11 unchanged sentences
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.
−Removed: Our focus in 2023 was on progressing the pipeline and executing financing activities to fund pipeline development.
+Added: 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.
4 unchanged sentences
Our main activities through December 31, 2024 have been organizational and capital raising activities and the completion of the in-license agreements for our two drug candidates, NXP800 and NXP900, regulatory filings with the MHRA and FDA, preparation and execution for the Phase 1a and Phase 1b clinical trial for NXP800, which commenced in December 2021 and May 2023, respectively, and Phase 1a clinical trial for NXP900, which commenced in September 2023.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The current period
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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
+Added: 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.
7 unchanged sentences
In September 2021, we paid the upfront payment in connection with this license agreement, also in the amount of $3.5 million.
−Removed: 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.
+Added: 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.
1 unchanged sentence
No overallotment shares were purchased by the underwriter and no Over-Allotment Options were granted to the underwriter.
−Removed: As part of the UoE license agreement, we paid UoE $0.4 million associated with this fund raising.
+Added: As part of the UoE license agreement, we paid UoE $0.4 million associated with this fund raising in 2022.
The IPO closed on February 8, 2022, with gross proceeds of $16.0 million, before deducting underwriting discounts and expenses (for net proceeds of $13.6 million).
1 unchanged sentence
We also granted the placement agent 115,481 preferred investment options to purchase common stock.
−Removed: As part of the UoE license agreement, we owe UoE $0.4 million associated with this fund raising.
+Added: As part of the UoE license agreement, we paid UoE $0.4 million associated with this fund raising in 2023.
During the year ended December 31, 2023, we sold a total of 371,743 shares of common stock under the At-the-Market (“ATM”) offering program for aggregate total gross proceeds of approximately $5.3 million at an average selling price of $14.23 per share, resulting in net proceeds of approximately $5.1 million after deducting commissions and other transaction costs.
−Removed: 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.
+Added: During the year ended December 31, 2024, we sold a total of 1,504,270 shares of common stock under the ATM offering program for aggregate total gross proceeds of approximately $12.0 million at an average selling price of $8.00 per share, resulting in net proceeds of approximately $11.7 million after deducting commissions and other transaction costs.
+Added: On February 6, 2025, we announced the completion of the sale of 3,105,000 shares of common stock with aggregate gross proceeds of approximately $15.5 million at a sales price of $5.00 per share, resulting in approximate net proceeds of $13.9 million after deducting underwriter commissions and other transaction costs including $0.4 million payment due to the UoE related to a fundraising event in the NXP900 license agreement with UoE.
+Added: 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.
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.
−Removed: We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources
−Removed: sooner than we expect.
+Added: 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.
38 unchanged sentences
We have also entered into license and collaboration agreements with third parties, which are in the normal course of business.
−Removed: 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.
+Added: We have not included future payments under these agreements since obligations under these agreements are
+Added: 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.
1 unchanged sentence
Additionally, we will provide the ICR with up to an additional $0.9 million in research and development support.
−Removed: During the year ended
−Removed: December 31, 2023, we paid the ICR and $0.4 million in additional research and development support payments.
+Added: 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.
Pursuant to the NXP900 License Agreement, we are required to make payments to the UoE for certain development and regulatory milestones.
−Removed: 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.
+Added: 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.
−Removed: 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.
+Added: Through December 31, 2024, we paid the UoE $1.0 million in milestone payments.
We do not currently have any long-term leases.
19 unchanged sentences
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.
−Removed: We estimate the grant date fair value, and the resulting stock-
−Removed: 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.
+Added: 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.
13 unchanged sentences
Due to our lack of earnings history and uncertainties surrounding our ability to generate future taxable income, the net deferred tax assets have been fully offset by a valuation allowance.
−Removed: 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.
+Added: 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.
Utilization of the NOL and other credit carryforwards may be subject to an annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended and similar state provisions.
2 unchanged sentences
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.
−Removed: We have elected to not “opt out” of this provision and, as a
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
7 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.