IO Biotech Reports First Quarter 2024 Financial Results and Provides Business Highlights
IO Biotech has reported its financial results for Q1 2024, highlighting a net loss of $19.5 million, up from $17.0 million in Q1 2023. Research and development expenses increased to $14.3 million, attributed to clinical trial activities for its cancer vaccine candidate, IO102-IO103. General and administrative expenses slightly decreased to $5.9 million. The company ended the quarter with $118 million in cash, down from $143.2 million in December 2023.
Key developments include the completion of patient enrollment in the pivotal Phase 3 trial of IO102-IO103 in combination with pembrolizumab for advanced melanoma. The interim analysis for the overall response rate (ORR) is expected in Q3 2024, and the primary endpoint of progression-free survival (PFS) in H1 2025. Additionally, Phase 2 trials IOB-022 and IOB-032 have progressed, with significant enrollment milestones achieved. The executive team has been strengthened with new hires to enhance business and commercial development.
- Completion of enrollment in pivotal Phase 3 trial for IO102-IO103 in advanced melanoma.
- Interim analysis for ORR expected in Q3 2024 could lead to BLA submission for accelerated approval.
- Primary endpoint of PFS projected to occur in H1 2025, increasing trial visibility.
- Completed enrollment in Phase 2 basket trial IOB-022 and first cohort of Phase 2 neoadjuvant/adjuvant basket trial IOB-032.
- Strengthened executive team with key hires in business and commercial development.
- Ended Q1 2024 with $118 million in cash, maintaining cash runway into Q4 2025.
- Net loss increased to $19.5 million for Q1 2024 from $17.0 million in Q1 2023.
- Research and development expenses rose to $14.3 million, driven by clinical trial activities.
- Cash and cash equivalents decreased from $143.2 million at the end of 2023 to $118 million in Q1 2024.
- General and administrative expenses, though slightly decreased, remain high at $5.9 million.
Insights
The financial results released by IO Biotech provide critical insights into the company's current fiscal health and future prospects. The company reported a net loss of $19.5 million for Q1 2024, compared to a
Despite the rise in expenditures, the company's strong cash position, with
For retail investors, understanding the critical nature of R&D investments in biotech is essential. Although high R&D expenses can lead to short-term losses, they are a necessary expenditure for potential long-term gains, especially when a company is on the verge of significant clinical milestones.
IO Biotech's announcements about their ongoing clinical trials are of high interest, particularly the Phase 3 trial of IO102-IO103 combined with pembrolizumab for advanced melanoma. The anticipated interim analysis on overall response rate (ORR) by Q3 2024 and the primary endpoint of progression-free survival (PFS) projected for H1 2025 are pivotal events. Success in these trials can significantly enhance the value proposition of their lead therapeutic candidate.
Moreover, the completion of enrollment in Phase 2 basket trials and the expansion of the neo-adjuvant/adjuvant basket trial underline the company's advancement in broadening the clinical applications of their immuno-modulating cancer vaccines. For retail investors, these trials' outcomes might influence future stock performance.
The poster presentation at the AACR Annual Meeting provides an additional layer of validation for the dual mechanism of action of IO102-IO103, supporting its potential efficacy. This dual antigen approach could set IO Biotech apart in an increasingly competitive oncology market.
The strengthened executive team—with new hires focused on commercial development—signals IO Biotech’s preparation for potential market entry and commercialization of their lead product. Such strategic hires are important for a smooth transition from a clinical-stage to a commercial-stage company.
The company's strategic direction is clear: they are aligning their clinical progress with commercial readiness. This alignment can mitigate risks associated with scaling up production and distribution once regulatory approvals are in place. For retail investors, understanding that these hires are part of a larger commercialization strategy can provide reassurance about the company's long-term planning and market readiness.
These developments also highlight the importance of having a strong commercial pipeline to ensure that scientific advancements translate into tangible market success.
- Outcome of interim analysis for the overall response rate (ORR) for the first 225 patients randomized in the pivotal Phase 3 trial (IOB-013/KN-D18) of lead investigational therapeutic cancer vaccine, IO102-IO103, in combination with pembrolizumab still expected in Q3 2024; outcome of primary endpoint of progression free survival (PFS) is now projected to occur in first half of 2025
- Completed enrollment in Phase 2 basket trial IOB-022/KN-D38 and in first cohort of Phase 2 neoadjuvant/adjuvant basket trial IOB-032/PN-E40, which has been expanded to include a randomized melanoma cohort
- Presented poster at the American Association for Cancer Research (AACR) Annual Meeting 2024; non-clinical data presented further support the dual mechanism of action of IO102-IO103
- Strengthened executive team with key hires to business and commercial development positions
- Ended first quarter with approximately
$118. 0 million in cash and cash equivalents, maintaining expected cash runway into the fourth quarter of 2025
NEW YORK, May 14, 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 first quarter ended March 31, 2024.
“This will be a transformative year for IO Biotech as we approach the interim analysis of our pivotal Phase 3 study in first-line advanced melanoma, which, if supportive, could allow for a submission of a Biologics License Application (BLA) to the United States (US) Food and Drug Administration (FDA) this year,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “Last year, we expanded our Phase 3 study to potentially bring in the time to reach the primary endpoint of progression free survival and we concluded enrollment in the fourth quarter of 2023 with 407 patients. As we prepare for the interim analysis, we now have greater visibility to estimate the timing of reaching 226 events needed for the PFS analysis, which we now project will occur in the first half of 2025.”
Dr. Zocca continued, “With continued execution of our Phase 3 study and its planned interim analysis as our main priorities this year, we also continue both of our Phase 2 basket studies: completing enrollment in our IOB-022 study; and rapidly enrolling and expanding our newest basket study, IOB-032, in the neo-adjuvant/adjuvant settings of melanoma and squamous cell carcinoma of the head and neck (SCCHN). Finally, as we prepare for potential commercialization and partnering, I am very pleased with the strength of expertise we have added to our leadership team with the additions of Marjan Shamsaei as Senior Vice President, Commercial and Portfolio Lead, and Faiçal Miyara as Chief Business Officer. I founded IO Biotech 10 years ago and couldn’t be more proud of all that we have accomplished, and, with such a strong team in place, confident in what lies ahead.”
Recent Business Highlights
- The company recently completed enrollment of 407 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in advanced melanoma. The primary endpoint of the Phase 3 trial is PFS. The PFS analysis will be conducted when 226 events have occurred in the trial, which, based on the expanded trial size, reaching full enrollment ahead of schedule and the events to date in the study, the company now projects will occur in the first half of 2025. Additionally, a planned interim analysis of ORR will be conducted when the first 225 randomized patients reach one year of treatment in June 2024. The outcome of this analysis is expected in the third quarter of 2024 and, if supportive, we believe could allow for submission of a BLA for accelerated approval in the US.
- The independent data monitoring committee (IDMC) for the company’s IOB-013/KN-D18 Phase 3 trial convened its fourth meeting in March 2024 and recommended that the trial continue without modifications.
- The company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) completed enrollment; the company plans to submit abstracts with updates from this study to medical meetings in the fall of 2024.
- The company’s Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab given before (neo-adjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or SCCHN has been enrolling patients since December 2023 in cohorts A (melanoma) and B (SCCHN) in the US, European Union (EU) and Australia. Cohort A is now fully enrolled and the company recently expanded the study to include a randomized cohort C in melanoma, in which patients are randomized either to IO102-IO103 in combination with pembrolizumab or to pembrolizumab alone.
- In April, a poster presentation of new non-clinical data further supporting the dual mechanism of action of the company’s lead cancer vaccine, IO102-IO103, was delivered at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. While further studies are needed to fully discern the relationship between IDO1+/PD-L1+ target populations within the TME and the impact of IDO1/PD-L1 targeted vaccination, we believe the data presented support the use of a dual antigen approach to reduce the immunosuppression and enhance anti-tumor effect.
- In April, the company strengthened its executive team with the appointments of Faiçal Miyara, Ph.D., as Chief Business Officer, and Marjan Shamsaei, Pharm.D., as Senior Vice President, Commercial and Portfolio Lead.
First Quarter 2024 Financial Results
- Net loss for the three months ended March 31, 2024, was
$19.5 million , compared to$17.0 million for the three months ended March 31, 2023. - Research and development expenses were
$14.3 million for the three months ended March 31, 2024, compared to$11.9 million for the three months ended March 31, 2023. The increase was primarily related to 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 March 31, 2024, compared to$0.7 million for the three months ended March 31, 2023. - General and administrative expenses were
$5.9 million for the three months ended March 31, 2024, compared to$6.0 million for the three months ended March 31, 2023. The company recognized$1.0 million in general and administrative equity-based compensation for the three months ended March 31, 2024, compared to$1.2 million for the three months ended March 31, 2023. - Cash and cash equivalents as of March 31, 2024 were
$118.0 million , compared to$143.2 million at December 31, 2023. During the three months ended March 31, 2024, the company used cash, cash equivalents and restricted cash of$24.9 million . The increase in cash use was primarily driven by milestone payments and payment of other accrued expenses associated with clinical trials, as well as the payment of year-end bonuses. 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 neo-adjuvant/adjuvant treatment of patients with solid tumors.
The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck and Merck 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 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma, being conducted in collaboration with Merck. Patients have been enrolled from centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
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 neo-adjuvant/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 ≥30 melanoma patients will be randomized 1:1 to neo-adjuvant treatment with 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 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:
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com
| IO BIOTECH, INC. Consolidated Statements of Operations and Comprehensive Loss (Unaudited in thousands, except share and per share amounts) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 14,311 | $ | 11,900 | ||||
| General and administrative | 5,886 | 6,024 | ||||||
| Total operating expenses | 20,197 | 17,924 | ||||||
| Loss from operations | (20,197 | ) | (17,924 | ) | ||||
| Other income (expense) | ||||||||
| Currency exchange (loss) gain, net | (462 | ) | 258 | |||||
| Interest income | 1,617 | 1,028 | ||||||
| Total other income (expense) | 1,155 | 1,286 | ||||||
| Loss before income tax expense | (19,042 | ) | (16,638 | ) | ||||
| Income tax expense | 415 | 406 | ||||||
| Net loss | (19,457 | ) | (17,044 | ) | ||||
| Net loss attributable to common shareholders | (19,457 | ) | (17,044 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.30 | ) | $ | (0.59 | ) | ||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 65,880,914 | 28,815,267 | ||||||
| Other comprehensive loss | ||||||||
| Net loss | $ | (19,457 | ) | $ | (17,044 | ) | ||
| Foreign currency translation | 194 | 517 | ||||||
| Total comprehensive loss | $ | (19,263 | ) | $ | (16,527 | ) | ||
| IO BIOTECH, INC. Consolidated Balance Sheets (Unaudited in thousands, except share and per share amounts) | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 117,982 | $ | 143,193 | ||||
| Prepaid expenses and other current assets | 6,146 | 4,062 | ||||||
| Total current assets | 124,128 | 147,255 | ||||||
| Restricted cash | 268 | 268 | ||||||
| Property and equipment, net | 788 | 847 | ||||||
| Right of use lease asset | 2,092 | 2,259 | ||||||
| Other non-current assets | 883 | 89 | ||||||
| Total non-current assets | 4,031 | 3,463 | ||||||
| Total assets | $ | 128,159 | $ | 150,718 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,840 | $ | 3,878 | ||||
| Lease liability - current | 666 | 655 | ||||||
| Accrued expenses and other current liabilities | 6,537 | 11,184 | ||||||
| Total current liabilities | 11,043 | 15,717 | ||||||
| Lease liability - non-current | 1,650 | 1,839 | ||||||
| Total non-current liabilities | 1,650 | 1,839 | ||||||
| Total liabilities | 12,693 | 17,556 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock, par value of | — | — | ||||||
| Common stock, par value of | 66 | 66 | ||||||
| Additional paid-in capital | 408,154 | 406,587 | ||||||
| Accumulated deficit | (283,279 | ) | (263,822 | ) | ||||
| Accumulated other comprehensive loss | (9,475 | ) | (9,669 | ) | ||||
| Total stockholders’ equity | 115,466 | 133,162 | ||||||
| Total liabilities and stockholders’ equity | $ | 128,159 | $ | 150,718 | ||||
FAQ
What is IO Biotech's stock symbol?
When is the interim analysis for IO Biotech's Phase 3 trial expected?
What is the primary endpoint of IO Biotech's Phase 3 trial?
How much cash did IO Biotech have at the end of Q1 2024?
What was IO Biotech's net loss for Q1 2024?
When is the primary endpoint of IO Biotech's Phase 3 trial projected to occur?
What were IO Biotech's research and development expenses in Q1 2024?
How long does IO Biotech expect its cash runway to last?
