Form 8-K - Current report

IO BIOTECH, INC.

Date: November 13, 2023

/s/ Mai-Britt Zocca, Ph.D.

Mai-Britt Zocca, Ph.D.

Chief Executive Officer

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, 2023

IO BIOTECH, INC.

(Exact name of Registrant as Specified in its Charter)

Delaware

001-41008

87-0909276

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(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:

Title of each class

Trading
Symbol(s)

Name of each exchange

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 13, 2023, IO Biotech, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023 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.

Item 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On November 9, 2023, the Company increased the size of the Board from seven to eight directors, and appointed Helen Collins, M.D. as a Class II director of the Company to fill the vacancy, effective as of that same date. The Board also appointed Dr. Collins to serve as the Chairperson of the Board’s Research and Development Committee, which was established by the Board on November 9, 2023.

There are no arrangements or understandings between Dr. Collins and any other person pursuant to which Dr. Collins was selected as a director. There are no transactions involving Ms. Hunter that would be required to be reported under Item 404(a) of Regulation S-K.

In connection with her appointment as a director of the Company, Dr. Collins will enter into the Company’s standard indemnification agreement applicable to non-employee directors and will be eligible for compensation in accordance with the Company’s Non-Employee Directors’ Compensation Policy (the “Policy”), as described in the Company’s Definitive Proxy Statement on Schedule 14A filed with the U.S. Securities and Exchange Commission on April 26, 2023.

In addition, at the close of business on November 15, 2023, Dr. Collins will receive a grant of 64,238 stock options. The stock options will vest monthly over three years, subject to Ms. Hunter’s continuous service on each applicable vesting date. All stock options are to be settled in shares of the Company’s common stock. Like other eligible directors, Dr. Collins will be eligible to receive subsequent stock option awards if she is continuing her service on the Board of Directors of the Company following each annual meeting of stockholders. In accordance with the Policy, the value of such subsequent awards of stock option grants shall be $75,000 as of the grant date and will vest upon the one-year anniversary of the grant date, subject to Dr. Collins’ continuous service until such date. Notwithstanding the vesting schedules described above, if Dr. Collins remains in continuous service until a change of control of the Company, she will become fully vested in all of her then-outstanding equity awards.

Item 7.01.

Regulation FD Disclosure.

On November 13, 2023, the Company issued a press release announcing Dr. Collins’ appointment. A copy of the press release is attached hereto as Exhibit 99.2.

The information contained in this Current Report on Form 8-K is being furnished and shall not be deemed to be “filed” for 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 and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.


Exhibit Number		Exhibit Description

99.1		Press Release, dated as of November 13, 2023

99.2		Press Release, dated as of November 13, 2023

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.

Exhibit 99.1

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IO Biotech Announces 2023 Third Quarter Results

•

Completed enrollment of 380 patients in pivotal Phase 3 trial of lead therapeutic cancer vaccine, IO102-IO103 in combination with KEYTRUDA^® (pembrolizumab), in patients with advanced melanoma

•

Presented encouraging preliminary data from Phase 2 basket trial of IO102-IO103 at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and at the European Society of Medical Oncology (ESMO) annual meeting in October 2023

•

Presented three posters at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting; non-clinical data presented demonstrates clear impact of immune modulating vaccines targeting IDO1 and PD-L1 on several tumoral immune escape mechanisms in the tumor microenvironment leading to enhanced anti-tumor effect

•

Ended the third quarter with approximately $165.5 million in cash and cash equivalents, including proceeds from recently completed $75 million private placement; cash position is expected to support operations into the fourth quarter of 2025

New York, NY – November 13, 2023: IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win^® technology platform, today reported financial results for the third quarter ended September 30, 2023.

“Our focus for 2023 has been to successfully execute multiple clinical trials for our novel, investigational therapeutic cancer vaccine, IO102-IO103. We recently achieved several milestones, completion of enrollment in our pivotal Phase 3 trial in patients with advanced melanoma, the presentation of encouraging preliminary data from the Phase 2 basket trial of IO102-IO103 at WCLC and ESMO, and expanding into earlier stages of melanoma treatment with the initiation of an additional Phase 2 basket study in the neoadjuvant/adjuvant setting,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “With our strengthened balance sheet as a result of our $75 million private placement and key additions to both our management team and board of directors, we are in a strong position as we work diligently to bring our lead therapeutic cancer vaccine candidate, IO102-IO103, toward the market, potentially as early as 2025.”

Recent Business Highlights and Anticipated Milestones

•

The company completed enrollment of 380 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) in November 2023. The primary endpoint of the pivotal Phase 3 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 second half of 2025. Additionally, there is a per-protocol interim analysis of overall response rate (ORR) planned 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.

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•

The Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer, or recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) also continued to enroll patients. Encouraging preliminary data from this basket trial were presented at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and at the ESMO Congress in October 2023. [https://bit.ly/3uhelje; https://bit.ly/3MxPWwg]

•

The company presented three posters at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting. Non-clinical data presented demonstrate the clear impact of therapeutic vaccines targeting IDO1 and PD-L1 on several tumoral immune escape mechanisms in the tumor microenvironment leading to enhanced anti-tumor effect and support the clinical observations observed to date with the company’s lead therapeutic vaccine candidate, IO102-IO103. [https://bit.ly/469Lvyy]

•

On August 7, 2023, the company completed a $75 million private placement with participation from both new and existing healthcare-dedicated investors, extending the company’s cash runway into the fourth quarter of 2025. [https://bit.ly/3QSyaXl]

•

The company appointed a new member, Helen Collins, MD, to the company’s board of directors. Dr. Collins is currently the Chief Medical Officer at Enliven Therapeutics. Prior to joining Enliven, Helen served as Chief Medical Officer and Executive Vice President at Five Prime Therapeutics, a clinical-stage biotechnology company focused on oncology that was acquired by Amgen, Inc. She serves as a member of the board of directors of Kura Oncology. [Link to Press Release]

Third Quarter 2023 Financial Results

The company ended the third quarter with approximately $165.5 million in cash and cash equivalents, which is expected to fund the company’s operations into the fourth quarter of 2025.

•

Net loss for the three months ended September 30, 2023, was $21.7 million, compared to $15.7 million for the three months ended September 30, 2022.

•

Research and development expenses were $17.7 million for the three months ended September 30, 2023, compared to $10.0 million for the three months ended September 30, 2022. The increase was primarily related to clinical trial-related activities for our IO102-IO103 therapeutic vaccine candidate, including the continued execution of our Phase 3 clinical trial. The company recognized $2.1 million in research and development equity-based compensation for the three months ended September 30, 2023, compared to $1.0 million for the three months ended September 30, 2022.

•

General and administrative expenses were consistent at $5.8 million for the three months ended September 30, 2023 and 2022, respectively. The company recognized $0.9 million in general and administrative equity-based compensation for the three months ended September 30, 2023, compared to $1.4 million for the three months ended September 30, 2022.

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•

Cash and cash equivalents as of September 30, 2023, were $165.5 million, compared to $142.6 million at December 31, 2022. During the three months ended September 30, 2023, the company used cash, cash equivalents and restricted cash of $16.0 million from operating and investing activities, obtained $71.9 million in estimated net cash proceeds from our private placement and incurred an additional decrease of $0.5 million in cash due to the effects of foreign currency exchange rates.

Upcoming Events

Jefferies London Healthcare Conference from November 14-16, 2023 in London. Mai-Britt Zocca, PhD, President and CEO, and Amy Sullivan, CFO, will participate in one-on-one meetings on Wednesday, November 15.

Piper Sandler 35^th Annual Healthcare Conference from November 28-30, 2023 in New York. Dr. Zocca will present a corporate overview and Dr. Zocca and Ms. Sullivan will participate in one-on-one meetings on Wednesday, November 29.

About IO102-IO103

IO102-IO103 is an investigational immune-modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced non-small cell lung cancer and squamous cell cancer of the head and neck (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in solid tumors including melanoma and SCCHN.

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 IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win^® vaccine platform. The T-win platform is 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 advanced melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of unresectable / metastatic melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.

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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 the timing of the interim analysis of our 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

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IO BIOTECH, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Operating expenses
Research and development	$	17,655		$	10,022		$	46,059		$	32,553
General and administrative		5,829			5,843			17,201			18,482

Total operating expenses		23,484			15,865			63,260			51,035

Loss from operations		(23,484	)		(15,865	)		(63,260	)		(51,035	)

Other income (expense)
Currency exchange loss, net		(342	)		(87	)		(74	)		(392	)
Interest income		1,708			457			3,932			631
Interest expense		—			(78	)		—			(305	)

Total other income (expense), net		1,366			292			3,858			(66	)

Loss before income tax benefit (expense)		(22,118	)		(15,573	)		(59,402	)		(51,101	)
Income tax (benefit) expense		(439	)		115			499			286

Net loss		(21,679	)		(15,688	)		(59,901	)		(51,387	)

Net loss attributable to common shareholders		(21,679	)		(15,688	)		(59,901	)		(51,387	)

Net loss per common share, basic and diluted	$	(0.43	)	$	(0.54	)	$	(1.66	)	$	(1.78	)

Weighted-average number of shares used in computing net loss per common share, basic and diluted		50,168,303			28,815,267			36,011,162			28,815,267

Other comprehensive (loss) income
Net loss	$	(21,679	)	$	(15,688	)	$	(59,901	)	$	(51,387	)
Foreign currency translation		(108	)		(5,400	)		268			(12,427	)

Total comprehensive loss	$	(21,787	)	$	(21,088	)	$	(59,633	)	$	(63,814	)

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IO BIOTECH, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(unaudited)


	September 30, 2023			December 31, 2022
Assets
Current assets
Cash and cash equivalents	$	165,501		$	142,590
Prepaid expenses and other current assets		2,753			5,629

Total current assets		168,254			148,219

Restricted cash		268			268
Property and equipment, net		797			741
Right of use lease asset		2,367			2,493
Other non-current assets		867			84

Total non-current assets		4,299			3,586

Total assets	$	172,553		$	151,805

Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	6,645		$	4,004
Lease liability - current		627			515
Accrued expenses and other current liabilities		5,713			6,157

Total current liabilities		12,985			10,676

Lease liability - non-current		1,976			2,275

Total non-current liabilities		1,976			2,275

Total liabilities		14,961			12,951

Commitments and contingencies
Stockholders’ equity
Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of September 30, 2023 and December 31, 2022		—			—
Common stock, par value of $0.001 per share; 300,000,000 shares authorized at September 30, 2023 and December 31, 2022; 65,880,914 and 28,815,267 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively		66			29
Additional paid-in capital		405,039			326,705
Accumulated deficit		(237,640	)		(177,739	)
Accumulated other comprehensive loss		(9,873	)		(10,141	)

Total stockholders’ equity		157,592			138,854

Total liabilities and stockholders’ equity	$	172,553		$	151,805

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Exhibit 99.2

LOGO

IO Biotech Appoints Helen Collins, MD, to its Board of Directors

NEW YORK, November 13, 2023 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune modulating cancer vaccines based on its T-win^® technology platform, announced the appointment of Helen Collins, MD, to its board of directors. Dr. Collins is an industry veteran with significant experience in oncology/hematology drug development and will serve on the Research and Development Committee of the Board.

“We are pleased to welcome Helen, an accomplished healthcare executive with extensive drug development and corporate strategy experience, to our Board of Directors,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “I look forward to Helen’s contributions to the board as we work to potentially bring our lead cancer vaccine candidate, IO102-IO103, to market for patients with advanced melanoma as early as 2025.”

“I am inspired by IO Biotech’s unique approach that has the potential to transform the way many cancers are treated today,” said Dr. Collins. “The Phase 1/2 data of lO102-IO103 in combination with a PD-1 inhibitor to treat first-line advanced melanoma patients showed a remarkable overall response rate of 80% and the data generated from the company’s Phase 2 study in patients with non-small cell lung cancer and squamous cell cancer of the head and neck is promising. I look forward to working with the company as they complete their pivotal Phase 3 trial and work to fulfill their mission of changing the treatment paradigm for patients with cancer.”

Dr. Collins joins the IO Biotech board of directors with more than 25 years of medical experience. She is currently the Chief Medical Officer at Enliven Therapeutics. Prior to Enliven, she served as Chief Medical Officer and Executive Vice President at Five Prime Therapeutics, where she was responsible for the strategy and execution of the company’s clinical development plans until its acquisition by Amgen in April 2021. Previously, Dr. Collins held positions of increasing responsibility at Gilead Sciences, most recently as Program and Clinical Lead for Gilead’s GS-5829 (BET inhibitor) and GS-4059 (BTK inhibitor) programs, and Amgen, most recently as Global Lead of Oncology Biosimilars. Dr. Collins currently serves on the board of directors for Kura Oncology. Prior to her career in the biopharma industry, Dr. Collins practiced as a medical oncologist/hematologist for 12 years. She earned her MD from Johns Hopkins University School of Medicine, completing her residency at Johns Hopkins Hospital and oncology fellowship at Stanford University School of Medicine, and her BA from Bryn Mawr College.

About IO102-IO103

IO102-IO103 is an investigational immune modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed death ligand (PD-L1). The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with

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pembrolizumab in first-line advanced non-small cell lung cancer and head and neck cancer (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in solid tumors including melanoma and SCCHN. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck. 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 IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win^® vaccine platform. The T-win platform is 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 advanced melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of unresectable/metastatic 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.

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 and results, 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

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Document and Entity Information	Nov. 09, 2023
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001865494
Document Type	8-K
Document Period End Date	Nov. 09, 2023
Entity Registrant Name	IO BIOTECH, INC.
Entity Incorporation State Country Code	DE
Entity File Number	001-41008
Entity Tax Identification Number	87-0909276
Entity Address, Address Line One	Ole Maaløes Vej 3
Entity Address, Postal Zip Code	DK-2200
Entity Address, City or Town	Copenhagen N
Entity Address, Country	DK
City Area Code	+45
Local Phone Number	7070 2980
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, par value $0.001 per share
Trading Symbol	IOBT
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false