Nuvectis Pharma Inc

Previous wording

Our focus in 2023 was on progressing the pipeline and executing financing activities to fund pipeline development. Management’s primary evaluation of the success of our company is the ability to progress its pipeline assets forward towards commercialization. This success depends on not only the operational execution of the programs, but also the ability to secure sufficient funding to support the programs. We believe the ability to achieve the anticipated milestones as presented in the section entitled “Business” in Item 1 of this Annual Report on Form 10-K represents our most immediate evaluation points.

Current wording

Our focus has been on progressing the pipeline and executing financing activities to fund pipeline development. Management’s primary evaluation of the success of our company is the ability to progress its pipeline assets forward towards commercialization. This success depends on not only the operational execution of the programs, but also the ability to secure sufficient funding to support the programs. We believe the ability to achieve the anticipated milestones as presented in the section entitled “Business” in Item 1 of this Annual Report on Form 10-K represents our most immediate evaluation points.

Previous wording

For the year ended December 31, 2023, research and development expenses were approximately $15.4 million, compared to approximately $13.2 million for the year ended December 31, 2022, an increase of $2.2 million. The current period research and development expenses primarily consisted of $6.3 million related to employee compensation including $2.6 million related to non-cash stock compensation, $4.3 million related to clinical trial expenses for our product candidates, $1.0 million in one-time license fee payments, and $3.5 million related to the manufacturing costs of our product candidates. For the year ended December 31, 2022, research and development expenses primarily consisted of $4.6 million related to employee compensation including $0.9 million related to non-cash stock compensation, $3.7 million related to clinical trial expenses for our product candidates including $1.2 million in one-time IND enabling studies for NXP900, $2.3 million in one-time license fee payments, and $2.2 million related to the manufacturing costs of our product candidates.

Current wording

For the year ended December 31, 2024, research and development expenses were approximately $12.9 million, compared to approximately $15.4 million for the year ended December 31, 2023, a decrease of $2.5 million. The current period research and development expenses primarily consisted of $6.9 million related to employee compensation including $3.0 million related to non-cash stock compensation, $4.3 million related to clinical trial expenses for our product candidates, and $1.5 million related to the manufacturing costs of our product candidates. For the year ended December 31, 2023, research and development expenses primarily consisted of $6.3 million related to employee compensation including $2.6 million related to non-cash stock compensation, $4.3 million related to clinical trial expenses, $1.0 million in one-time license fee payments, and $3.5 million related to the manufacturing costs of our product candidates.

Previous wording

For the year ended December 31, 2023, general and administrative expenses were approximately $7.5 million, compared to approximately $6.0 million for the year ended December 31, 2022, an increase of $1.5 million. The current period

Current wording

For the year ended December 31, 2024, general and administrative expenses were approximately $6.9 million, compared to approximately $7.5 million for the year ended December 31, 2023, a decrease of $0.6 million. The current period general and administrative expenses primarily consisted of $3.5 million paid to certain professional and consulting services, $2.1 million in employee compensation including non-cash stock compensation expense of $1.9 million, and $0.6 million

Previous wording

general and administrative expenses primarily consisted of $3.5 million paid to certain professional and consulting services, $2.3 million in employee compensation including non-cash stock compensation expense of $1.0 million, and $0.8 million related to director and officer insurance. For the year ended December 31, 2022, general and administrative expenses primarily consisted of $2.4 million paid to certain professional and consulting services, $1.8 million in employee compensation including non-cash stock compensation expense of $0.8 million, and $1.2 million related to director and officer insurance.

Current wording

related to director and officer insurance. For the year ended December 31, 2023, general and administrative expenses primarily consisted of $3.5 million paid to certain professional and consulting services, $2.3 million in employee compensation including non-cash stock compensation expense of $1.0 million, and $0.8 million related to director and officer insurance.

Previous wording

As a result of the foregoing, our loss from operations for the year ended December 31, 2023 was $22.9 million, compared to a loss from operations of $19.2 million for the year ended December 31, 2022.

Current wording

As a result of the foregoing, our loss from operations for the year ended December 31, 2024 was $19.8 million, compared to a loss from operations of $22.9 million for the year ended December 31, 2023.

Previous wording

As of December 31, 2023, we had $19.1 million of cash and cash equivalents.

Current wording

As of December 31, 2024, we had $18.5 million of cash and cash equivalents.

Previous wording

On February 4, 2022, we announced the pricing of our initial public offering (“IPO”) of 3,200,000 shares of common stock for a price of $5.00 per share, less certain underwriting discounts and commissions. Upon closing of the IPO, we issued 128,000 representative warrants, with an exercise price of $6.25, to purchase common stock to the underwriter, equaling 4% of the total shares sold in the IPO. We also granted the underwriter a 30-day option to purchase up to 480,000 additional shares of common stock to cover any over-allotments (the “Over-Allotment Option"), and the right to receive, upon exercise of the Over-allotment Option, a number of additional warrants to purchase common stock totaling 4% of the shares sold in the IPO (including the 128,000 previously issued), on the same terms and conditions for the purpose of covering any over-allotments in connection with the IPO. No overallotment shares were purchased by the underwriter and no Over-Allotment Options were granted to the underwriter. As part of the UoE license agreement, we paid UoE $0.4 million associated with this fund raising.

Current wording

On February 4, 2022, we announced the pricing of our IPO of 3,200,000 shares of common stock for a price of $5.00 per share, less certain underwriting discounts and commissions. Upon closing of the IPO, we issued 128,000 representative warrants, with an exercise price of $6.25, to purchase common stock to the underwriter, equaling 4% of the total shares sold in the IPO. We also granted the underwriter a 30-day option to purchase up to 480,000 additional shares of common stock to cover any over-allotments (the “Over-Allotment Option"), and the right to receive, upon exercise of the Over-allotment Option, a number of additional warrants to purchase common stock totaling 4% of the shares sold in the IPO (including the 128,000 previously issued), on the same terms and conditions for the purpose of covering any over-allotments in connection with the IPO. No overallotment shares were purchased by the underwriter and no Over-Allotment Options were granted to the underwriter. As part of the UoE license agreement, we paid UoE $0.4 million associated with this fund raising in 2022.

Previous wording

On July 29, 2022, we announced the completion of private placement of common stock in which we received gross proceeds of $15.9 million before deducting fees and expenses (for net proceeds of $14.3 million). We also granted the placement agent 115,481 preferred investment options to purchase common stock. As part of the UoE license agreement, we owe UoE $0.4 million associated with this fund raising.

Current wording

On July 29, 2022, we announced the completion of private placement of common stock in which we received gross proceeds of $15.9 million before deducting fees and expenses (for net proceeds of $14.3 million). We also granted the placement agent 115,481 preferred investment options to purchase common stock. As part of the UoE license agreement, we paid UoE $0.4 million associated with this fund raising in 2023.

Previous wording

We will pay UoE 2.5% of the gross amount of each of our future orderly capital raising transactions up to a cumulative total of $3.0 million, including the $0.8 million related to the IPO and subsequent private placement.

Current wording

As part of the NXP900 license agreement, we will pay UoE 2.5% of the gross amount of each of our future orderly capital raising transactions up to a cumulative total of $3.0 million, including the $0.8 million related to the IPO and the July 2022 private placement, which have already been paid.

Previous wording

We believe that the proceeds from our IPO, private placement and shelf registration 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

Current wording

We believe that the proceeds from our IPO, private placement and shelf registration 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.

Previous wording

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.

Current wording

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

Previous wording

Pursuant to the NXP800 License Agreement, we are required to make payments to the ICR for certain development and regulatory milestones. As of December 31, 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 based on net sales. Additionally, we will provide the ICR with up to an additional $0.9 million in research and development support. During the year ended

Current wording

Pursuant to the NXP800 License Agreement, we are required to make payments to the ICR for certain development and regulatory milestones. As of December 31, 2024, 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 based on net sales. Additionally, we will provide the ICR with up to an additional $0.9 million in research and development support. During the year ended December 31, 2023, we paid the ICR $0.4 million in additional research and development support payments. As of December 31, 2023, we recorded a liability of $0.2 million associated with additional research and development support payments.

Previous wording

Pursuant to the NXP900 License Agreement, we are required to make payments to the UoE for certain development and regulatory milestones. As of December 31, 2023, we were obligated to make up to $45.5 million in milestone payments to the UoE related to pre-approval milestones, up to $279.5 million in regulatory and commercial sales milestones, mid-single digit to 8% royalties on a tiered basis based on net sales and 2.5% of the gross amount of each of our fund raisings up to a cumulative total of $3.0 million. Additionally, we will provide UoE with up to an additional £580,000 in research and development support. During the year ended December 31, 2023, we paid the UoE $1.0 million in milestone payments and $0.4 million in additional fundraising payments.

Current wording

Pursuant to the NXP900 License Agreement, we are required to make payments to the UoE for certain development and regulatory milestones. As of December 31, 2024, we were obligated to make up to $45.5 million in milestone payments to the UoE related to pre-approval milestones, up to $279.5 million in regulatory and commercial sales milestones, mid-single digit to 8% royalties on a tiered basis based on net sales and 2.5% of the gross amount of each of our fund raisings up to a cumulative total of $3.0 million, of which $0.8 million has already been paid through December 31, 2024. Additionally, we will provide UoE with up to an additional £580,000 in research and development support. Through December 31, 2024, we paid the UoE $1.0 million in milestone payments.

Previous wording

based compensation, using the Black-Scholes option-pricing model, and we use the accelerated method based on the multiple-option award approach for expense attribution. The fair-value-based measurements of options granted to non-employees are remeasured at each period end until the options vest and are amortized to expense as earned. The valuation model used for calculating the estimated fair value of stock awards is the Black-Scholes option-pricing model. The Black-Scholes model requires us to make assumptions and judgments about the variables used in the calculations, including the expected term (weighted-average period of time that the options granted are expected to be outstanding), the expected volatility of our common stock, the related risk-free interest rate and the expected dividend. We have elected to recognize forfeitures of stock-based awards as they occur.

Current wording

Stock-based compensation is measured using estimated grant date fair value and recognized as compensation expense over the service period in which the awards are expected to vest. We estimate the grant date fair value, and the resulting stock-based compensation, using the Black-Scholes option-pricing model, and we use the accelerated method based on the multiple-option award approach for expense attribution. The fair-value-based measurements of options granted to non-employees are remeasured at each period end until the options vest and are amortized to expense as earned. The valuation model used for calculating the estimated fair value of stock awards is the Black-Scholes option-pricing model. The Black-Scholes model requires us to make assumptions and judgments about the variables used in the calculations, including the expected term (weighted-average period of time that the options granted are expected to be outstanding), the expected volatility of our common stock, the related risk-free interest rate and the expected dividend. We have elected to recognize forfeitures of stock-based awards as they occur.

Previous wording

As of December 31, 2023, we had net operating loss (“NOL”) carryforwards for income tax purposes of approximately $45.0 million and all of the NOL does not expire but they are limited to 80% of the company’s taxable income in any given tax year.

Current wording

As of December 31, 2024, we had net operating loss (“NOL”) carryforwards for income tax purposes of approximately $45.0 million and all of the NOL does not expire but are limited to 80% of the company’s taxable income in any given tax year.

Previous wording

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to not “opt out” of this provision and, as a

Current wording

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to not “opt out” of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.

Previous wording

We are also a “smaller reporting company” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of our initial public offering is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We will continue to be a smaller reporting company for as long as either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Current wording

We are also a “smaller reporting company” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of our IPO is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We will continue to be a smaller reporting company for as long as either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.