HOUSTON, March 15, 2023 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today reported fourth quarter and full year ended December 31, 2022 financial results and provided corporate updates.
"As we reflect on a productive 2022, Aravive remains committed to driving progress across all aspects of our business," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We are on track with development activities around our PROC Phase 3 program, and we anticipate delivering topline results in mid-2023. Our trials in both clear cell renal cell carcinoma and pancreatic cancer continue to yield meaningful and encouraging data, further underscoring the potential of batiraxcept in multiple indications. Furthermore, we are pleased to have secured the funding needed to advance all of our programs beyond the PROC readout and progressing our clinical activities, with strong support from a respected syndicate of leading biotech investors. With a strengthened management team and a continued focus on scientific excellence, we are excited to build on our momentum and make significant strides in the year ahead. We look forward to updating you on our progress throughout the year as our clinical programs advance."
Recent Corporate Highlights
Fourth Quarter and Full Year 2022 Financial Results
Revenues for the three and twelve months ended December 31, 2022 were approximately $1.5 million and $9.1 million, respectively, compared with approximately $1.0 million and $7.4 million, respectively, for the three and twelve months ended December 31, 2021. Revenues for 2022 and 2021 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 China. Revenues represent 1) a portion of initial signing and milestone recorded from 3D Medicines that is recognized at the time it is probable the milestone will be met and 2) a portion of the milestone that is deferred and recognized over the PROC trial period. The increase in revenue for fiscal year 2022 compared to 2021 was driven primarily by increased expenditures related to the PROC trial, which drives the recognition of deferred revenue over the PROC trial period.
Total operating expenses for the three and twelve months ended December 31, 2022 were approximately $21.3 million and $80.0 million, respectively, compared with approximately $14.6 million and $48.1 million, respectively, for the three and twelve months ended December 31, 2021. Research and development expenses for the three and twelve months ended December 31, 2022 were approximately $18.0 million and $66.9 million, respectively, compared with approximately $12.2 million and $37.5 million, respectively, for the three and twelve months ended December 31, 2021. The increase in research and development expense in 2022 compared to the same periods in 2021 is driven by the continued advancement of our clinical trials and increases in CMC-related costs. General and administrative expenses for the three and twelve months ended December 31, 2022 were approximately $3.4 million and $13.0 million, respectively, compared with approximately $2.4 million and $10.6 million, respectively, for the three and twelve months ended December 31, 2021. The increase in general and administrative expense was primarily driven by higher salary expense, higher stock-based compensation expense, higher severance expense, and increased consulting fees.
For the three and twelve months ended December 31, 2022, Aravive reported a net loss of approximately $29.1 million and $76.3 million, or $0.46 per share and $2.10 per share, respectively compared to a net loss of approximately $13.0 million and $39.2 million, or $0.62 per share and $1.95 per share, respectively, for the three and twelve months ended December 31, 2021.
Cash Position
As of December 31, 2022, cash and cash equivalents were approximately $53.7 million, compared to approximately $27.9 million as of September 30, 2022. During October 2022, the Company received a $6 million milestone payment from the Company's licensee, 3D Medicines, Inc. and raised approximately $40 million in net proceeds from a private placement offering. The Company believes that its existing cash and cash equivalents will be sufficient to sustain operations into the fourth quarter of 2023.
About Aravive
Aravive, Inc. is a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease. 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 for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer 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). The Company is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016. Additional information at www.aravive.com.
Forward Looking Statements
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 includes statements regarding remaining on track with development activities around the PROC Phase 3 program, the Company reporting topline data from the PROC trial by mid-2023, the potential of batiraxcept in multiple indications, making significant strides in the year ahead, providing updates on progress throughout the year, CMC work remaining on track with the goal of filing a BLA by year-end 2023, the trial enrolling 350 patients with platinum resistant, high-grade serous ovarian cancer who have received 1-4 prior lines of therapy, 3D Medicines obtaining approval in China the open-label Phase 2 portion of the ccRCC enrolling 55 patients across three parts (part A enrolling approximately 25 patients and investigating batiraxcept 15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients; part B enrolling approximately 20 patients and evaluating batiraxcept 15 mg/kg in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC and part C evaluating batiraxcept 15 mg/kg monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies), use of the sAXL/GAS6 ratio as a potential basis for an accelerated approval, the Company reporting additional data from the P1b portion and preliminary data from the P2 portion of the ccRCC trial mid-2023, the Company dosing an additional 6-18 patients at higher doses in the Phase 1b pancreatic study, providing preliminary data from the 20gm/kg cohort in the second half of 2023 and cash and cash equivalents being sufficient to sustain operations into the fourth quarter of 2023. 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 enroll patients as anticipated, the ability to provide data when anticipated; the Company's dependence upon batiraxcept; batiraxcept's ability to have favorable results in clinical trials; the clinical trials of batiraxcept having results that are as favorable as those of preclinical and clinical trials; the ability to file a BLA by year-end 2023 and receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; 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; and the Company's reliance on its licensor of intellectual property and financing needs and the cash runway being sufficient to sustain operations into the fourth quarter of 2023 and beyond the readout on the Company’s PROC trial. 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, 2022, 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 Three Months Ended December 31, 2022 September 30, 2022 (unaudited) (unaudited) Revenue Collaboration revenue $1,474 $4,956 Total revenue 1,474 4,956 Operating expenses Research and development 17,952 18,668 General and administrative 3,385 2,836 Total operating expenses 21,337 21,504 Loss from operations (19,863) (16,548)Total other income (expense), net (9,262) 885 Net loss $(29,125) $(15,663)Net loss per share - basic and diluted $(0.46) $(0.51)Weighted-average common shares used to compute basic and diluted net loss per share 62,938 30,518
Aravive, Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts) Three Months Ended Year Ended December 31, December 31, 2022 2021 2022 2021 (unaudited) Revenue Collaboration revenue $1,474 $985 $9,137 $7,442 Total revenue 1,474 985 9,137 7,442 Operating expenses Research and development 17,952 12,194 66,938 37,541 General and administrative 3,385 2,448 13,036 10,550 Total operating expenses 21,337 14,642 79,974 48,091 Loss from operations (19,863) (13,657) (70,837) (40,649)Total other income (expense), net (9,262) 701 (5,485) 1,498 Net loss $(29,125) $(12,956) $(76,322) $(39,151)Net loss per share - basic and diluted $(0.46) $(0.62) $(2.10) $(1.95)Weighted-average common shares used to compute basic and diluted net loss per share 62,938 20,998 36,372 20,070
Aravive, Inc.
Consolidated Balance Sheets
(in thousands) December 31, September 30, 2022 2022 (unaudited)Assets: Cash and cash equivalents$ 53,689 $ 27,896Accounts receivable — 6,000Restricted cash 2,445 2,436Other assets 4,557 4,242Operating lease right-of-use assets 1,462 1,648Total assets$ 62,153 $ 42,222Liabilities and stockholders' equity: Accounts payable and accrued liabilities$ 15,503 $ 16,078Deferred revenue 5,035 6,456Operating lease obligation 4,077 4,646Warrant liability 26,881 —Total liabilities 51,496 27,180Total stockholders' equity 10,657 15,042Total liabilities and stockholders’ equity$ 62,153 $ 42,222
Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
cdavis@lifesciadvisors.com