8-K
IO Biotech, Inc. (IOBTQ)
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): November 9, 2022
IO BIOTECH, INC.
(Exact name of Registrant as Specified in its Charter)
| Delaware | 001-41008 | 87-0909276 |
|---|---|---|
| (State or other jurisdiction<br> <br>of incorporation) | (Commission<br> <br>File Number) | (IRS Employer<br> <br>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:
| Title of each class | Trading<br> <br>Symbol(s) | Name of each exchange<br> <br>on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | IOBT | 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 November 9, 2022, IO Biotech, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022 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
| Exhibit<br> <br>No. | Description |
|---|---|
| 99.1 | Press Release of the Company, dated November 9, 2022 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| IO BIOTECH, INC. | ||
|---|---|---|
| Date: November 9, 2022 | By: | /s/ Mai-Britt Zocca |
| Name: | Mai-Britt Zocca, Ph.D. | |
| Title: | Chief Executive Officer |
EX-99.1
Exhibit 99.1
IO Biotech Announces Third Quarter Results for 2022
| • | Clinical trial site activation, a leading indicator of patient enrollment, has accelerated in the past threemonths in the company’s global Phase 3 combination trial of IO102-IO103 and KEYTRUDA^®^ (pembrolizumab) as first-line treatment in advanced melanoma |
|---|---|
| • | Oral presentation and two poster presentations at the Society for Immunotherapy of Cancer’s (SITC) thisweek will provide an overview of the Phase 1/2 study (MM1636) with IO102-IO103 in combination with nivolumab for metastatic melanoma and discuss preclinical work on the next two candidates in the IO Biotech pipeline, which target theimmunosuppressive effects of Arginase 1 and transforming growth factor beta 1 (TGF-ß1) |
| --- | --- |
| • | Results from a new October 2022 data cut off for the MM1636 Phase 1/2 study with IO102-IO103 in combinationwith nivolumab for metastatic melanoma continue to be encouraging with median overall survival (mOS) at 46.8 months; median progression free survival (mPFS) at 22.5 months, and a complete response rate of 50% |
| --- | --- |
| • | The company ended the third quarter with $151.2 million in cash, which supports multipleexpected data readouts into mid-2024 |
| --- | --- |
New York, New York– November 9, 2022: IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win^®^ technology platform, announced today financial results for the quarter ending September 30, 2022.
“During the last three months, we have made significant progress with the activation of clinical sites participating in our global Phase 3 combination trial of IOB102-IO103 with pembrolizumab as a potential first-line treatment in advanced melanoma,” said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. “We ended October with 55 sites actively enrolling in study, compared to 19 actively enrolling sites at the end of July. We view the pace of site activation as a leading indicator of patient enrollment, and we are very pleased with our progress.”
Dr. Zocca continued, “Additionally, enrollment in our second ongoing clinical study, the Phase 2 basket trial of IO102-IO103 in combination with pembrolizumab, is progressing nicely and we continue to expect to receive preliminary data in one indication this quarter with additional data in 2023. We believe that our T-win^®^ platform—and its novel approach to activate naturally occurring T cells to target immunosuppressive mechanisms—has the potential to benefit patients in need of more treatment options and look forward to reporting our progress in the coming months.”
| IO Biotech ApS<br> <br>Ole Maaløes Vej3<br> <br>2200 Copenhagen N, Denmark<br><br><br>www.iobiotech.com | Page 1 of 7 |
|---|
Highlights for Third Quarter 2022 and Recent Weeks
| • | An oral presentation and two poster presentations related to the company’s programs are being presented at<br>the 2022 SITC Meeting this week. See the following press release for more information, “IO Biotech ApS—IO Biotech Announces Invited Oral Presentation and Two Poster Presentations at the Society for Immunotherapy of Cancer’s (SITC)<br>37th Annual Meeting.” |
|---|---|
| • | Consistent with the earlier reported data, with an additional 12 months of patient<br>follow-up, results from a new October 2022 data cut for the MM1636 Phase 1/2 study with IO102-IO103 in combination with nivolumab for metastatic melanoma continue to be encouraging. As of that data cut-off, 30 PD-1 naïve patients were enrolled with a median follow-up time of 31.7 months. Median overall survival (mOS) was<br>reached at 46.8 months post first trial treatment, median progression free survival (mPFS) was 22.5 months, and 50% of patients (15/30) achieved a complete response (CR), or complete disappearance of their tumors. The overall response rate for the<br>study was 73.3% as previously reported. Patients who were PD-1 refractory and enrolled in cohort B in this study had no response to therapy, which we believe shows that our vaccine works best in front-line<br>metastatic melanoma patients, as we expected in this setting. |
| --- | --- |
| • | In the past three months, the company has accelerated the rate of clinical trial site activation in the global<br>Phase 3 trial of IO102-IO103 in combination with pembrolizumab for front-line treatment of PD-1 naïve metastatic melanoma patients. |
| --- | --- |
| • | In October 2022, the company named Amy Sullivan as Chief Financial Officer. Ms. Sullivan brings 30 years of<br>experience building biotech companies to IO Biotech. |
| --- | --- |
| • | In November 2022, the company entered into a fourth clinical trial collaboration and supply agreement with<br>Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary. See the following press release for more information, “IO Biotech ApS—IO Biotech Announces New Clinical Collaboration<br>with Merck to Evaluate Neoadjuvant and Adjuvant IO102-IO103 in Combination With KEYTRUDA^®^ (pembrolizumab) in a Phase 2, Multi-cohort Trial in Patients with Resectable Tumors.”<br> |
| --- | --- |
Third Quarter Financial Results
| • | Net loss for the three months ended September 30, 2022 was $15.7 million, compared to $4.5 million<br>for the three months ended September 30, 2021. |
|---|---|
| • | Research and development expenses were $10.0 million for the three months ended September 30, 2022,<br>compared to $4.1 million for the three months ended September 30, 2021. The increase of $5.9 million was primarily related to an increase in preclinical studies and clinical trial-related activities for our IO102-IO103 product<br>candidate, including the continued execution of our Phase 3 clinical trial, of $2.9 million and an increase in personnel costs of $2.8 million primarily related to an increase in headcount and related recruiting costs.<br> |
| --- | --- |
| IO Biotech ApS<br> <br>Ole Maaløes Vej3<br> <br>2200 Copenhagen N, Denmark<br><br><br>www.iobiotech.com | Page 2 of 7 |
| --- | --- |
| • | General and administrative expenses were $5.8 million for the three months ended September 30, 2022,<br>compared to $2.9 million for the three months ended September 30, 2021. The increase of $2.9 million was primarily related to costs associated with being a public company. |
|---|---|
| • | Other income, net was $0.3 million for the three months ended September 30, 2022, compared to<br>$2.6 million for the three months ended September 30, 2021. The decrease of $2.3 million was primarily due to the decrease in the fair value adjustments on the Company’s preferred stock tranche obligations. |
| --- | --- |
| • | Cash and cash equivalents as of September 30, 2022 were $151.2 million, compared to $211.5 million<br>at December 31, 2021. During the third quarter 2022, the Company used cash, cash equivalents and restricted cash of $13.5 million from operating, investing and financing activities with an additional decrease of $5.5 million in cash<br>due to the effects of foreign currency exchange rates. Cash on hand is expected to support operations through anticipated data readouts into mid-2024. |
| --- | --- |
About the IOB-013/KN-D18 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
About IOB-022/KN-D38
IOB-022/KN-D38 is a non-comparative, open label Phase 2 trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line indications: non-small cell lung cancer, squamous cell carcinoma of the head and neck, and metastatic urothelial bladder cancer. The clinical trial will be sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.
About IO102-IO103
IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.
| IO Biotech ApS<br> <br>Ole Maaløes Vej3<br> <br>2200 Copenhagen N, Denmark<br><br><br>www.iobiotech.com | Page 3 of 7 |
|---|
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win^®^ technology platform. The T-win^®^ platform is a novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. IO Biotech is advancing in clinical studies its lead immuno-oncology candidate, IO102-IO103, targeting IDO and PD-L1, and through preclinical development its other pipeline candidates. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.
For further information, please visit www.iobiotech.com
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 future clinical trials, trials results and clinical site activation, 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.
Company Contact:
Amy Sullivan
Chief Financial Officer
IO Biotech, Inc.
asu@iobiotech.com
Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com
| IO Biotech ApS<br> <br>Ole Maaløes Vej3<br> <br>2200 Copenhagen N, Denmark<br><br><br>www.iobiotech.com | Page 4 of 7 |
|---|
Media Contact:
Raena Mina, Ph.D.
LifeSci Communications
646-606-1438
rmina@lifescicomms.com
KEYTRUDA^®^ is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
| IO Biotech ApS<br> <br>Ole Maaløes Vej3<br> <br>2200 Copenhagen N, Denmark<br><br><br>www.iobiotech.com | Page 5 of 7 |
|---|
IO BIOTECH, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(unaudited)
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Operating expenses | ||||||||||||
| Research and development | $ | 10,022 | $ | 4,128 | $ | 32,553 | $ | 13,712 | ||||
| General and administrative | 5,843 | 2,914 | 18,482 | 6,127 | ||||||||
| Total operating expenses | 15,865 | 7,042 | 51,035 | 19,839 | ||||||||
| Loss from operations | (15,865 | ) | (7,042 | ) | (51,035 | ) | (19,839 | ) | ||||
| Other income (expense) | ||||||||||||
| Currency exchange (loss) gain, net | (87 | ) | 17 | (392 | ) | 309 | ||||||
| Interest income | 457 | — | 631 | — | ||||||||
| Interest expense | (78 | ) | (67 | ) | (305 | ) | (210 | ) | ||||
| Fair value adjustments on preference shares tranche obligations | — | 2,630 | — | (26,830 | ) | |||||||
| Total other income (expense), net | 292 | 2,580 | (66 | ) | (26,731 | ) | ||||||
| Loss before income tax expense | (15,573 | ) | (4,462 | ) | (51,101 | ) | (46,570 | ) | ||||
| Income tax expense | 115 | — | 286 | — | ||||||||
| Net loss | (15,688 | ) | (4,462 | ) | (51,387 | ) | (46,570 | ) | ||||
| Cumulative dividends on class B and C preference shares | — | (2,073 | ) | — | (6,006 | ) | ||||||
| Net loss attributable to common shareholders | (15,688 | ) | (6,535 | ) | (51,387 | ) | (52,576 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.54 | ) | $ | (36.88 | ) | $ | (1.78 | ) | $ | (296.70 | ) |
| Weighted-average number of shares used in computing net loss per common share, basic and<br>diluted | 28,815,267 | 177,200 | 28,815,267 | 177,200 | ||||||||
| Other comprehensive loss | ||||||||||||
| Net loss | (15,688 | ) | (4,462 | ) | (51,387 | ) | (46,570 | ) | ||||
| Foreign currency translation | (5,400 | ) | (681 | ) | (12,427 | ) | (1,256 | ) | ||||
| Total comprehensive loss | (21,088 | ) | (5,143 | ) | (63,814 | ) | (47,826 | ) | ||||
| IO Biotech ApS<br> <br>Ole Maaløes Vej3<br> <br>2200 Copenhagen N, Denmark<br><br><br>www.iobiotech.com | Page 6 of 7 | |||||||||||
| --- | --- |
IO BIOTECH, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(unaudited)
| December 31,2021 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current assets | |||||
| Cash and cash equivalents | 151,168 | $ | 211,531 | ||
| Prepaid expenses and other current assets | 6,583 | 10,207 | |||
| Total current assets | 157,751 | 221,738 | |||
| Restricted cash | 268 | 268 | |||
| Property and equipment, net | 640 | 155 | |||
| Right of use lease asset | 2,612 | — | |||
| Noncurrent assets | 886 | 127 | |||
| Total assets | 162,157 | $ | 222,288 | ||
| Liabilities, convertible preference shares and stockholders’ equity | |||||
| Current liabilities | |||||
| Accounts payable | 2,345 | $ | 3,928 | ||
| Lease liability—current | 492 | — | |||
| Accrued expenses and other current liabilities | 3,484 | 6,377 | |||
| Total current liabilities | 6,321 | 10,305 | |||
| Lease liability—noncurrent | 2,347 | — | |||
| Other long-term liabilities | — | 59 | |||
| Total liabilities | 8,668 | 10,364 | |||
| Convertible preference shares | — | — | |||
| Stockholders’ equity | |||||
| Preferred stock, par value of 0.001 per share; 5,000,000 shares authorized, no shares issued and<br>outstanding as of September 30, 2022 and December 31, 2021 | — | — | |||
| Common stock, par value of 0.001 per share; 300,000,000 shares authorized, 28,815,267 shares<br>issued and outstanding as of September 30, 2022 and December 31, 2021 | 29 | 29 | |||
| Additional paid-in capital | 325,044 | 319,665 | |||
| Accumulated deficit | (157,668 | ) | (106,281 | ) | |
| Accumulated other comprehensive loss | (13,916 | ) | (1,489 | ) | |
| Total stockholders’ equity | 153,489 | 211,924 | |||
| Total liabilities, convertible preference shares and stockholders’ equity | 162,157 | $ | 222,288 |
All values are in US Dollars.
| IO Biotech ApS<br> <br>Ole Maaløes Vej3<br> <br>2200 Copenhagen N, Denmark<br><br><br>www.iobiotech.com | Page 7 of 7 |
|---|