8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 7, 2019

 

 

Aravive, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36361   26-4106690

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

LyondellBasell Tower

1221 McKinney Street, Suite 3200

Houston, Texas 77010

(Address of principal executive offices, including zip code)

(936) 355-1910

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On March 7, 2019, Aravive, Inc., a Delaware corporation (the “Company”), issued a press release that included financial information for the year ended December 31, 2018. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1 is being furnished to the Securities and Exchange Commission (the “Commission”), shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, and shall not be deemed incorporated by reference into any of the Company’s registration statements or other filings with the Commission.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.   

Description

99.1    Press Release issued by Aravive, Inc., dated March 7, 2019


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

ARAVIVE, INC.

(Registrant)

Date: March 7, 2019

 

By:

 

/s/ Jay P. Shepard

 

Name:

 

Jay P. Shepard

 

Title:

 

Chief Executive Officer

EX-99.1

Exhibit 99.1

 

LOGO

Aravive Reports Fourth Quarter and Full Year 2018 Financial Results and

Provides Recent Corporate Updates

HOUSTON, TEXAS (March 7, 2019): Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical company focused on developing innovative therapies that target important survival pathways for cancer, announced recent corporate updates and financial results for the fourth quarter and full year ended December 31, 2018.

“2019 will be an important year for Aravive, with several data readouts expected along with the initiation of two additional studies. Enrollment in the Phase 1b portion of the Phase 1b/2 clinical trial of AVB-S6-500 in patients with platinum-resistant recurrent ovarian cancer is on-track and we are eager to report preliminary data in the third quarter of this year,” said Jay Shepard, president and chief executive officer. “At our KOL event in February, we announced the planned expansion of our pipeline with two additional indications, clear cell renal cell carcinoma and IgA nephropathy. We remain committed to further exploring the potential of our platform in the treatment for both oncology and fibrotic indications.”

Recent Corporate Updates

AVB-S6-500

AVB-S6-500 is a novel, high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway by intercepting the binding of GAS6 to its receptor AXL. AXL receptor signaling plays an important role in multiple types of malignancies by promoting metastasis, cancer cell survival, resistance to treatments, and immune suppression. The GAS6-AXL signaling pathway also plays a significant role in fibrogenesis. Below are some recent highlights from the program:

 

   

Presented detailed results from the Phase 1 clinical trial of AVB-S6-500 at the 2018 EORTC-NCI-AACR Symposium. A copy of the poster presentation is available at www.aravive.com.

 

   

Initiated Phase 1b portion of Phase 1b/2 clinical trial of AVB-S6-500 in platinum-resistant recurrent ovarian cancer.

 

   

Highlighted AVB-S6-500 and GAS6/AXL pathway and announced indications for additional clinical trials at Key Opinion Leader Breakfast Symposium in New York on February 5, 2019.

 

  o

Announced first indication for a clinical trial outside of oncology is expected to be a Phase 1b trial of AVB-S6-500 in patients with IgA nephropathy. The company expects to initiate a clinical trial in the second half of 2019.

 

  o

Announced next oncology study is expected to be a Phase 1b/2 clinical trial of AVB-S6-500 in patients with clear cell renal cell carcinoma. The company expects to initiate a Phase 1b/2 clinical trial in the second half of 2019.


   

Findings from a preclinical study of AVB-S6-500 will be presented at the Society of Gynecologic Oncology’s 50th Annual Meeting on Women’s Cancer to be held March 16-19, 2019, in Honolulu, Hawaii. The data will be presented by Maggie Mullen, MD and Katherine Fuh, MD, PhD, both from the Center for Reproductive Health Sciences, Department of Obstetrics & Gynecology, Washington University School of Medicine.

Date & Time: Monday, March 18, 2019 6:00 – 7:00 PM HST

Session Title: Oral Featured Poster Session II: Trials, Basic Science, and Translational Science

Abstract & Poster Number: Abstract 68

Poster Title: Therapeutic AXL/GAS6 inhibition of tumor and tumor microenvironment stromal cells improves response to chemotherapy in ovarian cancer

Company

 

   

Completed the merger of Aravive Biologics and Versartis to form Aravive, Inc. in October 2018 (the “Merger”).

 

   

Expanded executive team with promotion of Gail McIntyre, PhD, DABT to chief scientific officer. Dr. McIntyre has over 25 years of experience in the biopharmaceutical industry, having focused much of her time moving compounds through lead optimization and preclinical development and onto the market. She has worked closely with Aravive Biologics since August 2016, most recently serving as the company’s senior vice president of research and development.

Anticipated Milestones

 

   

Report interim safety, pharmacodynamic, and pharmacokinetic data for the Phase 1b portion of the Phase 1b/2 clinical trial of AVB-S6-500 in patients with platinum-resistant recurrent ovarian cancer in the third quarter of 2019.

 

   

Initiate Phase 1b clinical trial in patients with IgA nephropathy in the second half of 2019.

 

   

Initiate the Phase 2 portion of the Phase 1b/2 clinical trial of AVB-S6-500 in patients with platinum-resistant recurrent ovarian cancer in the second half of 2019.

 

   

Initiate Phase 1b/2 clinical trial in patients with clear cell renal cell carcinoma in the second half of 2019.

Fourth Quarter and Full Year 2018 Financial Results

The following commentary and condensed consolidated statements of operations and balance sheets include the results of Aravive, Inc. (formerly Versartis, Inc.), which include the results of Aravive Biologics from October 12, 2018 onward, the effective date of the Merger. The condensed consolidated statements of operations for the comparative periods in 2017 and the December 31, 2017 condensed consolidated balance sheet include only those of Aravive, Inc. (formerly Versartis, Inc.). All share and per share figures for all periods presented reflect the 1-for-6 reverse stock split effective on October 16, 2018.


For the fourth quarter ended December 31, 2018, Aravive reported a net loss of approximately $51.0 million, or $4.82 per share, basic and diluted, compared to net income for the same period in 2017 of $31.1 million, or $5.20 per share on a diluted basis.

Total operating expenses for the quarter ended December 31, 2018 were $52.6 million compared to $8.9 million for the same period in 2017. Research and development (R&D) expenses for the quarter ended December 31, 2018 were $3.0 million, compared to $1.3 million for the same period in 2017. General and administrative (G&A) expenses were $11.3 million for the quarter ended December 31, 2018 compared to $7.6 million for the same period in 2017.

Also included in fourth quarter 2018 operating expenses is a one-time non-cash charge for acquired in-process research and development of $38.3 million incurred in connection with the completion of the Merger.

Total operating expenses for the quarter ended December 31, 2018 include non-cash stock-based compensation expense of $9.9 million, of which $8.2 million relates to the assumption of options in connection with the Merger, compared to $2.2 million of non-cash stock-based compensation expense for the same period in 2017.

For the year ended December 31, 2018, Aravive reported a net loss of $76.3 million, or $10.64 per share, compared to a net loss for the same period in 2017 of $85.0 million, or $14.47 per share.

Total operating expenses for the year ended December 31, 2018 were $76.8 million, compared to $124.5 million for the same period in 2017. R&D expenses for the year ended December 31, 2018 were $11.1 million, compared to $94.6 million for the same period in 2017. G&A expenses for the year ended December 31, 2018 were $27.4 million, compared to $29.9 million for the same period in 2017.

Total operating expenses for the year ended December 31, 2018 include non-cash stock-based compensation expense of $16.1 million, of which $8.2 million relates to the assumption of options in connection with the Merger, compared to $13.3 million of non-cash stock-based compensation expense for the same period in 2017.

Cash Position and Guidance

Cash and cash equivalents were $57.0 million as of December 31, 2018. Aravive expects current cash and cash equivalents will enable the company to fund its operating plans into the end of 2020.

About Aravive

Aravive, Inc. (Nasdaq: ARAV) is a clinical-stage biopharmaceutical company focused on developing innovative therapies that target important survival pathways for cancer. Aravive’s lead candidate, AVB-S6-500, is a novel, high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway by intercepting the binding of GAS6 to its receptor AXL. AXL receptor signaling


plays an important role in multiple types of malignancies by promoting metastasis, cancer cell survival, resistance to treatments, and immune suppression. Aravive has initiated the phase 1b portion of a phase 1b/2 clinical trial of AVB-S6-500 combined with standard of care therapies in patients with platinum-resistant recurrent ovarian cancer, and intends to expand development into additional oncology and fibrotic indications. For more information, please visit www.aravive.com.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended), express or implied, concerning the Company’s goals, intentions and expectations as to future plans or events, including statements regarding the following anticipated milestones: the reporting of interim safety, pharmacodynamic, and pharmacokinetic data for the Phase 1b portion of the Phase 1b/2 clinical trial of AVB-S6-500 in patients with platinum-resistant recurrent ovarian cancer in the third quarter of 2019, initiation of a Phase 1b clinical trial in patients with IgA Nephropathy in the second half of 2019, initiation of the Phase 2 portion of the Phase 1b/2 clinical trial of AVB-S6-500 in patients with platinum-resistant recurrent ovarian cancer in the second half of 2019, and initiation of a Phase 1b/2 clinical trial in patients with clear cell renal cell carcinoma in the second half of 2019. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could 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 Company’s ability to expand development in 2019 into additional oncology and fibrotic indications, the anticipated development strategy for AVB-S6-500 being successful, AVB-S6-500’s ability to have favorable results in clinical trials or receive regulatory approval, including its ability to meet the primary and secondary endpoint for the Phase 1b portion of the clinical trial and show a clinical benefit; potential delays in the Company’s clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that AVB-S6-500 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 AVB-S6-500; if AVB-S6-500 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company’s intellectual property rights; the Company’s reliance on its licensor of intellectual property and financing needs. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s proxy statement/prospectus/information statement filed with the SEC on September 6, 2018, the Company’s Form S-4 filed with the SEC on August 3, 2018, as subsequently amended, Annual Report on Form 10-K and Form 10-K/A for the fiscal year ended December 31, 2017, Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, recent Current Reports on Form 8-K and subsequent filings with the SEC. Additional information will also be set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. 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.


###

Contacts:

Investors:

Mike Zanoni

Endurance Advisors

mzanoni@enduranceadvisors.com

610-442-8570

Media:

Jordann Phillips

Canale Communications

jordann@canalecomm.com

619-849-6009


Aravive, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share amounts)

 

     Three Months Ended     Twelve Months Ended  
     December 31,     December 31,  
     2018     2017     2018     2017  

Revenue

        

Contract revenue

   $     $ 40,000     $     $ 40,000  

Grant revenue

     1,371         1,371    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     1,371       40,000       1,371       40,000  

Operating expenses

        

Research and development

     3,010       1,317       11,075       94,612  

Acquired in-process research and development

     38,313             38,313        

General and administrative

     11,284       7,569       27,395       29,870  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     52,607       8,886       76,783       124,482  
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     (51,236     31,114       (75,412     (84,482

Interest income

     286       186       989       847  

Interest expense

     (604     (528     (2,429     (528

Other income (expense), net

     600       (19     519       (1,063
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) before provision for income taxes

     (50,954     30,753       (76,333     (85,226

Benefit from income taxes

           (375           (247
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ (50,954   $ 31,128     $ (76,333   $ (84,979
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per share- basic (1)

   $ (4.82   $ 5.21     $ (10.64   $ (14.47
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per share- diluted (1)

   $ (4.82   $ 5.20     $ (10.64   $ (14.47

Weighted-average common shares used to compute
basic net income (loss) per share (1)

             10,580               5,979               7,171               5,871  

Weighted-average common shares used to compute
diluted net income (loss) per share (1)

     10,580       5,984       7,171       5,871  

(1)     All share and per share figures for all periods presented reflect the 1-for-6 reverse stock split effective on October 16, 2018.


Aravive, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands)

 

     December 31,      December 31,  
     2018      2017  

Assets:

     

Cash and cash equivalents

   $ 56,992      $ 81,146  

Other assets

     3,827        3,743  

Build-to-suit lease asset

     8,651        8,888  
  

 

 

    

 

 

 

Total assets

   $             69,470      $             93,777  
  

 

 

    

 

 

 

Liabilities and stockholders’ equity:

     

Accounts payable and other current liabilities

   $ 1,937      $ 5,593  

Build-to-suit lease obligation

     7,324        5,428  

Contingent payables

     264         
  

 

 

    

 

 

 

Total liabilities

     9,525        11,021  
  

 

 

    

 

 

 

Total stockholders’ equity

     59,945        82,756  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 69,470      $ 93,777