Form 8-K AVEO PHARMACEUTICALS For: May 17

 

 

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): May 17, 2016

 

 

AVEO Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware		001-34655		04-3581650
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)
One Broadway, 14th Floor Cambridge, Massachusetts				02142
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s telephone number, including area code: (617) 588-1960

 

 

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))

 

 

 

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Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

On May 13, 2016, AVEO Pharmaceuticals, Inc. (the “Company”) reported on a Current Report on Form 8-K (the “May 13, 2016 Form 8-K”) that it had entered into an Amendment No. 4 to Loan and Security Agreement (the “Amendment”) with Hercules Capital, Inc. (“Hercules”), as lender and administrative agent, Hercules Technology III, L.P. and the several banks and financial institutions from time to time parties thereto (collectively, the “Lenders”), amending that certain Loan and Security Agreement, dated as of May 28, 2010, by and among the Company and the Lenders, as amended to date (the “Loan Agreement”).

Pursuant to the Amendment, upon receipt by the Company of at least $15 million in gross cash proceeds from the issuance and sale by the Company of its equity securities to certain investors (the “Term Loan A Condition”), the Company was eligible to receive a new term loan advance from the Lenders. The Company satisfied the Term Loan A Condition upon the closing, on May 17, 2016, of its previously announced private placement of common stock. Accordingly, on May 17, 2016, the Company borrowed from the Lenders an additional $5.0 million under the Loan Agreement (“New Term Loan A”). New Term Loan A bears per annum interest in accordance with the terms of the Loan Agreement. As of May 17, 2016, New Term Loan A bore interest at a rate of 11.90% per year, which is subject to adjustment from time to time as provided in the Loan Agreement. Other terms and conditions of the Loan Agreement, the Amendment and New Term Loan A are set forth in the May 13, 2016 Form 8-K and are incorporated herein by reference thereto.

The foregoing descriptions of the Loan Agreement, the Amendment and New Term Loan A are not complete and are qualified in their entirety by reference to the full text of (i) the Loan Agreement, which was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 4, 2010, (ii) Amendment No. 1 to the Loan Agreement, which was filed as Exhibit 10.25 to the Company’s Annual Report on Form 10-K filed on March 20, 2012, (iii) Amendment No. 2 to the Loan Agreement, which was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 4, 2012, (iv) Amendment No. 3 to the Loan Agreement, which was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on November 5, 2014 and (v) Amendment No. 4 to the Loan Agreement, which was filed as Exhibit 10.4 to the May 13, 2016 Form 8-K.

Item 8.01 Other Events.

On May 18, 2016, the Company issued a press release announcing (i) that it completed the closing of its previously disclosed private placement in which it sold to certain qualified institutional buyers, institutional accredited investors and accredited investors units to purchase an aggregate of approximately $17,025,000 of common stock and warrants to purchase common stock and (ii) that the Company borrowed $5.0 million from the Lenders pursuant to New Term Loan A. The full text of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

Neither the filing of the press release as an exhibit to this Current Report on Form 8-K nor the inclusion in the press release of a reference to the Company’s internet address shall, under any circumstances, be deemed to incorporate the information available at its internet address into this Current Report on Form 8-K. The information available at the Company’s internet address is not part of this Current Report on Form 8-K or any other report filed by the Company with the Securities and Exchange Commission.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Form 8-K and the exhibit attached hereto contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Form 8-K or in the exhibit attached hereto are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. This Form 8-K and the exhibit attached hereto also contain forward-looking statements regarding, among other things, the Company and its collaborators’ future discovery, development and commercialization efforts, plans, timelines and strategies, the Company’s collaborations, its future operating results, future prospects and financial position, its business strategy, and other objectives for its operations. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes due to a number of important factors, including risks relating to its ability to maintain its third party collaboration agreements, and its ability, and the ability of its licensees, to achieve development and commercialization objectives under these arrangements; the Company’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of the Company’s product candidates; the Company’s ability to successfully enroll and complete clinical trials of its product candidates, including its planned TIVO-3 study; the Company’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; the Company’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to the Company’s ongoing shareholder litigation; the Company’s ability to successfully implement its strategic plans; the Company’s ability to raise the substantial additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, each as filed with the SEC, and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this Form 8-K and in the exhibit attached hereto represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

Item 9.01 Financial Statements and Exhibits.

The Exhibit to this Current Report on Form 8-K is listed in the Exhibit Index attached hereto.

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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.

 

				AVEO Pharmaceuticals, Inc.
Date: May 18, 2016
				By:		/s/ Michael Bailey
						Michael Bailey
						President and Chief Executive Officer

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EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press Release, dated May 18, 2016

Exhibit 99.1

 

AVEO Announces Closing of Private Placement and Amended Term Loan to Fund

Pivotal TIVO-3 Trial and Combination PD-1 Trial of Tivozanib in Renal Cell Cancer

Private Placement Provides Gross Proceeds of Approximately $17 Million;

Amended Term Loan to Provide up to $10 Million in Funding

CAMBRIDGE, Mass. - May 18, 2016 - AVEO Oncology (NASDAQ: AVEO) today announced that it has closed its previously announced private placement of 17,642,482 units, consisting of one share of common stock and a warrant to purchase one share of common stock, at a price of $0.965 per unit, for gross proceeds of approximately $17 million. The transaction was led by New Enterprise Associates and included New Leaf Venture Partners and Perceptive Advisors, among other institutional investors. Certain members of the Company’s management team and Board of Directors also participated in the financing.

Piper Jaffray & Co. served as the exclusive placement agent for the financing.

Concurrent with the closing, the Company also announced that it entered into an amendment to its 2010 loan and security agreement, with Hercules Capital, Inc. Pursuant to the loan amendment, the Company borrowed an additional $5.0 million from Hercules. If specified conditions are met, AVEO may borrow an additional tranche of $5.0 million from Hercules in the first half of 2017 and repayment of principal on AVEO’s loans may be deferred to begin in 2018.

“We expect that proceeds from our private placement and amended loan agreement, together with our existing resources and certain anticipated operational milestone payments, will allow us to fully fund our U.S. tivozanib development strategy, including through at least pivotal Phase 3 TIVO-3 top-line data and a tivozanib-PD-1 inhibitor combination trial,” said Michael Bailey, president and chief executive officer. “Securing funding for these studies, which we look forward to initiating in the near term, represents an important step forward toward our goal of making tivozanib available to patients with renal cell cancer in North America. We also look forward to upcoming decisions on marketing applications in the EU, submitted by our partner EUSA Pharma, and Russia, submitted by our partner Pharmstandard, for tivozanib as a treatment for first line renal cell cancer. We believe that these potential milestones, along with progress in our partnership-driven pipeline, could enable us to create meaningful shareholder value.”

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. AVEO has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of common stock issuable upon the exercise of the warrants issued in the private placement.

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This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercializing its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for Renal Cell Carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialize tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome).

AVEO Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others: AVEO’s ability to access additional funds under the Hercules loan agreement and defer repayment; AVEO’s expectation that its existing resources, together with proceeds from the private placement and amended loan agreement, will allow it to fund its U.S pivotal Phase 3 trial of tivozanib at least through top-line data and support a combination trial of tivozanib with a PD-1 inhibitor; AVEO’s goals and objectives for making tivozanib available to renal cell cancer patients in North America; AVEO’s expectations regarding registration decisions in the EU and Russia for tivozanib for first line renal cell cancer; the potential for AVEO to receive a number of partnership-driven and development-related milestone payments; and the potential for AVEO to create meaningful shareholder value in the near- and long-term. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to AVEO’s ability to maintain its third party collaboration agreements, and its ability, and the ability of its licensees, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates, including its planned TIVO-3 study; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its

 

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goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

AVEO Contact:

David Pitts, Argot Partners

(212) 600-1902

[email protected]

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