IO Biotech Reports Second Quarter 2024 Financial Results and Provides Business Highlights
IO Biotech (Nasdaq: IOBT) reported Q2 2024 financial results and business highlights. Key points include:
1. Phase 3 interim analysis for IO102-IO103 in advanced melanoma expected in Q3 2024.
2. Completed enrollment in Phase 2 trials for NSCLC and SCCHN.
3. Data from SCCHN cohort accepted for ESMO 2024 presentation.
4. Ended Q2 with $100.7 million in cash, expected to support operations into Q4 2025.
5. Net loss of $20.7 million for Q2 2024, compared to $21.2 million in Q2 2023.
6. R&D expenses decreased to $15.8 million from $16.5 million year-over-year.
7. G&A expenses increased to $5.7 million from $5.3 million year-over-year.
IO Biotech (Nasdaq: IOBT) ha riportato i risultati finanziari e i punti salienti aziendali del secondo trimestre del 2024. I punti chiave includono:
1. L'analisi intermedia della fase 3 per IO102-IO103 nel melanoma avanzato è prevista per il terzo trimestre del 2024.
2. Completata l'arruolamento negli studi di fase 2 per NSCLC e SCCHN.
3. I dati del gruppo SCCHN sono stati accettati per la presentazione a ESMO 2024.
4. A fine secondo trimestre ci sono $100,7 milioni in contante, che si prevede possano sostenere le operazioni fino al quarto trimestre del 2025.
5. La perdita netta per il secondo trimestre del 2024 è stata di $20,7 milioni, rispetto a $21,2 milioni nel secondo trimestre del 2023.
6. Le spese per R&D sono diminuite a $15,8 milioni rispetto ai $16,5 milioni dell'anno precedente.
7. Le spese generali e amministrative sono aumentate a $5,7 milioni rispetto ai $5,3 milioni dell'anno precedente.
IO Biotech (Nasdaq: IOBT) informó sobre los resultados financieros y los aspectos destacados del negocio en el segundo trimestre de 2024. Los puntos clave incluyen:
1. Se espera un análisis intermedio de la fase 3 para IO102-IO103 en melanoma avanzado en el tercer trimestre de 2024.
2. Se completó la inscripción en ensayos de fase 2 para NSCLC y SCCHN.
3. Los datos del grupo SCCHN fueron aceptados para presentación en ESMO 2024.
4. Al cierre del segundo trimestre, había $100,7 millones en efectivo, que se espera que apoyen las operaciones hasta el cuarto trimestre de 2025.
5. La pérdida neta fue de $20,7 millones para el segundo trimestre de 2024, en comparación con $21,2 millones en el segundo trimestre de 2023.
6. Los gastos de I+D disminuyeron a $15,8 millones desde $16,5 millones interanualmente.
7. Los gastos generales y administrativos aumentaron a $5,7 millones desde $5,3 millones interanualmente.
IO Biotech (Nasdaq: IOBT)는 2024년 2분기 재무 결과 및 사업 주요 내용을 보고했습니다. 주요 사항은 다음과 같습니다:
1. 2024년 3분기에 진행되는 고급 흑색종의 IO102-IO103에 대한 3상 중간 분석이 예상됩니다.
2. NSCLC 및 SCCHN에 대한 2상 시험의 등록이 완료되었습니다.
3. SCCHN 집단의 데이터가 ESMO 2024 발표를 위해 수락되었습니다.
4. 2분기 말에는 1억 7백만 달러의 현금을 보유하고 있으며, 이 자금은 2025년 4분기까지 운영을 지원할 것으로 예상됩니다.
5. 2024년 2분기 순손실은 2070만 달러로, 2023년 2분기 2120만 달러와 비교됩니다.
6. 연구 개발 비용은 전년 대비 1650만 달러에서 1580만 달러로 감소했습니다.
7. 일반 관리 비용은 전년 대비 530만 달러에서 570만 달러로 증가했습니다.
IO Biotech (Nasdaq: IOBT) a publié les résultats financiers et les points saillants de l'entreprise pour le deuxième trimestre 2024. Les points clés incluent :
1. Une analyse intermédiaire de la phase 3 pour IO102-IO103 dans le mélanome avancé est prévue pour le troisième trimestre 2024.
2. Le recrutement dans les essais de phase 2 pour NSCLC et SCCHN est terminé.
3. Les données du groupe SCCHN ont été acceptées pour une présentation à l'ESMO 2024.
4. Le deuxième trimestre s'est terminé avec 100,7 millions de dollars en liquidités, prévus pour soutenir les opérations jusqu'au quatrième trimestre 2025.
5. La perte nette pour le deuxième trimestre 2024 était de 20,7 millions de dollars, par rapport à 21,2 millions de dollars au deuxième trimestre 2023.
6. Les dépenses de R&D ont diminué de 16,5 millions de dollars à 15,8 millions de dollars d'une année à l'autre.
7. Les dépenses générales et administratives ont augmenté de 5,3 millions de dollars à 5,7 millions de dollars d'une année à l'autre.
IO Biotech (Nasdaq: IOBT) hat die finanziellen Ergebnisse und Unternehmenshighlights für das zweite Quartal 2024 berichtet. Die wichtigsten Punkte umfassen:
1. Eine Zwischenanalyse der Phase 3 für IO102-IO103 bei fortgeschrittenem Melanom wird für das dritte Quartal 2024 erwartet.
2. Die Einschreibung in die Phase-2-Studien für NSCLC und SCCHN wurde abgeschlossen.
3. Daten aus der SCCHN-Kohorte wurden zur Präsentation auf der ESMO 2024 akzeptiert.
4. Das zweite Quartal wurde mit 100,7 Millionen Dollar in Bargeld abgeschlossen, was voraussichtlich die Betriebe bis ins vierte Quartal 2025 unterstützen wird.
5. Der Nettoverlust für das zweite Quartal 2024 betrug 20,7 Millionen Dollar, im Vergleich zu 21,2 Millionen Dollar im zweiten Quartal 2023.
6. Die Forschung und Entwicklungsausgaben sanken im Jahresvergleich von 16,5 Millionen Dollar auf 15,8 Millionen Dollar.
7. Die allgemeinen und Verwaltungskosten stiegen im Jahresvergleich von 5,3 Millionen Dollar auf 5,7 Millionen Dollar.
- Phase 3 interim analysis for IO102-IO103 in advanced melanoma expected in Q3 2024
- Completed enrollment in Phase 2 trials for NSCLC and SCCHN
- Data from SCCHN cohort accepted for ESMO 2024 presentation
- $100.7 million cash position expected to support operations into Q4 2025
- Slight decrease in net loss from $21.2 million in Q2 2023 to $20.7 million in Q2 2024
- R&D expenses decreased from $16.5 million to $15.8 million year-over-year
- G&A expenses increased from $5.3 million to $5.7 million year-over-year
- Cash and cash equivalents decreased from $143.2 million at end of 2023 to $100.7 million at end of Q2 2024
Insights
IO Biotech's Q2 2024 results show a net loss of
IO Biotech's IO102-IO103 cancer vaccine shows promise across multiple indications. The pivotal Phase 3 trial in advanced melanoma is approaching a critical juncture with the Q3 2024 interim analysis. If positive, it could lead to a BLA submission for accelerated approval by Q4 2024. The completion of enrollment in NSCLC and SCCHN trials is significant, potentially expanding the vaccine's applicability. The initiation of a neoadjuvant/adjuvant trial in resectable tumors is particularly intriguing, as it could position IO102-IO103 in earlier treatment lines. The combination with pembrolizumab across trials suggests a strategy to enhance immune responses, potentially improving outcomes in hard-to-treat cancers.
IO Biotech's focus on immune-modulating cancer vaccines aligns with the growing trend of immunotherapy in oncology. The potential for accelerated approval in melanoma by 2025 could be a game-changer, offering a first-mover advantage in this specific combination therapy. The company's multi-pronged approach, targeting various cancer types and treatment stages, mitigates risk and expands market potential. Upcoming data presentations at ESMO 2024 and other conferences could significantly impact investor sentiment. The cash runway into Q4 2025 provides a buffer for potential commercialization efforts. However, success hinges heavily on the pivotal trial results, making the next 12 months important for IO Biotech's market position and valuation.
- Phase 3 interim analysis outcome still expected in Q3 2024 for the overall response rate (ORR) in the pivotal trial (IOB-013/KN-D18) of lead investigational therapeutic cancer vaccine, IO102-IO103, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma; outcome of primary endpoint of progression free survival (PFS) expected in first half of 2025
- Completed enrollment in Phase 2 basket trial IOB-022/KN-D38 evaluating IO102-IO103 in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN); data from SCCHN cohort has been accepted for poster presentation at the European Society for Medical Oncology (ESMO 2024) congress; abstract with data from NSCLC cohort has been submitted for poster presentation at an upcoming fall medical meeting
- Completed enrollment in first cohort (cohort A) of Phase 2 solid tumor basket trial (IOB-032/PN-E40) evaluating IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment of patients with resectable solid tumors; initiated enrollment in randomized melanoma cohort
- Ended second quarter with approximately
$100.7 million in cash and cash equivalents; the company confirms that cash position is expected to support operations into the fourth quarter of 2025
NEW YORK, Aug. 13, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today reported financial results for the second quarter ended June 30, 2024.
“During the first half of this year, we’ve continued to execute on our mission of developing breakthrough cancer vaccines that could potentially change the treatment paradigm for people living with melanoma and other types of cancer,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “We look forward to the planned interim analysis of our pivotal Phase 3 trial in first-line advanced melanoma followed by the data readout of the primary endpoint of progression free survival (PFS) in the first half of next year. Strategically, we continue to prepare for a potential launch in 2025 if the interim analysis data supports accelerated approval in the US.”
Dr. Zocca continued, “We are also focused on progressing our Phase 2 studies of IO102-IO103 in other hard-to-treat cancers and earlier line of treatment in melanoma patient populations, and are excited to share new insights this fall on the potential of IO102-IO103 in the first-line treatment of SCCHN and metastatic NSCLC.”
Recent Business Highlights
- The independent data monitoring committee (IDMC) for the company’s pivotal Phase 3 trial (IOB-013/KN-D18), which is evaluating IO102-IO103 in combination with KEYTRUDA® (pembrolizumab) in advanced melanoma, is expected to independently conduct a review of interim analysis data in the third quarter of 2024. The primary endpoint of the Phase 3 trial is PFS, which will be analyzed when 226 events have occurred in the trial, and the outcome of which the company projects will occur in the first half of 2025. If the IDMC recommendation after review of the interim analysis data is supportive, we believe the outcome could allow for submission of a Biologics License Application (BLA) in fourth quarter of 2024 for accelerated approval in the US.
- Updated data for the head and neck cohort of the company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic NSCLC or recurrent or metastatic SCCHN was accepted for poster presentation at the European Society of Medical Oncology (ESMO 2024) congress taking place September 13-17 in Barcelona. This presentation will share efficacy and safety data for the full patient cohort, which completed enrollment earlier this year. The company plans to share updates from the NSCLC cohort, which also completed enrollment, at a medical meeting this fall.
- The company continued to progress its Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab given before (neoadjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or SCCHN. The single arm melanoma cohort of the trial, cohort A, is now fully enrolled and enrollment in the single arm SCCHN cohort, cohort B, continues. Enrollment is also ongoing in the randomized melanoma cohort, cohort C, in which patients are randomized either to IO102-IO103 in combination with pembrolizumab or to pembrolizumab alone.
Second Quarter 2024 Financial Results
- Net loss for the three months ended June 30, 2024, was
$20.7 million , compared to$21.2 million for the three months ended June 30, 2023. - Research and development expenses were
$15.8 million for the three months ended June 30, 2024, compared to$16.5 million for the three months ended June 30, 2023. The decrease 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$0.7 million in research and development equity-based compensation for the three months ended June 30, 2024, compared to$0.9 million for the three months ended June 30, 2023. - General and administrative expenses were
$5.7 million for the three months ended June 30, 2024, compared to$5.3 million for the three months ended June 30, 2023. The company recognized$1.0 million in general and administrative equity-based compensation for the three months ended June 30, 2024, compared to$0.7 million for the three months ended June 30, 2023. - Cash and cash equivalents as of June 30, 2024 were
$100.7 million , compared to$143.2 million at December 31, 2023. During the three months ended June 30, 2024, the company used cash, cash equivalents and restricted cash of$17.0 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 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 neoadjuvant/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 (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 the IOB-013/KN-D18 Clinical Trial Endpoints
The primary endpoint of the IOB-013/KN-D18 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the first half of 2025. Additionally, there is a planned per-protocol interim analysis of overall response rate when the first 225 randomized patients reach one year of treatment in mid-2024. The outcome of this analysis is expected in the third quarter of 2024. There is a high statistical bar for the Phase 3 interim analysis (p≤0.005), which was set to preserve most of the alpha for the primary endpoint of PFS. Regardless of the outcome of the interim analysis, the trial is designed to continue to the primary PFS endpoint.
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 neoadjuvant/adjuvant treatment of patients with solid tumors. The study will enroll approximately 15 patients with melanoma and 15 patients with SCCHN in cohort A and cohort B respectively as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C ≥60 melanoma patients will be randomized 1:1 to either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone. In the neoadjuvant 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 neoadjuvant 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 of the interim and primary analyses of the company’s Phase 3 trial, 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, National Health Media
Edelman
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 June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 15,848 | $ | 16,504 | $ | 30,159 | $ | 28,404 | |||||||
| General and administrative | 5,685 | 5,348 | 11,571 | 11,372 | |||||||||||
| Total operating expenses | 21,533 | 21,852 | 41,730 | 39,776 | |||||||||||
| Loss from operations | (21,533 | ) | (21,852 | ) | (41,730 | ) | (39,776 | ) | |||||||
| Other income (expense) | |||||||||||||||
| Currency exchange (loss) gain, net | (90 | ) | 10 | (552 | ) | 268 | |||||||||
| Interest income | 1,311 | 1,196 | 2,928 | 2,224 | |||||||||||
| Total other income (expense), net | 1,221 | 1,206 | 2,376 | 2,492 | |||||||||||
| Loss before income tax expense | (20,312 | ) | (20,646 | ) | (39,354 | ) | (37,284 | ) | |||||||
| Income tax expense | 374 | 532 | 789 | 938 | |||||||||||
| Net loss | (20,686 | ) | (21,178 | ) | (40,143 | ) | (38,222 | ) | |||||||
| Net loss attributable to common shareholders | (20,686 | ) | (21,178 | ) | (40,143 | ) | (38,222 | ) | |||||||
| Net loss per common share, basic and diluted | $ | (0.31 | ) | $ | (0.74 | ) | $ | (0.61 | ) | $ | (1.33 | ) | |||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 65,880,914 | 28,815,267 | 65,880,914 | 28,815,267 | |||||||||||
| Other comprehensive loss | |||||||||||||||
| Net loss | $ | (20,686 | ) | $ | (21,178 | ) | $ | (40,143 | ) | $ | (38,222 | ) | |||
| Foreign currency translation | (151 | ) | (141 | ) | 43 | 376 | |||||||||
| Total comprehensive loss | $ | (20,837 | ) | $ | (21,319 | ) | $ | (40,100 | ) | $ | (37,846 | ) | |||
| IO BIOTECH, INC. | |||||||
| Consolidated Balance Sheets | |||||||
| (Unaudited in thousands, except share and per share amounts) | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 100,747 | $ | 143,193 | |||
| Prepaid expenses and other current assets | 6,905 | 4,062 | |||||
| Total current assets | 107,652 | 147,255 | |||||
| Restricted cash | 268 | 268 | |||||
| Property and equipment, net | 735 | 847 | |||||
| Right of use lease asset | 1,936 | 2,259 | |||||
| Other non-current assets | 876 | 89 | |||||
| Total non-current assets | 3,815 | 3,463 | |||||
| Total assets | $ | 111,467 | $ | 150,718 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 5,016 | $ | 3,878 | |||
| Lease liability - current | 678 | 655 | |||||
| Accrued expenses and other current liabilities | 8,029 | 11,184 | |||||
| Total current liabilities | 13,723 | 15,717 | |||||
| Lease liability - non-current | 1,472 | 1,839 | |||||
| Total non-current liabilities | 1,472 | 1,839 | |||||
| Total liabilities | 15,195 | 17,556 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity | |||||||
| Preferred stock, par value of issued and outstanding as of June 30, 2024 and December 31, 2023 | — | — | |||||
| Common stock, par value of June 30, 2024 and December 31, 2023; 65,880,914 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 66 | 66 | |||||
| Additional paid-in capital | 409,797 | 406,587 | |||||
| Accumulated deficit | (303,965 | ) | (263,822 | ) | |||
| Accumulated other comprehensive loss | (9,626 | ) | (9,669 | ) | |||
| Total stockholders’ equity | 96,272 | 133,162 | |||||
| Total liabilities and stockholders’ equity | $ | 111,467 | $ | 150,718 | |||
FAQ
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