Correcting & Replacing – Y-mAbs Provides Strategic Business Update and 2025 Priorities
Y-mAbs Therapeutics (NASDAQ: YMAB) announced strategic updates and 2025 priorities, establishing two business units: Radiopharmaceuticals and DANYELZA. The company reported 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, with preliminary data showing good tolerability and no dose-limiting toxicities. Y-mAbs plans to present Part A data in Q2 2025. The business restructuring includes a workforce reduction of up to 13% and relocation of some roles from Denmark to the US to optimize radiopharmaceutical platform advancement.
The company expects to dose its first patient in the CD38-SADA Phase 1 trial in Q1 2025 and anticipates potential marketing approval for DANYELZA in new ex-US markets in 2025.
Y-mAbs Therapeutics (NASDAQ: YMAB) ha annunciato aggiornamenti strategici e priorità per il 2025, istituendo due unità di business: Radiofarmaceutici e DANYELZA. L'azienda ha riportato un fatturato netto totale preliminare non verificato di circa 88 milioni di dollari per il 2024, all'interno delle previsioni, e una posizione di cassa di 67 milioni di dollari al 31 dicembre 2024, prevista per sostenere le operazioni fino al 2027.
Il trial di Fase 1 GD2-SADA dell'azienda ha trattato 21 pazienti in sei siti, con dati preliminari che mostrano una buona tollerabilità e senza tossicità limitanti alla dose. Y-mAbs prevede di presentare i dati della Parte A nel secondo trimestre del 2025. La ristrutturazione aziendale include una riduzione della forza lavoro fino al 13% e il trasferimento di alcune posizioni dalla Danimarca agli Stati Uniti per ottimizzare l'avanzamento della piattaforma radiofarmaceutica.
L'azienda si aspetta di trattare il suo primo paziente nel trial CD38-SADA di Fase 1 nel primo trimestre del 2025 e prevede un potenziale approvazione per DANYELZA in nuovi mercati al di fuori degli Stati Uniti nel 2025.
Y-mAbs Therapeutics (NASDAQ: YMAB) anunció actualizaciones estratégicas y prioridades para 2025, estableciendo dos unidades de negocio: Radiofármacos y DANYELZA. La compañía reportó ingresos netos preliminares no auditados de aproximadamente 88 millones de dólares para 2024, dentro de las proyecciones, 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 GD2-SADA de la compañía ha administrado dosis a 21 pacientes en seis sitios, con datos preliminares que muestran una buena tolerabilidad y sin toxicidades limitantes por dosis. Y-mAbs planea presentar los datos de la Parte A en el segundo trimestre de 2025. La reestructuración empresarial incluye una reducción de la fuerza laboral de hasta un 13% y la reubicación de algunos roles de Dinamarca a los Estados Unidos para optimizar el avance de la plataforma de radiofármacos.
La empresa espera administrar la dosis a su primer paciente en el ensayo CD38-SADA de Fase 1 en el primer trimestre de 2025 y anticipa una posible aprobación de marketing para DANYELZA en nuevos mercados fuera de los Estados Unidos en 2025.
Y-mAbs Therapeutics (NASDAQ: YMAB)는 2025년을 위한 전략적 업데이트와 우선순위를 발표하며 두 개의 사업 부문: 방사선 의약품과 DANYELZA를 설립했습니다. 회사는 2024년 비공식 총 순수익이 약 8,800만 달러로 예상되며, 2025년 목표 범위 내에 있고, 2024년 12월 31일 기준 현금 보유액이 6,700만 달러로 2027년까지 운영을 지원할 것으로 기대하고 있습니다.
회사의 GD2-SADA 1상 시험은 6개 사이트에서 21명의 환자에게 투여되었으며, 초기 데이터는 좋은 내약성과 용량 제한 독성이 없음을 보여주고 있습니다. Y-mAbs는 2025년 2분기에 Part A 데이터를 발표할 계획입니다. 사업 재구성에는 최대 13%의 인력 감축과 덴마크에서 미국으로 일부 역할을 이전하여 방사선 의약품 플랫폼을 최적화하는 것이 포함됩니다.
회사는 2025년 1분기 CD38-SADA 1상 시험에서 첫 번째 환자에게 투여할 예정이며, 2025년에는 미국 외 새로운 시장에서 DANYELZA의 마케팅 승인을 받을 것으로 예상하고 있습니다.
Y-mAbs Therapeutics (NASDAQ: YMAB) a annoncé des mises à jour stratégiques et des priorités pour 2025, créant deux unités commerciales : les radiopharmaceutiques et DANYELZA. La société a rapporté des revenus nets totaux préliminaires non audités d'environ 88 millions de dollars pour 2024, dans les prévisions, et une position de trésorerie de 67 millions de dollars au 31 décembre 2024, qui devrait soutenir ses opérations jusqu'en 2027.
L'essai de phase 1 GD2-SADA de la société a administré des doses à 21 patients sur six sites, avec des données préliminaires montrant une bonne tolérance et aucune toxicité limite par dose. Y-mAbs prévoit de présenter les données de la Partie A au deuxième trimestre 2025. La réorganisation de l'entreprise inclut une réduction de la main-d'œuvre allant jusqu'à 13 % et la relocalisation de certains postes du Danemark vers les États-Unis pour optimiser l'avancement de la plateforme de radiopharmaceutiques.
L'entreprise s'attend à administrer sa première dose à un patient dans l'essai CD38-SADA de phase 1 au premier trimestre 2025 et anticipe une éventuelle approbation marketing pour DANYELZA sur de nouveaux marchés hors des États-Unis en 2025.
Y-mAbs Therapeutics (NASDAQ: YMAB) gab strategische Updates und Prioritäten für 2025 bekannt und gründete zwei Geschäftsbereiche: Radiopharmazeutika und DANYELZA. Das Unternehmen berichtete über preliminäre, nicht überprüfte Gesamtnettoeinnahmen von etwa 88 Millionen Dollar für 2024, innerhalb der Prognose, sowie eine Liquiditätsposition von 67 Millionen Dollar am 31. Dezember 2024, die voraussichtlich die Geschäftstätigkeit bis 2027 unterstützen wird.
Die GD2-SADA Phase-1-Studie des Unternehmens hat 21 Patienten an sechs Standorten behandelt, wobei erste Daten eine gute Verträglichkeit und keine dosislimitierenden Toxizitäten zeigen. Y-mAbs plant, die Daten von Teil A im zweiten Quartal 2025 zu präsentieren. Die Unternehmensumstrukturierung umfasst eine Reduzierung der Belegschaft um bis zu 13% und die Verlagerung einiger Rollen von Dänemark in die USA zur Optimierung des Fortschritts der radiopharmazeutischen Plattform.
Das Unternehmen erwartet, im ersten Quartal 2025 seinen ersten Patienten in der CD38-SADA Phase-1-Studie zu behandeln und rechnet mit einer potenziellen Marktzulassung für DANYELZA in neuen Märkten außerhalb der USA im Jahr 2025.
- 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 in 2024, below guidance of $15-20M
- Positive preliminary GD2-SADA Phase 1 trial data showing good tolerability
- 13% workforce reduction planned
- Operational restructuring and relocation of roles from Denmark to US
Insights
The preliminary
The
The preliminary data from GD2-SADA Phase 1 trial marks a important validation point for Y-mAbs' novel radioimmunotherapy platform. The absence of dose-limiting toxicities and treatment-related adverse events in the initial 21 patients across multiple tumor types (SCLC, melanoma, sarcomas, adult neuroblastoma) demonstrates a favorable safety profile for this pre-targeted approach.
The advancement of CD38-SADA into clinical trials with first patient dosing expected in Q1 2025 indicates pipeline expansion potential. The SADA PRIT platform's ability to deliver targeted payloads while minimizing off-target exposure could represent a significant advancement over traditional radioimmunotherapy approaches, particularly in addressing manufacturing and infrastructure challenges.
The establishment of separate Radiopharmaceuticals and DANYELZA business units reflects a strategic pivot to maximize value from both commercial and development assets. DANYELZA's position as the only FDA-approved treatment for high-risk relapsed/refractory neuroblastoma provides a stable revenue base, while the radiopharmaceuticals unit can focus on advancing the innovative SADA platform.
The geographical consolidation of operations from Denmark to the U.S. should streamline development efforts and improve operational efficiency. The planned presentation of Part A data and pipeline reprioritization in Q2 2025 could serve as significant catalysts for market revaluation of Y-mAbs' therapeutic potential in the rapidly growing radiopharmaceutical space.
Company establishes two business units with goal of accelerating clinical development 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
Correcting & Replacing: Y-mAbs Therapeutics, Inc. is re-issuing in entirety its press release, originally issued on January 10, 2025 at 7:05 a.m. ET, to correct a scrivener’s error in the presentation of the previously announced total net revenue guidance.
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 towards 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 into 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 our business strategy, the Company 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 for DANYELZA in new ex-US 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”) Pre-targeted 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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