Form 8-K AVEO PHARMACEUTICALS For: Mar 06

 

 

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): March 6, 2015

 

 

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.)
650 East Kendall Street Cambridge, Massachusetts				02142
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s telephone number, including area code: (617) 299-5000

(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))

 

 

 

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Item 2.02

Results of Operations and Financial Condition.

On March 6, 2015, AVEO Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its results for the fourth quarter and year ended December 31, 2014. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 of this Form 8-K and Exhibit 99.1 shall not be deemed “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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01

Other Events.

On March 6, 2015, the Company issued a press release announcing the presentation of final results and a predefined biomarker analysis of its BATON-CRC (Biomarker Assessment of Tivozanib in Oncology-Colorectal Cancer) study. The full text of this press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and the information contained therein is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

(d) The following exhibits are included in this report:

 

Exhibit No.		Description
99.1		Earnings press release issued by the Company on March 6, 2015
99.2		Press release entitled “AVEO Oncology Announces Presentation of Phase 2 Study Analysis Showing Longer PFS with Tivozanib versus Bevacizumab in Low Serum NRP-1 Patients with Advanced CRC” issued by the Company on March 6, 2015

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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: March 6, 2015
By:		/s/ Michael Bailey
		Michael Bailey
		President and Chief Executive Officer

Exhibit 99.1

 

DRAFT – NOT FOR IMMEDIATE RELEASE

AVEO Oncology Reports Full Year 2014 Financial Results

CAMBRIDGE, Mass. – March 6, 2015 – AVEO Oncology (NASDAQ: AVEO) today reported financial results for the full year ended December 31, 2014.

“At the beginning of 2015, AVEO implemented several important changes designed to maximize the value of our portfolio of clinical stage products,” said Michael Bailey, president and chief executive officer. “Our approach to realizing this value is to leverage biomarker insights, including the promising new NRP-1 findings for tivozanib in metastatic colorectal cancer, and our demonstrated ability to advance our assets through partnerships. In support of these efforts, we have streamlined our organization to better align it with our clinically focused strategic needs going forward, extending our financial runway into the third quarter of 2016. We look forward to a productive 2015 as we work toward making progress in executing our strategy.”

Recent Highlights

 

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Announced Presentation of Phase 2 Study Analysis Showing Longer PFS with Tivozanib versus Bevacizumab in Low Serum NRP-1 Patients with Advanced CRC – Today, AVEO announced the presentation of final results, including a predefined biomarker analysis, from the BATON-CRC study, a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer (CRC). The presentation, titled “Neuropilin-1 as a potential biomarker of progression-free survival benefit for tivozanib + mFOLFOX6 versus bevacizumab + mFOLFOX6 in metastatic colorectal cancer: post-hoc biomarker analysis of BATON-CRC Phase 2 trial,” will be presented in a poster session today at the American Association for Cancer Research (AACR) Tumor Angiogenesis and Vascular Normalization Conference, taking place March 5-8, 2015, in Orlando, FL.

 

•

Named Michael P. Bailey as President and Chief Executive Officer – In January 2015, AVEO announced that its board of directors appointed Michael P. Bailey as the Company’s president and chief executive officer and has elected Mr. Bailey as a director. Mr. Bailey succeeds Tuan Ha-Ngoc, who was named chairman of AVEO’s board of directors.

 

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Announced Corporate Restructuring – In January 2015, AVEO announced the elimination of its internal research function, as well as certain corporate support positions, to align resources with the Company’s future strategic plans, focusing on advancement of its pipeline in the clinical setting and reducing corporate expenses. AVEO expects that the related severance and outplacement charges of approximately $4.5 million incurred in connection with the restructuring will be included in its results of operations for the first quarter of 2015. The reduction in force is expected to reduce compensation expenses annually by approximately $6 million and will further reduce AVEO’s facilities requirements, by more than 80% of its current space, including the elimination of lab and vivarium needs. The Company announced today that it will exit its current facility by the end of May 2015.

 

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Named Michael N. Needle, M.D. as Chief Medical Officer – In January 2015, AVEO announced the appointment of Michael N. Needle, M.D., to the position of chief medical officer. In this role, Dr. Needle, a board certified hematologist/oncologist, will take a leadership role in evaluating and implementing clinical development strategies for advancement of the Company’s proprietary and partnered clinical-stage programs.

 

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Received Confirmation of Eligibility for Submission of a Tivozanib Marketing Authorization Application (MAA) to the European Medicines Agency – In January 2015, AVEO announced that, in response to submission of a letter of intent, it has received written confirmation from the European Medicine Agency (EMA) that tivozanib is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure. AVEO intends to evaluate the decision to submit a tivozanib Marketing Authorization Application (MAA) in Europe for the treatment of RCC. Confirmation of eligibility for submission is not predictive of the EMA’s approval of a MAA.

 

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Entered into Research and Exclusive Option Agreement with Ophthotech for Tivozanib for the Treatment of Ocular Diseases – In November 2014, AVEO announced its entry into a research and exclusive option agreement with Ophthotech Corporation, under which it has provided Ophthotech an exclusive license to investigate the potential of tivozanib outside of Asia for the potential treatment of non-oncologic diseases of the eye. The agreement enables AVEO to potentially realize additional value for tivozanib in an indication outside of cancer, while retaining oncology rights for further development through additional potential partnerships.

Under the terms of the agreement, if Ophthotech exercises its option, AVEO would be eligible to receive, from Ophthotech, a total of up to $105.5 million in option fees and milestone payments, based on achievement of specified development, regulatory, sales and business goals, in addition to tiered, double digit royalties, up to the mid-teens, on net sales. This includes an upfront option fee of $500,000 received in the fourth quarter of 2014. Ophthotech is responsible for all research and development activities and costs, and upon exercise of its option, further development and commercialization activities and costs for tivozanib ocular indications. A percentage of all upfront, milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

Full Year 2014 Financial Highlights

 

•

AVEO ended 2014 with $52.3 million in cash and cash equivalents.

 

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Total collaboration revenue for 2014 was approximately $18.1 million compared with $1.3 million for 2013. The increase was primarily due to recognition of an additional $13.7 million of previously deferred revenue as a result of the modification of the Company’s arrangement with Biogen Idec. In addition, the Company recognized an additional $3.1 million of collaboration revenue in connection with the change in the estimated period of performance associated with the Company’s collaboration with Astellas as a result of the termination of the agreement in August 2014.

 

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Research and development (R&D) expense for 2014 was $38.3 million compared with $68.5 million for 2013. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following AVEO’s June 2013 strategic restructuring as well as a decrease in external clinical trial, research, and medical affairs costs associated with reduced tivozanib clinical trial activity, and a decrease of costs relating to the manufacturing of ficlatuzumab, which was completed in 2013.

 

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General and administrative (G&A) expense for 2014 was $18.6 million compared with $28.7 million for 2013.The decrease in G&A expense was primarily due to a reduction in personnel-related expenses following AVEO’s June 2013 strategic restructuring as well as a decrease in marketing and consulting costs due to termination of work related to tivozanib pre-commercialization activities.

 

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Restructuring and lease exit expense for 2014 was $11.7 million compared with $8.0 million for 2013. The expenses incurred during 2014 relate to costs associated with partially vacating and subsequently terminating the agreement for the Company’s leased space. The expenses incurred during 2013 relate to severance and employee benefits incurred as part of the June 2013 strategic restructuring.

 

•

Net loss for 2014 was $52.7 million, or a net loss of $1.01 per basic and diluted share compared with net loss of $107.0 million or a net loss of $2.10 per basic and diluted share for 2013.

Updated Financial Guidance

Based on its current operating plan, the Company expects its $52.3 million in cash resources as of December 31, 2014 will be sufficient to fund operations into the third quarter of 2016.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “objective,” “could,” “should,” “seek,” or the negative of

 

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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, statements about: the Company’s strategy for future growth; the Company’s strategy and ability to rebuild shareholder value; the Company’s estimated restructuring charges and realized cost reductions from the reduction in its facilities requirement; anticipated benefits from the restructuring; statements about payments that may be received by AVEO under both the option agreement and any future license agreement with Ophthotech; AVEO’s estimates regarding its financial runway; and the Company’s future growth and long-term success. 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 successfully implement and manage its restructuring and obtain the benefits it expects to derive from the reduction in its workforce and internal research functions; AVEO’s ability to execute on its business strategy and enter into and maintain new strategic partnerships and collaboration agreements, including the risk that Ophthotech does not elect to exercise its option to enter into a license agreement with AVEO to further develop tivozanib; the risk of any breach, event of default under, or acceleration of the payment terms of AVEO’s loan agreement with Hercules; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to demonstrate to the satisfaction of the FDA, EMA or other equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; 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 and expenses related to AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’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” included in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in 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 will cause its views to change. However, 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 subsequent to the date of this press release.

 

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AVEO Pharmaceuticals, Inc.

Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

		December 31,				December 31,
		2014				2013
Assets
Cash, cash equivalents and marketable securities		$	52,306			$	118,506
Accounts receivable			2,341				984
Prepaid expenses and other current assets			4,481				9,429
Property and equipment, net			11,295				14,140
Other assets			239				3,287
Total assets		$	70,662			$	146,346
Liabilities and stockholders’ equity
Accounts payable and accrued expenses		$	17,527			$	17,501
Total loans payable			20,652				19,205
Total deferred revenue			768				18,392
Total deferred rent			10,569				20,072
Other liabilities			540				1,238
Stockholder’s equity			20,606				69,938
Total liabilities and stockholders’ equity		$	70,662			$	146,346

 

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AVEO Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

		For the Three Months								For the Years
		Ended December 31,								Ended December 31,
		2014				2013				2014				2013
Collaboration revenue		$	115			$	323			$	18,123			$	1,293
Operating expenses:
Research and development			8,702				11,889				38,254				68,468
General and administrative			3,104				4,499				18,589				28,712
Restructuring and lease exit			1,302				4				11,729				8,017
			13,108				16,392				68,572				105,197
Loss from operations			(12,993	)			(16,069	)			(50,449	)			(103,904	)
Other income and expense:
Other (expense) income, net			(37	)			(3	)			66				(123	)
Interest expense			(866	)			(676	)			(2,388	)			(3,127	)
Interest income			2				23				32				125
Other expense, net			(901	)			(656	)			(2,290	)			(3,125	)
Net loss		$	(13,894	)		$	(16,725	)		$	(52,739	)		$	(107,029	)
Basic and diluted net loss per share
Net loss		$	(0.27	)		$	(0.32	)		$	(1.01	)		$	(2.10	)
Weighted average number of common shares outstanding			51,802				51,546				52,289				50,928

Company, Media and Investor Contact:

David Pitts, Argot Partners

(212) 600-1902

[email protected]

 

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Exhibit 99.2

 

DRAFT – NOT FOR IMMEDIATE RELEASE

AVEO Oncology Announces Presentation of Phase 2 Study Analysis Showing Longer PFS

with Tivozanib Compared to Bevacizumab in Low Serum NRP-1 Patients with

Advanced CRC

Results Presented at AACR Tumor Angiogenesis and Vascular Normalization Conference

AVEO to Host Conference Call Today, March 6, 2015 at 8:00 am ET

CAMBRIDGE, Mass. – Mar 6, 2015 – AVEO Oncology (NASDAQ: AVEO) today announced the presentation of final results, including a predefined biomarker analysis, from the BATON- (Biomarker Assessment of Tivozanib in ONcology) CRC study, a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer (CRC). The presentation, titled “Neuropilin-1 as a potential biomarker of progression-free survival benefit for tivozanib + mFOLFOX6 versus bevacizumab + mFOLFOX6 in metastatic colorectal cancer: post-hoc biomarker analysis of BATON-CRC Phase 2 trial,” will be presented in a poster session today at the American Association for Cancer Research (AACR) Tumor Angiogenesis and Vascular Normalization Conference, taking place March 5-8, 2015, in Orlando, FL. Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor (VEGF) with a long half-life and activity against all three VEGF receptors.

The BATON-CRC study enrolled a total of 265 patients randomized 2 to 1 to receive tivozanib in combination with mFOLFOX6 (n=177) compared to bevacizumab and mFOLFOX6 (n=88) as first-line treatment in patients with advanced metastatic CRC. A key objective of the BATON-CRC study is the assessment of prospectively defined biomarkers that may be predictive of response in selected patient subpopulations. Among these, patients with low neuropilin-1 (NRP-1) showed an improved progression free survival (PFS) versus patients with high NRP-1 in both treatment arms, supporting the value of NRP-1 as a potential prognostic marker for angiogenesis inhibitors. Further, patients with serum NRP-1 levels below the median demonstrated longer PFS when treated with tivozanib (17.9 months, n=52), compared to bevacizumab (11.2 months, n=28) (HR=0.380, p=0.0075), suggesting NRP-1 may have potential as a predictive biomarker of tivozanib activity relative to bevacizumab. Patients with high serum NRP-1 had PFS of 7.3 months and 7.5 months for the tivozanib and bevacizumab arms, respectively. With only 21 deaths in the NRP-1 low group upon study termination, no conclusion could be reached in an analysis of overall survival.

An earlier, pre-specified interim futility analysis determined that tivozanib was unlikely to demonstrate superiority to bevacizumab in the primary endpoint of PFS in the intent to treat population (ESMO 2014), resulting in discontinuation of the study. The results presented today are the final results, and include five additional months of study conduct and patient follow-up beyond the data cutoff for the interim futility analysis. In the intent to treat population, the tivozanib and bevacizumab combinations demonstrated comparable results for PFS, the primary

 

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endpoint (9.8 months and 9.5 months for tivozanib and bevacizumab, respectively, HR=0.908, p=0.598), and overall response rate (46.9% and 43.2%, for tivozanib and bevacizumab, respectively), while demonstrating comparable safety. The most common toxicities included diarrhea, nausea, fatigue, neutropenia and hypertension. Serious adverse events were reported for 46.3% of patients in the tivozanib group and 48.3% in the bevacizumab group.

“Where NRP-1 expression is low, the tumor appears to rely more heavily on the VEGF pathway and become more susceptible to anti-VEGF therapies, such as bevacizumab or tivozanib, an observation seen across several tumor types, including breast, gastric, colorectal and renal cell cancers,” said Al B. Benson III, MD, FACP, Professor of Medicine at the Feinberg School of Medicine, Associate Director for Clinical Investigations at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and principal investigator of the study. “Results from the BATON-CRC study are consistent with these observations. Further, the increase in PFS for patients treated with tivozanib compared to bevacizumab is both interesting and encouraging. I believe that these findings warrant further study in a prospectively defined trial of patients with low serum NRP-1 metastatic colorectal cancer.”

“These results underscore tivozanib’s activity and differentiating properties, including the potential benefit of a more complete anti-angiogenesis blockade in selected patient populations,” said Michael Needle, MD, chief medical officer of AVEO. “We believe these data suggest a promising new development path forward in a significant patient population.”

A copy of the poster presentation is available on AVEO’s website at www.aveooncology.com.

Today’s Conference Call and Webcast Information

The AVEO management team will host a conference call today, March 6, at 8:00 am (ET). The call can be accessed by dialing 1-877-280-4954 (domestic) or 1-857-244-7311 (international) five minutes prior to the start of the call and providing the passcode 38640881. A replay of the call will be available two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 54500453. The replay will be available for two weeks from the date of the live call.

The live webcast of the conference call can be accessed by visiting the investors section of the AVEO website at www.aveooncology.com. A replay of the webcast will be archived on the AVEO website for two weeks following the call.

About Colorectal Cancer

The American Cancer Society estimates that more than 130,000 men and women in the United States will be diagnosed with colorectal cancer (CRC) and nearly 50,000 will die of the disease in the United States in 2015.¹ CRC is the third most commonly diagnosed cancer in both men and women and the third leading cause of cancer death in the United States. In Europe, it is estimated that almost 180,000 men and women are diagnosed with CRC and that nearly 80,000 die from the disease each year.²

 

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About Tivozanib

Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “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, statements about potential strategic options for the development of tivozanib and the expected beneficial properties of tivozanib, including its potential to provide a more complete anti-angiogenesis blockade. 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 execute on its business strategy, including its ability to enter into and maintain new strategic partnerships and collaboration agreements; AVEO’s ability to successfully enroll and complete clinical trials and preclinical studies of its product candidates; AVEO’s ability to demonstrate to the satisfaction of the FDA, EMA or other equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO’s ability to demonstrate in later clinical trials positive results that may be observed in earlier-stage clinical trials; 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 and expenses related to AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise the substantial additional funds required to achieve its goals; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” included in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in 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 will cause its views to change. However, 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 subsequent to the date of this press release.

 

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References

1	American Cancer Society. Available at:

http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/index

 

2	Ferlay, J. et al. European Journal of Cancer, Volume 46, Issue 4, 765 – 781, 2009

Company, Media and Investor Contact:

David Pitts, Argot Partners

(212) 600-1902

[email protected]

 

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