Aravive, Inc. (ARAV) 10-K Annual Report Fri Mar 27 2020

-- Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis, announced recent corporate updates and financial results for the fourth quarter and twelve months ended December 31, 2019.

With the recent and rapidly evolving impact of COVID-19 on patient recruitment in clinical trials and considering patient safety and trial integrity, Aravive has decided to make certain changes to its clinical plans:

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The company has decided to amend its clear cell renal cell carcinoma (ccRCC) trial to initiate treatment at 15 mg/kg or 20 mg/kg given the positive safety profile seen with the 15 mg/kg dosing cohort of the platinum resistant ovarian cancer (PROC) trial and the recent initiation of the 20 mg/kg dosing cohort in the PROC population. While this may delay first patient dosing, the overall timelines for top line data may not be significantly impacted given the higher starting dose, assuming the COVID-19 situation does not interfere with ongoing clinical studies.

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To reduce the risk of unnecessary exposure of patients to COVID-19 that may be caused by patients coming to health centers for their AVB-500 intravenous infusion, the company will pause new enrollment in its IgA nephropathy (IgAN) trial as this is a relatively healthy patient population with a chronic disease.

Aravive plans to continue enrollment in its ongoing Ph 1b dose escalation cohort at the 20 mg/kg dose in patients with PROC with the goal of targeting up to twelve patients in the trial, subject to the impact of COVID-19.

Based on updated clinical plans, Aravive anticipates that its cash and cash equivalents will be sufficient to fund operations into 2022.

The following information was filed by Aravive, Inc. (ARAV) on Friday, March 27, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Aravive, Inc.'s 10-K Annual Report:

Other - Other Highlight
The increase in cash provided by financing activities primarily relates to proceeds received from issuance of our common stock in a public offering which was completed in December of 2019.

M & A - Other Highlight
The decrease was primarily driven by a smaller workforce, absence of Merger related costs and other operating expenses as a result of the termination of the somavaratan program following the Phase 3 VELOCITY trial failure.
Financial - Expense Highlight
For the period from October 13, 2018 through December 31, 2018, research and development costs mostly related to AVB-500 clinical trials along with additional costs incurred with winding down our somavaratan program.
Financial - Expense Highlight
Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed.
Financial - Expense Highlight
General and administrative expense General and administrative expense decreased by $13.7 million, or 50%, to $13.7 million in 2019 from $27.4 million for the same period in 2018.
Financial - Expense
Internal research and development costs...Read more
Financial - Expense
If we had made different...Read more
Financial - Expense
For build-to-suit leases recorded on...Read more
Financial - Expense
The financial terms of these...Read more
Financial - Expense
The lease expense related to...Read more
Revenue - Product
Revenues from the CPRIT Grant...Read more
Other - Other
At December 31, 2019, we...Read more
Other - Other
The amendments in ASU 2016-02...Read more
Other - Other
? Incremental borrowing rate- We...Read more
Revenue - Product
Grant revenue increased by $3.4...Read more
Financial - Income
Other income (expense), net Other...Read more
Other - Other
We have elected the practical...Read more
Financial - Shares
Since our inception and through...Read more
Other - Other
Importantly, AVB-500 had a favorable...Read more
Other - Other
Fair market value is used...Read more
Financial - Expense
Interest expense Interest expense decreased...Read more
Other - Other
The intrinsic value of all...Read more
Other - Other
Our understanding of the status...Read more
M & A - Other
The fair value of options...Read more
M & A - Other
In 2018, we also had...Read more
Financial - Income
The increase in other income...Read more
Other - Other
The most significant estimates used...Read more
Financial - Expense
Variable lease costs such as...Read more
Other - Other
As our leases do not...Read more
Financial - Expense
We have elected the practical...Read more
Financial - Shares
On December 2, 2019, we...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Aravive, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 4.2: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.48: Material Contract

Exhibit 10.49: Material Contract

Exhibit 10.50: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: ARAV
CIK: 1513818
Form Type: 10-K Annual Report
Accession Number: 0001564590-20-013390
Submitted to the SEC: Fri Mar 27 2020 8:11:44 AM EST
Accepted by the SEC: Fri Mar 27 2020
Period: Tuesday, December 31, 2019
Industry: Pharmaceutical Preparations