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Investor releaseQuarter not tagged2026-08-06NextCure Provides Business Update and Reports Second Quarter 2026 Financial Results
GlobeNewswire
NextCure Provides Business Update and Reports Second Quarter 2026 Financial Results
Announced Proposed Merger with Avere Therapeutics Preserving Capital in Support of Merger Closing; Continuing Clinical Transition and Legacy Asset Activities BELTSVILLE, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, today provided a business update and reported second quarter 2026 financial results. "Following quarter end, we announced our proposed merger with Avere Therapeutics, together with Avere’s concurrent private financing expected to generate approximately $320 million in gross proceeds, and we are working toward a closing in the second half of 2026. In parallel, we are preserving capital in support of that closing. Our team continues to support the ongoing clinical programs and obligations to our partners, and opportunities to preserve value for our shareholders,” said Michael Richman, President and CEO of NextCure. Recent Business Highlights Announced a definitive merger agreement with Avere Therapeutics in an all-stock transaction. Upon closing, the combined company is expected to operate as Avere Therapeutics and trade on Nasdaq under the ticker symbol “AVRX”. Existing NextCure stockholders are expected to receive contingent value rights (“CVRs”) tied to certain legacy NextCure assets. Concurrently, Avere Therapeutics entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing of the merger, subject to customary closing conditions. Entered into a Transition and Continuation Agreement with LigaChem Biosciences (“LigaChem”) under which LigaChem has elected to continue the development of LNCB74 as the “Sole Developing Party” pursuant to the terms under the parties’ November 2022 Research Collaboration and Co-Development Agreement. NextCure, according to these agreements, remains eligible to receive future milestone and royalty payments for the development and commercialization of LNCB74. Advanced restructuring initiatives to reduce operating expenses, including facility footprint reductions and the sale of certain manufacturing, laboratory and facility-related assets in preparation for completion of the merger. Initiated efforts to preserve value of SIM0505 and our current clinical and pre-clinical a…Read full documentShow less
Announced Proposed Merger with Avere Therapeutics Preserving Capital in Support of Merger Closing; Continuing Clinical Transition and Legacy Asset Activities BELTSVILLE, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, today provided a business update and reported second quarter 2026 financial results. "Following quarter end, we announced our proposed merger with Avere Therapeutics, together with Avere’s concurrent private financing expected to generate approximately $320 million in gross proceeds, and we are working toward a closing in the second half of 2026. In parallel, we are preserving capital in support of that closing. Our team continues to support the ongoing clinical programs and obligations to our partners, and opportunities to preserve value for our shareholders,” said Michael Richman, President and CEO of NextCure. Recent Business Highlights Announced a definitive merger agreement with Avere Therapeutics in an all-stock transaction. Upon closing, the combined company is expected to operate as Avere Therapeutics and trade on Nasdaq under the ticker symbol “AVRX”. Existing NextCure stockholders are expected to receive contingent value rights (“CVRs”) tied to certain legacy NextCure assets. Concurrently, Avere Therapeutics entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing of the merger, subject to customary closing conditions. Entered into a Transition and Continuation Agreement with LigaChem Biosciences (“LigaChem”) under which LigaChem has elected to continue the development of LNCB74 as the “Sole Developing Party” pursuant to the terms under the parties’ November 2022 Research Collaboration and Co-Development Agreement. NextCure, according to these agreements, remains eligible to receive future milestone and royalty payments for the development and commercialization of LNCB74. Advanced restructuring initiatives to reduce operating expenses, including facility footprint reductions and the sale of certain manufacturing, laboratory and facility-related assets in preparation for completion of the merger. Initiated efforts to preserve value of SIM0505 and our current clinical and pre-clinical assets for our shareholders. Financial Results for the Quarter Ended June 30, 2026 Cash, cash equivalents, and marketable securities as of June 30, 2026 were $20.1 million as compared to $41.8 million as of December 31, 2025. The decrease of $21.7 million was primarily due to cash used to fund operations of $23.1 million, partially offset by proceeds of $1.2 million from equity sales under our existing ATM program. In connection with the proposed merger with Avere Therapeutics and related restructuring activities, NextCure is focused on preserving capital, completing the proposed transaction and pursuing efforts to preserve value of our current clinical and pre-clinical assets. Research and development expenses were $7.4 million for the three months ended June 30, 2026, as compared to $24.1 million for the three months ended June 30, 2025. The decrease of $16.7 million was due to $17.0 million of license fees incurred in the prior year that did not occur in the current year. General and administrative expenses were $2.6 million for the three months ended June 30, 2026, as compared to $3.2 million for the three months ended June 30, 2025. The decrease of $0.6 million was primarily related to lower personnel related costs. Asset impairment costs associated with our recently announced restructuring initiatives to reduce our footprint and sell certain facility and laboratory assets totaled $5.1 million in the second quarter. Net loss was $14.9 million for the three months ended June 30, 2026, as compared to a net loss of $26.8 million for the three months ended June 30, 2025. The lower net loss for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 was driven by the lower research and development and general and administrative expenses mentioned above, partially offset by impairment costs of $5.1 million and lower other income, net, of $0.3 million. About the Merger On July 14, 2026 NextCure announced a definitive merger agreement with Avere Therapeutics, a privately held biotechnology company developing oral therapies for IL-23-driven inflammatory diseases, in an all-stock transaction. Concurrently with the merger agreement, Avere entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing, subject to customary closing conditions. Upon closing, the combined company is expected to operate as Avere Therapeutics and trade on Nasdaq under the ticker symbol "AVRX." Following completion of the merger, the combined company will be led by Avere's management team and governed by a board of directors constituted in accordance with the merger agreement. Existing NextCure stockholders are expected to retain an ownership interest in the combined company and receive CVRs tied to the potential future value of specified legacy NextCure assets. The transaction is expected to close in the second half of 2026, subject to stockholder approval and other customary closing conditions. About SIM0505 SIM0505 is an investigational antibody-drug conjugate (ADC) targeting CDH6 and incorporating a proprietary topoisomerase I inhibitor payload. On July 14, 2026, the Company announced it had informed all U.S. clinical trial sites to stop screening, consenting, and enrolling new patients and that it no longer intends to expand the clinical site footprint. The Company is seeking opportunities to preserve the value of SIM0505 for our shareholders. About LNCB74 LNCB74 is a novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and MMAE payload. Following execution of a Transition and Continuation Agreement with LigaChem, LigaChem has elected to continue the program as Sole Developing Party. NextCure is providing transition support to facilitate the transfer of program-related activities and ongoing clinical trial operations. Pursuant to the November 2022 LigaChem Agreement, NextCure remains eligible to receive future development, regulatory and commercial milestone payments and royalties. About NextCure, Inc. NextCure is a biopharmaceutical company headquartered in Beltsville, Maryland. NextCure's retained clinical, regulatory, CMC, and finance personnel support the ongoing clinical development of LNCB74 under the Company's Transition and Continuation Agreement with LigaChem Biosciences, manage the transition of patients enrolled in the SIM0505 study, and conduct the Company's efforts to partner, license or otherwise monetize its legacy clinical and preclinical assets. NextCure has entered into a definitive merger agreement with Avere Therapeutics and, upon closing, the combined company is expected to operate as Avere Therapeutics and to be listed on Nasdaq under the ticker symbol “AVRX.” Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning NextCure, Avere Therapeutics, the proposed merger and other matters, including with respect to the structure, timing and completion of the proposed merger; the combined company’s listing on Nasdaq after closing of the proposed merger; expectations regarding the ownership structure of the combined company; expectations regarding the contingent value rights; the future operations of the combined company; the nature, strategy and focus of the combined company; as well as funding for our operations, our expected cash runway, objectives and expectations for our business, operations and financial performance and condition, and expectations regarding the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. 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: risks associated with the possible failure to satisfy the conditions to the closing or consummation of the merger, including NextCure’s failure to obtain stockholder approval for the merger; risks associated with the uncertainty as to the timing of the consummation of the merger and the ability of each of NextCure and Avere Therapeutics to consummate the transactions contemplated by the merger; risks associated with NextCure’s continued listing on Nasdaq until closing of the merger; the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the merger; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger prior to the closing or consummation of the merger; risks associated with the possible failure to realize certain anticipated benefits of the merger, including with respect to future financial and operating results; the effect of the completion of the merger on the combined company’s business relationships, operating results and business generally; risks associated with the combined company’s ability to manage expenses and unanticipated spending and costs that could reduce the combined company’s cash resources; risks related to the combined company’s ability to correctly estimate its operating expenses and other events; changes in capital resource requirements; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance its product candidates or its preclinical programs; the outcome of any legal proceedings that may be instituted against the combined company or any of its directors or officers related to the merger or the transactions contemplated thereby; the ability of the combined company to obtain, maintain and protect its intellectual property rights, in particular those related to its product candidates; the combined company’s ability to advance the development of its product candidates or preclinical activities under the timelines it anticipates in planned and future clinical trials; the combined company’s ability to replicate in later clinical trials positive results found in preclinical studies and clinical trials of its product candidates; the combined company’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, licensing programs or other collaborations; regulatory requirements or developments and the combined company’s ability to obtain necessary approvals from the U.S. Food and Drug Administration or other regulatory authorities; changes to clinical trial designs and regulatory pathways; competitive responses to the merger and changes in expected or existing competition; unexpected costs, charges or expenses resulting from the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger; legislative, regulatory, political and economic developments; risks regarding the timing, progress and results of preclinical studies and clinical trials for SIM0505, LNCB74 and any of our other legacy assets; our expenses, future revenues, capital requirements, needs for or ability to obtain additional financing and the period over which our current cash, cash equivalents and marketable securities to be sufficient to fund our operations; market and other conditions; the timing or likelihood of regulatory filings for SIM0505, LNCB74 and any of other legacy assets and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; the potential benefits of and our ability to maintain our relationship with LigaChem Biosciences, Inc., Simcere Zaiming Pharmaceutical Co, Ltd., and other third-party vendors and collaborators; our ability to retain key personnel; our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers; changes in international relations, tariffs, and other trade regulations between the U.S. and China; developments and projections relating to our competitors and our industry, including competing therapies; and the impact of current and future laws and regulations. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. No Offer or Solicitation This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy, or a solicitation of any vote, consent or approval in any jurisdiction in connection with the proposed merger or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom. Important Additional Information About the Merger Will Be Filed with the SEC In connection with the proposed merger, NextCure intends to file with the SEC a registration statement on Form S-4 that will contain a proxy statement of NextCure and a prospectus of NextCure, and each of NextCure and Avere Therapeutics may file other documents with the SEC regarding the proposed merger. After the registration statement is declared effective by the SEC, a definitive proxy statement/prospectus will be mailed to NextCure stockholders. This communication is not a substitute for the registration statement, the proxy statement/prospectus or any other document that NextCure may file with the SEC in connection with the proposed merger. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT NEXTCURE, AVERE THERAPEUTICS, THE PROPOSED MERGER AND RELATED MATTERS. Investors and security holders may obtain free copies of the registration statement, the proxy statement/prospectus and other documents filed with the SEC by NextCure through the website maintained by the SEC at www.sec.gov or from NextCure's website at www.nextcure.com under the “Investors” section. Participants in the Solicitation NextCure, Avere Therapeutics and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NextCure's stockholders in respect of the proposed merger. Information regarding the directors and executive officers of NextCure is contained in NextCure's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC, and in subsequent filings made by NextCure with the SEC. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of proxies in connection with the proposed merger, and a description of their direct and indirect interests in the proposed merger, by security holdings or otherwise, will be included in the proxy statement/prospectus and other relevant materials to be filed with the SEC when they become available. These documents may be obtained free of charge from the sources indicated above. Investor InquiriesTimothy Mayer, Ph.D.NextCure, Inc.Chief Operating Officer(240) [email protected] Mike MoyerManaging Director,LifeSci Advisors, LLCPhone: (617) [email protected]
Investor releaseQuarter not tagged2026-05-08NextCure Provides Business Update and Reports First Quarter 2026 Financial Results
GlobeNewswire
NextCure Provides Business Update and Reports First Quarter 2026 Financial Results
SIM0505/CDH6 ADC dose optimization initiated in gynecologic cancers SIM0505 Phase 1 dose escalation study data to be presented at ASCO 2026 LNCB74 Phase 1 dose escalation trial update planned in second half of 2026 BELTSVILLE, Md., May 07, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, today provided a business update and reported first quarter 2026 financial results. "Our SIM0505 program reached critical milestones this quarter, headlined by the U.S. Food and Drug Administration (FDA) granting Fast Track designation for platinum-resistant ovarian cancer (PROC) and the upcoming presentation of initial Phase 1 data at the American Society for Clinical Oncology (ASCO 2026)," said Michael Richman, President and CEO of NextCure. "We believe Fast Track designation validates the potential of this CDH6 antibody drug conjugate (ADC) and the urgent need for new therapies. As we prepare to present our data at ASCO 2026, we are also focusing on accelerating development, with plans to increase our U.S. trial sites and expand our footprint into Canada and Europe. With the recent initiation of the dose optimization this month, we are fully committed to bringing this transformative treatment to patients." Business Highlights and Near-Term Milestones SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026 SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. Received Fast Track designation for the treatment of women with PROC from the FDA. Data from the Phase 1 open-label dose escalation study in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on PROC (NCT06792552) are expected to be presented at ASCO 2026 on June 1, 2026, including results from patients in the U.S. and China. Announced in May 2026 the initiation of the Phase 1 dose optimization study in gynecologic cancers by dosing patients with PROC. NextCure anticipates increasing the number of trial sites in the second half of 2026, including the activation…Read full documentShow less
SIM0505/CDH6 ADC dose optimization initiated in gynecologic cancers SIM0505 Phase 1 dose escalation study data to be presented at ASCO 2026 LNCB74 Phase 1 dose escalation trial update planned in second half of 2026 BELTSVILLE, Md., May 07, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, today provided a business update and reported first quarter 2026 financial results. "Our SIM0505 program reached critical milestones this quarter, headlined by the U.S. Food and Drug Administration (FDA) granting Fast Track designation for platinum-resistant ovarian cancer (PROC) and the upcoming presentation of initial Phase 1 data at the American Society for Clinical Oncology (ASCO 2026)," said Michael Richman, President and CEO of NextCure. "We believe Fast Track designation validates the potential of this CDH6 antibody drug conjugate (ADC) and the urgent need for new therapies. As we prepare to present our data at ASCO 2026, we are also focusing on accelerating development, with plans to increase our U.S. trial sites and expand our footprint into Canada and Europe. With the recent initiation of the dose optimization this month, we are fully committed to bringing this transformative treatment to patients." Business Highlights and Near-Term Milestones SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026 SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. Received Fast Track designation for the treatment of women with PROC from the FDA. Data from the Phase 1 open-label dose escalation study in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on PROC (NCT06792552) are expected to be presented at ASCO 2026 on June 1, 2026, including results from patients in the U.S. and China. Announced in May 2026 the initiation of the Phase 1 dose optimization study in gynecologic cancers by dosing patients with PROC. NextCure anticipates increasing the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027. LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation LNCB74 is a novel ADC directed to B7-H4, overexpressed in several cancers, with limited expression in healthy tissues. LNCB74 features a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. Ongoing open-label Phase 1 dose escalation study (NCT06774963) continues to prioritize patients with high B7-H4 expression in breast and gynecological cancers, as well as the inclusion of patients with adenoid cystic carcinoma type 1. NextCure intends to backfill patients to investigate particular dose levels and schedules in the expected therapeutic window. Trial progress update planned in the second half of 2026. Financial Results for the Quarter Ended March 31, 2026 Cash, cash equivalents, and marketable securities as of March 31, 2026 were $29.7 million as compared to $41.8 million as of December 31, 2025. The decrease of $12.1 million was primarily due to cash used to fund operations of $13.4 million, partially offset by proceeds of $1.2 million from equity sales under our existing ATM program. NextCure expects current financial resources to be sufficient to fund operating expenses and capital expenditures into the first half of 2027 through proof-of-concept for SIM0505. Research and development expenses were $6.8 million for the three months ended March 31, 2026, as compared to $7.9 million for the three months ended March 31, 2025. The decrease of $1.1 million was due to lower costs related to deprioritized programs which were largely offset by costs for the SIM0505 program, and lower personnel costs, primarily non-cash stock compensation costs and lower depreciation. General and administrative expenses were $3.3 million for the three months ended March 31, 2026, as compared to $3.7 million for the three months ended March, 2025. The decrease of $0.4 million was primarily related to lower non-cash stock compensation costs. Net loss was $9.8 million for the three months ended March 31, 2026, as compared to a net loss of $11.0 million for the three months ended March 31, 2025. The lower net loss for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was driven by the lower research and development and general and administrative expenses mentioned above, partially offset by lower other income of $0.3 million. About SIM0505 SIM0505 is a novel ADC directed to CDH6 ADC, featuring a proprietary TOPOi payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd. About LNCB74 LNCB74 is a novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor MMAE payload. LNCB74 is being evaluated in an open-label, Phase 1 dose escalation study for the potential treatment of advanced solid tumors. NextCure shares global co-development rights with LigaChem Biosciences, Inc. through a 50-50 cost share arrangement. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, our expected cash runway, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. 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: our expectations regarding the timing, progress and results of preclinical studies and clinical trials for SIM0505, LNCB74 and any other product candidates we develop; our estimates regarding our expenses, future revenues, capital requirements, needs for or ability to obtain additional financing and the period over which we expect our current cash, cash equivalents and marketable securities to be sufficient to fund our operations, market and other conditions; ; the timing or likelihood of regulatory filings for SIM0505, LNCB74 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; the identification, analysis and use of biomarkers and biomarker data; our drug product sourcing and manufacturing strategy, including the scalability of our methods and processes; our expectations regarding the potential benefits, activity, effectiveness and safety of SIM0505, LNCB74 and any other product candidates we develop; our intentions and ability to successfully commercialize, including through partnering, our product candidates; our expectations regarding the nature of the biological pathways we are targeting; our expectations regarding our ability to discover and advance product candidates using our technologies; the potential benefits of and our ability to maintain our relationship with LigaChem Biosciences, Inc., Simcere Zaiming Pharmaceutical Co, Ltd., and other third-party vendors and collaborators; our ability to retain key personnel; our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers; changes in international relations, tariffs, and other trade regulations between the U.S. and China; our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; developments and projections relating to our competitors and our industry, including competing therapies; and the impact of current and future laws and regulations. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 [email protected] Mike Moyer Managing Director, LifeSci Advisors, LLC Phone: (617) 308-4306 [email protected]
Investor releaseQuarter not tagged2026-03-06NextCure Provides Business Update and Reports Full Year 2025 Financial Results
GlobeNewswire
NextCure Provides Business Update and Reports Full Year 2025 Financial Results
Data readout for SIM0505/CDH6 ADC Phase 1 dose escalation study and initiation of dose optimization in ovarian cancer are both anticipated in Q2 2026 LNCB74 Phase 1 dose escalation trial update planned in second half of 2026 BELTSVILLE, Md., March 05, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported full year 2025 financial results. “2026 is on track to be transformational for NextCure, as we set the stage to present clinical dose escalation data from the Phase 1 trial for SIM0505, in development for multiple cancers,” said Michael Richman, President and CEO of NextCure. “Since acquiring the program in June of 2025, we have made rapid clinical and regulatory progress and soon expect to begin enrolling platinum resistant ovarian cancer patients in the Phase 1 dose optimization study. To accelerate the program, we plan to double the number of U.S. trial sites and expand our footprint into multiple other countries.” Business Highlights and Near-Term Milestones SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026 SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. Data from the Phase 1 open-label dose escalation study is expected to be presented in the second quarter of 2026, including results from patients in the U.S. and China. The study (NCT06792552) is evaluating SIM0505 in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on platinum resistant ovarian cancer (PROC). Initiation of Phase 1 dose optimization study in ovarian cancer expected in the second quarter of 2026 with a continued focus on PROC. The Company anticipates doubling the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027. LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation LNCB74 is a novel ADC directed to B7-H4, overexpressed in several ca…Read full documentShow less
Data readout for SIM0505/CDH6 ADC Phase 1 dose escalation study and initiation of dose optimization in ovarian cancer are both anticipated in Q2 2026 LNCB74 Phase 1 dose escalation trial update planned in second half of 2026 BELTSVILLE, Md., March 05, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported full year 2025 financial results. “2026 is on track to be transformational for NextCure, as we set the stage to present clinical dose escalation data from the Phase 1 trial for SIM0505, in development for multiple cancers,” said Michael Richman, President and CEO of NextCure. “Since acquiring the program in June of 2025, we have made rapid clinical and regulatory progress and soon expect to begin enrolling platinum resistant ovarian cancer patients in the Phase 1 dose optimization study. To accelerate the program, we plan to double the number of U.S. trial sites and expand our footprint into multiple other countries.” Business Highlights and Near-Term Milestones SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026 SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. Data from the Phase 1 open-label dose escalation study is expected to be presented in the second quarter of 2026, including results from patients in the U.S. and China. The study (NCT06792552) is evaluating SIM0505 in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on platinum resistant ovarian cancer (PROC). Initiation of Phase 1 dose optimization study in ovarian cancer expected in the second quarter of 2026 with a continued focus on PROC. The Company anticipates doubling the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027. LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation LNCB74 is a novel ADC directed to B7-H4, overexpressed in several cancers, with limited expression in healthy tissues. LNCB74 features a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. Higher dose cohort enrollment initiated in the ongoing open-label Phase 1 dose escalation study (NCT06774963), following the November 2025 protocol amendment announcement. The next dose cohort will prioritize patients with high B7-H4 expression in breast and gynecological cancers, as well as the inclusion of patients with adenoid cystic carcinoma type 1. NextCure continues to plan to provide a trial update in the second half of 2026. Financial Results for the Full Year Ended December 31, 2025 Cash, cash equivalents, and marketable securities as of December 31, 2025 were $41.8 million as compared to $68.6 million as of December 31, 2024. The decrease of $26.8 million was primarily due to cash used to fund operations of $49.6 million, including $13.5 million of upfront license fees and milestone payments to Simcere Zaiming Pharmaceutical Co., Ltd. for the rights to SIM0505, partially offset by proceeds of $22.3 million from equity sales including a $21.5 million private placement of common stock in November 2025. NextCure expects current financial resources to be sufficient to fund operating expenses and capital expenditures into the first half of 2027 through proof-of-concept for SIM0505. Research and development expenses were $44.9 million for the full year ended December 31, 2025, as compared to $41.5 million for the full year ended December 31, 2024. The increase of $3.4 million was due to $18.5 million of license fees and milestone payments for SIM0505 partially offset by lower costs related to deprioritized programs, lower preclinical development costs and lower personnel-related costs. General and administrative expenses were $12.7 million for the full year ended December 31, 2025, as compared to $15.7 million for the full year ended December 31, 2024. The decrease of $3.0 million was primarily related to lower personnel costs. Net loss was $55.8 million for the full year ended December 31, 2025, as compared to a net loss of $55.7 million for the full year ended December 31, 2024. Net loss for the year ended December 31, 2025 was driven by higher research and development costs and lower other income of $2.3 million, partially offset by lower general and administrative costs and lower restructuring charges. About SIM0505 SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd. About LNCB74 LNCB74 is a novel antibody drug conjugate (ADC) directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. LNCB74 is being evaluated in an open-label, Phase 1 dose escalation study for the potential treatment of advanced solid tumors. NextCure shares global co-development rights with LigaChem Biosciences, Inc. through a 50-50 cost share arrangement. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. 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: market and other conditions; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s reliance upon collaborators and international vendors for advancing clinical programs; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 [email protected] Mike Moyer Managing Director, LifeSci Advisors, LLC Phone: (617) 308-4306 [email protected]
Investor releaseQuarter not tagged2025-11-06NextCure Provides Business Update and Reports Third Quarter 2025 Financial Results
GlobeNewswire
NextCure Provides Business Update and Reports Third Quarter 2025 Financial Results
BELTSVILLE, Md., Nov. 05, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported third quarter 2025 financial results. “We have made significant progress advancing our promising ADC programs,” said Michael Richman, NextCure’s president and CEO. “We recently began U.S. enrollment in the Phase 1 trial for SIM0505, our CDH6 ADC, initiating at a mid-tier dose range where multiple clinical responses were observed in China by our partner Simcere Zaiming. We expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China. We believe the ability to dose at levels that match or exceed competitor CDH6-targeting ADCs should demonstrate the promise of this program. We also received FDA clearance for our LNCB74 protocol amendment, giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readouts on SIM0505 and LNCB74 in the first half of 2026.” Business Highlights and Near-Term Milestones SIM0505 (CDH6 ADC) A novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. Acquired global rights in June 2025, excluding greater China where Simcere Zaiming retained rights. First U.S. patient dosed in October 2025 at a mid-tier dose level where multiple responses have been observed along with good tolerability in the ongoing Chinese trial. Proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026. LNCB74 (B7-H4 ADC) A novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. Co-developed with LigaChem Biosciences Inc. in a 50-50 cost share arrangement. Received Food and Drug Administration (FDA) acceptance of a protocol amendment giving us the ability to add higher dose escalation cohorts. Proof of concept data readout in the first half of 2026. Financial Results for Quarter Ended September 30, 2025 Cash, cash equivalents, and marketable securities as of September 30, 2025 w…Read full documentShow less
BELTSVILLE, Md., Nov. 05, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported third quarter 2025 financial results. “We have made significant progress advancing our promising ADC programs,” said Michael Richman, NextCure’s president and CEO. “We recently began U.S. enrollment in the Phase 1 trial for SIM0505, our CDH6 ADC, initiating at a mid-tier dose range where multiple clinical responses were observed in China by our partner Simcere Zaiming. We expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China. We believe the ability to dose at levels that match or exceed competitor CDH6-targeting ADCs should demonstrate the promise of this program. We also received FDA clearance for our LNCB74 protocol amendment, giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readouts on SIM0505 and LNCB74 in the first half of 2026.” Business Highlights and Near-Term Milestones SIM0505 (CDH6 ADC) A novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. Acquired global rights in June 2025, excluding greater China where Simcere Zaiming retained rights. First U.S. patient dosed in October 2025 at a mid-tier dose level where multiple responses have been observed along with good tolerability in the ongoing Chinese trial. Proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026. LNCB74 (B7-H4 ADC) A novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. Co-developed with LigaChem Biosciences Inc. in a 50-50 cost share arrangement. Received Food and Drug Administration (FDA) acceptance of a protocol amendment giving us the ability to add higher dose escalation cohorts. Proof of concept data readout in the first half of 2026. Financial Results for Quarter Ended September 30, 2025 Cash, cash equivalents, and marketable securities as of September 30, 2025 were $29.1 million as compared to $68.6 million as of December 31, 2024. The decrease of $39.5 million was primarily due to cash used to fund operations, including the $12.0 million upfront license fee to Simcere Zaiming. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026. Research and development expenses were $6.1 million for the three months ended September 30, 2025, as compared to $8.8 million for the three months ended September 30, 2024. The decrease of $2.6 million was due to lower costs related to deprioritized programs, lower preclinical development costs and lower personnel-related costs. General and administrative expenses were $2.8 million for the three months ended September 30, 2025, as compared to $3.7 million for the three months ended September 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs. Net loss was $8.6 million for the three months ended September 30, 2025, as compared to a net loss of $11.5 million for the three months ended September 30, 2024 due to the lower research and development costs and lower general and administrative costs as described above, partially offset by lower other income. About NextCure, Inc. NextCure is 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 targeted therapies including antibody-drug conjugates. 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. Please visit www.nextcure.com for more information. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. 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; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 [email protected]
Investor releaseQuarter not tagged2025-08-08NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results
GlobeNewswire
NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results
Announced strategic partnership with Simcere Zaiming for Phase 1 program SIM0505 (CDH6 ADC) with plans to dose the first SIM0505 patient in the United States this quarter Currently in cohort 4 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers Plan to provide SIM0505 and LNCB74 program updates by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026 BELTSVILLE, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported second quarter 2025 financial results. “Our recent strategic acquisition of the global rights, excluding greater China, for SIM0505 targeting CDH6 (cadherin-6 or K-cadherin) positions us uniquely within the antibody-drug conjugate (“ADC”) field. We now are developing ADCs against two clinically validated targets leveraging two distinct payloads, a Topoisomerase 1 Inhibitor (SIM0505) and a Tubulin Inhibitor (LNCB74),” said Michael Richman, NextCure’s president and CEO. “We are on track to dose our first SIM0505 patient in the United States this quarter and plan to provide program updates on both SIM0505 and LNCB74 by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026.” Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) First patient dosed in January 2025 in the Phase 1 trial, cleared cohort 3 in June 2025. Currently treating patients in cohort 4. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a program update by the fourth quarter of 2025 and proof of concept data readout in the first half of 2026. SIM0505 (CDH6 ADC) Acquired global rights, excluding greater China, where Simcere Zaiming will retain rights. Phase 1 clinical trial ongoing in China with initial data as of April 16, 2025 reporting clinical activity in cohort 1 with a partial response based on a six-week assessment. Investigational New Drug application transferred to NextCure in June 2025, with anticipated first patient dosed in the US within the third quarter of 2025. Plan to provide a program update by the fourth quarter of 2025 and a proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the firs…Read full documentShow less
Announced strategic partnership with Simcere Zaiming for Phase 1 program SIM0505 (CDH6 ADC) with plans to dose the first SIM0505 patient in the United States this quarter Currently in cohort 4 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers Plan to provide SIM0505 and LNCB74 program updates by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026 BELTSVILLE, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported second quarter 2025 financial results. “Our recent strategic acquisition of the global rights, excluding greater China, for SIM0505 targeting CDH6 (cadherin-6 or K-cadherin) positions us uniquely within the antibody-drug conjugate (“ADC”) field. We now are developing ADCs against two clinically validated targets leveraging two distinct payloads, a Topoisomerase 1 Inhibitor (SIM0505) and a Tubulin Inhibitor (LNCB74),” said Michael Richman, NextCure’s president and CEO. “We are on track to dose our first SIM0505 patient in the United States this quarter and plan to provide program updates on both SIM0505 and LNCB74 by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026.” Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) First patient dosed in January 2025 in the Phase 1 trial, cleared cohort 3 in June 2025. Currently treating patients in cohort 4. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a program update by the fourth quarter of 2025 and proof of concept data readout in the first half of 2026. SIM0505 (CDH6 ADC) Acquired global rights, excluding greater China, where Simcere Zaiming will retain rights. Phase 1 clinical trial ongoing in China with initial data as of April 16, 2025 reporting clinical activity in cohort 1 with a partial response based on a six-week assessment. Investigational New Drug application transferred to NextCure in June 2025, with anticipated first patient dosed in the US within the third quarter of 2025. Plan to provide a program update by the fourth quarter of 2025 and a proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026. Assets For Which We Are Seeking Partners Clinical programs NC410 (LAIR-2 fusion) and NC525 (LAIR-1 antibody). Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, have demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation. Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), have demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI. Other Simcere Zaiming US affiliate $2.0 million equity investment in NextCure in June 2025. Regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. Financial Results for Quarter Ended June 30, 2025 Cash, cash equivalents, and marketable securities as of June 30, 2025 were $35.3 million as compared to $68.6 million as of December 31, 2024. The decrease of $33.3 million was primarily due to cash used to fund operations. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026. Research and development expenses were $24.1 million for the three months ended June 30, 2025, as compared to $12.4 million for the three months ended June 30, 2024. The increase of $11.7 million was due to $17.0 million of up-front license fees incurred in connection with the licensing agreement announced June 16, 2025. This fee was partially offset by lower costs related to other programs, lower preclinical development costs and lower personnel-related costs. General and administrative expenses were $3.2 million for the three months ended June 30, 2025, as compared to $4.1 million for the three months ended June 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs and lower insurance costs. Net loss was $26.8 million for the three months ended June 30, 2025, as compared to a net loss of $15.4 million for the three months ended June 30, 2024 as the $17.0 million up-front license fee was partially offset by lower other research and development costs and lower general and administrative costs as described above. About NextCure, Inc. NextCure is 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 targeted therapies including antibody-drug conjugates. 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. Please visit www.nextcure.com for more information. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. 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; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 [email protected]
Investor releaseQuarter not tagged2025-05-02NextCure Provides Business Update and Reports First Quarter 2025 Financial Results
GlobeNewswire
NextCure Provides Business Update and Reports First Quarter 2025 Financial Results
Dosing cohort 3 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers and plan to initiate backfill cohorts in the second half of 2025 Plan to provide a proof of concept data readout in the first half of 2026 Cash of approximately $55.9 million expected to fund operations into the second half of 2026 BELTSVILLE, Md., May 01, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported first quarter 2025 financial results. “With our LNCB74 antibody-drug conjugate (“ADC”) program completing cohort 2 in April 2025, we are progressing as planned through the dose escalation portion of the Phase 1 study. We expect to be in a position to initiate backfill cohorts in the second half of the year with 10 active investigator sites, and an additional 3 sites projected to be onboard in May 2025. We plan to provide a proof of concept data readout in the first half of 2026,” said Michael Richman, NextCure’s president and CEO. Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) Dosed our first patient in January 2025 in the Phase 1 trial, cleared cohort 2 in April 2025 and currently dosing cohort 3. Expanded clinical footprint for the LNCB74 study with a total of 10 active trial sites. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a proof of concept data readout in the first half of 2026. Preclinical Non-Oncology Programs Seeking Partnering Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, has demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation. Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), has demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI. Both programs could lead to investigational new drug (IND) filings within 12 to 18 months if financial support from partners or third parties is secured. Financial Results for Quarter Ended March 31, 2025 Cash, cash equivalents, and marketable securities as of March 31, 2025 were $55.9 million as compared to $68.6 million as of December 31, 2024. The decrease of $12.8 million w…Read full documentShow less
Dosing cohort 3 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers and plan to initiate backfill cohorts in the second half of 2025 Plan to provide a proof of concept data readout in the first half of 2026 Cash of approximately $55.9 million expected to fund operations into the second half of 2026 BELTSVILLE, Md., May 01, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported first quarter 2025 financial results. “With our LNCB74 antibody-drug conjugate (“ADC”) program completing cohort 2 in April 2025, we are progressing as planned through the dose escalation portion of the Phase 1 study. We expect to be in a position to initiate backfill cohorts in the second half of the year with 10 active investigator sites, and an additional 3 sites projected to be onboard in May 2025. We plan to provide a proof of concept data readout in the first half of 2026,” said Michael Richman, NextCure’s president and CEO. Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) Dosed our first patient in January 2025 in the Phase 1 trial, cleared cohort 2 in April 2025 and currently dosing cohort 3. Expanded clinical footprint for the LNCB74 study with a total of 10 active trial sites. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a proof of concept data readout in the first half of 2026. Preclinical Non-Oncology Programs Seeking Partnering Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, has demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation. Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), has demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI. Both programs could lead to investigational new drug (IND) filings within 12 to 18 months if financial support from partners or third parties is secured. Financial Results for Quarter Ended March 31, 2025 Cash, cash equivalents, and marketable securities as of March 31, 2025 were $55.9 million as compared to $68.6 million as of December 31, 2024. The decrease of $12.8 million was primarily due to cash used to fund operations. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into the second half of 2026. Research and development expenses were $7.9 million for the three months ended March 31, 2025, as compared to $11.4 million for the three months ended March 31, 2024. The decrease of $3.5 million was due to lower costs related to programs other than LNCB74, lower preclinical development costs and lower personnel-related costs resulting from the restructuring and reduction-in-force announced during the first quarter of 2024 (the “2024 Restructuring”). General and administrative expenses were $3.7 million for the three months ended March 31, 2025, as compared to $4.4 million for the three months ended March 31, 2024. The decrease of $0.6 million was primarily related to lower personnel costs and lower insurance costs resulting from the 2024 Restructuring. There were no restructuring and asset impairment costs for the three months ended March 31, 2025 as compared to $2.5 million for the three months ended March 31, 2024, which costs resulted from the 2024 Restructuring. Net loss was $11.0 million for the three months ended March 31, 2025, as compared to a net loss of $17.1 million for the three months ended March 31, 2024 due to lower costs as described above. About NextCure, Inc. NextCure is 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 targeted therapies including antibody-drug conjugates. 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. Please visit www.nextcure.com for more information. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. 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; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 [email protected]

