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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aravive Inc | NASDAQ:ARAV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.0401 | 0.042 | 0.0428 | 0 | 01:00:00 |
“In 2021, Aravive made significant progress in advancing the clinical development of batiraxcept for the potential treatment of ovarian, kidney and pancreatic cancer,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. “We initiated the registrational Phase 3 trial of batiraxcept in ovarian cancer and recently reported positive safety and efficacy data from the ongoing Phase 1b trials of batiraxcept in clear cell renal cell carcinoma and pancreatic cancer. We are encouraged by batiraxcept's early profile in patients across each of these life-threatening cancers with unmet medical needs and are laser-focused on building value for patients and shareholders.”
Recent Corporate Highlights
Fourth Quarter and Full Year 2021 Financial ResultsRevenue for the three and twelve months ended December 31, 2021 was $1.0 million and $7.4 million, respectively, compared with $5.7 million for the same periods in 2020. Revenues for 2021 and 2020 were derived solely from the Company’s collaboration and license agreement with 3D Medicines, executed in November 2020 to develop and commercialize batiraxcept in oncology indications in Greater China. Revenues represent a portion of initial signing and milestone payments received from 3D Medicines that is recognized at the time of the receipt and a portion of the payments that is deferred and recognized over the PROC trial period.
Total operating expenses for the three and twelve months ended December 31, 2021 were $14.6 million and $48.1 million, respectively compared with $9.7 million and $36.5 million, respectively, for the same periods in 2020. Non-cash stock-based compensation for the three and twelve months ended December 31, 2021 was $0.6 million and $2.3 million, respectively compared with $0.4 million and $2.0 million, respectively, for the same periods in 2020. In addition, during the twelve months ended December 31, 2020, there were non-recurring non-cash charges for impairment of the Company’s right-of-use asset and leasehold improvements of $5.8 million.
For the three and twelve months ended December 31, 2021, Aravive reported a net loss of $13.0 million and $39.2 million, or $0.62 per share and $1.95 per share, respectively compared to a net loss of $4.0 million and $30.5 million, or $0.25 per share and $1.93 per share, respectively, for the same periods in 2020.
Cash PositionAs of December 31, 2021, cash and cash equivalents were $59.4 million, compared to $60.5 million as of December 31, 2020. In January 2022, Aravive announced an approximately $10.0 million investment by Eshelman Ventures and in March 2022, Aravive announced an additional approximately $10 million investment by a healthcare-focused institutional investor and Eshelman Ventures, LLC. The combined approximately $20 million in new capital strengthened the Company’s financial position ahead of multiple anticipated clinical milestones throughout 2022 for each of the Company’s three ongoing clinical programs. The Company anticipates that its current cash and cash equivalents will fund operating plans into 1Q’23.
About AraviveAravive, Inc. is a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease. Our lead product candidate, batiraxcept (formerly AVB-500), is an ultra-high affinity decoy protein that binds to GAS6, the sole ligand that activates AXL, thereby inhibiting metastasis and tumor growth, and restoring sensitivity to anti-cancer agents. Batiraxcept has been granted Fast Track Designation by the U.S. FDA and Orphan Drug Designation by the European Commission in platinum-resistant recurrent ovarian cancer. Batiraxcept is in an active registrational Phase 3 trial in platinum resistant ovarian cancer (NCT04729608), a Phase 1b/2 trial in clear cell renal cell carcinoma (NCT04300140), and a Phase 1b/2 trial in pancreatic adenocarcinoma (NCT04983407). Additional information at www.aravive.com.
Forward Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions and include statements regarding the additional biomarker data from Phase 1b ccRCC trial anticipated in 2Q’22, anticipated cash runway into 1Q’23, reporting updated data in 1H’22 from the Phase 1b trials of batiraxcept in clear cell renal cell carcinoma and pancreatic adenocarcinoma, completing enrollment in the registration directed Phase 3 trial in the second half of 2022, topline data from the trial being available in the second quarter of 2023 and being ready to potentially file a BLA during the fourth quarter of 2023; continuing to provide updated biomarker data throughout 2022, being on track to report additional updated results from the Phase 1b portion of the trial for the treatment of ccRCC in the second quarter of 2022, being on track to report preliminary results from the Phase 2 portion of the trial for the treatment of ccRCC in the second quarter of 2022, being on track to report additional updated data from the Phase 1b portion of the trial of batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment in patients with advanced or metastatic pancreatic adenocarcinoma in the second quarter of 2022, the anticipated enrollment of 55 patients across three part in the Phase 2 portion of the Phase 1b/2 trial of batiraxcept in ccRCC and the capital infusions funding operations into 1Q’23. Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: the ability to report data from the current clinical trials in accordance with current timelines,, the data from patients treated in the future with batiraxcept being consistent with the results reported, the ability to enroll the expected number of patients, the impact of COVID-19 on the Company's clinical strategy, clinical trials, supply chain and fundraising, the Company's ability to expand development into additional indications, the Company's dependence upon batiraxcept, batiraxcept’s ability to have favorable results in clinical trials and ISTs, the clinical trials of batiraxcept having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that batiraxcept may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing batiraxcept; if batiraxcept is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company's intellectual property rights; the Company's reliance on its licensor of intellectual property and financing needs. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Aravive, Inc.Consolidated Statements of Operations(in thousands, except per share amounts)
Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(unaudited) | ||||||||||||||||
Revenue | ||||||||||||||||
Collaboration revenue | $ | 985 | $ | 5,685 | $ | 7,442 | $ | 5,685 | ||||||||
Total revenue | 985 | 5,685 | 7,442 | 5,685 | ||||||||||||
Operating expenses | ||||||||||||||||
Research and development | 12,194 | 6,535 | 37,541 | 17,620 | ||||||||||||
General and administrative | 2,448 | 3,199 | 10,550 | 13,065 | ||||||||||||
Loss on impairment of long-lived assets | — | — | — | 5,784 | ||||||||||||
Total operating expenses | 14,642 | 9,734 | 48,091 | 36,469 | ||||||||||||
Loss from operations | (13,657 | ) | (4,049 | ) | (40,649 | ) | (30,784 | ) | ||||||||
Interest income | 8 | 4 | 37 | 255 | ||||||||||||
Other income (expense), net | 693 | (1 | ) | 1,461 | (14 | ) | ||||||||||
Net loss | $ | (12,956 | ) | $ | (4,046 | ) | $ | (39,151 | ) | $ | (30,543 | ) | ||||
Net loss per share- basic and diluted | $ | (0.62 | ) | $ | (0.25 | ) | $ | (1.95 | ) | $ | (1.93 | ) | ||||
Weighted-average common shares used to compute basic and diluted net loss per share | 20,998 | 16,183 | 20,070 | 15,790 |
Aravive, Inc.Consolidated Balance Sheets (in thousands)
December 31, | December 31, | |||||||
2021 | 2020 | |||||||
Assets: | ||||||||
Cash and cash equivalents | $ | 59,424 | $ | 60,541 | ||||
Restricted cash | 2,431 | 2,430 | ||||||
Other assets | 3,725 | 1,781 | ||||||
Operating lease right-of-use assets | 2,207 | 2,958 | ||||||
Total assets | $ | 67,787 | $ | 67,710 | ||||
Liabilities and stockholders' equity: | ||||||||
Accounts payable and accrued liabilities | $ | 11,073 | $ | 4,823 | ||||
Deferred revenue | 8,119 | 6,315 | ||||||
Operating lease obligation | 6,373 | 8,517 | ||||||
Total liabilities | 25,565 | 19,655 | ||||||
Total stockholders' equity | 42,222 | 48,055 | ||||||
Total liabilities and stockholders’ equity | $ | 67,787 | $ | 67,710 |
Contact:Marek Ciszewski, J.D.Vice President, Investor Relationsmarek@aravive.com (562) 373-5787
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