milestones. As of September 2023, we were obligated to pay up to $22.0 million in milestone payments to the ICR related to pre-approval milestones, up to $178 million (in addition to the $22.0 million) in regulatory and commercial sales milestones, and mid-single digit to 10% royalties on a tiered basis on net sales, unless development ceases. Additionally, the Company originally agreed to provide the ICR with up to an additional $0.5 million in research and development. On March 31, 2022, the Company and ICR agreed to research and development support of an additional $0.4 million ($0.9 million total).

Pursuant to the NXP900 License Agreement, we are required to make payments to the UoE for certain development and regulatory milestones. As of September 30, 2023, we were obligated to make up to $45.0 million in milestone payments to the UoE related to pre-approval milestones, including $0.5 million on the first anniversary of the agreement which we paid as of September 30, 2023, up to $279.6 million in regulatory and commercial sales milestones, mid-single digit to 8% royalties on a tiered basis on net sales and 2.5% of the gross amount of each of our future fund raising up to a cumulative total of $3.0 million, unless development ceases. Additionally, we will provide UoE with up to an additional $754,000 in research and development support.

We do not currently have any long-term leases. We rent our office space in Fort Lee, New Jersey, based on a one-year agreement signed on May 1, 2023.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.

Critical Accounting Policies and Significant Judgments and Estimates

Our condensed financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q are prepared in accordance with U.S. generally accepted accounting principles. The preparation of condensed financial statements also requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs, expenses, and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ significantly from the estimates made by management. To the extent that there are differences between our estimates and actual results, our future financial statement presentation, financial condition, results of operations, and cash flows will be affected.

There have been no significant changes to our critical accounting policies and estimates as compared to those described in “Note 2 – Summary of Significant Accounting Policies” to our audited financial statements set forth in our Annual Report on Form 10-K filed with the SEC on March 8, 2023.

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