Site icon pharmaceutical daily

AVEO Oncology Reports First Quarter 2020 Financial Results and Provides Business Update

BOSTON–(BUSINESS WIRE)–AVEO Oncology (NASDAQ: AVEO) today reported financial results for the first quarter ended March 31, 2020 and provided a business update.

“Our recent submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for tivozanib as a treatment for relapsed or refractory renal cell carcinoma (R/R RCC) is both an important milestone and a significant achievement for AVEO,” said Michael Bailey, president and chief executive officer of AVEO. “There is no current standard of care for the third+ line R/R RCC population and, prior to TIVO-3, there was no robust clinical dataset to support treatment choice. If approved, we believe tivozanib has the opportunity to address this meaningful and growing segment of treatment. We look forward to the presentation of results from the final TIVO-3 overall survival (OS) analysis as we continue to build on our foundation for commercial readiness.”

“In addition, our clinical and business development teams’ attention is turning toward opportunities to expand tivozanib-immunotherapy combination studies that build on the TiNivo and DEDUCTIVE trials in RCC and HCC, where we believe tivozanib’s safety and activity profile could make it a companion TKI of choice. We also remain committed to advancing the balance of our pipeline, which includes ficlatuzumab, currently in an ongoing randomized Phase 2 trial in head and neck cancer (HNSCC) which, with a favorable outcome, could characterize a potential registration path, and AV-380, for which we look forward to filing an IND in the second half of 2020,” continued Mr. Bailey.

Tivozanib Updates

Ficlatuzumab Updates

Recent Corporate Updates

First Quarter 2020 Financial Results

Financial Guidance

AVEO believes that its cash, cash equivalents and marketable securities of approximately $33.6 million at March 31, 2020, along with anticipated partnership payments from cost sharing obligations and royalty revenues from sales of FOTIVDA® by EUSA, would allow the Company to fund its planned operations into the second quarter of 2021.

About Tivozanib (FOTIVDA®)

Tivozanib (FOTIVDA®) is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union, the United Kingdom, Norway, New Zealand and Iceland. 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.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in a clinical study of patients with squamous cell carcinoma of the head and neck (HNSCC).

About AVEO

AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. AVEO’s strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb) is in a Phase 2 clinical trial in head and neck cancer and has reported early clinical data in pancreatic cancer. AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb). 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 fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” 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: the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC, and following earlier TKI and immunotherapy treatment; AVEO’s plan to conduct a final OS analysis in the second quarter based on a May 1, 2020 data cutoff date and to report results by June 2020; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; AVEO’s execution of its clinical and regulatory strategy for tivozanib; AVEO’s plans and strategies for commercialization of tivozanib in the United States and Europe; and AVEO’s strategy, prospects, plans and objectives for its product candidates and for the Company generally. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. 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: the potential for unfavorable final OS data from the TIVO-3 trial; the potential for the FDA to not accept AVEO’s NDA for filing; whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may determine to be relevant to approvability; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; and AVEO’s ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements. AVEO faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s ability to maintain compliance with 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; AVEO’s ability to successfully implement its strategic plans, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO’s business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; and those risks discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and 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. Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

References

  1. Fotivda (Tivozanib) SmPC August 2017
  2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9
  3. Pawlowski N et al. AACR 2013. Poster 3971
  4. Barthelemy et al. ESMO 2018. Poster 878P
 

AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

Three Months Ended

March 31,

 

 

 

2020

 

 

2019

 

Revenues:

 

 

 

 

 

 

 

 

Collaboration and licensing revenue

 

$

493

 

 

$

1,454

 

Partnership royalties

 

 

291

 

 

 

157

 

 

 

 

784

 

 

 

1,611

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

7,826

 

 

 

6,852

 

General and administrative

 

 

3,672

 

 

 

2,455

 

 

 

 

11,498

 

 

 

9,307

 

Loss from operations

 

 

(10,714

)

 

 

(7,696

)

Other income, net:

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(315

)

 

 

(564

)

Change in fair value of PIPE Warrant liability

 

 

2,648

 

 

 

8,815

 

Other income, net

 

 

2,333

 

 

 

8,251

 

Net income (loss)

 

$

(8,381

)

 

$

555

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per share

 

 

 

 

 

 

 

 

Net income (loss) per share

 

$

(0.52

)

 

$

0.04

 

Weighted average number of common shares outstanding

 

 

16,081

 

 

 

13,230

 

 

 

 

 

 

 

 

 

 

Diluted net income (loss) per share

 

 

 

 

 

 

 

 

Net income (loss) per share

 

$

(0.52

)

 

$

(0.62

)

Weighted average number of common shares and dilutive

common share equivalents outstanding

 

 

16,081

 

 

 

13,283

 

Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

March 31,

2020

 

 

December 31,

2019

 

Assets

 

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

33,620

 

 

$

47,745

 

Accounts receivable

 

 

2,779

 

 

 

1,631

 

Prepaid expenses and other current assets

 

 

665

 

 

 

1,224

 

Property and equipment, net

 

 

100

 

 

 

 

Operating lease right-of-use asset

 

 

1,225

 

 

 

 

Other assets

 

 

158

 

 

 

 

Total assets

 

$

38,547

 

 

$

50,600

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

9,541

 

 

$

9,482

 

Loans payable, net of discount

 

 

13,486

 

 

 

15,766

 

Deferred revenue and research and development reimbursements

 

 

4,243

 

 

 

4,619

 

PIPE Warrant liability

 

 

2,449

 

 

 

5,097

 

Operating lease liability

 

 

1,030

 

 

 

 

Other liabilities

 

 

790

 

 

 

790

 

Stockholder’s equity

 

 

7,008

 

 

 

14,846

 

Total liabilities and stockholders’ equity

 

$

38,547

 

 

$

50,600

 

 

Contacts

AVEO Contact:
David Pitts, Argot Partners

(212) 600-1902

aveo@argotpartners.com

Exit mobile version