arav-8k_20190807.htm

 

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): August 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.)

 

River Oaks Tower

3730 Kirby Drive, Suite 1200

Houston, Texas 77098

(Address of principal executive offices)

 

(936) 355-1910

(Registrant’s telephone number, including area code)

 

LyondellBasell Tower

1221 McKinney Street, Suite 3200

Houston, Texas 77010

(Former Name, Former Address and Former Fiscal Year, if changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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))

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

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

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 Operation and Financial Condition

On August 7, 2019, Aravive, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2019. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K 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. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit is furnished with this Current Report on Form 8-K.

 

Exhibit

Number

 

Exhibit Description

 

 

 

99.1

 

Press Release, issued by Aravive, Inc. on August 7, 2019

 


 

SIGNATURES

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

 

Date: August 7, 2019

ARAVIVE, INC.

(Registrant)

 

 

 

By:

 

/s/ Jay P. Shepard

 

Name:

 

Jay P. Shepard

 

Title:

 

Chief Executive Officer

 

 

arav-ex991_77.htm

 

Exhibit 99.1

 

 

Aravive Reports Second Quarter 2019 Financial Results and Provides Recent Corporate Updates

 

 

HOUSTON – August 7, 2019 – Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis, announced recent corporate updates and financial results for the quarter ended June 30, 2019.

 

“We continue to advance AVB-500 on multiple fronts and are very encouraged by the recent safety and topline efficacy data we reported in our AVB-500 clinical program in platinum-resistant recurrent ovarian cancer,” said Jay Shepard, president and CEO of Aravive. “The first half of the year is off to a strong start and we are making progress toward initiating additional clinical programs.”

 

Recent Corporate Updates

 

AVB-500

 

AVB-500 is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway. By capturing serum GAS6, AVB-500 starves the AXL pathway of its signal, potentially halting the biological programming that promotes disease progression. 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 ovarian cancer program:

 

 

On July 8, we reported that data from the first six patients enrolled into two cohorts (n=12) of the Phase 1b portion of the Phase 1b/2 trial of AVB-500 in patients with platinum-resistant recurrent ovarian cancer, one investigating a combination of AVB-500 with pegylated liposomal doxorubicin (PLD), and the other, a combination of AVB-500 with paclitaxel (PAC) was evaluated by an independent data monitoring committee (DMC). The data demonstrated suppression of serum GAS6 levels, a biomarker associated with efficacy in preclinical tumor models, with the current dose. The DMC did not identify safety concerns and unanimously recommended the trial continue as planned.

 

 

On July 31, we announced that the preliminary efficacy data from our ongoing clinical trial with AVB-500, as described above, showed compelling anti-tumor activity in the 12 patients treated where response to standard of care chemotherapy alone in patients is typically 10-15 percent. The overall best response rate (ORR) in the AVB-500 combination cohorts to date by investigator determined RECIST v1.1 criteria was greater than response rates observed historically with

 


 

 

standard of care chemotherapy alone in this clinical setting. We therefore have decided to expand enrollment in the Phase 1b portion of the study, to validate the unanticipated early positive efficacy signal. Detailed safety, pharmacokinetic, pharmacodynamic and preliminary efficacy results for the above 12 patients are anticipated to be presented at an upcoming scientific meeting.

 

Second Quarter 2019 Financial Results

 

The condensed consolidated statements of operations for the three and six months ended June 30, 2019 include the operations of Aravive Biologics, Inc., which were not included in the three and six months ended June 30, 2018, due to the fact that the merger with Aravive Biologics, Inc. was consummated in October 2018.

Total revenue for the three and six months ended June 30, 2019 was $3.1 million and $4.8 million, respectively, derived solely from the Cancer Prevention Research Institute of Texas (CPRIT) grant.

Total operating expenses for the three and six months ended June 30, 2019 were $6.9 million and $14.4 million, respectively, compared to $9.4 million and $18.0 million for the same periods in 2018.

Total operating expenses for the three and six months ended June 30, 2019 includes non-cash stock-based compensation expense of $0.9 million and $2.0 million, respectively, compared to $2.1 million and $5.0 million for the same periods in 2018.

For the three and six months ended June 30, 2019, Aravive reported a net loss of approximately $3.0 million and $7.7 million, or $0.27 per share and $0.69 per share, respectively, compared to a net loss of $9.8 million and $18.8 million, or $1.64 per share and $3.14 per share, for the same periods in 2018.

Cash Position

 

At June 30, 2019, cash and cash equivalents were $48.4 million.  

 

About Aravive

 

Aravive, Inc. (Nasdaq: ARAV) is a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis. Aravive’s lead product candidate, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway. By capturing serum GAS6, AVB-500 starves the AXL pathway of its signal, potentially halting the biological programming that promotes disease progression. 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. Aravive has 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, and intends to expand development into additional oncology and fibrotic indications. Aravive is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016.  Aravive was one of FierceBiotech's Fierce 15 in 2017. 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 making progress toward initiating additional clinical programs in renal cell carcinoma and renal fibrosis, the presentation of detailed safety, pharmacokinetic, pharmacodynamic and preliminary efficacy results at an upcoming  scientific meeting and the potential of AVB-500 halting the biological programming that promotes disease progression. Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: the Company’s ability to expand development in 2019 into additional oncology and fibrotic indications, the Company’s dependence upon AVB-500, AVB-500’s ability to have favorable results in clinical trials or receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that AVB-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-500; if AVB-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 Annual Report on Form 10-K and Form 10-K/A for the fiscal year ended December 31, 2018,  recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

###

Contacts for Aravive:

Investors:

Vinay Shah

CFO

Aravive, Inc.

Vinay@aravive.com

 

Media:

Heidi Chokeir

Canale Communications

heidi@canalecomm.com

619-203-5391

 

 

 


 

 

Aravive, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share amounts)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant revenue

$

3,054

 

 

$

 

 

$

4,753

 

 

$

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

3,637

 

 

 

3,438

 

 

$

6,485

 

 

$

7,038

 

General and administrative

 

3,291

 

 

 

6,003

 

 

 

7,881

 

 

 

10,920

 

Total operating expenses

 

6,928

 

 

 

9,441

 

 

 

14,366

 

 

 

17,958

 

Loss from operations

 

(3,874

)

 

 

(9,441

)

 

 

(9,613

)

 

 

(17,958

)

Interest income

 

233

 

 

 

249

 

 

 

579

 

 

 

442

 

Other income (expense), net

 

597

 

 

 

(656

)

 

 

1,286

 

 

 

(1,313

)

Net loss

$

(3,044

)

 

$

(9,848

)

 

$

(7,748

)

 

$

(18,829

)

Net loss per share- basic and diluted

$

(0.27

)

 

$

(1.64

)

 

$

(0.69

)

 

$

(3.14

)

Weighted-average common shares used to compute

     basic and diluted net loss per share

 

11,280

 

 

 

6,023

 

 

 

11,277

 

 

 

6,002

 

 

 

 


 


 

 

 

 

 

Aravive, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands)

 

 

 

June 30,

 

 

December 31,

 

 

2019

 

 

2018

 

Assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

48,384

 

 

$

56,992

 

Restricted cash

 

2,409

 

 

 

2,396

 

Other assets

 

6,452

 

 

 

1,431

 

Build-to-suit lease asset

 

 

 

 

8,651

 

Operating lease right-of-use assets

 

9,501

 

 

 

 

Total assets

$

66,746

 

 

$

69,470

 

Liabilities and stockholders' equity:

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

$

2,111

 

 

$

1,791

 

Deferred revenue

 

 

 

 

146

 

Build-to-suit lease obligation

 

 

 

 

7,324

 

Operating lease obligation

 

11,500

 

 

 

 

Contingent payable

 

264

 

 

 

264

 

Total liabilities

 

13,875

 

 

 

9,525

 

Total stockholders' equity

 

52,871

 

 

 

59,945

 

Total liabilities and stockholders’ equity

$

66,746

 

 

$

69,470