Form 8-K - Current report
August 13 2024 - 7:05AM
Edgar (US Regulatory)
false 0001865494 0001865494 2024-08-13 2024-08-13
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 13, 2024
IO BIOTECH, INC.
(Exact name of Registrant as Specified in its Charter)
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Delaware |
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001-41008 |
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87-0909276 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
Ole Maaløes Vej 3
DK-2200 Copenhagen N
Denmark
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: +45 7070 2980
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
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IOBT |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 |
Results of Operations and Financial Condition |
On August 13, 2024, IO Biotech, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended June 30, 2024 and an update on the Company’s operations for the same period. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information included in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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IO BIOTECH, INC. |
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Date: August 13, 2024 |
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By: |
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/s/ Mai-Britt Zocca |
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Name: |
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Mai-Britt Zocca, Ph.D. |
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Title: |
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Chief Executive Officer |
Exhibit 99.1
IO Biotech Reports Second Quarter 2024 Financial Results and Provides Business Highlights
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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 Mercks 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 |
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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 |
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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 |
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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, NY
August 13, 2024: 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, weve 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.
1
Recent Business Highlights
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The independent data monitoring committee (IDMC) for the companys 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. |
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Updated data for the head and neck cohort of the companys 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. |
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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 (neo-adjuvant) 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
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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. |
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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 companys IO102-IO103 therapeutic cancer vaccine candidate, including the continued
execution of the companys 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. |
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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. |
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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 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 (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.
3
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 ≥60 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 (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor;
central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
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
4
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 companys Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the companys financial position or cash runway, are based on IO Biotechs 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
5
IO BIOTECH, INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited in thousands, except share and per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses |
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Research and development |
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$ |
15,848 |
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$ |
16,504 |
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$ |
30,159 |
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$ |
28,404 |
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General and administrative |
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5,685 |
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5,348 |
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11,571 |
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11,372 |
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Total operating expenses |
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21,533 |
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21,852 |
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41,730 |
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39,776 |
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Loss from operations |
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(21,533 |
) |
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(21,852 |
) |
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(41,730 |
) |
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(39,776 |
) |
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Other income (expense) |
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Currency exchange (loss) gain, net |
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(90 |
) |
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10 |
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(552 |
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268 |
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Interest income |
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1,311 |
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1,196 |
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2,928 |
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2,224 |
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Total other income (expense), net |
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1,221 |
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1,206 |
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2,376 |
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2,492 |
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Loss before income tax expense |
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(20,312 |
) |
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(20,646 |
) |
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(39,354 |
) |
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(37,284 |
) |
Income tax expense |
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374 |
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532 |
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789 |
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938 |
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Net loss |
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(20,686 |
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(21,178 |
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(40,143 |
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(38,222 |
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Net loss attributable to common shareholders |
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(20,686 |
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(21,178 |
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(40,143 |
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(38,222 |
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Net loss per common share, basic and diluted |
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$ |
(0.31 |
) |
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$ |
(0.74 |
) |
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$ |
(0.61 |
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$ |
(1.33 |
) |
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Weighted-average number of shares used in computing net loss per common share, basic and
diluted |
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65,880,914 |
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28,815,267 |
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65,880,914 |
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28,815,267 |
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Other comprehensive loss |
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Net loss |
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$ |
(20,686 |
) |
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$ |
(21,178 |
) |
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$ |
(40,143 |
) |
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$ |
(38,222 |
) |
Foreign currency translation |
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(151 |
) |
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(141 |
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43 |
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376 |
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Total comprehensive loss |
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$ |
(20,837 |
) |
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$ |
(21,319 |
) |
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$ |
(40,100 |
) |
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$ |
(37,846 |
) |
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6
IO BIOTECH, INC.
Consolidated Balance Sheets
(Unaudited in thousands, except share and per share amounts)
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June 30, 2024 |
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December 31, 2023 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
100,747 |
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$ |
143,193 |
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Prepaid expenses and other current assets |
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6,905 |
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4,062 |
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Total current assets |
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107,652 |
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147,255 |
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Restricted cash |
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268 |
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268 |
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Property and equipment, net |
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735 |
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847 |
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Right of use lease asset |
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1,936 |
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2,259 |
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Other non-current assets |
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876 |
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89 |
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Total non-current assets |
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3,815 |
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3,463 |
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Total assets |
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$ |
111,467 |
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$ |
150,718 |
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Liabilities and stockholders equity |
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Current liabilities |
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Accounts payable |
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$ |
5,016 |
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$ |
3,878 |
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Lease liability - current |
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678 |
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|
655 |
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Accrued expenses and other current liabilities |
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8,029 |
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11,184 |
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Total current liabilities |
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13,723 |
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15,717 |
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Lease liability - non-current |
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1,472 |
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1,839 |
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Total non-current liabilities |
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1,472 |
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1,839 |
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Total liabilities |
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15,195 |
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|
17,556 |
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Commitments and contingencies |
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Stockholders equity |
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Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and
outstanding as of June 30, 2024 and December 31, 2023 |
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Common stock, par value of $0.001 per share; 300,000,000 shares authorized at June 30, 2024
and December 31, 2023; 65,880,914 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
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|
66 |
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|
66 |
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Additional paid-in capital |
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|
409,797 |
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|
406,587 |
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Accumulated deficit |
|
|
(303,965 |
) |
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|
(263,822 |
) |
Accumulated other comprehensive loss |
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(9,626 |
) |
|
|
(9,669 |
) |
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Total stockholders equity |
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96,272 |
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|
133,162 |
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Total liabilities and stockholders equity |
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$ |
111,467 |
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7
v3.24.2.u1
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
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dei_AmendmentFlag |
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X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
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X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
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dei_DocumentType |
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X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
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- Definition
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- DefinitionISO 3166-1 alpha-2 country code.
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- DefinitionCode for the postal or zip code
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X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
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- DefinitionIndicate if registrant meets the emerging growth company criteria.
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X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
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X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
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X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
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- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
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- DefinitionLocal phone number for entity.
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- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
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- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
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- DefinitionTitle of a 12(b) registered security.
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- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
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- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
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- DefinitionTrading symbol of an instrument as listed on an exchange.
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- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
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