Attached files

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EX-99.1 - EX-99.1 - Iterum Therapeutics plcd936614dex991.htm
EX-10.1 - EX-10.1 - Iterum Therapeutics plcd936614dex101.htm
EX-5.1 - EX-5.1 - Iterum Therapeutics plcd936614dex51.htm
EX-4.2 - EX-4.2 - Iterum Therapeutics plcd936614dex42.htm
EX-4.1 - EX-4.1 - Iterum Therapeutics plcd936614dex41.htm

 

 

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): June 30, 2020

 

 

ITERUM THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

 

 

 

Ireland   001-38503   98-1283148

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

Block 2 Floor 3, Harcourt Centre,

Harcourt Street,
Dublin 2, Ireland

  Not Applicable
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: +353 1 903 8920

Not Applicable

(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

Ordinary Shares, nominal value $0.01 per share   ITRM   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 1.01.

Entry into a Material Definitive Agreement.

On June 30, 2020, Iterum Therapeutics plc (the “Company”) entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional investors (the “Purchasers”) pursuant to which the Company agreed to issue and sell in a registered direct offering an aggregate of 3,372,686 ordinary shares (the “Shares”), $0.01 nominal value per share, at a purchase price per share of $1.4825 (the “Shares”), for aggregate gross proceeds to the Company of approximately $5.0 million, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company (the “Registered Offering”). The Shares are being offered by the Company pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission (the “SEC”) on July 16, 2019 (File No. 333-232569) (the “Registration Statement”), and a prospectus supplement thereunder.

Pursuant to the Securities Purchase Agreement, in a concurrent private placement, the Company has also agreed to issue and sell to the Purchasers warrants (the “Warrants”) to purchase up to 1,686,343 ordinary shares (the “Private Placement” and together with the Registered Offering, the “Offerings”). The Warrants will be exercisable immediately at an exercise price of $1.42 per ordinary share, subject to adjustment in certain circumstances, and will expire on January 2, 2026. The Offerings are expected to close on or about July 2, 2020, subject to customary closing conditions.

The Warrants and the ordinary shares issuable upon exercise of the Warrants (the “Warrant Shares”) have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Registration Statement and were instead offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

The Company has agreed to pay H.C. Wainwright & Co., LLC (“Wainwright”) a cash fee of approximately $350,000, which represents 7.0% of the gross proceeds of the Offerings. The Company will also reimburse Wainwright’s reasonable and documented expenses in connection with the Offerings, including fees and expenses of outside counsel, in the amount of up to $90,000 and Wainwright’s clearing expenses in the amount of up to $12,900. In addition, Wainwright, or its designees, will also receive placement agent warrants (the “Placement Agent Warrants”) to purchase a number of ordinary shares equal to 7.0% of the aggregate number of Shares sold to the Purchasers (the “Placement Agent Warrant Shares”). The Placement Agent Warrants generally will have the same terms as the Warrants, except they will have an exercise price of $1.8531 and will expire on June 30, 2025.

The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, including for liabilities arising under the Securities Act, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Securities Purchase Agreement were made only for the purposes of such agreement and as of the specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties.

Pursuant to the Securities Purchase Agreement, the Company has agreed to use commercially reasonable efforts to file a registration statement as soon as practicable (and in any event within 45 calendar days of the date of the Securities Purchase Agreement), providing for the resale of Warrant Shares by the Purchasers of the Warrants in the Private Placement and for the resale of ordinary shares issued and issuable upon exercise of warrants purchased by such Purchasers in the June Offering (as defined below). The Company has agreed to use commercially reasonable efforts to cause such registration statement to become effective within 91 days following the closing date of the Private Placement and to keep such registration statement effective at all times until no Purchaser of the Warrants in the Private Placement owns any Warrants or Warrant Shares or the Warrant Shares are subject to resale, assuming cashless exercise, by the holder thereof pursuant to Rule 144 promulgated under the Securities Act (“Rule 144”) without volume or manner-of-sale restrictions.

In the event that the registration statement has not been (i) filed on or before the date that is 45 calendar days following the date of the Securities Purchase Agreement or (ii) declared effective by the SEC by the date that is 91 calendar days following the closing of the Private Placement, then the Company will make pro rata payments to each Purchaser then holding Warrant Shares as liquidated damages in an amount equal to 1% of the aggregate exercise price of such Purchaser’s Warrants held by such Purchaser on the day of the failure to file the registration statement or the failure of the registration statement to be declared effective and for each 30-day period (or pro rata for any portion thereof) until the earlier of (i) the date such failure is cured and (ii) the date such Warrant Shares, assuming cashless exercise, become eligible for resale without volume or manner-of-sale restrictions and without current public information requirements pursuant to Rule 144. In the event the Company fails to make such payments in a timely manner, such payments shall bear interest at the rate of 1.5% per month (prorated for partial months) until paid in full.


Pursuant to the terms of the investor rights agreement that the Company entered into in connection with its January 2020 private placement, the Company is required to provide Sarissa Capital Offshore Master Fund LP and certain of its affiliates (collectively “Sarissa”) the opportunity to purchase an aggregate of up to 865,796 ordinary shares and up to 432,898 Warrants on the terms provided for in the Offerings at a price per ordinary share equal to the public offering price and a price per Warrant equal to the price per Warrant in the Private Placement. In addition, pursuant to such investor rights agreement, Sarissa has the right to purchase 829,688 ordinary shares and up to 414,844 warrants on the terms and at the prices provided for in the Company’s public offering of ordinary shares and concurrent private placement of warrants that the Company completed on June 5, 2020 (the “June Offering”). To the extent Sarissa elects to exercise such purchase rights, any sale to Sarissa will be carried out in a separate transaction.

The foregoing descriptions of the Warrants, the Placement Agent Warrants and the Securities Purchase Agreement are not complete and are qualified in their entirety by reference to the full text of the Form of Warrant, the Form of Placement Agent Warrant and the Form of Securities Purchase Agreement, which are attached hereto as Exhibit 4.1, Exhibit 4.2 and Exhibit 10.1, respectively.

A copy of the legal opinion of A&L Goodbody as to the legality of the Shares is attached as Exhibit 5.1 hereto.

 

Item 3.02

Unregistered Sales of Equity Securities.

Please see the disclosure regarding the Warrants, the Placement Agent Warrants, the Warrant Shares and the Placement Agent Warrant Shares set forth under Item 1.01, which is incorporated by reference into this Item 3.02. The Warrants, the Placement Agent Warrants, the Warrant Shares and the Placement Agent Warrant Shares were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. Each Purchaser has represented that, among other things, it is an accredited investor, as defined in Rule 501(a), (a)(2), (a)(3), (a)(7) or (a)(5) under the Securities Act, or a qualified institutional buyer, as defined in Rule 144A(a) under the Securities Act. The Warrants, the Placement Agent Warrants, the Warrant Shares and the Placement Agent Warrant Shares were not offered through any general solicitation or advertisement.

 

Item 8.01.

Other Events.

The full text of the press release announcing the pricing of the Offerings on June 30, 2020 is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

Cash Runway

The Company estimates that the net proceeds from the Offerings, together with its existing cash and cash equivalents, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2020, including through the potential filing of a new drug application for sulopenem. The Company has based this estimate on assumptions that may prove to be wrong, and the Company’s operating plans may change as a result of many factors and various risks and uncertainties. This estimate assumes, among other things, the continuation of regular monthly amortization payments of the principal amount outstanding under the Company’s credit facility with Silicon Valley Bank and that the balance of the principal amount does not become due and payable until the maturity date of March 1, 2022. The Company could deplete its capital resources sooner than expected.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the anticipated closing of the Offerings, the use of proceeds from the Offerings, the transactions contemplated by the transaction documents, the sufficiency of the Company’s cash resources and the Company’s plans, strategies and prospects for its business. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company’s control, including whether the conditions for the closing of the Offerings will be satisfied, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, the Company’s ability to apply for regulatory approval, changes in regulatory requirements or decisions of regulatory authorities, changes in public policy or legislation, commercialization plans and timelines, if sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company’s expectations regarding how far into the future the


Company’s cash on hand will fund the Company’s ongoing operations, the sufficiency of the Company’s cash resources and the Company’s ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of the Company’s evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company’s ability to complete one at all, the price of the Company’s securities, the expected use of proceeds from the Offerings and other factors discussed under the caption “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this Current Report on Form 8-K. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

4.1    Form of Warrant
4.2    Form of Placement Agent Warrant
5.1    Opinion of A&L Goodbody, Irish counsel to Iterum Therapeutics plc
10.1    Form of Securities Purchase Agreement, dated June 30, 2020, by and among Iterum Therapeutics plc and the purchasers party thereto
23.1    Consent of A&L Goodbody (contained in Exhibit 5.1 above)
99.1    Press Release dated June 30, 2020


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    ITERUM THERAPEUTICS PLC
Date: June 30, 2020     By:  

/s/ Corey N. Fishman

      Corey N. Fishman
      Chief Executive Officer