10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 10-Q

 

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________________ to ___________________

Commission File Number: 001-39401

 

 

iTeos Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

84-3365066

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer
Identification No.)

321 Arsenal St

Watertown, MA

 

02472

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (339) 217 0161

 

 

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, $0.001 par value per share

 

ITOS

 

Nasdaq Global Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

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.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of August 3, 2023, the registrant had 35,781,919 shares of common stock, $0.001 par value per share, outstanding.

 


 

Summary of the material risks associated with our business

Our business is subject to numerous risks and uncertainties that you should be aware of before making an investment decision, including those highlighted in the section entitled “Risk Factors”. These risks include, but are not limited to, the following:

We must complete successful preclinical studies and clinical trials that demonstrate the safety and efficacy of the product candidates before we can begin the commercialization process.
Challenges enrolling patients in our clinical trials delay and may prevent completion of clinical trials of our product candidates. Patient enrollment requires initiation of clinical trial sites; accordingly, delays in initiation of sites exacerbate enrollment challenges.
We anticipate that our future product candidates will be used in combination with third-party drugs or biologics, some of which are still in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics.
Interim “top-line” and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available, and audit and verification procedures could result in material changes in the final data.
We may not be able to file investigational new drug ("IND") applications or IND amendments to commence additional clinical trials on the timelines indicated, and, even if we are able to file, the Federal Drug Administration, or FDA, or a comparable foreign regulatory authority may not permit us to proceed.
We face significant competition from other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations, which may result in others discovering, developing, or commercializing products more quickly or marketing them more successfully than us. If their product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or eliminated.
Negative developments in the field of immuno-oncology or in the field of TIGIT (as defined herein) or adenosine pathway therapeutics could damage public perception of our product candidates or negatively affect our business.
If we are unable to successfully commercialize any product candidate for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed.
The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we experience delays in obtaining, required regulatory approvals, our ability to generate revenue may be materially impaired.
We rely on third parties to conduct our clinical trials and perform some of our research and preclinical studies. Failure by these third parties to satisfactorily carry out their contractual duties or to meet expected deadlines may adversely impact our development programs, business and prospects.
We may not realize the benefits of our collaborations, alliances or licensing arrangements, including our collaboration with GSK (as defined herein) for the global development of belrestotug (formerly EOS-448).
We rely on third parties to manufacture our product candidates, and we expect to continue to rely on third parties for the clinical as well as any future commercial supply of our product candidates and other future product candidates. The development of our current and future product candidates, and the commercialization of any approved products, could be stopped, delayed or made less profitable if any such third party fails to provide us with sufficient clinical or commercial quantities of such product candidates or products, fails to do so at acceptable quality levels or prices or fails to achieve or maintain satisfactory regulatory compliance.
Our limited operating history may make it difficult for you to evaluate our business and assess our future viability.
We will require additional financing to achieve our goals, and failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
If we are unable to obtain and maintain sufficient intellectual property protection for our current product candidates or any future product candidates, or if the scope of the intellectual property protection is not

i


 

sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to commercialize successfully our products may be adversely affected.
We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to implement successfully our business strategy.
The trading price of our common stock has been and may continue to be volatile.
 

The above summary risk factors should be read together with the full risk factors under in the heading “Risk factors” and the other information in this Quarterly Report on Form 10-Q, including our condensed consolidated financial statements and the related notes, as well as in other documents that we file with the Securities and Exchange Commission ("SEC"). The risks summarized above or described below are not the only risks that we face. Additional risks and uncertainties not precisely known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations and future growth prospects.

 

 

Special note regarding forward-looking statements

 

This Quarterly Report on Form 10-Q, including the section entitled “Management’s discussion and analysis of financial condition and results of operations” contains express or implied forward-looking statements. These statements relate to future events or future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

the timing, progress and success of our clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
whether the results of our trials will be sufficient to support domestic or foreign regulatory filings or approvals;
regulatory actions with respect to our product candidates or our competitors’ products and product candidates;
our ability to obtain, including on an expedited basis, and maintain regulatory approval of our product candidates;
the outcomes of our preclinical studies;
our ability to enroll patients in our clinical trials at the pace that we project;
the costs of development of our product candidates or clinical development programs;
the period of time over which our existing capital resources will be sufficient to fund our operating expenses and capital expenditures, and the degree to which such resources will enable us to fund our planned development of our product candidates;
the potential attributes and clinical benefits of our product candidates;
our ability to successfully establish or maintain collaborations or strategic relationships for our product candidates;
the expected benefits of collaborations, including potential milestones and royalty payments from GSK pursuant to the GSK Collaboration Agreement (as defined herein);
the rate and degree of market acceptance of our product candidates;
our ability to obtain orphan drug or Breakthrough Therapy designation or other accelerated approval for any of our product candidates or any other product candidates that we may identify and pursue;
our ability to manufacture our product candidates in conformity with the U.S. Food and Drug Administration’s ("FDA") requirements and to scale up manufacturing of our product candidates to commercial scale, if approved;
our ability to compete with companies currently producing or engaged in the clinical development of treatments for the disease indications that we pursue or treatment modalities that we develop;
our reliance on third parties to conduct our clinical trials;

ii


 

our reliance on third-party contract manufacture organizations ("CMOs") to manufacture and supply our product candidates for us;
our ability to retain and recruit key personnel;
our ability to obtain and maintain intellectual property protection for our product candidates;
our estimates of our expenses, ongoing losses, future revenue, cash runway, capital requirements and our need for or ability to obtain additional financing;
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act, or JOBS Act;
our future financial performance; and
the impact of laws and regulations applicable to our industry.

 

In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negatives of these terms or other comparable terminology, although not all forward-looking statements contain such identifying terminology. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect our results and financial condition. Factors that may cause actual results to differ materially include, among other things, those listed under the section titled “Risk factors” in this Quarterly Report on Form 10-Q and in any subsequent filings with the SEC. These risks and uncertainties may result in actual events or results varying significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed with the SEC and exhibits to this Quarterly Report on Form 10-Q, completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Statements regarding our cash runway do not indicate when we may access the capital markets.

Unless required by law, we undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q.

 

iii


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

2

Condensed Consolidated Statements of Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

19

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4.

Controls and Procedures

31

PART II.

OTHER INFORMATION

32

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

65

Item 3.

Defaults Upon Senior Securities

65

Item 4.

Mine Safety Disclosures

65

Item 5.

Other Information

65

Item 6.

Exhibits

66

 

Signatures

67

 

 

 

iv


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

iTeos Therapeutics, Inc. and subsidiaries

Condensed consolidated balance sheets

(unaudited)

 

(in thousands, except share amounts)

 

June 30,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

216,213

 

 

$

284,803

 

Short-term investments (amortized cost of $384,005)

 

 

383,011

 

 

 

328,359

 

Grants receivable

 

 

433

 

 

 

1,001

 

Refundable income taxes

 

 

3,250

 

 

 

1,434

 

     Prepaid expenses and other currents assets

 

 

11,640

 

 

 

12,701

 

Total current assets

 

 

614,547

 

 

 

628,298

 

Property and equipment, net

 

 

2,548

 

 

 

2,121

 

Long-term investments (amortized cost of $78,886)

 

 

78,260

 

 

 

118,225

 

Research and development tax credits receivable

 

 

1,882

 

 

 

1,128

 

Restricted cash

 

 

270

 

 

 

235

 

Right of use assets

 

 

5,427

 

 

 

4,652

 

Other assets

 

 

812

 

 

 

332

 

Total assets

 

$

703,746

 

 

$

754,991

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,227

 

 

$

7,662

 

Accrued expenses and other current liabilities

 

 

21,247

 

 

 

19,727

 

Deferred income

 

 

2,528

 

 

 

1,180

 

Deferred revenue

 

 

-

 

 

 

12,595

 

Lease liabilities

 

 

1,021

 

 

 

836

 

Total current liabilities

 

 

30,023

 

 

 

42,000

 

Grants repayable, net of current portion

 

 

6,570

 

 

 

6,622

 

Lease liabilities, net of current portion

 

 

4,427

 

 

 

3,837

 

Unrecognized tax benefits

 

 

39,200

 

 

 

39,200

 

Total liabilities

 

 

80,220

 

 

 

91,659

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.001 par value: 150,000,000 shares authorized at
   June 30, 2023 and December 31, 2022 respectively;
35,781,919
   and
35,611,219 shares issued and outstanding; respectively

 

 

36

 

 

 

36

 

Additional paid-in capital

 

 

449,232

 

 

 

435,665

 

Accumulated other comprehensive loss

 

 

(13,166

)

 

 

(9,644

)

Retained earnings

 

 

187,424

 

 

 

237,275

 

Total stockholders’ equity

 

 

623,526

 

 

 

663,332

 

Total liabilities and stockholders’ equity

 

$

703,746

 

 

$

754,991

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

1


 

iTeos Therapeutics, Inc. and subsidiaries

Condensed consolidated statements of operations and comprehensive income (loss)

(unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(in thousands, except share and per share amounts)

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

License and collaboration revenue

 

$

 

 

$

41,716

 

 

$

12,595

 

 

$

194,238

 

Total revenue

 

 

 

 

 

41,716

 

 

 

12,595

 

 

 

194,238

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

29,186

 

 

 

26,910

 

 

 

54,885

 

 

 

48,006

 

General and administrative expenses

 

 

13,435

 

 

 

11,471

 

 

 

25,385

 

 

 

22,086

 

Total operating expenses

 

 

42,621

 

 

 

38,381

 

 

 

80,270

 

 

 

70,092

 

(Loss) income from operations

 

 

(42,621

)

 

 

3,335

 

 

 

(67,675

)

 

 

124,146

 

Other income and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

 

 

799

 

 

 

147

 

 

 

1,534

 

 

 

638

 

Research and development tax credits

 

 

386

 

 

 

292

 

 

 

729

 

 

 

546

 

Interest income

 

 

8,042

 

 

 

1,063

 

 

 

15,893

 

 

 

1,151

 

Other income (expense), net

 

 

326

 

 

 

3,606

 

 

 

2,099

 

 

 

1,495

 

(Loss) Income before income taxes

 

 

(33,068

)

 

 

8,443

 

 

 

(47,420

)

 

 

127,976

 

Income tax expense

 

 

(1,232

)

 

 

(2,817

)

 

 

(2,431

)

 

 

(52,768

)

Net (loss) income

 

$

(34,300

)

 

$

5,626

 

 

$

(49,851

)

 

$

75,208

 

Basic net (loss) income per common share

 

$

(0.96

)

 

$

0.16

 

 

$

(1.39

)

 

$

2.12

 

Diluted net (loss) income per common share

 

$

(0.96

)

 

$

0.15

 

 

$

(1.39

)

 

$

1.98

 

Weighted-average common shares outstanding - basic

 

 

35,768,952

 

 

 

35,546,605

 

 

 

35,742,641

 

 

 

35,520,086

 

Weighted-average common shares outstanding - diluted

 

 

35,768,952

 

 

 

37,635,828

 

 

 

35,742,641

 

 

 

37,931,692

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income

 

$

(34,300

)

 

$

5,626

 

 

$

(49,851

)

 

$

75,208

 

Foreign currency translation adjustments

 

 

104

 

 

 

(741

)

 

 

(1,902

)

 

 

(1,291

)

Unrealized loss on available-for-sale securities

 

 

(1,722

)

 

 

 

 

 

(1,620

)

 

 

 

Comprehensive (loss) income

 

$

(35,918

)

 

$

4,885

 

 

$

(53,373

)

 

$

73,917

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

2


 

iTeos Therapeutics, Inc. and subsidiaries

Condensed consolidated statements of stockholders’ equity

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

other

 

 

 

 

 

Total

 

In thousands except share amounts

 

Common stock

 

 

paid-in

 

 

comprehensive

 

 

Retained

 

 

stockholders’

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

loss

 

 

earnings

 

 

equity

 

Balance at December 31, 2021

 

 

35,466,001

 

 

$

35

 

 

$

413,180

 

 

$

(1,018

)

 

$

140,623

 

 

$

552,820

 

Stock-based compensation

 

 

 

 

 

 

 

 

4,193

 

 

 

 

 

 

 

 

 

4,193

 

Common stock issued upon exercises of options

 

 

50,911

 

 

 

1

 

 

 

332

 

 

 

 

 

 

 

 

 

333

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(550

)

 

 

 

 

 

(550

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

69,582

 

 

 

69,582

 

Balance at March 31, 2022

 

 

35,516,912

 

 

$

36

 

 

$

417,705

 

 

$

(1,568

)

 

$

210,205

 

 

$

626,378

 

Stock-based compensation

 

 

 

 

 

 

 

 

5,760

 

 

 

 

 

 

 

 

 

5,760

 

Common stock issued upon exercises of options

 

 

58,411

 

 

 

 

 

 

278

 

 

 

 

 

 

 

 

 

278

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(741

)

 

 

 

 

 

(741

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,626

 

 

 

5,626

 

Balance at June 30, 2022

 

 

35,575,323

 

 

$

36

 

 

$

423,743

 

 

$

(2,309

)

 

$

215,831

 

 

$

637,301

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

other

 

 

 

 

 

Total

 

In thousands except share amounts

 

Common stock

 

 

paid-in

 

 

comprehensive

 

 

Retained

 

 

stockholders’

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

loss

 

 

earnings

 

 

equity

 

Balance at December 31, 2022

 

 

35,611,219

 

 

$

36

 

 

$

435,665

 

 

$

(9,644

)

 

$

237,275

 

 

$

663,332

 

Stock-based compensation

 

 

 

 

 

 

 

 

5,807

 

 

 

 

 

 

 

 

 

5,807

 

Common stock issued upon exercises of options

 

 

149,408

 

 

 

 

 

 

578

 

 

 

 

 

 

 

 

 

578

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(2,006

)

 

 

 

 

 

(2,006

)

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

102

 

 

 

 

 

 

102

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,551

)

 

 

(15,551

)

Balance at March 31, 2023

 

 

35,760,627

 

 

$

36

 

 

$

442,050

 

 

$

(11,548

)

 

$

221,724

 

 

$

652,262

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,964

 

 

 

 

 

 

 

 

 

6,964

 

Common stock issued upon exercises of options, ESPP purchases, and release of restricted stock units

 

 

21,292

 

 

 

 

 

 

218

 

 

 

 

 

 

 

 

 

218

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

104

 

 

 

 

 

 

104

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(1,722

)

 

 

 

 

 

(1,722

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,300

)

 

 

(34,300

)

Balance at June 30, 2023

 

 

35,781,919

 

 

$

36

 

 

$

449,232

 

 

$

(13,166

)

 

$

187,424

 

 

$

623,526

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


 

iTeos Therapeutics, Inc. and subsidiaries

Condensed consolidated statements of cash flows

(unaudited)

 

 

 

Six Months Ended June 30,

 

(in thousands)

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net (loss) income

 

$

(49,851

)

 

$

75,208

 

Adjustments to reconcile net (loss) income to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

447

 

 

 

375

 

Stock-based compensation

 

 

12,771

 

 

 

9,953

 

Non-cash: Net accretion of available-for-sale debt securities

 

 

(5,386

)

 

 

-

 

Change in operating lease right-of-use assets

 

 

-

 

 

 

4

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Grants receivable

 

 

584

 

 

 

(333

)

Research and development tax credits receivable

 

 

(729

)

 

 

(41

)

Refundable income taxes

 

 

(1,839

)

 

 

7,544

 

Prepaid expenses and other current assets

 

 

702

 

 

 

4,360

 

Accounts payable