NextCure Provides Business Update and Reports Third Quarter 2024 Financial Results
NextCure has provided a business update and reported its third-quarter 2024 financial results. The company is focusing on LNCB74 (B7-H4 ADC) with a planned IND submission by year-end and aims to advance into Phase 1 trials. NextCure's cash reserves of approximately $75 million are expected to fund operations into the second half of 2026. The NC410 combo trial showed encouraging results in ovarian cancer and CRC patients but will conclude as the company seeks a partner for further development. Financially, NextCure's cash and equivalents decreased from $108.3 million to $75.3 million in 2024, primarily due to operational expenses. R&D expenses dropped to $8.8 million from $11.0 million, and G&A expenses decreased to $3.7 million from $4.6 million. The net loss for the quarter was $11.5 million, down from $14.3 million in the same period in 2023.
NextCure ha fornito un aggiornamento aziendale riportando i suoi risultati finanziari del terzo trimestre 2024. L'azienda si sta concentrando su LNCB74 (B7-H4 ADC) con una presentazione dell'IND prevista entro la fine dell'anno e mira ad avanzare verso la fase 1 degli studi clinici. Le riserve di liquidità di NextCure, che ammontano a circa 75 milioni di dollari, sono previste per finanziare le operazioni fino alla seconda metà del 2026. Il trial combinato NC410 ha mostrato risultati incoraggianti nei pazienti affetti da cancro ovarico e CRC, ma si concluderà mentre l'azienda cerca un partner per ulteriori sviluppi. Dal punto di vista finanziario, il cash e le equivalenti di NextCure sono diminuiti da 108,3 milioni di dollari a 75,3 milioni di dollari nel 2024, principalmente a causa delle spese operative. Le spese per la R&S sono scese a 8,8 milioni di dollari da 11,0 milioni di dollari, mentre le spese generali e amministrative sono diminuite a 3,7 milioni di dollari da 4,6 milioni di dollari. La perdita netta per il trimestre è stata di 11,5 milioni di dollari, in calo rispetto ai 14,3 milioni di dollari nello stesso periodo del 2023.
NextCure ha proporcionado una actualización empresarial y ha informado sobre sus resultados financieros del tercer trimestre de 2024. La compañía se está enfocando en LNCB74 (B7-H4 ADC) con una presentación del IND prevista para fin de año y busca avanzar a ensayos de fase 1. Las reservas de efectivo de NextCure, que ascienden a aproximadamente 75 millones de dólares, se espera que financien las operaciones hasta la segunda mitad de 2026. El ensayo combinado NC410 mostró resultados alentadores en pacientes con cáncer de ovario y CRC, pero concluirá mientras la empresa busca un socio para un desarrollo adicional. Desde el punto de vista financiero, el efectivo y equivalentes de NextCure disminuyeron de 108,3 millones de dólares a 75,3 millones de dólares en 2024, principalmente debido a los gastos operativos. Los gastos de I+D cayeron a 8,8 millones de dólares desde 11,0 millones de dólares, y los gastos de G&A disminuyeron a 3,7 millones de dólares desde 4,6 millones de dólares. La pérdida neta para el trimestre fue de 11,5 millones de dólares, en comparación con los 14,3 millones de dólares del mismo período en 2023.
NextCure는 비즈니스 업데이트를 제공하고 2024년 3분기 재무 결과를 보고했습니다. 회사는 LNCB74 (B7-H4 ADC)에 집중하고 있으며, 연말까지 IND 제출을 계획하고 있으며, 1상 시험으로 나아가는 것을 목표로 하고 있습니다. NextCure의 현금 보유액 약 7,500만 달러는 2026년 하반기까지 운영 자금을 지원할 것으로 예상됩니다. NC410 조합 시험은 난소암 및 CRC 환자에서 고무적인 결과를 보였으나, 회사가 추가 개발을 위한 파트너를 찾고 있는 동안 종료될 것입니다. 재무적으로, NextCure의 현금 및 현금 등가물은 2024년 1억 830만 달러에서 7,530만 달러로 감소했으며, 이는 주로 운영 비용 때문입니다. R&D 비용은 1,100만 달러에서 880만 달러로 줄어들었고, 일반 관리비용은 460만 달러에서 370만 달러로 감소했습니다. 분기의 순 손실은 1,150만 달러로, 2023년 같은 기간의 1,430만 달러에서 감소했습니다.
NextCure a fourni une mise à jour de son activité et a présenté ses résultats financiers du troisième trimestre 2024. L'entreprise se concentre sur LNCB74 (B7-H4 ADC) avec une soumission d'IND prévue d'ici la fin de l'année et vise à entrer dans les essais de phase 1. Les réserves de liquidités de NextCure, d'environ 75 millions de dollars, devraient financer les opérations jusqu'à la seconde moitié de 2026. L'essai combiné NC410 a montré des résultats encourageants chez les patients atteints de cancer de l'ovaire et de CRC, mais prendra fin alors que l'entreprise recherche un partenaire pour un développement ultérieur. Sur le plan financier, la trésorerie et les équivalents de NextCure ont diminué de 108,3 millions de dollars à 75,3 millions de dollars en 2024, principalement en raison des frais d'exploitation. Les dépenses de R&D ont chuté à 8,8 millions de dollars, contre 11 millions de dollars, et les frais généraux ont baissé à 3,7 millions de dollars, contre 4,6 millions de dollars. La perte nette pour le trimestre s'est élevée à 11,5 millions de dollars, en baisse par rapport à 14,3 millions de dollars au cours de la même période en 2023.
NextCure hat ein Unternehmensupdate bereitgestellt und über die finanziellen Ergebnisse des dritten Quartals 2024 berichtet. Das Unternehmen konzentriert sich auf LNCB74 (B7-H4 ADC) mit einer geplanten IND-Einreichung bis Ende des Jahres und hat das Ziel, in die Phase-1-Studien überzugehen. Die Barreserven von NextCure in Höhe von etwa 75 Millionen US-Dollar sollen die Geschäftstätigkeit bis zur zweiten Hälfte des Jahres 2026 finanzieren. Die Kombinationstestung NC410 zeigte ermutigende Ergebnisse bei Patientinnen mit Ovarialkarzinom und CRC, wird aber enden, da das Unternehmen einen Partner für die weitere Entwicklung sucht. Finanzielle gesehen sind die liquiden Mittel und Äquivalente von NextCure von 108,3 Millionen US-Dollar auf 75,3 Millionen US-Dollar im Jahr 2024 gesunken, hauptsächlich aufgrund betrieblicher Aufwendungen. Die F&E-Ausgaben sanken von 11 Millionen US-Dollar auf 8,8 Millionen US-Dollar, und die allgemeinen Verwaltungskosten fielen von 4,6 Millionen US-Dollar auf 3,7 Millionen US-Dollar. Der Nettoverlust für das Quartal betrug 11,5 Millionen US-Dollar, ein Rückgang von 14,3 Millionen US-Dollar im gleichen Zeitraum 2023.
- NextCure's planned IND submission for LNCB74 by year-end.
- Encouraging Phase 1b results for NC410 in ovarian cancer and CRC patients.
- Financial resources expected to fund operations into the second half of 2026.
- Decreased R&D expenses to $8.8 million from $11.0 million.
- Decreased G&A expenses to $3.7 million from $4.6 million.
- Reduced net loss to $11.5 million from $14.3 million.
- Cash reserves decreased from $108.3 million to $75.3 million.
- NC410 trial conclusion without a partner yet secured.
- Prioritize and focus resources on LNCB74 (B7-H4 ADC) with a planned IND submission by year-end
- Cash of approximately
$75 million expected to fund operations into second half of 2026
BELTSVILLE, Md., Nov. 07, 2024 (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 2024 financial results.
“The November SITC presentation of LNCB74 preclinical data will highlight the differentiation of our B7-H4 ADC from other ADC’s that also target B7-H4. We plan to file an IND in the fourth quarter of this year and advance into Phase 1, shortly following receipt of an FDA safe-to-proceed letter,” said Michael Richman, NextCure’s president and CEO. “Additionally, while the NC410 combo has shown encouraging Phase 1b clinical activity in both ovarian cancer and CRC patients, we plan to conclude the current trial and seek a partner to advance the program, allowing us to focus our resources on advancing the development of LNCB74.”
Business Highlights and Near-Term Milestones
LNCB74 (B7-H4 ADC)
- Leveraging LigaChem Biosciences, Inc. glucuronidase cleavable site-specific linkage as part of a collaboration agreement that includes a 50-50 cost sharing of external development expenses and certain internal cost sharing associated with the development of the antibody- drug conjugate (ADC) program.
- Preclinical data from LNCB74 (B7-H4 ADC) will be presented at the Society of Immunotherapy of Cancer (SITC) annual meeting in November.
- Planned submission of an Investigational New Drug (IND) application in the fourth quarter of this year.
NC410 (LAIR-2 fusion)
- Additional colorectal cancer (CRC) patient Phase 1b clinical data along with biomarker data supporting mechanism of action to be presented at SITC annual meeting in November.
- As of October 14, 2024 (the cut-off date), 11 patients (4 with ovarian cancer and 7 with CRC) remain in the Phase 1b study evaluating NC410 in combination with pembrolizumab and will continue to be monitored while the study concludes.
- As of the cut-off date, the response rate for the ovarian cancer patients that were immune checkpoint inhibitor (ICI) naïve was
25% based on 5 out of 20 patients, which consisted of 2 partial responses (PRs) at 200 mg, and 3 PRs at 100mg in ICI naïve. - As of the cut-off date, the 100 mg cohort CRC response rate was
8.3% based on 3 out of 36 patients, which consisted of 3 PRs in ICI naïve, MSS/microsatellite instability-low with a disease control rate (DCR) of47% (17/36), median disease control (mDC) duration of 8.5 months, and median duration of response of 15.2 months. A 200 mg CRC cohort of 7 showed no clinical responses with a DCR of86% (6/7) and a mDC duration of 8.3 months. - Will seek a partner or pursue third party financing to advance NC410 in further clinical trials.
Preclinical Non-Oncology Programs Seeking Third Party Financing
- NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease (AD). In preclinical AD animal models, NC181 has demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation.
- NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI). Preclinical data reported that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI.
- Both programs could lead to IND filings within 12 to 18 months if financial support from third parties is secured.
Financial Results for Quarter Ended September 30, 2024
- Cash, cash equivalents, and marketable securities as of September 30, 2024 were
$75.3 million as compared to$108.3 million as of December 31, 2023. The decrease of$33.0 million was primarily due to cash used to fund operations. NextCure expects financial resources to fund operating expenses and capital expenditures into the second half of 2026. - Research and development expenses were
$8.8 million for the three months ended September 30, 2024, as compared to$11.0 million for the three months ended September 30, 2023. Net costs on the LNCB74 program were more than offset by lower costs on other programs and preclinical development and lower personnel-related costs. - General and administrative expenses were
$3.7 million for the three months ended September 30, 2024, as compared to$4.6 million for the three months ended September 30, 2023. The decrease of$0.9 million was primarily related to lower payroll, lower stock compensation expense and lower insurance costs. - Net loss was
$11.5 million for the three months ended September 30, 2024, as compared to a net loss of$14.3 million for the three months ended September 30, 2023.
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 differentiated mechanisms of actions including antibody-drug conjugates, antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. www.nextcure.com
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; 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 | Nine Months Ended | |||||||||||||
| September 30, | September 30, | ||||||||||||||
| (in thousands, except share and per share amounts) | 2024 | 2023 | 2024 | 2023 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 8,770 | $ | 11,010 | $ | 32,586 | $ | 36,104 | |||||||
| General and administrative | 3,725 | 4,608 | 12,165 | 15,743 | |||||||||||
| Restructuring and asset impairment | — | — | 2,542 | — | |||||||||||
| Loss from operations | (12,495 | ) | (15,618 | ) | (47,293 | ) | (51,847 | ) | |||||||
| Other income, net | 955 | 1,317 | 3,242 | 3,591 | |||||||||||
| Net loss | $ | (11,540 | ) | $ | (14,301 | ) | $ | (44,051 | ) | $ | (48,256 | ) | |||
| Net loss per common share - basic and diluted | $ | (0.41 | ) | $ | (0.51 | ) | $ | (1.58 | ) | $ | (1.73 | ) | |||
| Weighted-average shares outstanding - basic and diluted | 27,975,840 | 27,839,968 | 27,950,634 | 27,814,655 | |||||||||||
| Selected Balance Sheet Items: | |||||||||||||||
| September 30, | December 31, | ||||||||||||||
| (in thousands) | 2024 | 2023 | |||||||||||||
| Cash, cash equivalents, and marketable securities | $ | 75,308 | $ | 108,299 | |||||||||||
| Total assets | $ | 90,345 | $ | 128,038 | |||||||||||
| Accounts payable and accrued liabilities | $ | 8,672 | $ | 6,883 | |||||||||||
| Total stockholders' equity | $ | 75,592 | $ | 114,421 | |||||||||||
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
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