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Aravive(ARAV) - 2021 Q3 - Quarterly Report
2021-10-28 20:10
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Aravive, Inc.'s unaudited condensed consolidated financial statements for Q3 2021 detail its financial position, operations, and cash flows [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2021, shows an increase in total assets to $76.8 million, primarily driven by a rise in cash and cash equivalents from financing activities | Financial Metric | Sep 30, 2021 (unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $67,511 thousand | $60,541 thousand | | Total current assets | $71,523 thousand | $61,689 thousand | | Total assets | $76,793 thousand | $67,710 thousand | | **Liabilities & Equity** | | | | Total current liabilities | $14,194 thousand | $9,461 thousand | | Total liabilities | $22,457 thousand | $19,655 thousand | | Total stockholders' equity | $54,336 thousand | $48,055 thousand | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2021, Aravive reported new collaboration revenue of $2.4 million, while R&D expenses more than doubled to $11.3 million, resulting in an $11.1 million net loss | Metric (in thousands, except per share) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $2,412 | $0 | $6,457 | $0 | | Research and development | $11,343 | $5,070 | $25,347 | $11,085 | | General and administrative | $2,643 | $2,715 | $8,102 | $9,866 | | Loss from operations | $(11,574) | $(10,699) | $(26,992) | $(26,735) | | Net loss | $(11,086) | $(10,660) | $(26,195) | $(26,497) | | Net loss per share | $(0.53) | $(0.66) | $(1.33) | $(1.69) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased to $54.3 million as of September 30, 2021, driven by capital raised from direct and at-the-market offerings - For the nine months ended September 30, 2021, total stockholders' equity increased from **$48.1 million** to **$54.3 million**, primarily due to proceeds from a direct offering (**$20.9 million**) and an at-the-market offering (**$7.8 million**), partially offset by the net loss for the period[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $23.8 million for the nine months ended September 30, 2021, largely offset by $30.8 million from financing activities | Cash Flow Activity (in thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,834) | $(16,393) | | Net cash provided by financing activities | $30,804 | $5,233 | | Net change in cash, cash equivalents, and restricted cash | $6,970 | $(11,160) | | Cash, cash equivalents, and restricted cash at end of period | $69,941 | $56,397 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail Aravive's business, accounting policies, and financial items, highlighting its clinical-stage focus and going concern doubt - Aravive is a clinical-stage biopharmaceutical company developing batiraxcept, a decoy protein targeting the GAS6-AXL signaling pathway for treating cancer and fibrosis[23](index=23&type=chunk) - The company has a history of net losses and negative cash flows, with an accumulated deficit of **$526.8 million** as of September 30, 2021, raising **substantial doubt** about its ability to continue as a going concern[39](index=39&type=chunk) - In November 2020, the company entered a collaboration and license agreement with 3D Medicines, receiving **$21 million** in upfront and milestone payments to date, with revenue recognized over time for R&D services and at a point in time for the intellectual property license[29](index=29&type=chunk)[94](index=94&type=chunk)[101](index=101&type=chunk) - The company initiated a registrational Phase 3 trial of batiraxcept in platinum-resistant ovarian cancer (PROC) in Q1 2021, a Phase 1b/2 trial in clear cell renal cell carcinoma (ccRCC) in Q4 2020, and a trial in pancreatic adenocarcinoma in May 2021[30](index=30&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Aravive's financial condition, operations, and liquidity, emphasizing clinical program progress, R&D expenses, and financing needs [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of operating results, highlighting $6.5 million in collaboration revenue and a 129% increase in R&D expenses for the nine months ended September 30, 2021 | Metric (in thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $6,457 | $0 | N/A | | Research and development | $25,347 | $11,085 | +129% | | General and administrative | $8,102 | $9,866 | -18% | | Net loss | $(26,195) | $(26,497) | -1% | - The increase in R&D expense was primarily due to clinical trial expenses for the Phase 3 trial of batiraxcept in PROC, along with Phase 1b trials in ccRCC and pancreatic adenocarcinoma[156](index=156&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2021, Aravive had $67.5 million in cash, which management believes is sufficient into H2 2022, despite substantial doubt about its going concern ability - The company had cash and cash equivalents of approximately **$67.5 million** as of September 30, 2021[160](index=160&type=chunk) - Management believes current cash will fund planned operations into the second half of 2022, but **substantial doubt** exists about the company's ability to continue as a going concern without additional financing[162](index=162&type=chunk)[183](index=183&type=chunk) - Net cash used in operating activities increased to **$23.8 million** for the nine months ended Sep 30, 2021, from **$16.4 million** in the prior year, primarily due to the ramp-up of clinical trials[166](index=166&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk exposure is to interest rate fluctuations on its cash and cash equivalents, which is not considered significant due to their short-term nature - The company's main market risk is interest rate risk on its **$67.5 million** of cash and cash equivalents, which is considered **not significant** due to the short-term duration of the investments[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) As of September 30, 2021, the company's disclosure controls and procedures were deemed effective, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of September 30, 2021[172](index=172&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[173](index=173&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal proceedings](index=41&type=section&id=Item%201.%20Legal%20proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, Aravive is not subject to any material legal proceedings[176](index=176&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section updates Aravive's risk factors, emphasizing financial vulnerabilities, operational challenges, and capital needs - The company has a history of significant operating losses, an accumulated deficit of **$526.8 million** as of September 30, 2021, and expects to incur substantial losses, raising **substantial doubt** about its ability to continue as a going concern[178](index=178&type=chunk)[179](index=179&type=chunk)[183](index=183&type=chunk) - Aravive will require additional funds to support its operations and complete the development of batiraxcept, and such financing may not be available on acceptable terms, or at all[184](index=184&type=chunk) - The company's clinical trials for batiraxcept involve combination therapies with standard-of-care drugs, creating a dependency on the availability and safety of these third-party products[189](index=189&type=chunk)[190](index=190&type=chunk) - As of September 30, 2021, executive officers, directors, and their controlled entities owned approximately **27.8%** of the company's common stock, giving them significant influence over matters submitted to stockholders[196](index=196&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and certifications by the CEO and CFO - The report includes certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[198](index=198&type=chunk)[199](index=199&type=chunk)
Aravive(ARAV) - 2021 Q1 - Quarterly Report
2021-05-06 11:14
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Aravive, Inc.'s unaudited condensed consolidated financial information, including statements, MD&A, market risk, and controls [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Aravive, Inc.'s unaudited condensed consolidated financial statements for Q1 2021 are presented, detailing balance sheets, operations, equity, cash flows, and notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Aravive's total assets increased to **$87.3 million** by March 31, 2021, driven by higher cash from financing, while stockholders' equity grew to **$68.7 million** Condensed Consolidated Balance Sheets (in thousands of US dollars) | | March 31, 2021 (unaudited) | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $78,682 | $60,541 | | Total current assets | $81,486 | $61,689 | | Total assets | $87,267 | $67,710 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $9,102 | $9,461 | | Total liabilities | $18,551 | $19,655 | | Total stockholders' equity | $68,716 | $48,055 | | Total liabilities and stockholders' equity | $87,267 | $67,710 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Aravive's Q1 2021 net loss decreased to **$8.0 million** from **$10.8 million** in Q1 2020, driven by lower G&A and no impairment charge Condensed Consolidated Statements of Operations (in thousands of US dollars, except per share data) | | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Collaboration revenue | $256 | $— | | Research and development | $5,884 | $3,491 | | General and administrative | $2,380 | $3,951 | | Loss on impairment of long-lived assets | $— | $2,870 | | Loss from operations | $(8,008) | $(10,312) | | Net loss | $(8,004) | $(10,796) | | Net loss per share - basic and diluted | $(0.44) | $(0.72) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity increased by **$20.7 million** to **$68.7 million** in Q1 2021, primarily due to **$20.9 million** from a direct offering and **$7.0 million** from an ATM offering - Stockholders' equity increased from **$48.1 million** on January 1, 2021, to **$68.7 million** on March 31, 2021[14](index=14&type=chunk) - The increase was driven by **$20.9 million** from a direct offering, **$7.0 million** from an at-the-market offering, and **$0.3 million** from stock option exercises, partially offset by a **$8.0 million** net loss[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Aravive used **$10.0 million** in operating cash in Q1 2021 but generated **$28.2 million** from financing, increasing cash to **$81.1 million** Summary of Cash Flows (in thousands of US dollars) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,019) | $(4,462) | | Net cash provided by financing activities | $28,160 | $33 | | Net change in cash, cash equivalents, and restricted cash | $18,141 | $(4,429) | | Cash, cash equivalents, and restricted cash at end of period | $81,112 | $63,128 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail Aravive's clinical-stage biopharmaceutical business, **AVB-500** development, 3D Medicines collaboration, accounting policies, and a **$6 million** Phase 3 milestone - The company's lead product candidate, **AVB-500**, is a decoy protein targeting the GAS6-AXL signaling pathway for cancer and fibrosis treatment[20](index=20&type=chunk) - A collaboration and license agreement with 3D Medicines for **AVB-500** in Greater China includes a **$12 million** upfront payment and up to **$207 million** in potential milestones[24](index=24&type=chunk)[89](index=89&type=chunk) - The company believes its **$78.7 million** in cash and cash equivalents as of March 31, 2021, are sufficient to fund operations for at least the next 12 months[35](index=35&type=chunk) - Subsequent Event: Dosing of the first patient in the Phase 3 trial of **AVB-500** in April 2021 triggered a **$6 million** milestone payment from 3D Medicines[124](index=124&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial results and operational progress, including **AVB-500** clinical trial advancements, a **69%** R&D increase, **40%** G&A decrease, and liquidity [Overview](index=21&type=section&id=MD%26A%20Overview) Aravive, a clinical-stage oncology company, initiated **AVB-500** Phase 3 trials in PROC and Phase 1b/2 in ccRCC, with plans for pancreatic cancer trials - A registrational Phase 3 trial of **AVB-500** in PROC was initiated in Q1 2021, with the first patient dosed in April 2021[131](index=131&type=chunk) - A Phase 1b/2 trial of **AVB-500** in ccRCC was initiated, with the first patient dosed in March 2021[131](index=131&type=chunk) - Plans for a Phase 1b/P2 trial investigating **AVB-500** for pancreatic cancer are expected to begin in the second half of 2021[131](index=131&type=chunk)[132](index=132&type=chunk) [Results of Operations](index=24&type=section&id=MD%26A%20Results%20of%20Operations) Aravive's Q1 2021 net loss decreased to **$8.0 million** from **$10.8 million** in Q1 2020, driven by lower G&A and no impairment charge Comparison of Operations (in thousands of US dollars) | | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $256 | $— | N/A | | Research and development | $5,884 | $3,491 | +69% | | General and administrative | $2,380 | $3,951 | -40% | | Loss on impairment | $— | $2,870 | N/A | | Net loss | $(8,004) | $(10,796) | -26% | - The increase in R&D expense was primarily due to increased clinical trial expenses for the Phase 3 trial of **AVB-500** in PROC[147](index=147&type=chunk) - The decrease in G&A expense was driven by lower stock-based compensation, rent, legal, and consulting fees[148](index=148&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=MD%26A%20Liquidity%20and%20Capital%20Resources) Aravive held **$78.7 million** in cash as of March 31, 2021, bolstered by **$21 million** from a private placement and **$7.0 million** from an ATM offering, sufficient for 12 months but requiring additional funding - The company held **$78.7 million** in cash and cash equivalents as of March 31, 2021[152](index=152&type=chunk) - In Q1 2021, the company raised **$20.9 million** (net) from a private placement and **$7.0 million** (net) from its ATM offering[152](index=152&type=chunk)[153](index=153&type=chunk) - Management believes current cash is sufficient for at least the next 12 months but will need to raise substantial additional capital for future activities[154](index=154&type=chunk)[155](index=155&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate exposure on its **$78.7 million** in short-term cash and cash equivalents, which management deems insignificant - The company's main market risk is interest rate risk on its **$78.7 million** in cash and cash equivalents held in money market funds[165](index=165&type=chunk) - Management considers the interest rate risk to be insignificant due to the short-term duration of its investments[165](index=165&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2021[167](index=167&type=chunk) - No material changes to internal control over financial reporting were identified during the first quarter of 2021[168](index=168&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information, including legal proceedings, key risk factors, and a list of exhibits filed with the report [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20proceedings) The company is not currently involved in any material legal proceedings - Aravive is not currently subject to any material legal proceedings[171](index=171&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section highlights key risks, including a history of significant losses (accumulated deficit of **$508.7 million**), the need for additional funding, CPRIT grant obligations, and concentrated stock ownership - The company has a history of significant losses, with an accumulated deficit of approximately **$508.7 million** as of March 31, 2021, and expects to incur substantial losses for the foreseeable future[173](index=173&type=chunk) - Additional funding is required to support operations and complete the development and commercialization of **AVB-500**[178](index=178&type=chunk) - The terminated CPRIT grant still carries obligations, including potential repayment of the **$20.0 million** grant if the company relocates its principal place of business outside of Texas within a specified timeframe[181](index=181&type=chunk) - As of March 31, 2021, executive officers, directors, and their controlled entities owned approximately **28.6%** of common stock, giving them significant influence over stockholder matters[189](index=189&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including CEO and CFO certifications and interactive data files (XBRL) - The filing includes CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[191](index=191&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk) - Interactive data files (XBRL documents) are also included as exhibits[195](index=195&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk)
Aravive (ARAV) Investor Presentation - Slideshow
2021-03-12 17:56
Company Overview - Aravive is developing AVB-500, a first-in-class decoy protein targeting the GAS6/AXL signaling pathway, which is overexpressed in many cancers and associated with tumor growth and drug resistance[10, 12, 15] - Top shareholders, including insiders and institutional investors, hold approximately 70% of the company's outstanding shares[8] Clinical Development - AVB-500 in Platinum Resistant Ovarian Cancer (PROC) - Phase 1b trial data showed patients with trough concentrations >13.8 mg/L (MEC) had a median Progression Free Survival (mPFS) of 7.5 months compared to 2.8 months for those below MEC[32] - In patients with >MEC, the Overall Response Rate (ORR) was 50%, including 2 Complete Responses (CRs), compared to 22.2% below MEC[32] - Patients with >MEC achieved a median Overall Survival (mOS) of 19.0 months, compared to 8.7 months for those below MEC[32] - In bevacizumab-naive patients with >MEC, mPFS was 9.1 months and ORR was 71%[33] - A Phase 3 registrational trial in PROC is planned, using 15 mg/kg of AVB-500 plus paclitaxel, stratifying by prior bevacizumab use, with interim analyses to explore biomarkers[57] Clinical Development - AVB-500 in Clear Cell Renal Cell Carcinoma (ccRCC) - A Phase 1b/2 trial of AVB-500 in combination with cabozantinib is underway in ccRCC, with Phase 1b open and recruiting[79] Strategic Collaborations - Aravive has a collaboration with Wuxi Biologics to develop bispecific antibodies against CCN2 for cancer and fibrosis, with a potential best-in-class clinical therapeutic targeting desmoplasia and tumor growth expected in 2023[86] - Aravive entered an exclusive collaboration and license agreement with 3D Medicines for the development and commercialization of AVB-500 in Greater China, receiving an upfront payment of $12 million and eligible for up to $207 million in milestone payments, plus tiered royalties[89] Financial Position - As of September 30, 2020, Aravive had approximately $54 million in cash and cash equivalents, excluding $12 million from the China licensing collaboration and a $21 million investment from Eshelman Ventures[96] - The company expects its cash runway to fund current operating plans into the second half of 2022[96]
Aravive(ARAV) - 2020 Q3 - Quarterly Report
2020-11-05 21:31
Financial Performance - For the three months ended September 30, 2020, the net loss was $10,660,000, compared to a net loss of $6,142,000 for the same period in 2019, indicating an increase in loss of approximately 73.5%[8] - Total operating expenses for the nine months ended September 30, 2020, were $26,735,000, up from $21,364,000 in the same period of 2019, reflecting an increase of about 25.2%[8] - The Company has an accumulated deficit of $496.6 million as of September 30, 2020, with working capital of $50.6 million[27] - The net loss for the three months ended September 30, 2020, was $10.66 million, resulting in a basic and diluted net loss per share of $(0.66)[89] - For the three months ended September 30, 2020, the company reported a net loss of $10.7 million, a 53% increase compared to a net loss of $7.0 million for the same period in 2019[127] Assets and Liabilities - As of September 30, 2020, total assets decreased to $61,230,000 from $82,121,000 as of December 31, 2019, representing a decline of approximately 25.4%[6] - Total liabilities decreased to $11,864,000 as of September 30, 2020, from $13,072,000 at the end of 2019, a decrease of approximately 9.2%[6] - Cash and cash equivalents decreased to $53,967,000 as of September 30, 2020, down from $65,134,000 at the end of 2019, a reduction of approximately 17.1%[6] - Cash and cash equivalents as of September 30, 2020, were approximately $54.0 million, with a majority invested in money market funds[134] - As of September 30, 2020, the company's cash and cash equivalents consist solely of Level 1 assets, which are highly liquid money market funds[48] Research and Development - Research and development expenses for the three months ended September 30, 2020, were $5,070,000, compared to $3,840,000 for the same period in 2019, marking an increase of about 32.1%[8] - The company anticipates an increase in research and development expenses as it initiates its pivotal PROC trial during the fourth quarter of 2020 or first quarter of 2021[134] - The Phase 1 clinical trial of AVB-500 demonstrated proof of mechanism in neutralizing GAS6, with a favorable safety profile[19] - The Phase 1b clinical trial of AVB-500 demonstrated a 31% objective response rate (ORR) among patients treated with AVB-500 in combination with paclitaxel, with a complete response (CR) observed[106] - The company expects to initiate a pivotal trial of AVB-500 in Platinum Resistant Ovarian Cancer during Q4 2020/Q1 2021[99] COVID-19 Impact - The Company terminated its IgA nephropathy trial to focus on oncology due to the impact of COVID-19 on clinical trials[20] - The Company is in close contact with clinical research organizations to assess the impact of COVID-19 on its clinical studies[20] - The Company has implemented business continuity plans to mitigate the impact of the COVID-19 pandemic on its operations[33] - The company has implemented work-from-home policies due to COVID-19, which may negatively impact productivity and disrupt business operations[153] - The ongoing COVID-19 pandemic has contributed to broad market fluctuations, impacting the stock price and investor sentiment[167] Financing and Grants - The company expects to need additional financing to support its clinical development programs and operations in the foreseeable future[135] - The company raised $10.0 million in matching funds as required by the CPRIT Grant[21] - The company received approximately $1.6 million of additional funding from its CPRIT Grant during the nine months ended September 30, 2020[134] - The company has financed its operations primarily through private placements, debt financing, and grants, including a $20.0 million CPRIT Grant[156] - The CPRIT Grant requires the Company to pay a portion of revenues from sales of certain products at tiered percentages until payments equal 400% of the grant award[22] Stock and Ownership - As of September 30, 2020, executive officers and principal stockholders collectively owned approximately 24.3% of the common stock, allowing them to significantly influence shareholder decisions[170] - The stock price has fluctuated between $3.07 and $144.00 per share from January 1, 2015, to September 30, 2020, indicating significant volatility[167] - The company entered into an equity distribution agreement with Piper Sandler and Cantor Fitzgerald to sell shares of common stock with an aggregate offering price of up to $60 million[102] Impairment and Expenses - The company incurred a loss on impairment of long-lived assets of $2,914,000 for the three months ended September 30, 2020[8] - The company recognized an impairment charge of $2.4 million for the ROU asset and $0.5 million for leasehold improvement assets for the quarter ended March 31, 2020[43] - A total impairment loss of $5.8 million was reported on the Company's long-lived asset balances for the nine-month period ended September 30, 2020[44] - The company incurred non-cash impairment charges of $2.9 million and $5.8 million for long-lived assets for the three and nine months ended September 30, 2020, respectively[131] - The estimated discount rate used in the impairment analysis was 9.5%[43] Legal and Compliance - The company is not currently subject to any material legal proceedings[148] - The company may face potential financial penalties and liabilities if it fails to comply with government funding requirements, which could adversely affect its financial condition[166] - The company has not engaged in any off-balance sheet arrangements since its inception[141] Operational Challenges - EVA has defaulted on its obligation to pay rent, resulting in a decrease in sublease income of approximately $9.3 million[162] - The company has drawn down on a cash security deposit of $760,727 due to missed rent payments by EVA, affecting its cash position[162] - The company must ensure that any new or expanded clinical trials or commercialization related to the CPRIT project take place in Texas, necessitating the hiring of additional qualified personnel[165]
Aravive (ARAV) Investor Presentation - Slideshow
2020-08-11 19:33
Company Overview - Aravive is a clinical-stage company developing treatments for life-threatening diseases like cancer and fibrosis[4] - The company has a $20 million Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT)[4] - Multiple milestones are anticipated during 2020 & 2021[4] AVB-500 Clinical Program - AVB-500 is a first-in-class GAS6/AXL signaling pathway blocker[5] - Early proof-of-concept for anti-tumor activity was demonstrated in platinum-resistant ovarian cancer (PROC)[5] - The FDA granted fast-track designation to AVB-500[5] - Aravive completed Phase 1b and plans to initiate a Phase 2/3 trial for platinum-resistant ovarian cancer in 2H20/Q121[5] GAS6/AXL Pathway and AVB-500's Selectivity - AXL overexpression is linked to metastasis, poor survival, and drug resistance in many cancers[11] - AVB-500 has fM affinity to neutralize GAS6[15] - AVB-500 is a selective GAS6 inhibitor, unlike other AXL-targeting drugs in clinical development[16] Phase 1b Study Results - In the Phase 1b study, the RP2D (Recommended Phase 2 Dose) for AVB-500 was determined to be 15 mg/kg[24] - The overall response rate (ORR) in the PAC (paclitaxel) cohort was 35% (8/23), with 8.7% (2/23) achieving complete response (CR)[28] - The overall response rate (ORR) in the PLD (pegylated liposomal doxorubicin) cohort was 15% (4/26)[28] - Patients with trough levels above 13.8 mg/L showed improved clinical benefit[46] - In patients not previously treated with bevacizumab, the ORR with AVB-500 + PAC was 60% (6/10)[59] Planned Phase 2/3 Trial - Aravive is planning a randomized, double-blind, placebo-controlled Phase 2/3 trial to compare the efficacy and tolerability of AVB-500 + PAC versus PAC in platinum-resistant ovarian cancer[65, 66] Financial Status - Aravive has $60 million in cash and cash equivalents[72] - The company expects to fund its current operating plans into 2022 with the current cash, depending on the PROC P2/P3 design[73]
Aravive(ARAV) - 2020 Q2 - Quarterly Report
2020-08-03 20:15
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Aravive, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, cash flows, and detailed notes [a. Condensed Consolidated Balance Sheets](index=3&type=section&id=a.%20Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show a decrease in total assets and stockholders' equity from December 31, 2019, to June 30, 2020, primarily driven by a reduction in cash and cash equivalents and an impairment loss on long-lived assets Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2020 (unaudited) | December 31, 2019 | | :-------------------------- | :------------------------ | :---------------- | | Cash and cash equivalents | $60,062 | $65,134 | | Total current assets | $61,268 | $68,213 | | Total assets | $71,013 | $82,121 | | Total current liabilities | $4,532 | $4,968 | | Total liabilities | $11,566 | $13,072 | | Total stockholders' equity | $59,447 | $69,049 | [b. Condensed Consolidated Statements of Operations](index=4&type=section&id=b.%20Condensed%20Consolidated%20Statements%20of%20Operations) The company reported increased net losses for both the three and six months ended June 30, 2020, compared to the prior year, primarily due to the absence of grant revenue and a significant loss on impairment of long-lived assets in 2020 Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Grant revenue | $— | $3,054 | $— | $4,753 | | Research and development | $2,522 | $3,637 | $6,014 | $6,485 | | General and administrative | $3,201 | $3,291 | $7,151 | $7,881 | | Loss on impairment of long-lived assets | $— | $— | $2,870 | $— | | Total operating expenses | $5,723 | $6,928 | $16,035 | $14,366 | | Net loss | $(5,041) | $(3,044) | $(15,837) | $(7,748) | | Net loss per share - basic and diluted | $(0.32) | $(0.27) | $(1.02) | $(0.69) | - Net loss increased by **66%** for the three months and **104%** for the six months ended June 30, 2020, primarily due to the cessation of grant revenue and a **$2.9 million** impairment loss on long-lived assets[8](index=8&type=chunk)[122](index=122&type=chunk) [c. Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=c.%20Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from $69.0 million at January 1, 2020, to $59.4 million at June 30, 2020, mainly due to net losses, partially offset by proceeds from a private placement and stock-based compensation Condensed Consolidated Statements of Stockholders' Equity Highlights (in thousands) | Metric | January 1, 2020 | June 30, 2020 | | :----------------------------------- | :-------------- | :------------ | | Common Stock Shares | 15,001,795 | 15,996,177 | | Additional Paid-In Capital | $539,158 | $545,393 | | Accumulated Deficit | $(470,111) | $(485,948) | | Total Stockholders' Equity | $69,049 | $59,447 | **Key Changes (Six Months Ended June 30, 2020):** * Issuance of common stock in private placement: $4,922 * Stock-based compensation: $717 (Q1) + $488 (Q2) = $1,205 * Net loss: $(10,796) (Q1) + $(5,041) (Q2) = $(15,837) [d. Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=d.%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The company experienced a net decrease in cash, cash equivalents, and restricted cash for the six months ended June 30, 2020, primarily due to significant cash used in operating activities, partially offset by proceeds from financing activities Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :---------------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(10,096) | $(8,608) | | Net cash provided by financing activities | $5,030 | $13 | | Net change in cash, cash equivalents, and restricted cash | $(5,066) | $(8,595) | | Cash, cash equivalents, and restricted cash at end of period | $62,491 | $50,793 | - Cash used in operating activities increased by **$1.5 million (17.3%)** year-over-year, driven by ramp-up in clinical trials and the ccRCC program, partially offset by CPRIT Grant funds[134](index=134&type=chunk) - Financing activities provided **$5.0 million** in cash in 2020, primarily from a private placement of common stock, a significant increase from **$13 thousand** in 2019[135](index=135&type=chunk) [e. Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=e.%20Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed context for the financial statements, covering the company's business, accounting policies, liquidity challenges, and specific financial instrument details, including the impact of the COVID-19 pandemic and an impairment charge related to a sublease default - Aravive, Inc. is a clinical-stage oncology company developing AVB-500, a lead product candidate targeting the GAS6-AXL signaling pathway for life-threatening diseases[15](index=15&type=chunk)[16](index=16&type=chunk) - AVB-500 has completed Phase 1 and Phase 1b portions of a Phase 1b/2 trial for platinum-resistant ovarian cancer (PROC) with a favorable safety profile and demonstrated proof of mechanism. The FDA granted Fast Track designation for AVB-500 in PROC and cleared an IND for clear cell renal cell carcinoma (ccRCC)[18](index=18&type=chunk)[94](index=94&type=chunk) - The COVID-19 pandemic has led to business continuity plans, amendment of the ccRCC trial to initiate at a higher dose, and termination of the IgA nephropathy (IgAN) trial to focus on oncology, with potential for significant disruptions to clinical development timelines[19](index=19&type=chunk)[96](index=96&type=chunk) - The company incurred an accumulated deficit of **$486.0 million** as of June 30, 2020, and expects to continue incurring losses, requiring additional financing beyond the next 12 months to advance clinical programs[26](index=26&type=chunk)[151](index=151&type=chunk)[156](index=156&type=chunk) - An impairment charge of approximately **$2.9 million** was recognized for right-of-use and leasehold improvement assets due to the sublease tenant, EVA Automation, Inc., defaulting on future rental payments for the 1020 Marsh Road facility[43](index=43&type=chunk)[68](index=68&type=chunk)[120](index=120&type=chunk) Stock-Based Compensation Expense (in thousands) | Operating Expenses | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $135 | $112 | $256 | $198 | | General and administrative | $353 | $829 | $949 | $1,791 | | **Total** | **$488** | **$941** | **$1,205** | **$1,989** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance, operational highlights, and future outlook, emphasizing the progress of its lead product candidate AVB-500, the financial impact of the COVID-19 pandemic, and the company's liquidity and capital needs [Overview](index=18&type=section&id=Overview) Aravive is a clinical-stage oncology company focused on developing AVB-500, a decoy protein targeting the GAS6-AXL pathway. The company has completed Phase 1b/2 trials for ovarian cancer and received IND clearance for ccRCC, while adapting its clinical programs due to the COVID-19 pandemic - AVB-500 is an ultrahigh-affinity decoy protein targeting the GAS6-AXL signaling pathway, crucial for promoting metastasis, cancer cell survival, resistance to treatments, and immune suppression[92](index=92&type=chunk) - The Phase 1b portion of the Phase 1b/2 clinical trial for AVB-500 in platinum-resistant ovarian cancer was successfully completed in July 2020, and an IND application for clear cell renal cell carcinoma (ccRCC) was cleared in January 2020[94](index=94&type=chunk) - The company amended its ccRCC trial to initiate treatment at a higher dose and terminated the IgA nephropathy (IgAN) trial to prioritize oncology, acknowledging potential delays due to COVID-19[96](index=96&type=chunk) [Recent Developments](index=19&type=section&id=Recent%20developments) Recent developments include a $5.0 million investment from Eshelman Ventures, LLC, and the successful completion of the Phase 1b clinical trial for AVB-500 in platinum-resistant ovarian cancer, which established the recommended Phase 2 dose (RP2D) and showed promising preliminary efficacy and safety data - Eshelman Ventures, LLC purchased **931,098 shares** of common stock for approximately **$5.0 million** in April 2020[98](index=98&type=chunk) - The Phase 1b trial of AVB-500 in platinum-resistant ovarian cancer demonstrated a favorable safety profile with no dose-limiting toxicities. Pharmacokinetic data supported **15 mg/kg** as the Recommended Phase 2 Dose (RP2D)[99](index=99&type=chunk)[100](index=100&type=chunk) - Preliminary efficacy in the **10 mg/kg cohort** showed a **31% Objective Response Rate (ORR)** with AVB-500 plus PAC, improving to **50%** for patients achieving minimal efficacious concentration (MEC). The **15 mg/kg cohort** showed clinical benefit in all **5 evaluable patients (1 CR, 2 PR, 2 SD)**[101](index=101&type=chunk)[111](index=111&type=chunk) - AVB-500 combined with paclitaxel (PAC) appeared to perform better than with pegylated liposomal doxorubicin (PLD), and showed improved clinical outcomes in patients without prior bevacizumab exposure and in late-line therapy[104](index=104&type=chunk)[105](index=105&type=chunk)[108](index=108&type=chunk) - Serum levels of soluble AXL (sAXL)/GAS6 ratio correlated with response to AVB-500, suggesting its potential as a stratification biomarker for future trials[106](index=106&type=chunk) [Financial Overview](index=21&type=section&id=Financial%20overview) The company generated no grant revenue in 2020, contrasting with significant grant revenue in 2019. Research and development and general and administrative expenses are detailed, along with other income/expense, net, which was impacted by a sublease receivable write-down - No grant revenue was generated for the three and six months ended June 30, 2020, compared to **$3.1 million** and **$4.8 million**, respectively, in 2019, due to the termination of the CPRIT Grant[112](index=112&type=chunk)[123](index=123&type=chunk) - Research and development expenses decreased by **31%** for the three months and **7%** for the six months ended June 30, 2020, primarily due to the timing of clinical trials and temporary holds on programs due to COVID-19[124](index=124&type=chunk) - General and administrative expenses decreased by **3%** for the three months and **9%** for the six months ended June 30, 2020, mainly due to lower stock-based compensation and reduced accounting and legal fees[125](index=125&type=chunk) - Other income (expense), net, increased by **$59 thousand** for the three months ended June 30, 2020, but showed an overall increase in expense for the six months due to a **$1.4 million** write-down of a sublease receivable and capitalized commission charges related to the EVA sublease[117](index=117&type=chunk)[128](index=128&type=chunk) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=21&type=section&id=Critical%20accounting%20policies,%20significant%20judgments%20and%20use%20of%20estimates) The company's financial statements rely on estimates and judgments, particularly concerning the impairment of long-lived assets. A significant impairment charge of approximately $2.9 million was recorded in Q1 2020 due to the sublease tenant's default, necessitating a discounted cash flow analysis to determine fair value - The company recognized a **$2.9 million** impairment charge on right-of-use and leasehold improvement assets in Q1 2020 after its sublease tenant, EVA Automation, Inc., indicated inability to pay future rental payments and intent to exit the sublease[120](index=120&type=chunk)[126](index=126&type=chunk) - The impairment was measured using a discounted cash flow analysis, with key estimates including current real estate market rates, time to sublet, and a **9.5% discount rate**[121](index=121&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20operations) A detailed comparison of financial results for the three and six months ended June 30, 2020, versus 2019, highlighting the absence of grant revenue, decreases in R&D and G&A expenses, and the impact of the long-lived asset impairment and changes in other income/expense Key Financial Performance Changes (YoY, in thousands) | Metric | Three Months Ended June 30, 2020 vs 2019 | Six Months Ended June 30, 2020 vs 2019 | | :----------------------------------- | :--------------------------------------- | :------------------------------------- | | Grant revenue | $(3,054) (-100%) | $(4,753) (-100%) | | Research and development | $(1,115) (-31%) | $(471) (-7%) | | General and administrative | $(90) (-3%) | $(730) (-9%) | | Loss on impairment of long-lived assets | $— (N/A) | $2,870 (N/A) | | Loss from operations | $1,849 (48%) | $6,422 (67%) | | Interest income | $(207) (-89%) | $(336) (-58%) | | Other income (expense), net | $59 (10%) | $(1,331) (-104%) | | Net loss | $1,997 (66%) | $8,089 (104%) | [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20capital%20resources) The company's liquidity is supported by $60.1 million in cash and cash equivalents as of June 30, 2020, projected to sustain operations for at least 12 months. However, substantial additional financing will be required for future clinical development and commercialization, with risks including the impact of the COVID-19 pandemic and the default of a sublease tenant - As of June 30, 2020, the company had approximately **$60.1 million** in cash and cash equivalents, primarily invested in money market funds[129](index=129&type=chunk) - Existing cash and cash equivalents are believed to be sufficient for at least the next **12 months**, but additional financing is needed for later-stage clinical development and commercialization of AVB-500[130](index=130&type=chunk) - Future financing requirements are dependent on factors such as clinical study progress and costs, regulatory approvals, manufacturing scale-up, commercialization, intellectual property, and the impact of the COVID-19 pandemic[130](index=130&type=chunk) - The default by sublease tenant EVA Automation, Inc. on rent payments could adversely impact the company's cash position and liquidity if a replacement subtenant is not found[131](index=131&type=chunk) [Cash Flows](index=24&type=section&id=Cash%20flows) Net cash used in operating activities increased to $10.1 million for the six months ended June 30, 2020, driven by increased clinical trial activities, while financing activities provided $5.0 million, primarily from a private placement of common stock Net Cash Flows (Six Months Ended June 30, in thousands) | Activity | 2020 | 2019 | | :----------------------- | :---------- | :---------- | | Operating activities | $(10,096) | $(8,608) | | Financing activities | $5,030 | $13 | | Net decrease in cash | $(5,066) | $(8,595) | - The increase in cash used in operating activities in 2020 was primarily due to the ramp-up in clinical trials and the initiation of treatment for the ccRCC indication, partially offset by CPRIT Grant funds[134](index=134&type=chunk) - Financing activities in 2020 were significantly boosted by **$4.9 million** from a private placement of common stock[135](index=135&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate fluctuations, as its cash and cash equivalents are invested in highly liquid U.S. money market funds. Due to the short-term nature of these investments, the company believes its exposure to interest rate risk is not significant - The company's investment objective is to preserve capital and maximize income from cash and cash equivalents, primarily through investments in highly liquid U.S. money market funds[138](index=138&type=chunk) - As of June 30, 2020, cash and cash equivalents totaled approximately **$60.1 million**. Due to the short-term duration of investments, exposure to interest rate risk is considered not significant[138](index=138&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2020, and there were no material changes in internal control over financial reporting during the quarter. The company acknowledges the inherent limitations of any control system - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2020, ensuring timely and accurate reporting of required information[140](index=140&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2020[141](index=141&type=chunk) - The company recognizes that control systems provide reasonable, not absolute, assurance and are subject to inherent limitations[142](index=142&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - Aravive, Inc. is not currently subject to any material legal proceedings[144](index=144&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) This section updates and reiterates significant risks associated with investing in the company, including the adverse impacts of the COVID-19 pandemic on clinical trials and operations, the company's history of losses and need for future financing, the financial implications of a sublease default, and the inherent volatility of its common stock [Risks Related to Financial Position and Capital Requirements](index=26&type=section&id=Risks%20related%20to%20our%20financial%20position%20and%20capital%20requirements.) Key risks include the potential for severe disruptions to clinical trials and business operations due to the COVID-19 pandemic, the company's history of significant operating losses and the uncertainty of achieving profitability, and the critical need for additional funding which may not be available on favorable terms, potentially leading to delays or suspension of development programs. The default by a sublease tenant also poses a significant financial risk - The COVID-19 pandemic poses severe risks to clinical trials, including delays in patient enrollment, site initiation, diversion of healthcare resources, travel limitations, employee absenteeism, and potential regulatory delays or data acceptance issues[147](index=147&type=chunk) - The company has incurred significant operating losses since inception, with an accumulated deficit of approximately **$486.0 million** as of June 30, 2020, and expects to continue incurring substantial losses for the foreseeable future[151](index=151&type=chunk)[155](index=155&type=chunk) - Additional funds are required to complete the development and commercialization of AVB-500 and future product candidates, and failure to secure financing could lead to delays, reductions, or suspensions of research and development programs[156](index=156&type=chunk)[158](index=158&type=chunk) - The default by EVA Automation, Inc. on its sublease payment obligations for the 1020 Marsh property, totaling approximately **$9.8 million** in aggregate base rent, could significantly reduce or eliminate sublease income and adversely affect the company's cash position[159](index=159&type=chunk) [Risks Related to Our Business](index=29&type=section&id=Risks%20Related%20To%20Our%20Business) Reliance on government funding, specifically the CPRIT Grant, imposes specific requirements and potential financial penalties, including repayment obligations if certain covenants, such as maintaining operations in Texas, are violated, which could materially affect the business - The CPRIT Grant includes provisions for repayment of grant proceeds under certain circumstances, such as relocation of the principal place of business outside Texas, and requires the company to ensure new or expanded preclinical testing, clinical trials, commercialization, or manufacturing related to the project take place in Texas[160](index=160&type=chunk) - Failure to comply with CPRIT Grant requirements could result in significant expenses, including the potential repayment of the full grant amount[162](index=162&type=chunk) [Risks Related to the Ownership of Our Common Stock](index=30&type=section&id=Risks%20Related%20to%20the%20ownership%20of%20our%20common%20stock) The company's stock price has been and is expected to remain volatile, influenced by numerous factors including clinical trial results, regulatory developments, competition, and broader market conditions, particularly the ongoing COVID-19 pandemic. This volatility could lead to substantial losses for investors and potential class-action litigation. Additionally, current executive officers, directors, and principal stockholders maintain significant control over company matters - The company's stock price has experienced significant volatility, fluctuating between **$3.07** and **$144.00** per share from January 1, 2015, through June 30, 2020, with recent declines attributed to broad market and industry fluctuations, including the COVID-19 pandemic[163](index=163&type=chunk) - Factors influencing stock price volatility include investor reaction to business strategy and clinical data, success of competitive products, regulatory developments, financial results, collaborations, intellectual property disputes, capital raising efforts, and general economic conditions, including public health issues like COVID-19[163](index=163&type=chunk) - Current executive officers, directors, and principal stockholders collectively owned approximately **24.5%** of the common stock as of June 30, 2020, giving them significant influence over matters submitted to stockholders for approval[166](index=166&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications from the CEO and CFO, XBRL documents, and various agreements such as the Investment Agreement and Option Agreements - Exhibits include certifications (Sarbanes-Oxley Act Sections 302 and 906) from the Chief Executive Officer and Chief Financial Officer, XBRL Instance Document and Taxonomy Extensions, and various agreements such as the Investment Agreement dated April 6, 2020[168](index=168&type=chunk)[169](index=169&type=chunk) [Signatures](index=33&type=section&id=Signatures) The report is duly signed on behalf of Aravive, Inc. by its Chief Executive Officer, Gail McIntyre, and Chief Financial Officer, Vinay Shah, as of August 3, 2020 - The report was signed by Gail McIntyre, Chief Executive Officer, and Vinay Shah, Chief Financial Officer, on August 3, 2020[172](index=172&type=chunk)