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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: 001-38503

 

Iterum Therapeutics plc

(Exact name of registrant as specified in its charter)

 

 

Ireland

98-1283148

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

Fitzwilliam Court 1st Floor,

Leeson Close,

Dublin 2, Ireland

(Address of principal executive offices)

Not applicable

(Zip Code)

 

(+353) 1 669-4820

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Ordinary Shares, $0.01 par value per share

 

ITRM

 

The Nasdaq Stock Market LLC

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 July 31, 2023, the registrant had 13,041,041 ordinary shares, $0.01 par value per share, outstanding.

 

 


 

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 Loss

2

Condensed Consolidated Statements of Cash Flows

3

 

Condensed Consolidated Statements of Stockholders' Equity

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

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

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

36

Item 4.

Controls and Procedures

36

PART II.

OTHER INFORMATION

37

Item 1.

Legal Proceedings

37

Item 1A.

Risk Factors

37

Item 6.

Exhibits

96

 

Signatures

97

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

our use of cash reserves;
the design, initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs including the ongoing Phase 3 clinical trial being conducted in response to the Complete Response Letter (CRL) received from the U.S. Food and Drug Administration in July 2021 in connection with our New Drug Application (NDA) for oral sulopenem;
our ability to resolve the issues set forth in the CRL and resubmit our NDA;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
our ability to advance product candidates into, and successfully complete, clinical trials;
the potential advantages of our product candidates;
the timing or likelihood of regulatory filings and approvals, including with respect to the potential resubmission of our NDA for oral sulopenem;
the commercialization of our product candidates, if approved;
our manufacturing plans;
our sales, marketing and distribution capabilities and strategy;
market acceptance of any product we successfully commercialize;
the pricing, coverage and reimbursement of our product candidates, if approved;
the implementation of our business model, strategic plans for our business and product candidates;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to defend and enforce any such intellectual property rights;
our ability to enter into strategic arrangements, collaborations and/or commercial partnerships in the United States and other territories and the potential benefits of such arrangements;
our estimates regarding expenses, capital requirements and needs for additional financing;
our expectations regarding how far into the future our cash on hand will fund our ongoing operations;
our ability to continue as a going concern;
our financial performance;
developments relating to our competitors and our industry;
our ability to maintain compliance with listing requirements of the Nasdaq Capital Market;
the impact of general economic conditions, including inflation; and
the outcome, impact, effects and results of our evaluation of corporate, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic, financial or financing alternative and our ability to complete one at all.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

ii


 

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report to conform these statements to new information, actual results or to changes in our expectations, except as required by law.

You should read this Quarterly Report and the documents that we have filed with the Securities and Exchange Commission (SEC), as exhibits to this Quarterly Report with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect.

This Quarterly Report also contains industry, market and competitive position data from our own internal estimates and research as well as industry and general publications and research surveys and studies conducted by third parties. Industry publications, studies, and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our internal data and estimates are based upon information obtained from trade and business organizations and other contacts in the markets in which we operate and our management’s understanding of industry conditions. While we believe that each of these studies and publications is reliable, we have not independently verified market and industry data from third-party sources. While we believe our internal company research is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source. The industry in which we operate is subject to a high degree of uncertainty and risks due to various factors, including those described in the section titled “Risk Factors”.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

 

 

iii


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

ITERUM THERAPEUTICS PLC

Condensed Consolidated Balance Sheets

(In thousands except share and per share data)

(Unaudited)

 

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

13,734

 

 

$

21,092

 

Short-term investments

 

 

30,998

 

 

 

39,712

 

Income taxes receivable

 

 

7

 

 

 

302

 

Prepaid expenses and other current assets

 

 

2,914

 

 

 

1,338

 

Total current assets

 

 

47,653

 

 

 

62,444

 

Intangible asset, net

 

 

861

 

 

 

1,719

 

Property and equipment, net

 

 

69

 

 

 

69

 

Restricted cash

 

 

34

 

 

 

34

 

Other assets

 

 

2,404

 

 

 

2,567

 

Total assets

 

$

51,021

 

 

$

66,833

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,715

 

 

$

2,774

 

Accrued expenses

 

 

5,171

 

 

 

4,346

 

Derivative liability

 

 

154

 

 

 

196

 

Other current liabilities

 

 

1,789

 

 

 

1,748

 

Total current liabilities

 

$

10,829

 

 

$

9,064

 

Long-term debt, less current portion

 

 

11,666

 

 

 

10,094

 

Royalty-linked notes

 

 

20,251

 

 

 

18,372

 

Other liabilities

 

 

1,146

 

 

 

1,304

 

Total liabilities

 

$

43,892

 

 

$

38,834

 

Commitments and contingencies (Note 15)

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

Undesignated preferred shares, $0.01 par value per share: 100,000,000 shares
authorized at June 30, 2023 and December 31, 2022;
no shares issued at
June 30, 2023 and December 31, 2022

 

 

 

 

 

 

Ordinary shares, $0.01 par value per share: 80,000,000 shares authorized at June 30, 2023; 20,000,000 shares authorized at December 31, 2022, 13,028,403 shares issued at June 30, 2023; 12,598,641 shares issued at December 31, 2022

 

 

130

 

 

 

126

 

Additional paid-in capital

 

 

452,084

 

 

 

451,150

 

Accumulated deficit

 

 

(445,059

)

 

 

(422,927

)

Accumulated other comprehensive loss

 

 

(26

)

 

 

(350

)

Total shareholders' equity

 

 

7,129

 

 

 

27,999

 

Total liabilities and shareholders’ equity

 

$

51,021

 

 

$

66,833

 

 

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

 

1


 

ITERUM THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

(8,964

)

 

$

(3,984

)

 

$

(15,396

)

 

$

(7,424

)

General and administrative

 

 

(1,858

)

 

 

(4,066

)

 

 

(3,956

)

 

 

(7,999

)

Total operating expenses

 

 

(10,822

)

 

 

(8,050

)

 

 

(19,352

)

 

 

(15,423

)

Operating loss

 

 

(10,822

)

 

 

(8,050

)

 

 

(19,352

)

 

 

(15,423

)

Interest expense, net

 

 

(324

)

 

 

(766

)

 

 

(723

)

 

 

(1,805

)

Adjustments to fair value of derivatives

 

 

(960

)

 

 

2,155

 

 

 

(1,838

)

 

 

7,332

 

Other income, net

 

 

50

 

 

 

269

 

 

 

91

 

 

 

431

 

Total other (expense) / income

 

 

(1,234

)

 

 

1,658

 

 

 

(2,470

)

 

 

5,958

 

Loss before income taxes

 

 

(12,056

)

 

 

(6,392

)

 

 

(21,822

)

 

 

(9,465

)

Income tax expense

 

 

(187

)

 

 

(343

)

 

 

(310

)

 

 

(770

)

Net loss

 

$

(12,243

)

 

$

(6,735

)

 

$

(22,132

)

 

$

(10,235

)

Net loss per share – basic and diluted

 

$

(0.95

)

 

$

(0.55

)

 

$

(1.73

)

 

$

(0.84

)

Weighted average ordinary shares outstanding – basic and diluted

 

 

12,942,969

 

 

 

12,224,324

 

 

 

12,812,398

 

 

 

12,208,961

 

Statements of Comprehensive Income

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(12,243

)

 

$

(6,735

)

 

$

(22,132

)

 

$

(10,235

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

  Unrealized gain on marketable securities

 

 

105

 

 

 

 

 

 

324

 

 

 

 

Comprehensive loss

 

$

(12,138

)

 

$

(6,735

)

 

$

(21,808

)

 

$

(10,235

)

 

 

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

2


 

ITERUM THERAPEUTICS PLC

Condensed Consolidated Statements of Cash Flows

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(22,132

)

 

$

(10,235

)

Adjustments to reconcile net loss to cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

16

 

 

 

55

 

Amortization of intangible asset

 

 

858

 

 

 

858

 

Share-based compensation expense

 

 

503

 

 

 

3,879

 

Interest on short-term investments

 

 

54

 

 

 

(123

)

Amortization of debt discount and deferred financing costs

 

 

1,162

 

 

 

1,157

 

Interest on exchangeable notes - non-cash

 

 

410

 

 

 

410

 

Adjustments to fair value of derivatives

 

 

1,838

 

 

 

(7,332

)

Other

 

 

946

 

 

 

1,894

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(2,729

)

 

 

(1,366

)

Accounts payable

 

 

942

 

 

 

(92

)

Accrued expenses

 

 

812

 

 

 

1,797

 

Income taxes

 

 

302

 

 

 

(128

)

Other liabilities

 

 

(204

)

 

 

(443

)

Net cash used in operating activities

 

 

(17,222

)

 

 

(9,669

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property, plant and equipment

 

 

(16

)

 

 

(10

)

Purchases of short-term investments

 

 

(26,859

)

 

 

(34,858

)

Proceeds from sale of short-term investments

 

 

36,328

 

 

 

28,600

 

Net cash provided by (used in) investing activities

 

 

9,453

 

 

 

(6,268

)

Cash flows from financing activities:

 

 

 

 

 

 

Repayments of long-term debt

 

 

 

 

 

(2,251

)

Proceeds from issuance of ordinary shares, net of transaction costs

 

 

435

 

 

 

 

Net cash provided by / (used in) financing activities

 

 

435

 

 

 

(2,251

)

Effect of exchange rates on cash and cash equivalents

 

 

(24

)

 

 

(49

)

Net (decrease) / increase in cash, cash equivalents and restricted cash

 

 

(7,358

)

 

 

(18,237

)

Cash, cash equivalents and restricted cash, at beginning of period

 

 

21,126

 

 

 

27,510

 

Cash, cash equivalents and restricted cash, at end of period

 

$

13,768

 

 

$

9,273

 

Supplemental Disclosure of Cash Flow Information:

 

 

 

 

 

 

Income taxes paid - U.S.

 

$

11

 

 

$

898

 

Interest paid

 

$

 

 

$

22

 

 

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

3


 

ITERUM THERAPEUTICS PLC

Condensed Consolidated Statements of Stockholders' Equity

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Ordinary Shares

 

 

Additional

 

 

 

 

 

Accumulated Other

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Paid
in Capital

 

 

Accumulated Deficit

 

 

Comprehensive Income (Loss)

 

 

Total

 

Balance at March 31, 2023

 

 

12,805,833

 

 

$

128

 

 

$

451,776

 

 

$

(432,816

)

 

$

(131

)

 

$

18,957

 

Issuance of ordinary shares, net

 

 

222,570

 

 

 

2

 

 

 

198

 

 

 

 

 

 

 

 

 

200

 

Share-based compensation expense

 

 

 

 

 

 

 

 

110

 

 

 

 

 

 

 

 

 

110

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(12,243

)

 

 

 

 

 

(12,243

)

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

105

 

 

 

105

 

Balance at June 30, 2023

 

 

13,028,403

 

 

$

130

 

 

$

452,084

 

 

$

(445,059

)

 

$

(26

)

 

$

7,129

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary Shares

 

 

Additional

 

 

 

 

 

Accumulated Other

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Paid
in Capital

 

 

Accumulated Deficit

 

 

Comprehensive Income (Loss)

 

 

Total

 

Balance at December 31, 2022

 

 

12,598,641

 

 

$

126

 

 

$

451,150

 

 

$

(422,927

)

 

$

(350

)

 

$

27,999

 

Issuance of ordinary shares, net

 

 

429,762

 

 

 

4

 

 

 

431

 

 

 

 

 

 

 

 

 

435

 

Share-based compensation expense

 

 

 

 

 

 

 

 

503

 

 

 

 

 

 

 

 

 

503

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(22,132

)

 

 

 

 

 

(22,132

)

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

324

 

 

 

324

 

Balance at June 30, 2023

 

 

13,028,403

 

 

$

130

 

 

$

452,084

 

 

$

(445,059

)

 

$

(26

)

 

$

7,129

 

 

 

 

Ordinary Shares

 

 

Additional

 

 

 

 

 

Accumulated Other

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Paid
in Capital

 

 

Accumulated Deficit

 

 

Comprehensive Income (Loss)

 

 

Total

 

Balance at March 31, 2022

 

 

12,223,561

 

 

$

122

 

 

$

430,506

 

 

$

(381,993

)

 

$

 

 

$

48,635

 

Issuance of ordinary shares, net

 

 

9,813

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2

 

Share-based compensation expense

 

 

 

 

 

 

 

 

1,984

 

 

 

 

 

 

 

 

 

1,984

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,735

)

 

 

 

 

 

(6,735

)

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2022

 

 

12,233,374

 

 

$

122

 

 

$

432,492

 

 

$

(388,728

)

 

$

 

 

$

43,886

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ordinary Shares

 

 

Additional