NextCure Inc

Previous wording

Our product candidate NC410 is a fusion protein of LAIR-2, a naturally occurring soluble version of, and decoy protein for, LAIR-1 that is designed to block immune suppression mediated by LAIR-1. Early preclinical correlative biomarker work suggests that NC410 has the potential to overcome tumor resistance by remodeling the tumor’s extracellular matrix to remove a physical barrier surrounding the tumor to enhance T cell tumor killing. We have exclusive worldwide rights to NC410. We are currently conducting a Phase 1b/2 clinical trial to evaluate NC410 in combination with KEYTRUDA® (pembrolizumab), Merck & Co., Inc.’s (Merck) anti-PD-1 therapeutic. Based on clinical responses and biomarker observations, we are focused on ovarian cancer and colorectal cancer (CRC) patients who are immune checkpoint inhibitor (ICI) naïve. In January 2024, we completed enrollment of an additional 20 CRC patients in the 100 mg cohort and in March 2024 we commenced enrolling an additional 18 ovarian patients among the 100 mg and 200 mg cohorts. We expect to present CRC data at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024 and ovarian cancer data in the second half of this year.

Current wording

Our product candidate NC410 is a fusion protein of LAIR-2, a naturally occurring soluble version of, and decoy protein for, LAIR-1 that is designed to block immune suppression mediated by LAIR-1. Early preclinical correlative biomarker work suggests that NC410 has the potential to overcome tumor resistance by remodeling the tumor’s extracellular matrix to remove a physical barrier surrounding the tumor to enhance T cell tumor killing. We have exclusive worldwide rights to NC410. We are currently conducting a Phase 1b/2 clinical trial to evaluate NC410 in combination with KEYTRUDA® (pembrolizumab), Merck & Co., Inc.’s (Merck) anti-PD-1 therapeutic. Based on clinical responses and biomarker observations, we are focused on ovarian cancer and colorectal cancer (CRC) patients who are immune checkpoint inhibitor (ICI) naïve. In January 2024, we completed enrollment of an additional 20 CRC patients in the 100 mg cohort and in June 2024, we completed enrolling an additional 16 ovarian patients among the 100 mg and 200 mg cohorts. Also in June 2024, we presented initial clinical data from this study at the American Society of Clinical Oncology (ASCO) Annual Meeting. We expect to present the additional ovarian cancer patient data along with an update on the CRC data in the fourth quarter of this year.

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 completed i) pre-clinical experimentsin vitro andin vivo demonstrating potent tumor killing, ii) pilot toxicology studies, iii) received pre-IND feedback from the FDA, and iv) we are conducting ongoing activities associated with GLP toxicology studies, GMP manufacturing, and clinical development planning. We plan to file an Investigational New Drug application (IND) in the fourth quarter of 2024.

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. 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.

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 opportunities, raising capital, securing intellectual property rights related to the Company’s product candidates and organizing and staffing the Company.

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

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 March 31, 2024 and 2023, was $17.1 million and $16.1 million, respectively. As of March 31, 2024, we had an accumulated deficit of $341.6 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 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.

Previous wording

As of March 31, 2024, we had cash, cash equivalents and marketable securities of $96.0 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 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.

Previous wording

enrollment and related expenses at clinical investigator sites, contract services received, consulting agreement costs and efforts expended under contracts with research institutions and third-party contract research organizations that conduct and manage clinical trials on our behalf. We generally accrue estimated costs related to clinical trials based on contracted amounts applied to the level of patient enrollment and other activity according to the protocol. If future timelines or contracts are modified based on changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis. Historically, any such modifications have not been material.

Current wording

We expense research and development costs as incurred. Our expenses related to clinical trials are based on actual costs incurred and estimates of other incurred costs. These estimated costs are based on several factors, including patient enrollment and related expenses at clinical investigator sites, contract services received, consulting agreement costs and efforts expended under contracts with research institutions and third-party contract research organizations that conduct and manage clinical trials on our behalf. We generally accrue estimated costs related to clinical trials based on contracted amounts applied to the level of patient enrollment and other activity according to the protocol. If future timelines or contracts are modified based on changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis. Historically, any such modifications have not been material.

Previous wording

Comparison of the Three Months Ended March 31, 2024 and 2023

Current wording

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

Previous wording

Research and development expenses for the three months ended March 31, 2024 decreased by $0.2 million compared to the three months ended March 31, 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 internal costs, primarily due to reimbursement of costs subject to cost sharing under our collaboration with LigaChem and lower personnel-related costs.

Current 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.

Previous wording

General and administrative expenses for the three months ended March 31, 2024 decreased by $1.1 million compared to the three months ended March 31, 2023. The decrease was primarily due to lower payroll, lower stock compensation expense and lower insurance costs.

Current 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.

Previous wording

Restructuring and asset impairment charges were $2.5 million for the three months ended March 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 in the three months ended March 31, 2023.

Current 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.

Previous wording

Other income, net for the three months ended March 31, 2024 increased by $0.2 million compared to the three months ended March 31, 2023, due to higher interest income as a result of lower amortization on our investments.

Current 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.

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. As of March 31, 2024, no shares of our common stock had been sold pursuant to the Sales Agreement.

Current 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.

Previous wording

As of March 31, 2024, we had cash, cash equivalents and marketable securities of $96.0 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 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.

Previous wording

Net cash used in operating activities was $12.6 million for the three months ended March 31, 2024, which was primarily the result of our net loss of $17.1 million, partially offset by non-cash charges for depreciation of $0.8 million, stock-based compensation of $1.7 million and impairment charges of $1.8 million, and $0.4 million provided by net changes in operating assets and liabilities. Net cash used in operating activities was $14.8 million for the three months ended March 31, 2023, which was primarily the result of our net loss of $16.1 million and a $2.0 million net use of operating assets and liabilities, partially offset by non-cash charges for depreciation and amortization of $1.0 million and stock-based compensation of $2.1 million.

Current 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.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2024 was $17.9 million, which was due to net proceeds from sales and maturities of marketable securities of $17.9 million. Net cash provided by investing activities for the three months ended March 31, 2023 was $18.1 million, which was primarily due to net proceeds from maturities of marketable securities of $18.4 million, partially offset by purchases of property and equipment of $0.2 million.

Current 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.

Previous wording

Net cash provided by financing activities was $1,000 for the three months ended March 31, 2024 representing the exercise of stock options. Net cash provided by financing activities was $0 for the three months ended March 31, 2023.

Current 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.

Previous wording

There have been no material changes to our contractual obligations during the three months ended March 31, 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 six months ended June 30, 2024, as compared to those disclosed in our 2023 Annual Report.

Previous wording

During the three months ended March 31, 2024, there were no material changes to our critical accounting policies reported in our 2023 Annual Report.

Current 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.