AVEO Oncology (Nasdaq: AVEO) today reported financial results for the second quarter ended June 30, 2020 and provided a business update.
"The first half of 2020 was one of the most important periods in AVEO's history to date, with the successful completion of the TIVO-3 study and the acceptance for filing and substantive review of a New Drug Application (NDA) for tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC)," said Michael Bailey, president and chief executive officer of AVEO. "Through successful debt and equity financings, we now expect to have access to the capital to ensure a robust launch of FOTIVDA® (tivozanib) into 2022 to potentially address what we believe is a significant unmet need for an effective, better tolerated drug. Currently, more than half of patients are opting to forego third or later lines of therapy, largely due to issues of tolerability and a lack of evidence-based studies in this setting.1 Supported by positive results from TIVO-3, we believe tivozanib could address these challenges and allow patients to continue their fight against cancer, and therefore has the potential to become a standard of care in this large and growing segment of the market."
Mr. Bailey added, "With TIVO-3 complete, we are now evaluating several opportunities to initiate new pivotal studies for both tivozanib and ficlatuzumab. Building on the TiNivo and DEDUCTIVE trials in RCC and hepatocellular carcinoma (HCC) respectively, we believe tivozanib's activity, favorable safety profile, and ability to significantly reduce regulatory T cells2 all have the potential to make tivozanib a companion tyrosine kinase inhibitor of choice in these settings. In addition, the early data we have seen in the randomized head and neck cancer (HNSCC) study with ficlatuzumab combined with cetuximab (ERBITUX®), which could serve as the basis for pursuing a pivotal study in this tumor type, has led us to initiate the process to evaluate securing additional clinical manufacturing capacity. Finally, we expect AV-380 to enter into a Phase 1 study in the first quarter of 2021, if an Investigational New Drug (IND) application which we expect to file by year end 2020, is accepted by the U.S. Food and Drug Administration (FDA)."
Tivozanib Updates
Tivozanib Non-Oncology Partnership Update
Ficlatuzumab Update
AV-380 Update
Corporate Updates
Second Quarter 2020 Financial Results
Financial Guidance
AVEO believes that its as-adjusted $79.5 million in cash, cash equivalents and marketable securities as of June 30, 2020, consisting of $71.4 million in cash, cash equivalents and marketable securities at June 30, 2020 together with the $2.8 million KKC milestone and the $5.3 million in new loan funding from Hercules, along with partnership cost sharing reimbursements, royalties from EUSA's FOTIVDA sales and, if the pending marketing application for FOTIVDA is approved by the FDA, resulting product revenues upon commercial launch and the potential additional $20 million in credit under the Hercules loan, would allow the Company to fund planned operations into 2022.
In accordance with Accounting Standards Update No. 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern (Accounting Standards Codification Subtopic 205-40), cash flows that are contingent on FDA approval, such as product revenues, cannot be reflected in the going concern assessment. As a result, Hercules loan funding contingent on such approval and revenue is also excluded from our going concern assessment. Accordingly, the Company continues to have a going concern opinion.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation 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 and other countries in the EUSA territory. 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.8,9 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 models2 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.10 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin in non-oncology indications.
About AVEO Pharmaceuticals, Inc.
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 and other countries by AVEO's partner EUSA 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 and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.
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, following earlier TKI and immunotherapy treatment; 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 current and future clinical trials of tivozanib, ficlatuzumab and AV-380 and for commercialization of tivozanib in the United States; the period in which AVEO expects to have cash to fund its operations and the contingencies upon which such guidance is dependent ;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: 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 tivozanib's clinical trials, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may determine for approval; 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; AVEO's ability to access up to $20.0 million of the Hercules loan facility, which turns on the achievement of milestones related to the approval and commercialization of tivozanib in the U.S., which milestones may not be achieved; 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
AVEO PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) |
||||||||||||||||
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and licensing revenue |
|
$ |
494 |
|
|
$ |
493 |
|
|
$ |
987 |
|
|
$ |
1,947 |
|
Partnership royalties |
|
|
255 |
|
|
|
210 |
|
|
|
546 |
|
|
|
367 |
|
|
|
|
749 |
|
|
|
703 |
|
|
|
1,533 |
|
|
|
2,314 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,419 |
|
|
|
2,611 |
|
|
|
12,245 |
|
|
|
9,463 |
|
General and administrative |
|
|
3,737 |
|
|
|
2,986 |
|
|
|
7,409 |
|
|
|
5,441 |
|
|
|
|
8,156 |
|
|
|
5,597 |
|
|
|
19,654 |
|
|
|
14,904 |
|
Loss from operations |
|
|
(7,407 |
) |
|
|
(4,894 |
) |
|
|
(18,121 |
) |
|
|
(12,590 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(349 |
) |
|
|
(451 |
) |
|
|
(664 |
) |
|
|
(1,015 |
) |
Change in fair value of PIPE Warrant liability |
|
|
450 |
|
|
|
2,210 |
|
|
|
3,098 |
|
|
|
11,025 |
|
Other income (expense), net |
|
|
101 |
|
|
|
1,759 |
|
|
|
2,434 |
|
|
|
10,010 |
|
Net loss |
|
$ |
(7,306 |
) |
|
$ |
(3,135 |
) |
|
$ |
(15,687 |
) |
|
$ |
(2,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.18 |
) |
Weighted average number of common shares outstanding |
|
|
17,364 |
|
|
|
15,902 |
|
|
|
16,722 |
|
|
|
14,574 |
|
Consolidated Balance Sheet Data (In thousands) (Unaudited) |
||||||||
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
||
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
71,449 |
|
|
$ |
47,745 |
|
Accounts receivable |
|
|
1,208 |
|
|
|
1,631 |
|
Prepaid expenses and other current assets |
|
|
1,571 |
|
|
|
1,224 |
|
Property and equipment, net |
|
|
96 |
|
|
|
? |
|
Operating lease right-of-use asset |
|
|
1,120 |
|
|
|
? |
|
Other assets |
|
|
158 |
|
|
|
? |
|
Total assets |
|
$ |
75,602 |
|
|
$ |
50,600 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
8,906 |
|
|
$ |
9,482 |
|
Loans payable, net of discount |
|
|
11,133 |
|
|
|
15,766 |
|
Deferred revenue and research and development reimbursements |
|
|
3,798 |
|
|
|
4,619 |
|
PIPE Warrant liability |
|
|
1,999 |
|
|
|
5,097 |
|
Operating lease liability |
|
|
924 |
|
|
|
? |
|
Other liabilities |
|
|
790 |
|
|
|
790 |
|
Stockholder's equity |
|
|
48,052 |
|
|
|
14,846 |
|
Total liabilities and stockholders' equity |
|
$ |
75,602 |
|
|
$ |
50,600 |
|
These press releases may also interest you
|