NextCure Inc

Previous wording

*Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; our limited operating history and not having any products approved for commercial sale; our history of significant losses; our need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on our technologies; risks related to our restructuring and reduction in force; and our dependence on key personnel. More detailed information on these and additional factors that could affect our actual results are described under the heading “Risk Factors” in our 2023 Annual Report and in our other filings with the Securities and Exchange Commission (the “SEC”). You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this report, and we assume no obligation to update any forward-looking statements, even if expectations change.

Current wording

*Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: the potential that positive results in preclinical studies may not be predictive of the results of clinical trials; our limited operating history and lack of any products approved for commercial sale; our history of significant losses; our need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on our technologies; risks related to our restructuring and reduction in force; and our dependence on key personnel. More detailed information on these and additional factors that could affect our actual results are described under the heading “Risk Factors” in our 2023 Annual Report and in our other filings with the Securities and Exchange Commission (the “SEC”). You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this report, and we assume no obligation to update any forward-looking statements, even if expectations change.

Previous wording

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 improved safety and efficacy. LNCB74 is being advanced under a November 2022 Research Collaboration and Co-Development Agreement (“LigaChem Agreement”) with LigaChem Biosciences, Inc’s “(LigaChem”). To date, we have i) completed pre-clinical experimentsin vitro andin vivo demonstrating potent tumor killing, ii) completed pilot toxicology studies, iii) received pre-IND feedback from the U.S. Food and Drug Administration (the “FDA”), iv) completed GLP toxicology studies, and v) conducted ongoing activities associated with GMP manufacturing, and clinical development planning. We plan to file an Investigational New Drug application (IND) in the fourth quarter of this year.

Current wording

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 improved safety and efficacy compared to other ADCs targeting B7-H4. LNCB74 is being advanced under a November 2022 Research Collaboration and Co-Development Agreement (“LigaChem Agreement”) with LigaChem Biosciences, Inc. “(LigaChem”). Preclilnical studies demonstrated potent tumor killing in disease models and a favorable safety profile. We plan to file an IND application by year-end and advance into Phase 1, subject to and shortly after our receipt of an FDA safe-to-proceed letter.

Previous 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. We expect these actions to extend our cash runway into the second half of 2026. 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.

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 $75.3 million as of September 30, 2024.

Previous wording

Since commencing operations in 2015, we have devoted substantially all our efforts and financial resources to discovery, research and development activities for the Company’s product candidates, identifying business development

Current wording

Since commencing operations in 2015, we have devoted substantially all our efforts and financial resources to discovery, research, and development activities for the Company’s product candidates, identifying business development opportunities, raising capital, securing intellectual property rights related to the Company’s product candidates and organizing and staffing the Company.

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 March 31, 2024, we raised approximately $423 million in gross proceeds from the sale of equity instruments and previously received a $25 million upfront payment from our former collaboration partner. Our net loss for the three months ended June 30, 2024 and 2023 was $15.4 million and $17.9 million, respectively. Our net loss for the six months ended June 30, 2024 and 2023 was $32.5 million and $34.0 million, respectively. As of June 30, 2024, we had an accumulated deficit of $357.0 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 and commercialize a product candidate, and we cannot assure you 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 September 30, 2024, we raised approximately $423 million in gross proceeds from the sale of equity instruments and previously received a $25 million upfront payment from our former collaboration partner. Our net loss for the three months ended September 30, 2024 and 2023 was $11.5 million and $14.3 million, respectively. Our net loss for the nine months ended September 30, 2024 and 2023 was $44.1 million and $48.3 million, respectively. As of September 30, 2024, we had an accumulated deficit of $368.5 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 and commercialize a product candidate, and we cannot assure you that we will ever generate significant revenue or profits.

Previous wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $86.4 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 use our available capital resources sooner than we currently expect.

Current wording

As of September 30, 2024, we had cash, cash equivalents and marketable securities of $75.3 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 use 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 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.

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 ramping up clinical development activities with respect to LNCB74, concluding our Phase 1b/2 clinical trial of NC410 in combination with pembrolizumab, and other research and development activities.

Previous wording

Research and development expenses consist primarily of costs incurred for our clinical trials, discovery efforts, research activities, and development and testing of our product candidates:

Current wording

Research and development expenses consist primarily of costs incurred for our clinical trials, research activities, and development and testing of our product candidates:

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

Restructuring and asset impairment charges consist of severance charges associated with a reduction in force, and include salary continuation, payroll taxes and company funded benefits. Asset impairment charges reflect the write-down of long-lived assets that are considered impaired under ASC 360.

Current wording

Restructuring charges consist of severance charges associated with a reduction in force, and include salary continuation, payroll taxes and company funded benefits. Asset impairment charges reflect the write-down of long-lived assets that are considered impaired under ASC 360.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

We do not allocate personnel-related costs, including stock-based compensation costs, or other indirect costs to specific programs, as they are deployed across multiple projects under development and discovery and, as such, are separately classified as internal research and development expenses in the table above.

Current wording

We do not allocate personnel-related costs, including stock-based compensation costs, or other indirect costs to specific programs, as they are deployed across multiple projects under development and discovery and, as such, are separately classified as internal research and development expenses in the table above. The majority of other program expenses in the table above represent clinical programs that we seek to partner.

Previous wording

Research and development expenses for the three months ended June 30, 2024 decreased by $1.0 million compared to the three months ended June 30, 2023, ascosts for the LNCB74 program were offset by lower costs on other programs and preclinical development and lower internal costs, primarily due to lower personnel-related costs and depreciation.

Current wording

Research and development expenses for the three months ended September 30, 2024 decreased by $2.2 million compared to the three months ended September 30, 2023, due to lower costs on other programs and preclinical development and lower internal costs, primarily lower personnel-related costs and depreciation.

Previous wording

Research and development expenses for the six months ended June 30, 2024 decreased by $1.3 million compared to the six months ended June 30, 2023, as higher costs associated with adding patients in our Phase 1b clinical trial of NC410 in patients with ovarian cancer and colorectal cancer and net costs for the LNCB74 program were offset by lower costs on other programs and preclinical development and lower internal costs, primarily due to lower personnel-related costs.

Current wording

Research and development expenses for the nine months ended September 30, 2024 decreased by $3.5 million compared to the nine months ended September 30, 2023, asnet 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.

Previous wording

General and administrative expenses for the three months ended June 30, 2024 decreased by $1.6 million compared to the three months ended June 30, 2023. The decrease was primarily due to lower payroll, lower stock compensation expense, lower professional fees and lower insurance costs.

Current wording

General and administrative expenses for the three months ended September 30, 2024 decreased by $0.9 million compared to the three months ended September 30, 2023. The decrease was primarily due to lower payroll, lower stock compensation expense, and lower insurance costs.

Previous wording

General and administrative expenses for the six months ended June 30, 2024 decreased by $2.7 million compared to the six months ended June 30, 2023. The decrease was primarily due to the same factors stated above.

Current wording

General and administrative expenses for the nine months ended September 30, 2024 decreased by $3.6 million compared to the nine months ended September 30, 2023. The decrease was primarily due to lower payroll, lower stock compensation expense, and lower insurance costs.

Previous wording

Restructuring and asset impairment charges were $2.5 million for the six months ended June 30, 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 three and six months ended June 30, 2023.

Current wording

Restructuring and asset impairment charges were $2.5 million for the nine months ended September 30, 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 three and nine months ended September 30, 2023.

Previous wording

Other income, net for the three months ended June 30, 2024 decreased by $0.2 million compared to the three months ended June 30, 2023, due to lower interest income as a result of lower cash available to invest.

Current wording

Other income, net for the three months ended September 30, 2024 decreased by $0.4 million compared to the three months ended September 30, 2023, due to lower interest income as a result of lower cash available to invest.

Previous wording

We have financed our operations primarily with proceeds from public offerings of our common stock, private placements of our preferred stock and upfront fees received under the Company’s former agreement with Eli Lilly and Company, which was terminated in March 2020 (the “Lilly Agreement”). On May 13, 2019, we closed our IPO, in which we sold 5,750,000 shares of common stock at a public offering price of $15.00 per share, for net offering proceeds to us of approximately $77.0 million after deducting underwriting discounts and commissions and offering expenses. On November 19, 2019, we completed an underwritten public offering in which we sold 4,077,192 shares of common stock at a public offering price of $36.75 per share. On December 2, 2019, the underwriters exercised in full their option to purchase an additional 611,578 shares of common stock at a public offering price of $36.75. Net offering proceeds to us were approximately $160.9 million after deducting underwriting discounts and commissions and offering expenses. Since inception, we have received aggregate gross proceeds of $164.4 million from the sale and issuance of shares of our preferred stock. In addition, in November 2018, we received an upfront payment of $25.0 million in cash from Lilly pursuant to the Lilly Agreement. Our cash and cash equivalents are held in money market funds.

Current wording

We have financed our operations primarily with proceeds from public offerings of our common stock, private placements of our preferred stock and upfront fees received under the Company’s former agreement with Eli Lilly and Company, which was terminated in March 2020 (the “Lilly Agreement”). On May 13, 2019, we closed our IPO, in which we sold 5,750,000 shares of common stock at a public offering price of $15.00 per share, for net offering proceeds to us of approximately $77.0 million after deducting underwriting discounts and commissions and offering expenses. On November 19, 2019, we completed an underwritten public offering in which we sold 4,077,192 shares of common stock at a public offering price of $36.75 per share. On December 2, 2019, the underwriters exercised in full their option to purchase an additional 611,578 shares of common stock at a public offering price of $36.75. Net offering proceeds to us were approximately $160.9 million after deducting underwriting discounts and commissions and offering expenses. Since inception, we have received aggregate gross proceeds of $164.4 million from the sale and issuance of shares of our

Previous wording

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 us from time to time, including, among other things, market conditions, the trading price of the common stock, capital needs and determinations by us of the appropriate sources of funding for the Company. In the three months ended June 30, 2024, we sold 17,151 shares of common stock for net proceeds of approximately $39,000.

Current wording

On August 4, 2023, we entered into a sales agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Agent”), pursuant to which we may sell, from time to time, up to an aggregate sales price of $75 million of our 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 us from time to time, including, among other things, market conditions, the trading price of the common stock, capital needs and determinations by us of the appropriate sources of funding for the Company. In the nine months ended September 30, 2024, we sold 17,151 shares of common stock for net proceeds of approximately $39,000.

Previous wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $86.4 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 September 30, 2024, we had cash, cash equivalents and marketable securities of $75.3 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.

Previous wording

Net cash used in operating activities was $22.4 million for the six months ended June 30, 2024, which was primarily the result of our net loss of $32.5 million, partially offset by non-cash charges for depreciation of $1.5 million, stock-based compensation of $3.3 million and impairment charges of $1.8 million, and $3.9 million provided by net changes in operating assets and liabilities. Net cash used in operating activities was $29.5 million for the six months ended June 30, 2023, which was primarily the result of our net loss of $34.0 million and a $1.9 million net use of operating assets and liabilities, partially offset by non-cash charges for depreciation and amortization of $1.9 million and stock-based compensation of $4.2 million.

Current wording

Net cash used in operating activities was $33.8 million for the nine months ended September 30, 2024, which was primarily the result of our net loss of $44.1 million, partially offset by non-cash charges for depreciation of $2.2 million, stock-based compensation of $4.8 million and impairment charges of $1.8 million, and $1.9 million provided by net changes in operating assets and liabilities. Net cash used in operating activities was $42.3 million for the nine months ended September 30, 2023, which was primarily the result of our net loss of $48.3 million and a $3.1 million net use of operating assets and liabilities, partially offset by non-cash charges for depreciation and amortization of $2.9 million and stock-based compensation of $6.2 million.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2024 was $30.0 million, which was primarily due to net proceeds from sales and maturities of marketable securities of $30.4 million. Net cash provided by investing activities for the six months ended June 30, 2023 was $24.8 million, which was primarily due to net proceeds from sales and maturities of marketable securities of $25.4 million, partially offset by purchases of property and equipment of $0.5 million.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2024 was $48.3 million, which was primarily due to net proceeds from sales and maturities of marketable securities of $48.9 million. Net cash provided by investing activities for the nine months ended September 30, 2023 was $35.1 million, which was primarily due to net proceeds from sales and maturities of marketable securities of $35.9 million, partially offset by purchases of property and equipment of $0.8 million.

Previous wording

Net cash provided by financing activities was $0.1 million for the six months ended June 30, 2024 representing the exercise of stock options, sales of stock under the ESPP and the sale of 17,151 shares of common stock under the Sales Agreement. Net cash provided by financing activities was $0.1 million for the six months ended June 30, 2023 representing sales of our stock under the ESPP and the exercise of stock options.

Current wording

Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2024 representing the exercise of stock options, sales of stock under the ESPP and the sale of 17,151 shares of common stock under the Sales Agreement. Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2023 representing sales of our stock under the ESPP and the exercise of stock options.

Previous wording

There have been no material changes to our contractual obligations during the six months ended June 30, 2024, as compared to those disclosed in our 2023 Annual Report.

Current wording

There have been no material changes to our contractual obligations during the nine months ended September 30, 2024, as compared to those disclosed in our 2023 Annual Report.

Previous wording

During the six months ended June 30, 2024, there were no material changes to our critical accounting policies reported in our 2023 Annual Report.

Current wording

During the nine months ended September 30, 2024, there were no material changes to our critical accounting policies reported in our 2023 Annual Report.

Previous wording

As an emerging growth company, or “EGC”, under the Jumpstart Our Business Startups Act of 2012, or the “JOBS Act”, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. We have elected to take advantage of the extended transition period for adopting new or revised accounting standards that have different effective dates for public and private companies until such time as those standards apply to private companies.

Current wording

As an emerging growth company, or “EGC”, under the Jumpstart Our Business Startups Act of 2012, or the “JOBS Act”, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. We have elected to take advantage of the extended transition period for adopting new or revised accounting standards that have different effective dates for public and private companies until such time as those standards apply to private companies. The Company will cease to be an EGC effective December 31, 2024, meaning it will have to comply with all applicable SEC requirements for non-EGC’s starting with its next Form 10-K filing.