NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results
NextCure (Nasdaq: NXTC) reported Q2 2025 financial results and provided significant business updates. The company announced a strategic partnership with Simcere Zaiming for the Phase 1 program SIM0505 (CDH6 ADC), acquiring global rights excluding greater China. NextCure is advancing two key ADC programs: LNCB74 (currently in cohort 4) and SIM0505 (first US patient dosing expected this quarter).
Financial highlights include cash position of $35.3 million as of June 30, 2025, expected to fund operations into mid-2026. The company reported a net loss of $26.8 million for Q2 2025, largely due to a $17.0 million up-front license fee. Both ADC programs are expected to provide updates by Q4 2025 and proof of concept data in H1 2026.
NextCure (Nasdaq: NXTC) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito importanti aggiornamenti aziendali. La società ha annunciato una partnership strategica con Simcere Zaiming per il programma di Fase 1 SIM0505 (CDH6 ADC), acquisendo i diritti globali ad eccezione della grande Cina. NextCure sta portando avanti due programmi chiave ADC: LNCB74 (attualmente al quarto gruppo di dosaggio) e SIM0505 (si prevede la somministrazione al primo paziente negli USA in questo trimestre).
Tra i dati finanziari spicca una posizione di cassa di 35,3 milioni di dollari al 30 giugno 2025, sufficiente a finanziare le operazioni fino a metà 2026. La società ha riportato una perdita netta di 26,8 milioni di dollari per il secondo trimestre 2025, principalmente dovuta a una commissione di licenza anticipata di 17,0 milioni di dollari. Entrambi i programmi ADC prevedono aggiornamenti entro il quarto trimestre 2025 e dati di prova di concetto nella prima metà del 2026.
NextCure (Nasdaq: NXTC) informó los resultados financieros del segundo trimestre de 2025 y proporcionó importantes actualizaciones comerciales. La compañía anunció una asociación estratégica con Simcere Zaiming para el programa de Fase 1 SIM0505 (CDH6 ADC), adquiriendo los derechos globales excluyendo la gran China. NextCure está avanzando en dos programas clave de ADC: LNCB74 (actualmente en el cuarto grupo) y SIM0505 (se espera la dosificación del primer paciente en EE. UU. este trimestre).
Los aspectos financieros incluyen una posición de efectivo de 35,3 millones de dólares al 30 de junio de 2025, que se espera financie las operaciones hasta mediados de 2026. La compañía reportó una pérdida neta de 26,8 millones de dólares para el segundo trimestre de 2025, debido en gran parte a una tarifa inicial de licencia de 17,0 millones de dólares. Se espera que ambos programas ADC proporcionen actualizaciones para el cuarto trimestre de 2025 y datos de prueba de concepto en la primera mitad de 2026.
NextCure (나스닥: NXTC)는 2025년 2분기 재무 결과를 발표하고 중요한 사업 업데이트를 제공했습니다. 회사는 Simcere Zaiming과 1상 프로그램 SIM0505(CDH6 ADC)에 대한 전략적 파트너십을 발표했으며, 중국 본토를 제외한 전 세계 권리를 확보했습니다. NextCure는 두 가지 주요 ADC 프로그램인 LNCB74(현재 4번째 코호트 진행 중)와 SIM0505(이번 분기 내 미국 첫 환자 투여 예정)를 진행 중입니다.
재무 하이라이트로는 2025년 6월 30일 기준 현금 보유액 3,530만 달러가 있으며, 이는 2026년 중반까지 운영 자금을 지원할 것으로 예상됩니다. 회사는 2025년 2분기에 2,680만 달러의 순손실을 보고했으며, 이는 주로 1,700만 달러의 선불 라이선스 수수료 때문입니다. 두 ADC 프로그램 모두 2025년 4분기까지 업데이트를 제공하고 2026년 상반기에 개념 증명 데이터를 발표할 예정입니다.
NextCure (Nasdaq : NXTC) a publié ses résultats financiers du deuxième trimestre 2025 et fourni des mises à jour importantes sur ses activités. La société a annoncé un partenariat stratégique avec Simcere Zaiming pour le programme de phase 1 SIM0505 (CDH6 ADC), acquérant les droits mondiaux à l'exception de la Grande Chine. NextCure fait progresser deux programmes ADC clés : LNCB74 (actuellement en cohorte 4) et SIM0505 (la première administration à un patient américain est prévue ce trimestre).
Les points financiers marquants incluent une trésorerie de 35,3 millions de dollars au 30 juin 2025, suffisante pour financer les opérations jusqu'à la mi-2026. La société a enregistré une perte nette de 26,8 millions de dollars pour le deuxième trimestre 2025, principalement due à des frais de licence initiaux de 17,0 millions de dollars. Les deux programmes ADC devraient fournir des mises à jour d'ici le quatrième trimestre 2025 et des données de preuve de concept au premier semestre 2026.
NextCure (Nasdaq: NXTC) hat die Finanzergebnisse für das zweite Quartal 2025 veröffentlicht und wichtige geschäftliche Updates gegeben. Das Unternehmen kündigte eine strategische Partnerschaft mit Simcere Zaiming für das Phase-1-Programm SIM0505 (CDH6 ADC) an und erwarb die globalen Rechte mit Ausnahme Großchinas. NextCure treibt zwei wichtige ADC-Programme voran: LNCB74 (derzeit in Kohorte 4) und SIM0505 (erste US-Patientendosierung wird in diesem Quartal erwartet).
Zu den finanziellen Highlights gehört eine Barmittelposition von 35,3 Millionen US-Dollar zum 30. Juni 2025, die voraussichtlich den Betrieb bis Mitte 2026 finanzieren wird. Das Unternehmen meldete für das zweite Quartal 2025 einen Nettoverlust von 26,8 Millionen US-Dollar, hauptsächlich aufgrund einer Vorauszahlungs-Lizenzgebühr von 17,0 Millionen US-Dollar. Beide ADC-Programme sollen bis zum vierten Quartal 2025 Updates liefern und im ersten Halbjahr 2026 erste Wirksamkeitsnachweise vorlegen.
- Strategic acquisition of global rights for SIM0505 (CDH6 ADC), expanding ADC portfolio
- Initial clinical activity observed in SIM0505 Phase 1 trial with partial response in cohort 1
- LNCB74 trial progressing well, currently in cohort 4
- $2.0 million equity investment received from Simcere Zaiming
- Regained Nasdaq listing compliance
- Net loss increased to $26.8 million in Q2 2025 from $15.4 million in Q2 2024
- Cash position decreased by $33.3 million to $35.3 million since December 2024
- R&D expenses nearly doubled to $24.1 million due to license fees
- Multiple assets still seeking partnership deals
Insights
NextCure strengthens ADC pipeline with SIM0505 acquisition while advancing LNCB74, but faces cash runway concerns amid significant R&D spending.
NextCure's Q2 results highlight a strategic pivot toward antibody-drug conjugates (ADCs) through its acquisition of global rights (excluding China) to SIM0505, a CDH6-targeting ADC. This positions the company with two ADC candidates targeting clinically validated pathways with distinct payloads - a topoisomerase 1 inhibitor (SIM0505) and a tubulin inhibitor (LNCB74).
The LNCB74 program is progressing steadily through its Phase 1 dose-escalation, having cleared three cohorts and currently dosing patients in cohort 4. Meanwhile, SIM0505 has already shown preliminary clinical activity in China with a partial response observed in cohort 1. The company expects to dose its first U.S. patient this quarter.
While these pipeline developments are encouraging, the $35.3 million cash position represents a concerning $33.3 million decrease from December 2024 levels. The cash burn accelerated significantly due to the $17 million upfront license fee for SIM0505, pushing quarterly net loss to $26.8 million compared to $15.4 million in Q2 2024. Management projects runway into mid-2026, but this leaves limited margin for error without additional financing.
The company is actively seeking partners for several assets including NC410, NC525, NC181 (for Alzheimer's), and NC605 (for osteogenesis imperfecta), which could potentially bring in non-dilutive capital. The $2 million equity investment from Simcere's U.S. affiliate provides minimal runway extension but signals partner confidence.
NextCure's strategy of pursuing multiple shots on goal in the competitive ADC space is promising, but investors should monitor the rapid cash burn against the timeline for clinical proof-of-concept data expected in H1 2026, which will be crucial for the company's valuation and financing options.
- 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.
| Selected Financial Information | ||||||||||||||||
| Selected Statement of Operations Items: | Three Months Ended | Six Months Ended | ||||||||||||||
| June 30, | June 30, | |||||||||||||||
| (in thousands, except share and per share amounts) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 24,091 | $ | 12,418 | $ | 31,987 | $ | 23,816 | ||||||||
| General and administrative | 3,201 | 4,076 | 6,927 | 8,440 | ||||||||||||
| Restructuring and asset impairment | - | - | - | 2,542 | ||||||||||||
| Loss from operations | (27,292 | ) | (16,494 | ) | (38,914 | ) | (34,798 | ) | ||||||||
| Other income, net | 484 | 1,090 | 1,130 | 2,287 | ||||||||||||
| Net loss | $ | (26,808 | ) | $ | (15,404 | ) | $ | (37,784 | ) | $ | (32,511 | ) | ||||
| Net loss per common share - basic and diluted | $ | (11.29 | ) | $ | (6.61 | ) | $ | (16.05 | ) | $ | (13.96 | ) | ||||
| Weighted-average shares outstanding - basic and diluted | 2,374,729 | 2,331,062 | 2,354,425 | 2,328,157 | ||||||||||||
| Selected Balance Sheet Items: | ||||||||||||||||
| June 30, | December 31, | |||||||||||||||
| (in thousands) | 2025 | 2024 | ||||||||||||||
| Cash, cash equivalents, and marketable securities | $ | 35,308 | $ | 68,621 | ||||||||||||
| Total assets | $ | 47,689 | $ | 80,860 | ||||||||||||
| Accounts payable and accrued liabilities | $ | 10,781 | $ | 9,574 | ||||||||||||
| Total stockholders' equity | $ | 29,646 | $ | 65,472 | ||||||||||||
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
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