IO Biotech Reports Third Quarter 2024 Financial Results and Provides Business Highlights
IO Biotech (IOBT) reported Q3 2024 financial results and business updates. The company's pivotal Phase 3 trial of IO102-IO103 cancer vaccine in combination with KEYTRUDA® for advanced melanoma is on track, with primary endpoint data expected in H1 2025. The company reported a net loss of $24.0 million for Q3 2024, compared to $21.7 million in Q3 2023. R&D expenses increased to $20.2 million, up from $17.7 million year-over-year. Cash position stands at $80.2 million, expected to support operations into Q4 2025.
IO Biotech (IOBT) ha riportato i risultati finanziari e gli aggiornamenti aziendali per il terzo trimestre del 2024. Lo studio clinico principale di fase 3 del vaccino contro il cancro IO102-IO103, in combinazione con KEYTRUDA® per il melanoma avanzato, è in linea con le previsioni, con i dati sugli obiettivi primari attesi nel primo semestre del 2025. La società ha registrato una perdita netta di 24,0 milioni di dollari per il terzo trimestre del 2024, rispetto ai 21,7 milioni di dollari del terzo trimestre del 2023. Le spese per ricerca e sviluppo sono aumentate a 20,2 milioni di dollari, rispetto ai 17,7 milioni dell'anno precedente. La posizione di cassa si attesta a 80,2 milioni di dollari, prevedendo di supportare le operazioni fino al quarto trimestre del 2025.
IO Biotech (IOBT) informó sobre los resultados financieros y las actualizaciones comerciales del tercer trimestre de 2024. El ensayo clínico pivotal de fase 3 de la vacuna contra el cáncer IO102-IO103, en combinación con KEYTRUDA® para el melanoma avanzado, avanza según lo previsto, con datos de puntos finales primarios esperados para el primer semestre de 2025. La empresa reportó una pérdida neta de 24,0 millones de dólares para el tercer trimestre de 2024, en comparación con 21,7 millones de dólares en el tercer trimestre de 2023. Los gastos en I+D aumentaron a 20,2 millones de dólares, frente a los 17,7 millones del año anterior. La posición de efectivo se sitúa en 80,2 millones de dólares, lo que se espera que respalde las operaciones hasta el cuarto trimestre de 2025.
IO Biotech (IOBT)는 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. KEYTRUDA®와 함께 호주 진행 중인 IO102-IO103 암 백신의 3상 임상 시험은 순조롭게 진행되고 있으며, 주요 목표 데이터는 2025년 상반기 중에 발표될 예정입니다. 회사는 2024년 3분기에 24.0 백만 달러의 순손실을 기록했으며, 이는 2023년 3분기의 21.7 백만 달러에 비해 증가한 수치입니다. 연구 및 개발 비용은 20.2 백만 달러로 증가했으며, 이는 작년의 17.7 백만 달러에서 증가한 것입니다. 현금 보유액은 80.2 백만 달러로, 2025년 4분기까지 운영을 지원할 것으로 예상됩니다.
IO Biotech (IOBT) a rapporté les résultats financiers et les mises à jour commerciales du troisième trimestre 2024. L'essai clinique majeur de phase 3 du vaccin contre le cancer IO102-IO103, en combinaison avec KEYTRUDA®, pour le mélanome avancé est sur la bonne voie, avec des données sur les critères d'évaluation principaux attendues au premier semestre 2025. L'entreprise a annoncé une perte nette de 24,0 millions de dollars pour le troisième trimestre 2024, contre 21,7 millions de dollars au troisième trimestre 2023. Les dépenses en R&D ont augmenté pour atteindre 20,2 millions de dollars, contre 17,7 millions de dollars l'année précédente. La position de trésorerie s'élève à 80,2 millions de dollars, ce qui devrait soutenir les opérations jusqu'au quatrième trimestre 2025.
IO Biotech (IOBT) hat die finanziellen Ergebnisse und Geschäftsinformationen für das dritte Quartal 2024 veröffentlicht. Die entscheidende Phase-3-Studie des IO102-IO103 Krebsimpfstoffs in Kombination mit KEYTRUDA® für fortgeschrittenes Melanom ist auf Kurs, wobei die Daten zu den primären Endpunkten im ersten Halbjahr 2025 erwartet werden. Das Unternehmen berichtete von einem Nettoverlust von 24,0 Millionen Dollar für das dritte Quartal 2024, verglichen mit 21,7 Millionen Dollar im dritten Quartal 2023. Die F&E-Ausgaben stiegen auf 20,2 Millionen Dollar, gegenüber 17,7 Millionen Dollar im Vorjahr. Die Liquiditätsposition liegt bei 80,2 Millionen Dollar und soll die Betriebe bis ins vierte Quartal 2025 unterstützen.
- Phase 3 trial for advanced melanoma treatment progressing with potential BLA submission in 2025
- Primary endpoint met in Phase 2 trial for head and neck cancer treatment
- Phase 2 basket trial enrollment proceeding ahead of schedule
- $80.2 million cash position sufficient to support operations into Q4 2025
- Net loss increased to $24.0 million from $21.7 million year-over-year
- R&D expenses increased to $20.2 million from $17.7 million year-over-year
- Cash position decreased from $143.2 million to $80.2 million since December 2023
Insights
IO Biotech's Q3 results show significant R&D investment with
The clinical development pipeline shows promising momentum with multiple significant milestones. The Phase 3 trial for IO102-IO103 in advanced melanoma remains on track, with PFS data expected in H1 2025. Meeting the primary endpoint in the Phase 2 SCCHN cohort and proceeding ahead of schedule in the perioperative trial indicates strong clinical progress. The T-win platform's dual mechanism targeting both immune-suppressive and cancer cells differentiates it from conventional approaches. The planned IND submission for IO112 in 2025 adds pipeline depth. The IDMC's recommendation to continue the Phase 3 trial without modifications suggests a favorable safety profile.
- Pivotal Phase 3 trial (IOB-013/KN-D18) evaluating off-the-shelf therapeutic cancer vaccine IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma on track with primary endpoint of progression free survival (PFS) projected to be reached in first half of 2025
- Primary endpoint met in Phase 2 basket trial (IOB-022/KN-D38) cohort evaluating IO102-IO103 in combination with pembrolizumab in the first-line treatment of advanced squamous cell carcinoma of the head and neck (SCCHN)
- Enrollment in Phase 2 basket trial (IOB-032/PN-E40) evaluating IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment of patients with resectable melanoma or SCCHN is proceeding ahead of schedule
- Ended third quarter with approximately
$80 million in cash and cash equivalents; the company continues to expect its cash position will support operations into the fourth quarter of 2025
NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today reported financial results for the third quarter ended September 30, 2024.
“We continue to add to the body of evidence that our novel investigational therapeutic cancer vaccine, IO102-IO103, has the potential to bring clinical benefit to patients with strong signals of activity now observed in patients with three types of metastatic solid tumors,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “As we look to the primary endpoint data readout from our Phase 3 pivotal trial in the first half of next year, we plan to be prepared to submit a Biologics License Application (BLA) to the FDA in 2025 and potentially make our first therapeutic cancer vaccine available for patients in the US with advanced melanoma in 2026.”
Dr. Zocca continued, “Our T-win platform generates off-the-shelf therapeutic cancer vaccine candidates with a unique mechanism of action, capable of both targeting immune-suppressive cells and cancer cells. This dual action is what drives the strong activity we see when we combine IO102-IO103 with an anti-PD-1 therapy. In addition to IO102-IO103, the T-win platform has generated other novel candidates including IO112, targeting arginase 1 with a unique mechanism of action. We are excited about the strength of the data supporting the potential of IO112 and plan to submit an Investigational New Drug (IND) application to the FDA for this program in 2025.”
Recent Business Highlights
- The per-protocol interim analysis in the pivotal Phase 3 trial (IOB-013/KN-D18), which is evaluating IO102-IO103 in combination with KEYTRUDA® (pembrolizumab) in advanced melanoma, was completed by the IDMC in the third quarter of 2024. Based on review of safety and efficacy data, the IDMC recommended the trial continue without modifications and noted that no new safety signals were observed. The outcome of the primary endpoint of PFS is projected to be available in the first half of 2025, potentially followed by a BLA submission in 2025 depending on the PFS outcome.
- Encouraging data for the fully enrolled squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC) cohorts of the Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in the first-line treatment of patients with metastatic disease were presented at the 2024 European Society of Medical Oncology (ESMO) Congress in September and the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting in November, respectively. [https://bit.ly/3zgzsoY; https://bit.ly/4fsVCno]
- The company continues to progress its perioperative Phase 2 basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab dosed before (neo-adjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or SCCHN. Enrollment continues in both the single arm SCCHN cohort (cohort B) and the randomized melanoma cohort (cohort C), in which patients are randomized either to IO102-IO103 in combination with pembrolizumab or to pembrolizumab alone.
Third Quarter 2024 Financial Results
- Net loss for the three months ended September 30, 2024, was
$24.0 million , compared to$21.7 million for the three months ended September 30, 2023. - Research and development expenses were
$20.2 million for the three months ended September 30, 2024, compared to$17.7 million for the three months ended September 30, 2023. The increase was primarily related to timing of clinical trial-related activities for the company’s IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the company’s pivotal Phase 3 clinical trial. The company recognized$0.6 million in research and development equity-based compensation for the three months ended September 30, 2024, compared to$2.1 million for the three months ended September 30, 2023. - General and administrative expenses were
$6.3 million for the three months ended September 30, 2024, compared to$5.8 million for the three months ended September 30, 2023. The company recognized$1.0 million in general and administrative equity-based compensation for the three months ended September 30, 2024, compared to$0.9 million for the three months ended September 30, 2023. - Cash and cash equivalents as of September 30, 2024 were
$80.2 million , compared to$143.2 million at December 31, 2023. During the three months ended September 30, 2024, the company used cash, cash equivalents and restricted cash of$20.8 million . The company continues to expect that it will have sufficient cash to run the company into the fourth quarter of 2025.
About IO102-IO103
IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine 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 (IDO) 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 IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.
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 IO102-IO103.
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 IO102-IO103 in combination with 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, an event-driven analysis conducted when 226 events, defined as disease progression or death, have been reported in the study. Secondary endpoints include overall response rate (ORR), overall survival (OS), durable objective response rate (DRR), complete response rate (CRR), duration of response (DoR), time to complete response (TTCR), disease control rate (DCR), and incidence of AEs and SAEs (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed. 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 IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial
IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The study completed enrollment of 15 patients with melanoma in cohort A and continues to enroll 15 patients with SCCHN in cohort B as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C, melanoma patients will be randomized 1:1 to either the combination of IO102-IO103 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-modulating 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 the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, 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 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 timing or outcome of primary analysis of the company’s Phase 3 trial, 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
Salutem
917-498-1967
Julie.Funesti@salutemcomms.com
| IO BIOTECH, INC. Consolidated Statements of Operations and Comprehensive Loss (Unaudited in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 20,178 | $ | 17,655 | $ | 50,337 | $ | 46,059 | ||||||||
| General and administrative | 6,326 | 5,829 | 17,897 | 17,201 | ||||||||||||
| Total operating expenses | 26,504 | 23,484 | 68,234 | 63,260 | ||||||||||||
| Loss from operations | (26,504 | ) | (23,484 | ) | (68,234 | ) | (63,260 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Currency exchange gain (loss), net | 1,630 | (342 | ) | 1,078 | (74 | ) | ||||||||||
| Interest income | 1,068 | 1,708 | 3,996 | 3,932 | ||||||||||||
| Total other income (expense), net | 2,698 | 1,366 | 5,074 | 3,858 | ||||||||||||
| Loss before income tax expense (benefit) | (23,806 | ) | (22,118 | ) | (63,160 | ) | (59,402 | ) | ||||||||
| Income tax expense (benefit) | 209 | (439 | ) | 998 | 499 | |||||||||||
| Net loss | (24,015 | ) | (21,679 | ) | (64,158 | ) | (59,901 | ) | ||||||||
| Net loss attributable to common shareholders | (24,015 | ) | (21,679 | ) | (64,158 | ) | (59,901 | ) | ||||||||
| Net loss per common share, basic and diluted | $ | (0.36 | ) | $ | (0.43 | ) | $ | (0.97 | ) | $ | (1.66 | ) | ||||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 65,880,914 | 50,168,303 | 65,880,914 | 36,011,162 | ||||||||||||
| Other comprehensive loss | ||||||||||||||||
| Net loss | $ | (24,015 | ) | $ | (21,679 | ) | $ | (64,158 | ) | $ | (59,901 | ) | ||||
| Foreign currency translation | (1,374 | ) | (108 | ) | (1,331 | ) | 268 | |||||||||
| Total comprehensive loss | $ | (25,389 | ) | $ | (21,787 | ) | $ | (65,489 | ) | $ | (59,633 | ) | ||||
| IO BIOTECH, INC. Consolidated Balance Sheets (Unaudited in thousands, except share and per share amounts) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 80,185 | $ | 143,193 | ||||
| Prepaid expenses and other current assets | 6,059 | 4,062 | ||||||
| Total current assets | 86,244 | 147,255 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 695 | 847 | ||||||
| Right of use lease asset | 1,814 | 2,259 | ||||||
| Other non-current assets | 924 | 89 | ||||||
| Total non-current assets | 3,701 | 3,463 | ||||||
| Total assets | $ | 89,945 | $ | 150,718 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 5,256 | $ | 3,878 | ||||
| Lease liability - current | 694 | 655 | ||||||
| Accrued expenses and other current liabilities | 10,105 | 11,184 | ||||||
| Total current liabilities | 16,055 | 15,717 | ||||||
| Lease liability - non-current | 1,325 | 1,839 | ||||||
| Total non-current liabilities | 1,325 | 1,839 | ||||||
| Total liabilities | 17,380 | 17,556 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock, par value of | — | — | ||||||
| Common stock, par value of | 66 | 66 | ||||||
| Additional paid-in capital | 411,479 | 406,587 | ||||||
| Accumulated deficit | (327,980 | ) | (263,822 | ) | ||||
| Accumulated other comprehensive loss | (11,000 | ) | (9,669 | ) | ||||
| Total stockholders’ equity | 72,565 | 133,162 | ||||||
| Total liabilities and stockholders’ equity | $ | 89,945 | $ | 150,718 | ||||
FAQ
What were IO Biotech's (IOBT) Q3 2024 financial results?
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