Y-mAbs Provides Strategic Business Update and 2025 Priorities
Y-mAbs Therapeutics (YMAB) announces strategic reorganization into two business units: Radiopharmaceuticals and DANYELZA. The company reports preliminary unaudited total net revenue of approximately $88 million for 2024, within guidance, and cash position of $67 million as of December 31, 2024, expected to support operations into 2027.
The company's GD2-SADA Phase 1 trial has dosed 21 patients across six sites, showing promising tolerability with no dose-limiting toxicities. Part A data presentation is expected in Q2 2025. The reorganization includes a workforce reduction of up to 13% and relocation of some roles from Denmark to the U.S.
Key 2025 milestones include presenting GD2-SADA optimization data, dosing the first patient in CD38-SADA Phase 1 trial in Q1, and potential DANYELZA marketing approval in new ex-U.S. markets.
Y-mAbs Therapeutics (YMAB) annuncia una riorganizzazione strategica in due unità operative: Radiofarmaci e DANYELZA. La società riporta un fatturato netto totale preliminare e non verificato di circa 88 milioni di dollari per il 2024, in linea con le previsioni, e una posizione di liquidità di 67 milioni di dollari al 31 dicembre 2024, prevista per supportare le operazioni fino al 2027.
Lo studio clinico di Fase 1 GD2-SADA ha trattato 21 pazienti in sei centri, mostrando una tollerabilità promettente senza tossicità limitanti da dose. La presentazione dei dati della Parte A è attesa nel secondo trimestre del 2025. La riorganizzazione comprende una riduzione della forza lavoro fino al 13% e il trasferimento di alcuni ruoli dalla Danimarca agli Stati Uniti.
I principali traguardi del 2025 includono la presentazione dei dati di ottimizzazione di GD2-SADA, il trattamento del primo paziente nello studio clinico di Fase 1 CD38-SADA nel primo trimestre, e la potenziale approvazione per la commercializzazione di DANYELZA in nuovi mercati al di fuori degli Stati Uniti.
Y-mAbs Therapeutics (YMAB) anuncia una reorganización estratégica en dos unidades de negocio: Radiofármacos y DANYELZA. La compañía informa de unos ingresos netos preliminares no auditados de aproximadamente 88 millones de dólares para 2024, dentro de la guía, y una posición de efectivo de 67 millones de dólares al 31 de diciembre de 2024, que se espera que apoye las operaciones hasta 2027.
El ensayo de Fase 1 de GD2-SADA ha administrado medicamento a 21 pacientes en seis sitios, mostrando una tolerabilidad prometedora sin toxicidades limitantes de dosis. Se espera la presentación de datos de la Parte A en el segundo trimestre de 2025. La reorganización incluye una reducción de la fuerza laboral de hasta el 13% y la reubicación de algunos roles de Dinamarca a Estados Unidos.
Los hitos clave para 2025 incluyen presentar datos de optimización de GD2-SADA, administrar el primer tratamiento al paciente en el ensayo de Fase 1 de CD38-SADA en el primer trimestre, y la posible aprobación de comercialización de DANYELZA en nuevos mercados fuera de Estados Unidos.
Y-mAbs Therapeutics (YMAB)는 방사선의약품과 DANYELZA라는 두 개의 사업 단위로 전략적 조직 개편을 발표했습니다. 이 회사는 2024년 예상 매출 총액이 약 8,800만 달러에 이를 것이라고 보고했으며, 2024년 12월 31일 기준으로 6,700만 달러의 현금 보유액을 보유하고 있으며, 이는 2027년까지 운영을 지원할 것으로 예상됩니다.
회사의 GD2-SADA 1상 시험은 6개 장소에서 21명의 환자에게 투약되었으며, 용량 제한 독성이 없는 유망한 내약성을 보여주었습니다. Part A 데이터 발표는 2025년 2분기에 예상됩니다. 조직 개편에는 최대 13%의 인력 감축과 덴마크에서 미국으로 일부 역할 이전이 포함됩니다.
2025년의 주요 이정표에는 GD2-SADA 최적화 데이터 발표, 1분기에 CD38-SADA 1상 시험에서 첫 환자의 투약, 그리고 DANYELZA의 미국 외 신규 시장에서의 잠재적 마케팅 승인 등이 포함됩니다.
Y-mAbs Therapeutics (YMAB) annonce une réorganisation stratégique en deux unités d'affaires : les radio-pharmaceutiques et DANYELZA. La société fait état d'un chiffre d'affaires net total préliminaire non audité d'environ 88 millions de dollars pour 2024, conforme aux prévisions, et d'une position de trésorerie de 67 millions de dollars au 31 décembre 2024, qui devrait soutenir les opérations jusqu'en 2027.
Le premier essai de GD2-SADA a traité 21 patients dans six sites, montrant une tolérance prometteuse sans toxicités limitantes par rapport à la dose. La présentation des données de la Partie A est attendue au deuxième trimestre 2025. La réorganisation implique une réduction de l'effectif allant jusqu'à 13 % et le transfert de certains rôles du Danemark vers les États-Unis.
Les principales étapes de 2025 incluent la présentation des données d'optimisation de GD2-SADA, l'administration de la première dose à un patient dans l'essai de Phase 1 CD38-SADA au premier trimestre, et une approbation potentielle de la commercialisation de DANYELZA sur de nouveaux marchés hors des États-Unis.
Y-mAbs Therapeutics (YMAB) kündigt eine strategische Umstrukturierung in zwei Geschäftseinheiten an: Radionuklide und DANYELZA. Das Unternehmen berichtet von einem vorläufigen, ungeprüften Nettoumsatz von etwa 88 Millionen Dollar für 2024, innerhalb der Richtlinien, und einer Liquidität von 67 Millionen Dollar zum 31. Dezember 2024, die voraussichtlich die Betriebe bis 2027 unterstützen wird.
Die GD2-SADA-Phase-1-Studie hat 21 Patienten an sechs Standorten behandelt und zeigt eine vielversprechende Verträglichkeit ohne dosislimitierende Toxizitäten. Die Datenpräsentation aus Teil A wird im zweiten Quartal 2025 erwartet. Die Umstrukturierung umfasst eine Reduzierung der Belegschaft um bis zu 13% und die Verlagerung einiger Stellen von Dänemark in die USA.
Wichtige Meilensteine für 2025 sind die Präsentation von Optimierungsdaten zu GD2-SADA, die Verabreichung der ersten Dosis an einem Patienten in der Phase-1-Studie zu CD38-SADA im ersten Quartal und die mögliche Zulassung von DANYELZA in neuen Märkten außerhalb der USA.
- Preliminary 2024 revenue of $88M within guidance range
- Strong cash position of $67M expected to support operations into 2027
- Lower than expected cash burn of $11M for 2024
- Positive preliminary safety data from GD2-SADA Phase 1 trial with no dose-limiting toxicities
- 13% workforce reduction planned
- Operational restructuring and relocation of roles from Denmark to U.S.
Insights
The financial performance reveals a company in transformation, with
The strategic reorganization into two business units and
The preliminary GD2-SADA Phase 1 trial results mark a significant technical validation of the SADA PRIT platform. The absence of dose-limiting toxicities and treatment-related adverse events in 21 patients across multiple tumor types (SCLC, melanoma, sarcomas, adult neuroblastoma) suggests a promising safety profile. The pre-targeted approach's demonstrated tolerability addresses a critical challenge in radioimmunotherapy.
The parallel advancement of CD38-SADA trial initiation expands the platform's potential applications. The SADA PRIT technology's ability to deliver targeted payloads while minimizing off-target exposure represents a potential paradigm shift in radioimmunotherapy, offering improved therapeutic windows and operational efficiencies compared to traditional approaches.
The company's strategic bifurcation positions it to capture value in both established and emerging markets. DANYELZA's unique position as the only FDA-approved treatment for high-risk relapsed/refractory neuroblastoma provides a stable revenue base. The optimization of the commercial team around GD2 market opportunities suggests untapped potential in the current indication.
The radiopharmaceuticals unit's focus on the SADA PRIT platform represents a significant market opportunity. The platform's advantages in physician adoption and reduced infrastructure requirements could accelerate market penetration. The planned pipeline expansion into new high-value target indications in Q2 2025 could substantially expand the addressable market.
Company establishes two business units with goal of accelerating the advancement of its Radiopharmaceuticals Platform and optimizing the commercial potential of DANYELZA
Preliminary Part A data from GD2-SADA Phase 1 trial demonstrates tolerability and validity of SADA PRIT platform pre-targeting approach; Company expects to present Part A data in the second quarter of 2025
Company reports preliminary estimated unaudited Total Net Revenue of approximately
Company reports preliminary estimated unaudited cash, cash equivalents and marketable securities of approximately
Company presenting at 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2024 at 5:15 p.m. PT
NEW YORK, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced strategic business updates and 2025 priorities in the Company’s mission to improve and extend people’s lives.
Business Update
Y-mAbs is internally realigning operations with the establishment of two business units: Radiopharmaceuticals and DANYELZA.
- Radiopharmaceuticals
- Novel Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy (“SADA PRIT”) platform designed to improve upon traditional radioimmunotherapy by delivering high therapeutic dose while minimizing off-target exposure, increase physician participation and decrease manufacturing and infrastructure costs.
- SADA PRIT technology utilizes a pre-targeted payload delivery method where antibody constructs assemble in tetramers and bind to the tumor target.
- Platform can deliver a variety of payloads and could potentially be developed against multiple tumor targets, as well as for radiopharmaceutical purposes.
- Y-mAbs is currently evaluating its SADA PRIT technology in two clinical trials in the U.S.
- DANYELZA
- DANYELZA is a GD2 antibody and the only FDA-approved treatment for the treatment of patients one-year of age and older with high-risk relapsed/refractory neuroblastoma in the bone and bone marrow.
- Initially commercially launched in 2021, DANYELZA is commercialized across both U.S. and international markets.
The business realignment is designed to support the optimization of internal resources and provide flexibility and agility to advance the Company’s novel SADA PRIT platform programs through clinical development while simultaneously driving commercial growth of DANYELZA.
“Our mission at Y-mAbs has been clear from day one: bring important new cancer therapies to patients as quickly as possible. Since the successful commercial launch of DANYELZA, we are proud to have positively impacted the lives of children with high-risk relapsed/refractory neuroblastoma, giving the hope of a better future to families around the world,” said Michael Rossi, President and Chief Executive Officer. “As we look ahead to the potential of our novel Radiopharmaceutical platform and high value therapeutic areas, as well as the potential of DANYELZA, we believe now is the right time to focus our efforts in two business units. By doing so, we expect to expand our radiopharmaceutical capabilities, accelerate clinical execution, further improve capital efficiencies, and better align strategic priorities.”
With these updates to the business strategy, Y-mAbs anticipates a reduction in its current workforce of up to approximately
Recent Pipeline Advancement
GD2-SADA (Trial 1001): Y-mAbs has dosed 21 patients at six sites to date in Part A of the GD2-SADA Phase 1 trial in adults with solid tumors. Tumor types include small cell lung cancer (SCLC), malignant melanoma, sarcomas and adult neuroblastoma. Preliminary data from the Part A GD2-SADA Phase 1 trial has demonstrated this novel pre-targeting approach to be well-tolerated with no dose-limiting toxicities (DLTs) and no treatment-related adverse events (AEs) reported. Part A remains ongoing as the Company aggregates final data on patients in open cohorts and continues to study further patients incorporating various elements to further optimize the platform aiming to maximize tumor uptake and retention. The Company expects to share data from Part A in the second quarter of 2025.
“The preliminary data from Part A of our GD2-SADA Phase 1 trial demonstrates the viability of the pre-targeted approach of the platform. We continue to gather learnings from the 21 patients dosed to date, which we anticipate will allow us to improve tumor uptake, determine the optimal therapeutic dose, and establish the ideal construct to further advance Trial 1001 in the clinic,” said Norman LaFrance, M.D., Chief Development Officer. “We believe in the significant potential of our SADA PRIT platform, and we are excited to be at the forefront of this next-generation, pre-targeted radiotherapy technology.”
CD38-SADA (Trial 1201): To date, six sites have been selected, and three sites have been activated. The Company expects to dose the first non-Hodgkin Lymphoma (NHL) patient in Study 1201 in the first quarter of 2025.
Unaudited Preliminary FY2024 Results
Y-mAbs reported preliminary estimated unaudited full year 2024 total net revenue of approximately
Anticipated 2025 Milestones
- Part A data from GD2-SADA Phase 1 trial (Trial 1001) expected to be presented in the second quarter of 2025
- GD2-SADA optimization data expected to be presented in the second quarter of 2025
- Expect to present updates with respect to reprioritized SADA PRIT pipeline, including new high-value target indications and timelines, in the second quarter of 2025
- Expect to dose first patient in CD38-SADA Phase 1 trial (Trial 1201) in the first quarter of 2025
- Potential for marketing approval of DANYELZA in new ex-U.S. market in 2025
- Plan to provide full year 2025 guidance in conjunction with full year 2024 earnings report in the first quarter of 2025
Upcoming Investor Presentation
The company previously announced that Mr. Rossi will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 15, 2025 at 5:15 p.m. PT. A live webcast will be available under the Events section of the Company’s investor relations website at ir.ymabs.com. The webcast will be archived and available for replay for 30 days after the event.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about: our business model, expectations with respect to estimated charges and expenses in connection with the business realignment plan, including the amounts and timing thereof, preliminary estimated financial results and expectations for the year ended December 31, 2024, including estimated operating expenses, cash and cash equivalents and net revenue; the realignment plan, including the reduction in workforce and operations and resources, and the expected impacts, anticipated expenses and benefits thereof, including operational flexibility and acceleration of clinical development within the radiopharmaceutical platform; implied and express statements regarding the future of the Company’s business; the Company’s strategies, development, regulatory, commercialization and product distribution plans; expectations with respect to the Company’s products and product candidates, including market access expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA PRIT technology platform and product candidates based on such technology; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA and the SADA PRIT technology, including anticipated collection and presentation of data, and the timing thereof; current and future clinical and pre-clinical studies and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; and other statements that are not historical facts. Words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goal,” “guidance,” “hope,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with our financial condition and need for additional capital; the risk that our reported results may differ materially from our preliminary estimated operating expense, cash and cash equivalent and DANYELZA net product revenue results as a result of the completion of year-end closing procedures, final adjustments, and other developments arising between now and the time that our financial results are finalized; the risks that actual results of the business realignment plan will not be as expected, including the impact on employees and other parties; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; risks related to our ability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock; risks associated with ongoing geopolitical conflicts; and other risks and uncertainties affecting the Company including those described in the “Risk Factors” section included in our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2024, and in our other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
SADA®, SADA PRIT®, DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.
Investor Contact:
Courtney Dugan
VP, Head of Investor Relations
cdu@ymabs.com
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