NextCure Inc
For the period ended Dec 31, 2024. Filed Mar 6, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 6, 2025
NXTC$5.33+4.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-21.
0001558370-24-003672
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-06.
0001558370-25-002402
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 71 previous paragraphs and 72 current paragraphs.
45 unchanged; 17 reworded; 9 added; 7 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 23 previous and 24 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Our product candidate LNCB74 is designed as a state-of-the-art B7-H4 targeted ADC to kill tumors. An ADC consists of a monoclonal antibody conjugated to a cytotoxic drug via a chemical linker. B7-H4, a clinically validated target, is a cell surface protein expressed on multiple tumor types including breast, ovarian and endometrial cancers, that we believe represents a large market opportunity. LNCB74 will be positioned as a promising B7-H4 ADC with both potential improved safety and efficacy compared to other ADCs targeting B7-H4. Preclinical studies demonstrated potent tumor killing in disease models and a favorable safety profile. LNCB74 is being advanced under a November 2022
Current report
Research Collaboration and Co-Development Agreement (the “LigaChem Agreement”) with LigaChem Biosciences, Inc. (formerly known as LegoChem Biosciences, Inc., or hereinafter “LigaChem”).
Current report
In December 2024, we announced that the U.S. Food and Drug Administration (the “FDA”) accepted an Investigational New Drug (“IND”) application for initiation of a Phase 1 clinical trial to evaluate LNCB74 for treating multiple cancers known to have high B&-H4 expression. We announced in January 2025 that the first patient in our Phase 1 trial of LNCB74 had been dosed, and we are currently within cohort 2 of the dose escalation portion of the Phase 1 trial, enrolling patients with various tumor types, including breast, ovarian, and endometrial cancers. We plan to initiate backfill cohorts in the second half of 2025.
Current report
In addition, we are seeking to partner our other clinical programs NC410 and NC525 and pursue a partner or third-party financing to advance our preclinical non-oncology programs NC605 and NC181.
Current report
Research and development expenses for the year ended December 31, 2024 decreased by $6.4 million, or 13%, to $41.5 million compared to $47.9 million for the year ended December 31, 2023 as increased net costs for the LNCB74 program were offset by lower costs on other programs and preclinical development and lower internal costs, primarily lower personnel-related costs and depreciation.
Current report
General and Administrative Expenses
Current report
Restructuring and Asset Impairment Charges
Current report
Restructuring and asset impairment charges were $2.5 million for year ended December 31, 2024, consisting of $0.7 million of severance charges as a result of a reduction in force announced on March 21, 2024 and $1.8 million of asset impairment charges associated with the write-down of certain manufacturing equipment, right of use assets and related improvements as a result of the pause in manufacturing that we announced on March 21, 2024. There were no restructuring and asset impairment charges for the year ended December 31, 2023.
Current report
Effective December 31, 2024, we are no longer an “emerging growth company,” meaning we can no longer rely on certain exemptions from various public company reporting requirements, including having an extended transition period to comply with new or revised accounting standards applicable to public companies. We maintained our status as a smaller reporting company; thus, our independent registered public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial reporting.
Removed paragraphs (7)
Previous report
We are focusing on our highest-value opportunities:
Previous report
i)NC410, a LAIR-2 fusion protein that, in combination with pembrolizumab, demonstrated early evidence of clinical activity in colorectal (CRC) and ovarian cancers. We expect several potential catalysts in 2024.
Previous report
ii)LNCB74, an ADC that is directed to B7-H4, a clinically validated cancer target. Given our internal expertise of B7-H4 coupled with LegoChem Biosciences, Inc.’s (LegoChem) ADC technology, we plan for an Investigational New Drug application (IND) in 2024.
Previous report
Research and development expenses for the year ended December 31, 2023 decreased by $6.3 million, 12%, to $47.9 million compared to $54.2 million for the year ending December 31, 2022. The decrease was due to the decision to discontinue clinical development of NC762, which was announced in the fourth quarter of 2023 and lower costs on other programs and preclinical development.
Previous report
The Jumpstart Our Business Startups Act of 2012, or “the JOBS Act”, 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. We have elected to take advantage of this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
Previous report
For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over
Previous report
financial reporting audited by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002. We will remain an emerging growth company until the earliest of (i) December 31, 2024, (ii) the last day of the first fiscal year in which we have total annual gross revenues of at least $1.2 billion, (iii) the last day of the first fiscal year in which the market value of our common stock that is held by non-affiliates exceeds $700.0 million on June 30 th and (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
Reworded paragraphs (17)
Previous wording
We are a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including Antibody Drug Conjugates (ADCs), antibodies, and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response.
Current wording
We are a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or that have disease progression on, current therapies, through the use of differentiated mechanisms of actions, including antibody-drug conjugates (“ADCs”), antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response.
Previous wording
In March 2024, we announced a prioritization and restructuring of our operations to align with our focused pipeline. We are pausing our internal manufacturing operations and reducing our workforce. In addition, we are seeking to partner our clinical programs NC525 and NC318 and our preclinical non-oncology programs NC605, for chronic bone diseases, and NC181, for Alzheimer’s disease. We project these actions will extend our cash runway into the second half of 2026.
Current wording
In March 2024, we announced a prioritization and restructuring of our operations to align with our focused pipeline. We paused our internal manufacturing operations and reduced our workforce. In part because of these actions, we expect to fund our operations into the second half of 2026 with our existing cash position of approximately $68.6 million as of December 31, 2024.
Previous wording
To date, we have not generated any revenue from product sales and have financed our operations primarily through proceeds from public offerings of our common stock, with private placements of our preferred stock and with upfront fees received under our former research and development collaboration agreement. Since inception through December 31, 2023, we raised approximately $423 million in gross proceeds from the sale of equity instruments and had received a $25 million upfront payment from our former collaboration partner. We have never been profitable and have incurred net losses since the commencement of our operations. Our net losses for the years ended December 31, 2023 and 2022 were $62.7 million and $74.7 million, respectively. As of December 31, 2023, we had an accumulated deficit of $324.5 million, primarily as a result of research and development and general and administrative expenses. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a product candidate, and we cannot make assurances that we will ever generate significant revenue or profits.
Current wording
To date, we have not generated any revenue from product sales and have financed our operations primarily through proceeds from public offerings of our common stock, with private placements of our preferred stock and with upfront fees received under our former research and development collaboration agreement. Since inception through December 31, 2024, we raised approximately $423 million in gross proceeds from the sale of equity instruments and had received a $25 million upfront payment from our former collaboration partner. We have never been profitable and have incurred net losses since the commencement of our operations. Our net losses for the years ended December 31, 2024 and 2023 were $55.7 million and $62.7 million, respectively. As of December 31, 2024, we had an accumulated deficit of $380.1 million, primarily as a result of research and development and general and administrative expenses. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a product candidate, and we cannot make assurances that we will ever generate significant revenue or profits.
Previous wording
As of December 31, 2023, we had cash, cash equivalents and marketable securities of $108.3 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into the second half of 2026. We have based this estimate on assumptions that may prove to be incorrect, and we could exhaust our available capital resources sooner than we currently expect.
Current wording
As of December 31, 2024, we had cash, cash equivalents and marketable securities of $68.6 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into the second half of 2026. We have based this estimate on assumptions that may prove to be incorrect, and we could exhaust our available capital resources sooner than we currently expect.
Previous wording
We expect to incur substantial expenditures in the foreseeable future as we advance our product candidates through clinical development, the regulatory approval process and, if approved, commercialization. Specifically, in the
Current wording
We expect to incur substantial expenditures in the foreseeable future as we advance LNCB74 through clinical development, the regulatory approval process and, if approved, commercialization. Specifically, in the near term, we expect to incur expenses relating to clinical development activities with respect to LNCB74, and other research and development activities.
Previous wording
We cannot determine with certainty the duration and costs of future clinical trials of NC410, LNCB74 or any other product candidate we may develop or if, when or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we may obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of clinical trials and development of NC410, LNCB74 and any other product candidate we may develop will depend on a variety of factors, including:
Current wording
We cannot determine with certainty the duration and costs of future clinical trials of LNCB74 or any other product candidate we may develop or if, when or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we may obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of clinical trials and development of LNCB74 and any other product candidate we may develop will depend on a variety of factors, including:
Previous wording
General and administrative expenses for the year ended December 31, 2023 decreased by $2.0 million to $19.7 million as compared to $21.7 million for the year ending December 31, 2022. The decrease was driven primarily by $1.4 million lower personnel-related costs, including $1.2 million of stock compensation, and $0.4 million lower insurance costs.
Current wording
General and administrative expenses for the year ended December 31, 2024 decreased by $4.0 million to $15.7 million as compared to $19.7 million for the year ended December 31, 2023. The decrease was driven primarily by $2.5 million lower personnel-related costs, including $1.7 million of stock compensation, and $0.7 million lower insurance costs.
Previous wording
Other income, net for the year ended December 31, 2023 increased by $3.7 million to $4.9 million from $1.2 million for the year ended December 31, 2022 due to higher interest income as a result of higher interest rates.
Current wording
Other income, net for the year ended December 31, 2024 decreased by $0.8 million to $4.1 million from $4.9 million for the year ended December 31, 2023 due to lower interest income as a result of lower investable cash.
Previous wording
On August 4, 2023, the Company entered into a sales agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Agent”), pursuant to which the Company may sell, from time to time, up to an aggregate sales price of $75 million of its common stock through the Agent in negotiated transactions that are deemed to be an “at the market offering.” The Agent will be entitled to compensation equal to 3.0% of the gross proceeds from the sale of all shares of common stock sold through it as Agent under the Sales Agreement. Actual sales will depend on a variety of factors to be determined by the Company from time to time, including, among other things, market conditions, the trading price of the common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. We have not yet sold any shares of our common stock pursuant to the Sales Agreement.
Current wording
On August 4, 2023, the Company entered into a sales agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Agent”), pursuant to which the Company may sell, from time to time, up to an aggregate sales price of $75 million of its common stock through the Agent in negotiated transactions that are deemed to be an “at the market offering.” The Agent will be entitled to compensation equal to 3.0% of the gross proceeds from the sale of all shares of common stock sold through it as Agent under the Sales Agreement. Actual sales will depend on a variety of factors to be determined by the Company from time to time, including, among other things, market conditions, the trading price of the common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. In the year ended December 31, 2024, we sold 17,151 shares of common stock for net proceeds of approximately $39,000.
Previous wording
As of December 31, 2023, we had cash, cash equivalents and marketable securities of $108.3 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into the second half of 2026.
Current wording
As of December 31, 2024, we had cash, cash equivalents and marketable securities of $68.6 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into the second half of 2026.
Previous wording
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We may seek to raise capital through sale of equity, debt financings, strategic alliances and licensing arrangements. Adequate additional funding may not be available to us on acceptable terms or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue
Current wording
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We may seek to raise capital through sale of equity, debt financings, strategic alliances and licensing arrangements. Adequate additional funding may not be available to us on acceptable terms or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development of our product candidates. Our need to raise additional capital will depend on many factors, including:
Previous wording
Net cash used in operating activities was $53.0 million for the year ended December 31, 2023, which was primarily the result of our net loss of $62.7 million and a $1.9 million net use of operating assets and liabilities, partially offset by non-cash charges for depreciation and amortization of $3.7 million and stock-based compensation of $8.2 million. Net cash used in operating activities was $53.9 million for the year ended December 31, 2022, which was primarily due to our net loss of $74.7 million, partially offset by non-cash charges for depreciation and amortization of $4.1 million, amortization of premiums and discounts on marketable securities of $3.0 million, stock-based compensation of $9.5 million, a $2.0 million decrease in prepaid expenses and other assets and a $2.3 million increase in accounts payable.
Current wording
Net cash used in operating activities was $40.8 million for the year ended December 31, 2024, which was primarily the result of our net loss of $55.7 million, partially offset by non-cash charges for depreciation and amortization of $2.9 million, stock-based compensation of $6.3 million and impairment charges of $1.8 million, and $4.5 million provided by net changes in operating assets and liabilities. Net cash used in operating activities was $53.0 million for the year ended December 31, 2023, which was primarily the result of our net loss of $62.7 million and a $1.9 million net use of operating assets and liabilities, partially offset by non-cash charges for depreciation and amortization of $3.7 million and stock-based compensation of $8.2 million.
Previous wording
Cash provided by investing activities for the year ended December 31, 2023 was $39.3 million, which was primarily due to net proceeds from marketable securities of $40.1 million, partially offset by purchases of property and equipment of $0.8 million. Cash provided by investing activities for the year ended December 31, 2022 was $68.0 million, which was primarily due to net proceeds from marketable securities of $70.1 million, partially offset by purchases of property and equipment of $2.1 million.
Current wording
Cash provided by investing activities for the year ended December 31, 2024 was $55.3 million, which was primarily due to net proceeds from marketable securities of $55.8 million, partially offset by purchases of property and equipment of $0.5 million. Cash provided by investing activities for the year ended December 31, 2023 was $39.3 million, which was primarily due to net proceeds from marketable securities of $40.1 million, partially offset by purchases of property and equipment of $0.8 million.
Previous wording
Cash provided by financing activities was $0.2 million for the year ended December 31, 2023, which was due to the exercise of stock options and sales of our stock under the Employee Stock Purchase Plan (ESPP). Cash provided by financing activities was $0.2 million for the year ended December 31, 2022, which was due to the exercise of stock options and sales of our stock under the ESPP.
Current wording
Cash provided by financing activities was $0.1 million for the year ended December 31, 2024, representing the exercise of stock options, sales of stock under the Employee Stock Purchase Plan (ESPP) and the sale of 17,151 shares of common stock under the Sales Agreement. Cash provided by financing activities was $0.2 million for the year ended December 31, 2023, which was due to the exercise of stock options and sales of our stock under the ESPP.
Previous wording
We are party to several non-cancelable lease agreements for office and laboratory space that expire in March 2030. The monthly base rent for these leases totals $92,004 as of December 31, 2023 per month plus our prorated share of operating expenses. The monthly base rent is subject to annual 3% increases through the lease term.
Current wording
We are party to several non-cancelable lease agreements for office and laboratory space that expire in March 2030. The monthly base rent for these leases totals $94,760 as of December 31, 2024 per month plus our prorated share of operating expenses. The monthly base rent is subject to annual 3% increases through the lease term.
Previous wording
Research costs consist of employee-related costs, contractor expenses, laboratory supplies and facility costs, for research and development of product candidates which are expensed as incurred. Development costs, including clinical trial-related expenses, incurred by third parties, such as CROs, are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone results are probable of being achieved. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies, including the phase or completion of events, invoices received and contracted costs. For further discussion of research and development expenses, including clinical trial accruals, see Note 2 to our audited financial statements included elsewhere in this Annual Report.
Current wording
Research costs consist of employee-related costs, contractor expenses, laboratory supplies and facility costs, for research and development of product candidates which are expensed as incurred. Development costs, including clinical trial-related expenses, incurred by third parties, such as CROs, are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development arrangements, the milestone payment obligations are expensed when the milestone results are probable of being achieved. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies, including the phase or completion of events,
Previous wording
We account for stock-based compensation, including stock options and restricted stock units, based on the fair value of the award as of the grant date. We utilize the Black-Scholes option-pricing model as the method for estimating the fair value of our stock option grants. The Black-Scholes option-pricing model requires the use of highly subjective and complex assumptions, including the options’ expected term and the price volatility of the underlying stock. The fair value of the portion of the award that is ultimately expected to vest is recognized as compensation expense over the award’s requisite service period. We recognize stock-based compensation to expense using the straight-line method and recognize forfeitures as they occur. If there are any modifications or cancelations of stock-based awards, we may be required to accelerate, increase, or decrease any remaining unrecognized stock-based compensation expense.
Current wording
We account for stock-based compensation, including stock options and restricted stock units, based on the fair value of the award as of the grant date. We utilize the Black-Scholes option-pricing model as the method for estimating the fair value of our stock option grants. The Black-Scholes option-pricing model requires the use of objective and subjective assumptions, including the options’ expected term and the price volatility of the underlying stock. The fair value of the portion of the award that is ultimately expected to vest is recognized as compensation expense over the award’s requisite service period. We recognize stock-based compensation to expense using the straight-line method and recognize forfeitures as they occur. If there are any modifications or cancelations of stock-based awards, we may be required to accelerate, increase, or decrease any remaining unrecognized stock-based compensation expense.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
invoices received and contracted costs. For further discussion of research and development expenses, including clinical trial accruals, see Note 2 to our audited financial statements included elsewhere in this Annual Report.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
near term, we expect to incur substantial expenses relating to our Phase 1b/2 clinical trial of NC410 in combination with pembrolizumab, our pre-clinical development activities with respect to LNCB74 and other research and development activities.
Previous report — wording carried elsewhere
the development of our product candidates or delay our efforts to expand our pipeline of product candidates. Our need to raise additional capital will depend on many factors, including: