Vincerx Pharma to Implement Cost-Controls to Support Advancing Phase 1 Study of VIP943
Vincerx Pharma (VINC) announced cost-control measures and strategic alternatives exploration to support its Phase 1 study of VIP943, a CD123-targeted antibody-drug conjugate. The clinical trial has shown promising results, with one acute myeloid leukemia patient achieving CRi and one high-risk myelodysplastic syndrome patient achieving CRL out of nine evaluable patients. The company will implement a 55% workforce reduction to focus resources on VIP943's advancement.
Strategic options under consideration include out-licensing, mergers and acquisitions, reverse mergers, and asset sales. The company reported approximately $8.4 million in cash, cash equivalents, and marketable securities as of October 31, 2024. Additional cohort results are expected by early Q1 2025.
Vincerx Pharma (VINC) ha annunciato misure di controllo dei costi e l'esplorazione di alternative strategiche per supportare il suo studio di Fase 1 su VIP943, un coniugato anticorpale diretto contro CD123. La sperimentazione clinica ha mostrato risultati promettenti, con un paziente affetto da leucemia mieloide acuta che ha raggiunto una CRi e un paziente con sindrome mielodisplastica ad alto rischio che ha raggiunto una CRL su nove pazienti valutabili. L'azienda attuerà una riduzione del personale del 55% per concentrare le risorse sull'avanzamento di VIP943.
Le opzioni strategiche sotto considerazione includono licensing esterno, fusioni e acquisizioni, fusioni inverse e vendita di attivi. L'azienda ha riportato circa 8,4 milioni di dollari in contante, equivalenti di contante e titoli negoziabili al 31 ottobre 2024. Ulteriori risultati dei gruppi sono attesi entro inizio Q1 2025.
Vincerx Pharma (VINC) anunció medidas de control de costos y la exploración de alternativas estratégicas para apoyar su estudio de Fase 1 de VIP943, un conjugado de anticuerpo y fármaco dirigido a CD123. El ensayo clínico ha mostrado resultados prometedores, con un paciente con leucemia mieloide aguda logrando CRi y un paciente con síndrome mielodisplástico de alto riesgo alcanzando CRL de nueve pacientes evaluables. La compañía implementará una reducción del 55% en su fuerza laboral para concentrar recursos en el avance de VIP943.
Las opciones estratégicas bajo consideración incluyen licenciamiento externo, fusiones y adquisiciones, fusiones inversas y ventas de activos. La compañía reportó aproximadamente 8.4 millones de dólares en efectivo, equivalentes de efectivo y valores negociables al 31 de octubre de 2024. Se esperan resultados adicionales de cohortes para principios del Q1 2025.
Vincerx Pharma (VINC)는 CD123 표적 항체-약물 결합체인 VIP943의 1상 연구를 지원하기 위해 비용 절감 조치와 전략적 대안 탐색을 발표했습니다. 임상 시험에서는 한 급성 골수성 백혈병 환자가 CRi에 도달하고, 아홉 명의 평가 가능한 환자 중 한 명의 고위험 조혈모세포증 환자가 CRL에 도달하는 등의 유망한 결과를 보였습니다. 회사는 VIP943의 발전에 자원을 집중하기 위해 직원 수를 55% 축소할 것입니다.
고려 중인 전략적 옵션에는 아웃 라이센스, 인수 합병, 역합병 및 자산 매각이 포함됩니다. 회사는 2024년 10월 31일 현재 약 840만 달러의 현금, 현금 등가물 및 유가증권을 보유하고 있다고 보고했습니다. 추가 코호트 결과는 2025년 1분기 초에 기대됩니다.
Vincerx Pharma (VINC) a annoncé des mesures de contrôle des coûts et l'exploration d'alternatives stratégiques pour soutenir son étude de Phase 1 sur VIP943, un conjugué anticorps-médicament ciblant CD123. L'essai clinique a montré des résultats prometteurs, avec un patient atteint de leucémie myéloïde aiguë atteignant CRi et un patient à haut risque de syndrome myélodysplasique atteignant CRL sur neuf patients évaluables. L'entreprise mettra en œuvre une réduction de 55% de sa main-d'œuvre pour concentrer les ressources sur l'avancement de VIP943.
Les options stratégiques en cours d'examen incluent la licence extérieure, les fusions et acquisitions, les fusions inversées et la vente d'actifs. L'entreprise a déclaré avoir environ 8,4 millions de dollars en liquidités, équivalents de liquidités et valeurs mobilières négociables au 31 octobre 2024. Des résultats supplémentaires de cohortes sont attendus d'ici début Q1 2025.
Vincerx Pharma (VINC) hat Maßnahmen zur Kostenkontrolle und die Untersuchung strategischer Alternativen zur Unterstützung seiner Phase-1-Studie zu VIP943, einem auf CD123 zielgerichteten Antikörper-Arzneimittel-Konjugat, angekündigt. Die klinische Studie hat vielversprechende Ergebnisse gezeigt, wobei ein Patient mit akuter myeloischer Leukämie CRi erzielte und ein Patient mit Hochrisiko-myelodysplastischem Syndrom CRL bei neun evaluierbaren Patienten erzielte. Das Unternehmen plant eine Reduzierung der Belegschaft um 55%, um Ressourcen auf den Fortschritt von VIP943 zu konzentrieren.
Zu den in Betracht gezogenen strategischen Optionen gehören Out-Lizenzierungen, Fusionen und Übernahmen, umgekehrte Fusionen und den Verkauf von Vermögenswerten. Das Unternehmen berichtete zum 31. Oktober 2024 von etwa 8,4 Millionen Dollar in Bargeld, Bargeldäquivalenten und handelbaren Wertpapieren. Weitere Kohortenergebnisse werden für Anfang des 1. Quartals 2025 erwartet.
- Encouraging Phase 1 trial results with 2 responses out of 9 evaluable patients
- One patient showing continued improvement with only 1% cancer cells after 7 months
- Cost reduction initiative through 55% workforce reduction to extend cash runway
- cash position of $8.4M as of October 31, 2024
- Need for additional funding or strategic alternatives to continue operations
- Significant workforce reduction may impact operational capabilities
Insights
The implementation of cost-controls and strategic review at Vincerx Pharma represents a critical financial situation. With only
The focus on VIP943's Phase 1 study, while showing promising early clinical results, comes at a important time when biotech funding is challenging. Strategic options including M&A, reverse mergers, or asset sales could provide necessary capital, but the company's position may weaken further if additional funding isn't secured quickly. The stock faces significant near-term pressure due to cash constraints and uncertainty around strategic alternatives.
The preliminary efficacy data from VIP943's Phase 1 study shows encouraging signs, particularly in difficult-to-treat populations. The CRi achievement in a post-transplant relapsed AML patient, with continued improvement to 1% cancer cells over seven months, is noteworthy. The additional CRL response in HR-MDS further validates the potential of the VersAptx platform technology.
However, the small patient population (nine evaluable patients) and early stage of development create significant uncertainty. The planned cost-cutting measures could potentially impact the study's progression and data collection timeline. While the Q1 2025 data readout from additional cohorts could provide valuable insights, the company's financial constraints may compromise the program's full potential.
Also Exploring Strategic Alternatives to Complement Fundraising Efforts
PALO ALTO, Calif., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced plans to implement cost-controls and explore strategic alternatives to support advancing the Phase 1 study of VIP943, the Company’s novel CD123-targeted antibody-drug conjugate (ADC) developed with the Company’s next-generation VersAptx™ platform.
“We believe VIP943 is a highly differentiated and valuable asset, and we remain fully committed to advancing this program,” said Ahmed Hamdy, M.D., Chief Executive Officer. “As we shared in October, the Phase 1 dose-escalation study of VIP943 has demonstrated encouraging safety, efficacy, and tolerability. Of nine evaluable patients, one patient whose acute myeloid leukemia (AML) relapsed post-transplant achieved a CRi and one patient with higher-risk myelodysplastic syndrome (HR-MDS) achieved a CRL. Notably, since October, the patient with CRi has continued to improve, with their most recent bone marrow results showing only
Dr. Hamdy continued, “Our immediate focus is to give the program time to generate more data, with results from additional cohorts expected by early Q1 2025. To support this, we are implementing significant cost-cutting measures to focus resources on VIP943’s advancement. Additionally, we will begin exploring strategic alternatives to complement our ongoing fundraising efforts, with the goal of maximizing the value of the VIP943 program and our VersAptx platform.”
As part of its review of potential strategic alternatives, Vincerx will consider options such as out-licensing, merger and acquisition opportunities, including reverse mergers, sales of assets and technologies, and other transactions. To streamline operations and focus resources, Vincerx will implement a significant reduction in force of approximately
Vincerx has not set a timetable for completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its exploration of strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary.
As of October 31, 2024, the Company had approximately
About VIP943
VIP943, the first ADC from the VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerx’s CellTrapper™ technology. Vincerx’s proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. VIP943 is being evaluated in a Phase 1 dose-escalation trial in patients with relapsed/refractory AML, HR-MDS, and B-ALL who have exhausted standard therapeutic options (NCT06034275).
About VersAptx Platform
VersAptx is a versatile and adaptable next-generation bioconjugation platform. The modular nature of this innovative platform allows the combination of different targeting, linker, and payload technologies to develop bespoke bioconjugates that address different cancer biologies. With this platform, (i) antibodies and small molecules can be used to target different tumor antigens, (ii) linkers can be designed to reduce non-specific release of the payload, cleave intracellularly or extracellularly, and conjugate to single or multiple payloads, and (iii) payloads can be designed with reduced permeability using our CellTrapper technology to ensure accumulation in cancer cells or to be permeable for release in the tumor microenvironment. The VersAptx platform allows the development of bioconjugates designed to address the safety and efficacy challenges of historical ADCs.
About Vincerx Pharma, Inc.
Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. Vincerx’s diverse pipeline consists of a next-generation antibody drug conjugate (ADC) VIP943, currently in Phase 1; a small molecule drug conjugate VIP236, which has completed its Phase 1; a CDK9 inhibitor enitociclib, which has completed a Phase 1 monotherapy study and continues in a Phase 1 study in collaboration with the NIH; a preclinical ADC VIP924; and VersAptx, a versatile, next-generation bioconjugation platform.
Vincerx is based in Palo Alto, California, and has a research subsidiary in Monheim, Germany.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, plans, timing, and disclosure regarding strategic alternatives, product candidates and attributes, expectations regarding advancement, development, timing, and results of product candidates, and engagement of a financial advisor. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside Vincerx’s control.
Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to, Vincerx’s capital requirements and availability and sufficiency of capital; Vincerx’s ability to continue as a going concern; risks that Vincerx’s activities to evaluate and pursue potential strategic alternatives may not result in a transaction that enhances stockholder value on a timely basis or at all; risks related to Vincerx’s ability to reduce its expenses, and costs and expenses related to its streamlined operating plan; risks associated with clinical development of Vincerx’s product candidates; general economic, financial, legal, political, and business conditions; and the risks and uncertainties set forth in the Form 10-Q for the quarter ended September 30, 2024 and subsequent reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.
Vincerx, the Vincerx logo, CellTrapper, and VersAptx are trademarks of Vincerx.
Contacts:
Gabriela Jairala
Vincerx Pharma, Inc.
gabriela.jairala@vincerx.com
Totyana Simien
Inizio Evoke Comms
totyana.simien@inizioevoke.com
FAQ
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