AVEO Oncology Reports First Quarter 2020 Financial Results and Provides Business Update
“Our recent submission of a New Drug Application (NDA) to the
“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
Tivozanib Updates
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Final Overall Survival Analysis from the Phase 3 TIVO-3 Trial of Tivozanib in RCC to be Presented at the ASCO 2020 Virtual Scientific Program. Data from the final OS analysis from AVEO’s pivotal Phase 3 TIVO-3 trial comparing tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, to sorafenib in 3rd and 4th line renal cell carcinoma, will be presented at the ASCO 2020 Virtual Scientific Program. The presentation, titled, “TIVO-3: Final OS analysis of a phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma (RCC)” (abstract 5062) will be featured during a poster session (Genitourinary Cancer – Kidney and Bladder). A copy of the poster will be available at the ASCO virtual meeting and on the AVEO website
Friday, May 29, 2020 , at8:00 AM ET .
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Submitted an NDA to
U.S. FDA for Tivozanib in Patients with Relapsed or Refractory RCC and Results of Final TIVO-3 OS Analysis Expected by June. InMarch 2020 , AVEO announced the submission of an NDA to theU.S. FDA seeking marketing approval for tivozanib as a treatment for relapsed or refractory RCC. As previously announced, a final OS analysis of the study will be conducted in the second quarter based on aMay 1, 2020 data cutoff date. AVEO expects to report results from the final OS analysis byJune 2020 . The FDA and the Company agreed that if, during the review, the final analysis yields an OS HR above 1.00, the Company will withdraw its NDA.
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Announced Publication of Phase 1b/2 Trial of Tivozanib in Advanced, Inoperable Hepatocellular Carcinoma (HCC) in the
British Journal of Cancer . InFebruary 2020 , AVEO announced the publication of results from a monotherapy trial of tivozanib in patients with advanced, inoperable HCC in theBritish Journal of Cancer . 27 patients were enrolled in the trial that sought to evaluate the safety, dosing, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of tivozanib in patients with advanced HCC. The recommended Phase 2 dose (RP2D) was determined to be 1.0 mg once daily for 21 days followed by 7 days off treatment on a 28-day cycle. Median PFS and OS were 24 weeks and 9 months, respectively, for patients treated at the RP2D, with an overall response rate of 21%. A significant decrease in soluble plasma VEGFR-2 was also observed, suggesting adequate target engagement. The link to this publication is available on the Publications & Presentations section of AVEO’s website.
Ficlatuzumab Updates
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Presented Results from Phase 1b Trial of Ficlatuzumab, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer. In
January 2020 ,AVEO andBiodesix, Inc. announced the presentation of results from an investigator-sponsored Phase 1b trial of ficlatuzumab, AVEO’s potent hepatocyte growth factor inhibitory antibody product candidate, in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. The results were presented during a poster session at the 2020American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium .
A total of 24 patients were enrolled. The average number of 28-day cycles received was 7.5 (range 1-15), with 3 patients remaining on active treatment at the end of the trial. The combination was associated with a promising durable response rate relative to data observed for gemcitabine and nab-paclitaxel alone. This included a 29% partial response (PR) rate and 92% rate of disease control (PR + stable disease). Treatment with this regimen was associated with significant hypoalbuminemia and edema, and therefore a follow up safety study is under consideration of ficlatuzumab in combination with an alternate cytotoxic regimen. A copy of the presentation is available in the Publications & Presentations section of AVEO’s website.
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CyFi-2 Study of Ficlatuzumab in Relapsed and Refractory AML Discontinued. In
March 2020 ,AVEO andBiodesix, Inc. announced the discontinuation of their Phase 2 CyFi-2 study of ficlatuzumab in combination with high-dose cytarabine in relapsed and refractory AML. The decision was made due to the urgent shift among clinical sites toward efforts to combat the COVID-19 pandemic, which has impacted the feasibility of completing the study within the shelf-life of the current ficlatuzumab clinical trial supply.
Recent Corporate Updates
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Announced New Corporate Headquarters. AVEO today announced that it recently relocated its headquarters from
Cambridge, Massachusetts toBoston . The new headquarters will lower overall costs and support further growth as the Company continues to execute on its tivozanib development strategy and advance the balance of its pipeline.
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Building out
Foundation for Commercial Readiness . As part of the build-out of its commercial organization ahead of the potential launch of tivozanib in R/R RCC, AVEO recently announced the appointment of key commercial and medical affairs leadership, includingJason Noto , Vice President of Market Access;Kevin Peacock , Vice President of Marketing; andDaniel Powers , D.O., Vice President of Medical Affairs. The commercial organization has begun additional recruitment efforts in medical affairs, market access and patient access contingent on the near-term OS update from the TIVO-3 trial.
First Quarter 2020 Financial Results
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AVEO ended Q1 2020 with
$33.6 million in cash, cash equivalents and marketable securities as compared with$47.7 million atDecember 31, 2019 . -
Total revenue for Q1 2020 was approximately
$0.8 million compared with$1.6 million for Q1 2019. -
Research and development expense for Q1 2020 was
$7.8 million compared with$6.8 million for Q1 2019. Research and development expense for Q1 2020 includes the$2.9 million application user fee pursuant to the FDA’s Prescription Drug User Fee Act that was paid upon the submission of the tivozanib NDA to theU.S. FDA inMarch 2020 . -
General and administrative expense for Q1 2020 was
$3.7 million compared with$2.5 million for Q1 2019. -
Net loss for Q1 2020 was
$8.4 million , or net loss of$0.52 per basic and diluted share, compared with net income of$0.6 million for Q1 2019, or net income of$0.04 and net loss of$0.62 per basic and diluted share, respectively. -
The Company recognized approximately
$2.6 million and$8.8 million in non-cash gains in Q1 2020 and Q1 2019, respectively, that were attributable to the decrease in fair value of the 2016 private placement warrant liability that principally resulted from decreases in the stock price that occurred within each of the periods.
Financial Guidance
AVEO believes that its cash, cash equivalents and marketable securities of approximately
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
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.
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
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
References
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Fotivda (Tivozanib) SmPC
August 2017 - Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9
- Pawlowski N et al. AACR 2013. Poster 3971
- Barthelemy et al. ESMO 2018. Poster 878P
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Three Months Ended
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2020 |
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2019 |
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Revenues: |
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|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
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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
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Assets |
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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 |
|
|
|
— |
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Total assets |
|
$ |
38,547 |
|
|
$ |
50,600 |
|
|
|
|
|
|
|
|
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Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
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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 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200430005254/en/
AVEO Contact:
(212) 600-1902
aveo@argotpartners.com
Source: AVEO Oncology