Workflow
Aravive(ARAV)
icon
Search documents
Aravive(ARAV) - 2020 Q1 - Quarterly Report
2020-05-06 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.0001 per share ARAV Nasdaq Global Select Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission ...
Aravive(ARAV) - 2019 Q4 - Annual Report
2020-03-27 12:11
PART I [Business](index=3&type=section&id=Item%201.%20Business) Aravive, Inc. is a clinical-stage biopharmaceutical company developing cancer and fibrosis treatments, with lead candidate AVB-500, relying on grant revenue and licensed IP [Overview and Lead Candidate AVB-500](index=4&type=section&id=Overview%20and%20Lead%20Candidate%20AVB-500) Aravive is a clinical-stage biopharmaceutical company focused on developing treatments for life-threatening diseases, with AVB-500 as its lead candidate - Aravive is a clinical-stage biopharmaceutical company developing treatments for life-threatening diseases, including cancer and fibrosis[9](index=9&type=chunk) - The lead product candidate, AVB-500, is a high-affinity decoy protein that targets the GAS6-AXL signaling pathway, which is implicated in metastasis, cancer cell survival, and treatment resistance[10](index=10&type=chunk) - All company revenue for the years ended December 31, 2019 and 2018, was grant revenue from a **$20 million** Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT)[14](index=14&type=chunk) [Clinical Development - Ovarian Cancer](index=6&type=section&id=Clinical%20Development%20-%20Ovarian%20Cancer) The company is conducting a Phase 1b/2 trial for AVB-500 in platinum-resistant ovarian cancer, showing promising exposure-response relationships at the 10mg/kg dose - In December 2018, the company initiated the Phase 1b portion of a Phase 1b/2 clinical trial of AVB-500 combined with standard of care therapies in patients with platinum-resistant ovarian cancer (PROC). The FDA granted Fast Track designation for this indication in August 2018[12](index=12&type=chunk)[23](index=23&type=chunk) - Analysis of the initial 31 patients at the 10mg/kg dose showed that higher AVB-500 blood levels (minimal efficacious concentration or MEC) were strongly predictive of anti-tumor activity, correlating with a statistically significant improvement in progression-free survival (PFS)[27](index=27&type=chunk) Clinical Outcomes at 10 mg/kg Dose (n=31) | Metric | Above MEC (n=17) | Below MEC (n=14) | | :--- | :--- | :--- | | Median PFS | 8.1 months | 1.8 months | | Overall Response Rate (ORR) | 29% | 14% | | Clinical Benefit Rate (CBR) | 82% | 43% | - Based on the exposure-response relationship observed at the 10 mg/kg dose, the Phase 1b trial was expanded to investigate higher doses of 15 mg/kg and 20 mg/kg, with the goal of enabling a greater proportion of patients to achieve the target MEC[30](index=30&type=chunk)[31](index=31&type=chunk) [Clinical Development - Other Indications](index=10&type=section&id=Clinical%20Development%20-%20Other%20Indications) AVB-500 is in Phase 1b/2 trials for clear cell renal cell carcinoma and a paused Phase 2a trial for IgA Nephropathy, alongside investigator-sponsored trials - In January 2020, the FDA cleared the company's IND for a Phase 1b/2 trial of AVB-500 in combination with cabozantinib for the treatment of clear cell renal cell carcinoma (ccRCC)[39](index=39&type=chunk) - A Phase 2a proof-of-concept trial in patients with IgA Nephropathy (IgAN) was initiated in December 2019. However, new enrollment has been paused due to risks associated with the COVID-19 pandemic[42](index=42&type=chunk)[43](index=43&type=chunk) - The company is supplying AVB-500 for two investigator-sponsored trials: one in combination with durvalumab for ovarian cancer at M.D. Anderson Cancer Center, and another with avelumab for urothelial cancer at the University of Oklahoma[51](index=51&type=chunk) [Manufacturing, R&D, and Competition](index=18&type=section&id=Manufacturing%2C%20R%26D%2C%20and%20Competition) The company relies on a single third-party manufacturer for AVB-500 and faces competition from other AXL inhibitors and existing therapies - The company relies on a single third-party contract manufacturer for the clinical supply of AVB-500 drug substance and drug product[72](index=72&type=chunk) Research and Development Expenses | Year | R&D Expense (in millions) | | :--- | :--- | | 2019 | $12.8 | | 2018 | $11.1 | - Aravive faces competition from companies developing AXL inhibitors, such as BerGenBio ASA and Astellas Pharma Inc., as well as from existing and developing therapies for its target indications of ovarian cancer, renal cell carcinoma, and IgAN[79](index=79&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) [Intellectual Property and Licensing](index=20&type=section&id=Intellectual%20Property%20and%20Licensing) Aravive holds an exclusive, worldwide license from Stanford University for AXL receptor inhibitors, with patents extending to 2038 - The company has an exclusive, worldwide license agreement with Stanford University for intellectual property rights relating to biologic inhibitors targeting the AXL receptor, which is critical to the AVB-500 program[83](index=83&type=chunk) - The patent portfolio includes composition of matter claims for GAS6-binding fusion proteins and claims for their use in treating various oncological, antiviral, and antifibrotic disorders, with patent expirations ranging from 2031 to 2038[89](index=89&type=chunk) [Government Regulation](index=22&type=section&id=Government%20Regulation) Product candidates are subject to extensive FDA and international regulations covering development, manufacturing, and marketing, including multi-phase clinical trials and post-approval requirements - The company's product candidates are subject to extensive regulation by the FDA in the United States and comparable foreign authorities, covering research, development, testing, manufacturing, and marketing[93](index=93&type=chunk) - The U.S. drug approval process involves preclinical testing, submission of an Investigational New Drug (IND) application, and typically three phases of human clinical trials to establish safety and efficacy before a Biologics License Application (BLA) can be submitted[94](index=94&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - Post-approval, the company will be subject to ongoing FDA requirements, including cGMP for manufacturing, adverse event reporting, and strict regulations on promotion and advertising, particularly regarding 'off-label' use[112](index=112&type=chunk)[113](index=113&type=chunk) [Risk Factors](index=32&type=page&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including limited operating history, significant financial losses, dependence on AVB-500, funding needs, and potential clinical, regulatory, and market acceptance failures [Financial and Capital Risks](index=32&type=section&id=Financial%20and%20Capital%20Risks) Aravive has a limited operating history, significant accumulated deficit, and requires substantial additional funding, with tax attributes subject to limitations - The company has a limited operating history, has never generated product revenue, and has an accumulated deficit of approximately **$470.1 million** as of December 31, 2019[141](index=141&type=chunk)[145](index=145&type=chunk) - Substantial additional funding will be required to complete the clinical development and commercialization of AVB-500. Existing cash will not be sufficient for these purposes, and future financing may not be available on acceptable terms[149](index=149&type=chunk) - Net operating loss carryforwards and other tax attributes are subject to limitations under Section 382 of the Internal Revenue Code due to past ownership changes[159](index=159&type=chunk)[160](index=160&type=chunk) [Business and Operational Risks](index=36&type=section&id=Business%20and%20Operational%20Risks) Key risks include COVID-19 pandemic disruptions, dependence on the single product candidate AVB-500, and reliance on a single third-party manufacturer in China - The COVID-19 pandemic poses a significant risk to business operations, including potential delays in clinical trial enrollment, site initiation, and supply chain disruptions[162](index=162&type=chunk)[163](index=163&type=chunk) - The company is dependent on its single clinical product candidate, AVB-500. Failure of this candidate would materially harm the business[177](index=177&type=chunk)[179](index=179&type=chunk) - Aravive relies on a single third-party manufacturer located in China for AVB-500, creating risks related to supply interruptions, quality control, and geopolitical factors[195](index=195&type=chunk)[198](index=198&type=chunk) [Clinical, Regulatory, and Commercialization Risks](index=47&type=section&id=Clinical%2C%20Regulatory%2C%20and%20Commercialization%20Risks) Clinical trials are expensive and uncertain, the company faces intense competition, and market acceptance or reimbursement may not be achieved even with regulatory approval - Clinical trials are expensive, lengthy, and have uncertain outcomes. Favorable results in early-stage trials are not predictive of success in later-stage trials[221](index=221&type=chunk)[225](index=225&type=chunk) - The company faces significant competition from larger, better-funded pharmaceutical and biotechnology companies with more experience and resources[233](index=233&type=chunk)[234](index=234&type=chunk) - Even if regulatory approval is obtained, the company may fail to achieve market acceptance or secure adequate coverage and reimbursement from third-party payors, which is critical for commercial success[251](index=251&type=chunk)[254](index=254&type=chunk)[256](index=256&type=chunk) [Intellectual Property and Common Stock Risks](index=57&type=section&id=Intellectual%20Property%20and%20Common%20Stock%20Risks) Success depends on maintaining patent protection, the stock price is volatile, and executive officers and directors hold significant beneficial ownership - The company's success is highly dependent on its ability to obtain and maintain patent protection for its technology and product candidates, which is uncertain and can be challenged by third parties[278](index=278&type=chunk)[284](index=284&type=chunk) - The company's stock price has been and may continue to be volatile, influenced by clinical trial results, regulatory developments, and broader market conditions[302](index=302&type=chunk) - As of December 31, 2019, executive officers, directors, and principal stockholders beneficially owned approximately **25.9%** of the company's common stock, giving them significant influence over corporate matters[305](index=305&type=chunk) [Properties](index=67&type=section&id=Item%202.%20Properties) The company leases its principal executive offices in Houston and additional space in California, with a large Menlo Park facility fully subleased - The company's principal executive offices are located in leased space in Houston, Texas[319](index=319&type=chunk) - Aravive leases approximately 34,500 square feet of office space in Menlo Park, California, which it has fully subleased to EVA Automation, Inc. through October 2024[320](index=320&type=chunk)[321](index=321&type=chunk) [Legal Proceedings](index=67&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - As of the filing date, the company is not a party to any material legal proceedings[323](index=323&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=68&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is listed on Nasdaq under "ARAV", and it has never paid cash dividends, intending to retain earnings for growth - The company's common stock has been listed on The Nasdaq Global Select Market under the symbol "ARAV" since October 16, 2018[325](index=325&type=chunk) - The company has never paid dividends and currently intends to retain any future earnings to finance business growth[327](index=327&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=69&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes 2019 financial results, noting a decreased net loss due to the absence of a one-time write-off and lower G&A, with increased grant revenue and sufficient cash for the next 12 months [Results of Operations](index=71&type=section&id=Results%20of%20Operations) Net loss significantly decreased in 2019 due to the absence of a large IPR&D write-off and lower G&A expenses, while grant revenue increased Comparison of Operations (Years Ended Dec 31) | Line Item | 2019 (in thousands) | 2018 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Grant Revenue | $4,753 | $1,371 | 247% | | R&D Expense | $12,836 | $11,075 | 16% | | Write-off of IPR&D | $0 | $38,313 | N/A | | G&A Expense | $13,691 | $27,395 | -50% | | **Net Loss** | **($18,218)** | **($76,333)** | **-76%** | - The increase in grant revenue was due to a full year of activity under the CPRIT grant in 2019 compared to only a partial year in 2018 post-merger[350](index=350&type=chunk) - The decrease in general and administrative expense was primarily driven by a smaller workforce and the absence of merger-related costs incurred in 2018[353](index=353&type=chunk) [Liquidity and Capital Resources](index=72&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2019, the company had $65.1 million in cash and equivalents, an accumulated deficit of $470.1 million, and decreased net cash used in operations - As of December 31, 2019, the company had cash and cash equivalents of **$65.1 million** and an accumulated deficit of **$470.1 million**[356](index=356&type=chunk) - Net cash used in operating activities decreased to **$17.1 million** in 2019 from **$29.3 million** in 2018[359](index=359&type=chunk)[361](index=361&type=chunk) - Net cash provided by financing activities was **$25.3 million** in 2019, primarily from a public offering of common stock in December 2019[359](index=359&type=chunk)[363](index=363&type=chunk) - Management believes existing cash is sufficient to sustain operations for at least the next 12 months but will require substantial additional capital to advance its clinical programs[364](index=364&type=chunk) [Controls and Procedures](index=78&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2019 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2019[394](index=394&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2019[396](index=396&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=80&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section provides biographical information for directors and executive officers, detailing leadership changes and the composition of the independent board and its committees - Effective January 9, 2020, Rekha Hemrajani was appointed President and Chief Executive Officer, and Jay P. Shepard, the former CEO, became Chairman of the Board of Directors[403](index=403&type=chunk)[404](index=404&type=chunk) - The Board of Directors has determined that **five of its seven members** (Drs. Akkaraju and Giaccia, Messrs. Hoffman and Zhang, and Dr. Tabibiazar) are independent under Nasdaq listing standards[427](index=427&type=chunk) - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, with charters available on the company's website[429](index=429&type=chunk)[430](index=430&type=chunk) [Executive Compensation](index=87&type=section&id=Item%2011.%20Executive%20Compensation) This section details 2019 compensation for NEOs, including base salary, performance-based bonuses, and equity awards, along with employment agreements and director compensation policies 2019 Summary Compensation | Name and Principal Position | Salary ($) | Option Awards ($) | Non-Equity Incentive Plan Comp ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | Jay P. Shepard (Former CEO) | 506,763 | 569,398 | 231,250 | 1,315,235 | | Vinay Shah (CFO) | 335,000 | 186,527 | 123,950 | 650,038 | | Gail McIntyre (CSO) | 325,000 | 260,156 | 120,250 | 713,495 | - For 2019, the Compensation Committee determined that the company had achieved **92.5%** of its corporate performance goals, and bonuses were paid to NEOs based on this achievement level[471](index=471&type=chunk)[472](index=472&type=chunk) - In January 2020, Jay Shepard resigned as CEO and entered into a separation and consulting agreement. Rekha Hemrajani was appointed as the new President and CEO[483](index=483&type=chunk)[487](index=487&type=chunk)[489](index=489&type=chunk) - Non-employee directors receive annual cash retainers for board and committee service, as well as annual stock option grants[519](index=519&type=chunk)[520](index=520&type=chunk)[522](index=522&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=100&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details beneficial ownership of common stock as of March 16, 2020, highlighting key 5%+ shareholders and collective ownership by officers and directors Beneficial Ownership as of March 16, 2020 | Beneficial Owner | Percent of Total | | :--- | :--- | | Invus Public Equities, L.P. | 9.0% | | Amato Giaccia, Ph.D. (Director) | 7.7% | | Raymond Tabibiazar, M.D. (Director) | 10.5% | | New Leaf Biopharma Opportunities II, L.P. | 6.3% | | BC Axis Limited | 5.7% | | Eric Zhang (Director) | 5.8% | | All executive officers and directors as a group (9 persons) | 30.4% | [Certain Relationships and Related Transactions, and Director Independence](index=102&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has a policy for reviewing related-person transactions, with one disclosed $1 million investment by an affiliate of a director in a 2019 public offering - The company has a written policy requiring Audit Committee review and approval of related-person transactions exceeding **$100,000**[540](index=540&type=chunk)[541](index=541&type=chunk) - In December 2019, Samsara BioCapital LP, an entity affiliated with director Dr. Srinivas Akkaraju, purchased approximately **$1,000,000** of common stock in the company's public offering[543](index=543&type=chunk) [Principal Accounting Fees and Services](index=103&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This section discloses fees billed by BDO USA, LLP for audit and tax services in 2019 and 2018, all pre-approved by the Audit Committee Accountant Fees (in thousands) | Fee Category | 2019 | 2018 | | :--- | :--- | :--- | | Audit Fees | $254 | $254 | | Tax Fees | $54 | $0 | | **Total Fees** | **$308** | **$254** | PART IV [Exhibits, Financial Statement Schedule](index=105&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedule) This section provides an index to consolidated financial statements and a comprehensive list of all exhibits filed with the report - This section contains the index to the company's consolidated financial statements and a comprehensive list of exhibits filed with the report[553](index=553&type=chunk) Financial Statements and Notes [Report of Independent Registered Public Accounting Firm](index=107&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) BDO USA, LLP issued an unqualified audit opinion on the consolidated financial statements, noting the adoption of ASC Topic 842 on leases - BDO USA, LLP issued an unqualified audit opinion, stating that the consolidated financial statements present fairly, in all material respects, the financial position of the company[558](index=558&type=chunk) - The report highlights a change in accounting principle due to the company's adoption of ASC Topic 842, Leases, on January 1, 2019[559](index=559&type=chunk) [Consolidated Financial Statements](index=108&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements present the company's financial position, operations, equity changes, and cash flows for 2019 and 2018, including key figures like cash and net loss Consolidated Balance Sheet Data (as of Dec 31, in thousands) | Account | 2019 | 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $65,134 | $56,992 | | Total Assets | $82,121 | $69,470 | | Total Liabilities | $13,072 | $9,525 | | Total Stockholders' Equity | $69,049 | $59,945 | Consolidated Operations Data (Year ended Dec 31, in thousands) | Account | 2019 | 2018 | | :--- | :--- | :--- | | Grant Revenue | $4,753 | $1,371 | | Total Operating Expenses | $26,527 | $76,783 | | Net Loss | ($18,218) | ($76,333) | [Notes to Consolidated Financial Statements](index=112&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, including the 2018 merger as an asset acquisition, 2019 ASC 842 adoption, CPRIT grant revenue, and income tax assets with a full valuation allowance - The October 2018 merger with Private Aravive was accounted for as an asset acquisition, with the value of in-process research and development (IPR&D) for AVB-500 being expensed immediately as it was determined to have no alternative future use[634](index=634&type=chunk)[710](index=710&type=chunk) - The company adopted the new lease accounting standard, ASC 842, on January 1, 2019, resulting in the recognition of operating lease right-of-use assets of **$10.4 million** and lease obligations of **$12.6 million** on the balance sheet[627](index=627&type=chunk)[630](index=630&type=chunk) - As of December 31, 2019, the company had federal net operating loss carryforwards of approximately **$27.9 million**, the utilization of which is subject to Section 382 limitations. A full valuation allowance has been recorded against all net deferred tax assets[693](index=693&type=chunk)[694](index=694&type=chunk)
Aravive(ARAV) - 2019 Q3 - Quarterly Report
2019-11-07 21:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36361 Aravive, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organizati ...
Aravive(ARAV) - 2019 Q2 - Quarterly Report
2019-08-07 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36361 Aravive, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 2834 26-4106690 (State or Other Jurisdiction of Incorpo ...
Aravive(ARAV) - 2019 Q1 - Quarterly Report
2019-05-08 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------- ...
Aravive(ARAV) - 2018 Q4 - Annual Report
2019-03-15 01:59
Financial Performance - Total revenue for 2018 was $1.4 million, a decrease of 97% from $40 million in 2017[363]. - The company generated grant revenue of $1.4 million for the year ended December 31, 2018, and recognized contract revenue of $40.0 million for the year ended December 31, 2017[337]. - Net loss for 2018 was $76.3 million, a reduction of 10% from a net loss of $84.9 million in 2017[363]. - Net cash used in operating activities was $29.3 million in 2018, a decrease from $116.3 million in 2017[376]. - Interest income increased to approximately $1 million in 2018 from $0.8 million in 2017, primarily due to rising interest rates[368]. - Interest expense increased to $2.4 million in 2018 from $0.5 million in 2017, mainly due to lease obligations[369]. - Net cash provided by financing activities was $2.0 million in 2018, down from $3.0 million in 2017[378]. Expenses - Research and development expenses decreased by $83.5 million, or 88%, to $11.1 million in 2018 from $94.6 million in 2017[366]. - General and administrative expenses decreased by $2.5 million, or 8%, to $27.4 million in 2018 from $29.9 million in 2017[367]. - Stock-based compensation expense for the years ended December 31, 2018, and 2017 was $16.1 million and $13.3 million, respectively[353]. - The company anticipates a decrease in general and administrative expenses in future periods due to reduced headcount and infrastructure[340]. Cash Position - Cash and cash equivalents as of December 31, 2018, were $57 million, including $5.3 million acquired from the merger with Private Aravive[372]. - As of December 31, 2018, the company had cash and cash equivalents of approximately $57.0 million, sufficient to sustain operations for at least the next 12 months[378]. Merger and Acquisition - Following the merger, the company became a clinical-stage biotechnology company focused on developing therapies for advanced solid tumors and hematologic malignancies[336]. - The merger was accounted for as an asset acquisition, with the fair value primarily concentrated in in-process research and development[334]. - The merger with Private Aravive resulted in a significant write-off of in-process research and development of $38.3 million[366]. - Approximately 11,182,025 shares of common stock were outstanding immediately following the merger, with about 5,141,915 shares owned by former Private Aravive stockholders[333]. Future Outlook - Future revenue may be generated from product sales, license fees, milestones, and royalties from strategic collaborations[339]. - The company anticipates needing additional financing to advance its clinical development programs[373]. - The company will need to obtain additional financing to advance its clinical development program and fund operations for the foreseeable future[378]. Compliance and Reporting - The company opted out of the extended transition period under the JOBS Act, committing to comply with new or revised accounting standards as they are adopted[380]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[381]. - The company has not engaged in any off-balance sheet arrangements since its inception[379]. Deficit and Working Capital - As of December 31, 2018, the company had an accumulated deficit of approximately $450.6 million and working capital of $56.1 million[337].