Full Press Release Details
(In thousands, except share and per share amounts)
| June 30, 2021 | December 31, 2020 | |||||||
| Restated | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 54,752 | $ | 3,405 | ||||
| Prepaid expenses and other current assets | 5,410 | 2,230 | ||||||
| Total current assets | 60,162 | 5,635 | ||||||
| Noncurrent assets | 38 | 18 | ||||||
| Total assets | $ | 60,200 | $ | 5,653 | ||||
| Liabilities, convertible preference shares and stockholders deficit | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,696 | $ | 522 | ||||
| Accrued expenses and other current liabilities | 4,249 | 2,528 | ||||||
| Preference shares tranche obligations | 31,344 | |||||||
| Total current liabilities | 37,289 | 3,050 | ||||||
| Other long-term liabilities | ||||||||
| Total liabilities | 37,289 | 3,050 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Convertible preference shares | ||||||||
| Class B preference shares, $0.16 par value; 584,583 shares authorized, issued and outstanding at June 30, 2021 and December 31, 2020, respectively; liquidation value of $47,457 at June 30, 2021 | 37,906 | 37,906 | ||||||
| Class C preference shares, $0.16 par value; 1,263,804 shares authorized and 541,345 shares issued and outstanding at June 30, 2021. No shares authorized, issued and outstanding and December 31, 2020; liquidation value of $66,795 at June 30, 2021 | 62,982 | |||||||
| Stockholders deficit | ||||||||
| Class A ordinary shares, par value of $0.16 per share; 170,000 shares authorized, issued and outstanding as of June 30, 2021 and December 31, 2020 | 28 | 28 | ||||||
| Additional paid-in capital | 1,119 | 1,110 | ||||||
| Accumulated deficit | (80,509 | ) | (38,402 | ) | ||||
| Accumulated other comprehensive loss | 1,385 | 1,961 | ||||||
| Total stockholders deficit | (77,977 | ) | (35,303 | ) | ||||
| Total liabilities, convertible preference shares and stockholders deficit | $ | 60,200 | $ | 5,653 |
See accompanying notes to the financial statements.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Six Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Restated | ||||||||
| Operating expenses | ||||||||
| Research and development | $ | 9,583 | $ | 3,476 | ||||
| General and administrative | 3,213 | 699 | ||||||
| Total operating expenses | 12,796 | 4,175 | ||||||
| Loss from operations | (12,796 | ) | (4,175 | ) | ||||
| Other income (expense) | ||||||||
| Currency exchange gain (loss), net | 292 | 99 | ||||||
| Interest expense | (143 | ) | (8 | ) | ||||
| Fair value adjustments on preference shares tranche obligations | (29,460 | ) | ||||||
| Fair value adjustments on convertible notes | (1,916 | ) | ||||||
| Total other income (expense), net | (29,311 | ) | (1,825 | ) | ||||
| Net loss | (42,107 | ) | (6,000 | ) | ||||
| Cumulative dividends on class B and C preference shares | (3,933 | ) | (1,021 | ) | ||||
| Net loss attributable to class A ordinary shareholders | (46,040 | ) | (7,021 | ) | ||||
| Net loss per class A ordinary share, basic and diluted | $ | (259.82 | ) | $ | (39.62 | ) | ||
| Weighted-average number of shares used in computing net loss per class A ordinary share, basic and diluted | 177,200 | 177,200 | ||||||
| Other comprehensive loss | ||||||||
| Net loss | (42,107 | ) | (6,000 | ) | ||||
| Foreign currency translation | (576 | ) | 238 | |||||
| Total comprehensive loss | (42,683 | ) | (5,762 | ) |
See accompanying notes to the financial statements.
Statements of Convertible Preference Shares and Stockholders Deficit
(In thousands, except share amounts)
| Class B Convertible Preference Shares | Class C Convertible Preference Shares | Class A Ordinary Shares | Additional Paid-In Capital | Other Comprehensive Loss | Accumulated Deficit | Total Stockholders Deficit | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||
| Balance, January 1, 2020 | 366,301 | $ | 22,060 | $ | 177,200 | $ | 28 | $ | 1,504 | $ | 1,297 | $ | (26,360 | ) | $ | (23,531 | ) | |||||||||||||||||||||||
| Issuance of class B preference shares upon conversion of convertible notes, net of issuance costs of $4 | 142,437 | 10,273 | ||||||||||||||||||||||||||||||||||||||
| Equity-based compensation expense | 32 | 32 | ||||||||||||||||||||||||||||||||||||||
| Currency translation | 239 | 239 | ||||||||||||||||||||||||||||||||||||||
| Net loss | (6,000 | ) | (6,000 | ) | ||||||||||||||||||||||||||||||||||||
| Balance, June 30, 2020 | 508,738 | 32,333 | 177,200 | 28 | 1,536 | 1,536 | (32,360 | ) | (29,260 | ) | ||||||||||||||||||||||||||||||
| Balance, January 1, 2021 | 584,583 | $ | 37,906 | $ | 177,200 | $ | 28 | $ | 1,110 | $ | 1,961 | $ | (38,402 | ) | $ | (35,303 | ) | |||||||||||||||||||||||
| Issuance of class C preference shares, net of issuance costs of $340 | 541,345 | 62,982 | ||||||||||||||||||||||||||||||||||||||
| Equity-based compensation expense | 9 | 9 | ||||||||||||||||||||||||||||||||||||||
| Currency translation | (576 | ) | (576 | ) | ||||||||||||||||||||||||||||||||||||
| Net loss | (42,107 | ) | (42,107 | ) | ||||||||||||||||||||||||||||||||||||
| Balance, June 30, 2021 | 584,583 | $ | 37,906 | 541,345 | $ | 62,982 | 177,200 | $ | 28 | $ | 1,119 | $ | 1,385 | $ | (80,509 | ) | $ | (77,977 | ) |
See accompanying notes to the financial statements.
Statements of Cash Flows
| Six Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Restated | ||||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (42,107 | ) | $ | (6,000 | ) | ||
| Adjustment to reconcile net loss to net cash used in operating activities | ||||||||
| Equity-based compensation | 9 | 32 | ||||||
| Fair value adjustments preference shares tranche obligations | 29,460 | |||||||
| Fair value adjustments convertible notes | 1,985 | |||||||
| Other non-cash items, net | (349 | ) | (99 | ) | ||||
| Changes in operating assets and liabilities | ||||||||
| Prepaid expenses and other current assets | (3,180 | ) | (459 | ) | ||||
| Accounts payable | 1,174 | (722 | ) | |||||
| Accrued expenses and other current liabilities | 1,700 | 563 | ||||||
| Net cash used in operating activities | (13,293 | ) | (4,700 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of class C preference shares | 65,748 | |||||||
| Preference shares issuance costs | (340 | ) | (4 | ) | ||||
| Net cash provided by financing activities | 65,408 | (4 | ) | |||||
| Net decrease in cash and cash equivalents | 52,115 | (4,704 | ) | |||||
| Effect of exchange rate changes on cash and cash equivalents | (768 | ) | (34 | ) | ||||
| Cash and cash equivalents, beginning of period | 3,405 | 7,846 | ||||||
| Cash and cash equivalents, end of period | $ | 54,752 | $ | 3,108 | ||||
| Supplemental disclosures of non-cash financing activities: | ||||||||
| Exchange of convertible notes for class B preference shares | $ | $ | 10,277 |
See accompanying notes to the financial statements.
1. Description of Business, Organization and Liquidity
Biotech ApS is a clinical-stage biotechnology company dedicated to the identification and development of disruptive immune therapies for the treatment of cancer. As used in these financial statements, unless the context otherwise requires,
references to the Company , we, us, and our refer to IO Biotech ApS. We were incorporated in Denmark in December 2014. We are developing novel, immune-modulating cancer therapies based on our T-win technology platform.
Risks and Uncertainties
We are subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations,
protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and
development efforts, including extensive pre-clinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate
personnel infrastructure and extensive compliance reporting capabilities.
Our product candidates are in development. There can be no
assurance that our research and development will be successfully completed, that adequate protection for our intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any
approved products will be commercially viable. Even if our product development efforts are successful, it is uncertain when, if ever, we will generate significant revenue from product sales. We operate in an environment of rapid change in technology
and substantial competition from pharmaceutical and biotechnology companies. In addition, we are dependent upon the services of our employees and consultants.
Liquidity Considerations
inception, we have devoted substantially all our efforts to business planning, conducting research and development, recruiting management and technical staff, and raising capital. We have financed our operations primarily through the issuance of
convertible preference shares and convertible notes.
Our continued discovery and development of its product candidates will require
significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior t commercialization These efforts require significant amounts of additional capital, adequate personnel and
infrastructure and extensive compliance-reporting capabilities. Even if product development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales.
As of June 30, 2021, we had an accumulated deficit of $80.5 million. We have incurred losses and negative cash flows from operations
since inception, including net losses of $42.1 million and $6.0 million for the six months ended June 30, 2021 and year ended December 31, 2020, respectively. We expect that our operating losses and negative cash flows will
continue for the foreseeable future as we continue to develop our product candidates. We currently expect that our cash and cash equivalents of $54.8 million as of June 30, 2021 together with the proceeds on closings of the class C
preference shares, for gross proceeds of $84.1 million in October 2021 will be sufficient to fund our operating expenses and capital requirements for at least 12 months from the date the financial statements are issued. However, additional
funding will be necessary to fund future discovery research, pre-clinical and clinical activities. We will seek additional funding through public financings, debt financings, collaboration agreements,
strategic alliances and licensing arrangements. Although we have been successful in raising capital in the past, there is no assurance that we will be successful in obtaining such additional financing on terms acceptable to it, if at all, and we may
not be able to enter into collaborations or other arrangements. If we are unable to obtain funding, we could be forced to delay, reduce or eliminate our research and development programs, product portfolio expansion or commercialization efforts,
which could adversely affect our business prospects, even our ability to continue operations.
Coronavirus Pandemic
In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. In order to
mitigate the spread of COVID-19, governments have imposed unprecedented restrictions on business operations, travel and gatherings, resulting in a global economic downturn and other adverse economic and
societal impacts. The COVID-19 pandemic has also overwhelmed or otherwise led to changes in the operations of many healthcare facilities, including clinical trial sites. While we are considered an essential
business under applicable regulations and continue to operate, the impacts of COVID-19 initially placed significant strain on our clinical trial
sites, have raised concerns around monitoring patient safety, and resulted in changes to patient visit frequencies. We are continuing to work closely with our clinical partners and have taken
steps as necessary to adjust our protocols and timelines due to the impact of the COVID-19 pandemic. The COVID-19 pandemic and its impacts continue to evolve. We cannot
predict the scope and severity of any further disruptions as a result of COVID-19 or their impacts on us, but business disruptions for us or any of the third parties with whom we engage, including the
collaborators, contract organizations, third-party manufacturers, suppliers, clinical trial sites, regulators and other third parties with whom we conduct business could materially and negatively impact our ability to conduct our business in the
manner and on the timelines presently planned. The extent to which the COVID-19 pandemic may continue to impact our business and financial performance will depend on future developments, which are highly
uncertain and cannot be predicted with confidence, including the scope and duration of the pandemic, the extent and effectiveness of government restrictions and other actions, including relief measures, implemented to address the impact of the
pandemic, and resulting economic impacts.
The actual and perceived impact of the COVID-19
pandemic is changing daily, and its ultimate effect on our business cannot be predicted. As a result, there can be no assurance that we will not experience additional negative impacts associated with COVID-19,
which could be significant. The COVID-19 pandemic may negatively impact our business, financial condition and results of operations causing interruptions or delays in the Company s programs and services.
2. Summary of Significant Accounting Policies
There have been no changes to the significant accounting policies as disclosed in Note 2 to the Company s annual financial statements for
the years ended December 31, 2020 and 2019 included in this Form S-1.
The Company s condensed financial statements include the accounts of IO Biotech ApS. IO Bio US, Inc., a
wholly owned subsidiary of IO Biotech ApS, was incorporated in Delaware in May 2021. IO Bio US, Inc. had no activity as of June 30, 2021. IO Biotech Limited, a wholly owned subsidiary of IO Biotech ApS, was incorporated in the UK in August
2021. In October 2021, the Company engaged in a series of transactions, referred to collectively as the Corporate Reorganization. As a result of the Corporate Reorganization, IO Biotech ApS became a wholly-owned subsidiary of IO Biotech,
Inc. and accordingly, our consolidated financial statements will be those of IO Biotech, Inc. for the periods after the date of the Corporate Reorganization. IO Biotech, Inc. is a recently formed holding company, which, prior to our IPO, had
nominal assets and no liabilities, contingencies, or commitments, and which has not conducted any operations prior to our IPO other than acquiring the entire issued and outstanding stock of IO Biotech ApS. The Company, IO Biotech ApS, and
the holders of all of the issued and outstanding equity interests of IO Biotech ApS have entered into a Share Contribution and Exchange Agreement, dated as of October 29, 2021, pursuant to which the Corporate Reorganization was effected.
Unaudited Financial Information
The Company s condensed financial statements included herein have been prepared in conformity with accounting principles generally
accepted in the United States of America, or GAAP, and pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC. In the Company s opinion, the information furnished reflects all adjustments, all of which are of a
normal and recurring nature, necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company consider events or transactions that occur after the balance sheet date but before the
financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be
expected for the full year or any other interim period.
Restatement of Financial Statements
Subsequent to the issuance of these financial statements, we identified an error related to the recording of research and development expense,
and the related prepaid and accrued expenses, as of and for the six months ended June 30, 2021. We evaluated the error and determined that the related impact was material to our financial statements. Accordingly, we have restated previously
reported financial information for this error, as previously disclosed in our Form S-1 Registration Statement for the six months ended June 30, 2021. A summary of the restatement to certain previously
reported financial information presented herein for comparative purposes is included in Note 13.
Recently Issued Accounting
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), as
amended, with guidance regarding the accounting for and disclosure of leases. ASU 2016-02 requires lessees to recognize the liabilities related all leases, including operating leases, with a term greater than
12 months on the balance sheet. This update also requires lessees and lessors to disclose key information about their leasing transactions. This standard is effective for annual reporting periods beginning after December 15, 2021, and interim
periods within annual periods beginning after December 15, 2022. Early adoption is permitted. We are currently assessing the potential impact of adopting ASU 2016-02 on our financial statements and
financial statement disclosures.
In June 2016, the FASB issued Accounting Standards Update
No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments. ASU 2016-13 requires measurement and recognition
of expected credit losses for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification
Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, or ASU 2016-13. The guidance is effective for fiscal
years beginning after December 15, 2022. We are currently assessing the potential impact of adopting ASU 2016-13 on our financial statements and financial statement disclosures.
In December 2019, the FASB issued ASU 2019-12,
Simplifying the Accounting for Income Taxes, or ASU 2019-12. ASU 2019-12 eliminates certain exceptions related to the approach for intra-period tax allocation,
the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. This guidance is
effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. Early adoption is permitted. We are currently assessing the impact adoption of ASU 2019-12 will have on our financial statements and disclosures.
In August 2020, the FASB issued ASU No. 2020-06, Debt Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entity s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity s Own Equity. ASU 2020-06 will simplify the accounting for convertible instruments by
reducing the number of accounting models for convertible debt instruments and convertible preferred stock. Limiting the accounting models results in fewer embedded conversion features being separately recognized from the host contract
as compared with current GAAP. Convertible instruments that continue to be subject to separation models are (i) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the
definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (ii) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in capital. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity s own equity to reduce
form-over-substance-based accounting conclusions. ASU 2020-06 will be effective for us beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years
beginning after December 15, 2020, including interim periods within those fiscal years. We are currently assessing the impact adoption of ASU 2020-06 will have on our financial statements
3. Fair Value Measurements
The following table presents information about our financial assets and liabilities measured at fair value on a recurring basis and indicate
the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| June 30, 2021 | ||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
| Current liabilities | ||||||||||||||||
| Preference shares tranche obligations | $ | 31,344 | $ | $ | $ | 31,344 | ||||||||||
| Total financial liabilities measured at fair value | $ | 31,344 | $ | $ | $ | 31,344 |