IO Biotech Reports 2024 Business Highlights
IO Biotech (IOBT) reported key developments in Q4 2024 for its therapeutic cancer vaccine Cylembio®. The company's pivotal Phase 3 trial completed enrollment ahead of schedule with 407 patients, with primary endpoint readout expected in Q3 2025. A Biologics License Application (BLA) submission to FDA is planned by year-end 2025.
The company's Phase 2 basket trial for resectable melanoma and head and neck cancer completed enrollment with 95 patients, with initial data expected in H2 2025. The Phase 2 trial IOB-022/KN-D38 met its primary endpoint of overall response rate in head and neck cancer, with promising activity in lung cancer treatment.
Financial position shows $60.0 million in cash and equivalents at Q4 2024 end, supplemented by up to €57.5 million in EIB debt financing. The committed tranches are expected to extend cash runway into Q2 2026.
IO Biotech (IOBT) ha riportato sviluppi chiave nel quarto trimestre del 2024 per il suo vaccino terapeutico contro il cancro Cylembio®. Il trial di Fase 3 dell'azienda ha completato l'arruolamento anticipatamente con 407 pazienti, con la lettura del punto finale primario prevista per il terzo trimestre del 2025. Una domanda di licenza biologica (BLA) all'FDA è pianificata entro la fine del 2025.
Il trial di Fase 2 dell'azienda per melanoma resezionabile e cancro testa-collo ha completato l'arruolamento con 95 pazienti, con dati iniziali attesi nel secondo semestre del 2025. Il trial di Fase 2 IOB-022/KN-D38 ha raggiunto il suo obiettivo primario di tasso di risposta globale nel cancro testa-collo, mostrando un'attività promettente nel trattamento del cancro ai polmoni.
La posizione finanziaria mostra 60,0 milioni di dollari in contante e equivalenti alla fine del quarto trimestre del 2024, integrata da fino a 57,5 milioni di euro in finanziamenti debitori EIB. I tranches impegnati dovrebbero estendere la liquidità fino al secondo trimestre del 2026.
IO Biotech (IOBT) reportó desarrollos clave en el cuarto trimestre de 2024 para su vacuna terapéutica contra el cáncer Cylembio®. El ensayo de Fase 3 de la compañía completó la inscripción antes de lo previsto con 407 pacientes, y se espera que el resultado del objetivo primario se publique en el tercer trimestre de 2025. Se planea presentar una Solicitud de Licencia Biológica (BLA) a la FDA para finales de 2025.
El ensayo de Fase 2 de la compañía para melanoma resecable y cáncer de cabeza y cuello completó la inscripción con 95 pacientes, y se esperan datos iniciales en la segunda mitad de 2025. El ensayo de Fase 2 IOB-022/KN-D38 cumplió su objetivo primario de tasa de respuesta global en cáncer de cabeza y cuello, mostrando una actividad prometedora en el tratamiento del cáncer de pulmón.
La posición financiera muestra 60,0 millones de dólares en efectivo y equivalentes al final del cuarto trimestre de 2024, complementada por hasta 57,5 millones de euros en financiamiento de deuda del EIB. Se espera que los tramos comprometidos extiendan la liquidez hasta el segundo trimestre de 2026.
IO Biotech (IOBT)는 2024년 4분기에 치료용 암 백신 Cylembio®에 대한 주요 개발 사항을 보고했습니다. 회사의 3상 시험은 407명의 환자로 예정보다 빨리 등록을 완료했으며, 주요 목표의 결과는 2025년 3분기에 예상됩니다. FDA에 대한 생물학적 제품 면허 신청(BLA)은 2025년 연말까지 계획되어 있습니다.
회사의 2상 바구니 시험은 절제 가능한 흑색종 및 두경부 암에 대해 95명의 환자로 등록을 완료했으며, 초기 데이터는 2025년 하반기에 예상됩니다. 2상 시험 IOB-022/KN-D38은 두경부 암에서 전체 반응률이라는 주요 목표를 달성했으며, 폐암 치료에서 유망한 활성을 보였습니다.
재무 상태는 2024년 4분기 말에 6천만 달러의 현금 및 현금 등가물을 보여주며, EIB 채무 금융으로 최대 5천750만 유로가 추가됩니다. 약정된 분할금은 2026년 2분기까지 현금 흐름을 연장할 것으로 예상됩니다.
IO Biotech (IOBT) a rapporté des développements clés au quatrième trimestre 2024 pour son vaccin thérapeutique contre le cancer Cylembio®. L'essai de Phase 3 de l'entreprise a achevé son recrutement en avance avec 407 patients, avec des résultats du critère principal attendus au troisième trimestre 2025. Une demande de licence biologique (BLA) à la FDA est prévue d'ici la fin 2025.
L'essai de Phase 2 de l'entreprise pour le mélanome résécable et le cancer de la tête et du cou a complété son recrutement avec 95 patients, avec des données initiales attendues au second semestre 2025. L'essai de Phase 2 IOB-022/KN-D38 a atteint son critère principal de taux de réponse global dans le cancer de la tête et du cou, montrant une activité prometteuse dans le traitement du cancer du poumon.
La situation financière montre 60,0 millions de dollars en liquidités et équivalents à la fin du quatrième trimestre 2024, complétée par jusqu'à 57,5 millions d'euros de financement par emprunt de la BEI. Les tranches engagées devraient prolonger la trésorerie jusqu'au deuxième trimestre 2026.
IO Biotech (IOBT) berichtete über wichtige Entwicklungen im vierten Quartal 2024 für seinen therapeutischen Krebsimpfstoff Cylembio®. Die entscheidende Phase-3-Studie des Unternehmens hat die Rekrutierung vorzeitig mit 407 Patienten abgeschlossen, wobei die Ergebnisse des primären Endpunkts im dritten Quartal 2025 erwartet werden. Eine Einreichung des Biologics License Application (BLA) bei der FDA ist bis Ende 2025 geplant.
Die Phase-2-Basket-Studie des Unternehmens für resezierbares Melanom und Kopf-Hals-Krebs hat die Rekrutierung mit 95 Patienten abgeschlossen, wobei erste Daten in der zweiten Hälfte von 2025 erwartet werden. Die Phase-2-Studie IOB-022/KN-D38 erreichte ihren primären Endpunkt der Gesamtansprechrate bei Kopf-Hals-Krebs und zeigte vielversprechende Aktivitäten in der Behandlung von Lungenkrebs.
Die finanzielle Lage zeigt 60,0 Millionen Dollar in bar und Äquivalenten zum Ende des vierten Quartals 2024, ergänzt durch bis zu 57,5 Millionen Euro an EIB-Darlehensfinanzierung. Die zugesagten Tranchen sollen den Cashflow bis ins zweite Quartal 2026 verlängern.
- Phase 3 trial completed enrollment ahead of schedule with 407 patients
- Phase 2 basket trial met primary endpoint for head and neck cancer
- Secured €57.5M debt financing from European Investment Bank
- $60M cash position with runway extended to Q2 2026
- Promising Phase 2 results in lung cancer with 50% disease control at 12 months
- Phase 3 trial primary endpoint readout delayed to Q3 2025 due to slower PFS events
- Product launch delayed to 2026, pending FDA approval
Insights
IO Biotech's business update reveals a mixed clinical timeline picture for its lead candidate Cylembio. The pivotal Phase 3 melanoma trial readout has been pushed to Q3 2025 due to a slower rate of progression events - potentially a double-edged signal. While delayed readouts sometimes suggest better treatment efficacy (patients progressing more slowly), it also extends the timeline to potential commercialization.
The company has secured a €57.5 million debt facility from EIB alongside its $60 million cash position, extending runway into Q2 2026. This financing provides important operational flexibility through the pivotal data readout and potential BLA submission, though the debt structure introduces future repayment obligations.
Notably, the company reported meeting the primary endpoint in its Phase 2 head and neck cancer trial and showed promising activity in NSCLC with approximately 50% of patients progression-free at 12 months. The successful completion of enrollment in the perioperative Phase 2 trial ahead of schedule suggests strong investigator interest in the therapeutic approach.
Cylembio's mechanism targeting both immunosuppressive cells in the tumor microenvironment and cancer cells represents a potentially differentiated approach in the increasingly crowded cancer vaccine landscape. The company's anticipated 2026 commercial timeline remains feasible but depends entirely on positive Phase 3 data in 2025.
IO Biotech's financial positioning shows careful capital management with a strategic debt approach. The $60 million cash balance combined with the structured €57.5 million EIB debt facility (comprising three committed tranches totaling €37.5 million plus a €20 million accordion option) provides runway extension into Q2 2026. This timeline appropriately covers the critical Phase 3 readout and potential BLA submission.
The company has effectively de-risked its capital needs during this pivotal period, though investors should note the transition from equity to debt financing introduces future repayment obligations. The tranche-based structure suggests milestone-dependent capital access, a relatively investor-friendly approach that prevents immediate dilution while ensuring disciplined capital deployment.
The Phase 3 readout delay to Q3 2025 extends the pre-revenue period, with commercialization now targeted for 2026. For a company with ~$60 million market cap, the current valuation appears primarily anchored to the Phase 3 melanoma opportunity, with value assigned to earlier-stage indications despite positive Phase 2 signals in head and neck and lung cancers.
The slowing progression events in the Phase 3 trial warrant attention - if driven by improved efficacy, this could significantly enhance commercial potential. However, this remains speculative until data readout. The company's planned second program (IO112) moving toward IND in 2025 provides a secondary value driver that diversifies risk beyond the lead Cylembio program.
- Preparations for submission of a Biologics License Application (BLA) for Cylembio® (imsapepimut and etimupepimut, adjuvanted) to FDA by year end 2025 remain on track. The trial completed enrollment in December 2023 ahead of plan with 407 patients. The primary endpoint of the pivotal Phase 3 trial is progression free survival (PFS); the rate of PFS events has slowed and the readout of the primary endpoint is now expected in the third quarter of 2025
- Enrollment completed ahead of schedule in Phase 2 basket trial of Cylembio as neoadjuvant/adjuvant treatment for patients with resectable melanoma or head and neck cancer; initial data anticipated in the second half of 2025
- Cash and cash equivalents at the end of fourth quarter of 2024 of approximately
$6 0.0 million; secured up to€57.5 million in debt financing from the European Investment Bank (EIB); the company expects that the capital drawn from the three committed tranches of the EIB debt facility will extend cash runway into the second quarter of 2026 - Presentation at TD Cowen’s 45th Annual Health Care Conference on March 5, 2025
NEW YORK, March 04, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today reported business highlights for the fourth quarter of 2024.
“We accomplished significant milestones in 2024 as we continue to rapidly advance our clinical programs investigating the benefits of Cylembio for the treatment of patients with advanced melanoma, metastatic head and neck cancer, and metastatic lung cancer,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “With the primary endpoint readout of our pivotal Phase 3 trial investigating Cylembio in combination with pembrolizumab for patients with advanced melanoma now expected in the third quarter, we expect 2025 could be an exciting year for IO Biotech. Pending positive data, we expect to submit a BLA to the US FDA by the end of the year and a potential launch in the US in 2026.”
Dr. Zocca continued, “There is still a significant unmet medical need for new treatment options for patients suffering from advanced melanoma, metastatic head and neck cancer, and metastatic lung cancer. The full IO Biotech team is proud to be leading the next frontier of immune-oncology with the development of therapeutic cancer vaccines for these and other difficult-to-treat cancers. Our investigational therapeutic cancer vaccines are designed with a unique mechanism of action capable of targeting both immune-suppressive cells in the tumor microenvironment (TME) and cancer cells, which have demonstrated promising activity when combined with an anti-PD-1 therapy. We look forward to potentially commercializing a first-in-class immune-modulatory, off-the-shelf therapeutic cancer vaccine that could be delivered to cancer patients when treatment is needed.”
Upcoming Investor Conferences
- Cowen’s 45th Annual Health Care Conference: March 5, 2025
Fourth Quarter 2024 and other Recent Highlights
- The company’s Phase 3 pivotal trial (IOB-013/KN-D18), which is evaluating Cylembio® (imsapepimut and etimupepimut, adjuvanted), its investigational therapeutic cancer vaccine, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in advanced melanoma, is ongoing with full enrollment of 407 patients reached in December 2023. The primary endpoint of the Phase 3 trial is progression free survival (PFS); the rate of PFS events has slowed in the study, and as such, the company now expects the readout of the PFS primary endpoint in third quarter of 2025. The company continues to plan to submit a BLA to the FDA in 2025 for Cylembio and, subject to FDA approval, launch its first therapeutic cancer vaccine in the US in 2026 for patients with advanced melanoma.
- The company continues to progress clinical development of Cylembio in its perioperative Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying treatment with Cylembio in combination with pembrolizumab in earlier stage disease, with enrollment completed ahead of schedule with 95 patients. In this trial, patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) are dosed before (neo-adjuvant) and after (adjuvant) surgery with curative intent. The company expects initial data from this trial in the second half of 2025.
- Building on the body of clinical evidence for Cylembio, the company announced that the primary endpoint of overall response rate (ORR) was met, along with encouraging PFS data, from its Phase 2 basket trial IOB-022/KN-D38 investigating Cylembio given in combination with pembrolizumab as first-line treatment for SCCHN. Additionally, promising activity demonstrated in the first-line treatment for metastatic non-small cell lung cancer (NSCLC) with approximately half of patients having no disease progression at 12 months. The safety profiles in both cohorts were consistent with prior studies on the combination of Cylembio with checkpoint inhibitors and no significant added systemic toxicities compared to an anti-PD1 monotherapy. Patients in this basket trial will continue to be followed, with longer-term data expected in the second half of 2025.
- The company adopted Cylembio (imsapepimut and etimupepimut, adjuvant) as the US brand name for its IO102-IO103 lead investigational therapeutic cancer vaccine.
- New preclinical data for IO112, the company’s second immune-modulatory therapeutic cancer vaccine candidate targeting Arginase-1, was published in the Journal for ImmunoTherapy of Cancer. The company plans to submit an Investigational New Drug Application (IND) for IO112 to the FDA in 2025.
- In December, the company secured up to
€57.5 million in debt financing from the European Investment Bank to support the continued development of its portfolio generated from its T-Win® platform as well as pre-commercialization efforts for Cylembio. The debt facility includes three committed tranches totaling up to€37.5 million , which will become available if the company satisfies certain conditions, and one uncommitted accordion tranche of€20 million .
About Cylembio®
Cylembio® (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the three ongoing company-sponsored clinical trials is now complete.
The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.
Cylembio® is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival. Top-line data readout is expected in the third quarter of 2025. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.
About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial
IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial
IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial investigating Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) as neo-adjuvant/adjuvant treatment of patients with solid tumors at sites in Australia, the United States, France, Germany, Spain, and Denmark. The study completed enrollment in all cohorts: 18 patients with melanoma in cohort A and 16 patients with SCCHN in cohort B, both as single arm cohorts receiving combination of Cylembio with pembrolizumab. In cohort C, 61 melanoma patients were randomized 1:1 to either the combination of Cylembio with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio®, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.
For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the expected timing of the top-line data from, or outcome of, the company’s Phase 3 trial, the timing regarding submission of a BLA, the timing regarding launch of Cylembio, the timing or outcome of other current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Contact:
Investors
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com
Media
Julie Funesti
Edelman
917-498-1967
julie.funesti@edelman.com
FAQ
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