arav20211111_8k.htm
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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): November 12, 2021
 

 
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
(Registrants telephone number, including area code)
 

 
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 7.01.   Regulation FD Disclosure.
 
On November 12, 2021, Aravive, Inc. (the “Company”) issued a press release announcing positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC). A subset of these data was included in a poster presentation titled “A Phase 1b study of AVB-S6-500 in combination with cabozantinib in patients with advanced ccRCC who received front-line treatment” at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting being held November 10-14, 2021.
 
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. A copy of the poster presentation is furnished as Exhibit 99.2. In addition, on November 12, 2021, the Company also presented an updated corporate presentation that includes updated data from its Phase 1b study of batiraxcept (AVB-S6-500) in combination with cabozantinib in patients with advanced ccRCC. A copy of the corporate presentation is furnished as Exhibit 99.3 to this Current Report on Form 8-K.
 
The furnishing of the attached Poster is not an admission as to the materiality of any information therein. The information contained in the Poster is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the Securities and Exchange Commission (the “SEC”) and other public announcements that the Company has made and may make from time to time by press release or otherwise.
 
The information in this Item 7.01, the Poster, the press release and the corporate presentation are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended. The press release and corporate presentation furnished as Exhibit 99.1 and 99.3 to this Current Report on Form 8-K include “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical. The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.
 
Item 8.01. Other Information.
 
Phase 1b clear cell renal cell carcinoma data
 
On November 12, 2021, the Company issued a press release announcing positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with ccRCC. A subset of these data was included in a poster presentation titled “A Phase 1b study of AVB-S6-500 in combination with cabozantinib in patients with advanced ccRCC who received front-line treatment” at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting being held November 10-14, 2021.
 
As of November 9, 2021, the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of batiraxcept 15 mg/kg and 20 mg/kg in combination with cabozantinib in patients with 2L+ ccRCC has been evaluated in 18 patients. Clinical activity across these two doses has been evaluated in 16 patients.
 
Safety Data:
 
Analysis of all safety data demonstrates that batiraxcept has been well-tolerated with no dose-limiting toxicities.
 
There have been no batiraxcept-related serious adverse events reported to date.
 
There were no batiraxcept-related Grade 4 or 5 adverse events.
 
Three patients experienced Grade 3 adverse events considered by the investigator as potentially being related to both batiraxcept and cabozantinib.
 
o
At the batiraxcept 15 mg/kg dose, 1 patient experienced transient hypertension and 1 patient experienced transient thrombocytopenia. Both events resolved while still receiving batiraxcept.
 
o
At the batiraxcept 20 mg/kg dose, 1 patient experienced a thromboembolic event, small bowel obstruction, abdominal pain and vomiting. The bowel obstruction, abdominal pain and vomiting resolved while the patient continued batiraxcept treatment.
 
o
All events are known adverse events associated with cabozantinib use.
 
PK/PD Data:
 
PK analyses indicate that batiraxcept trough levels were above the minimally efficacious concentration (MEC) of 13.8 mg/L prior to cycle 2 day 1 in the first 10 efficacy-evaluable patients.
 
 

 
Clinical Activity Data:
 
Best overall response of partial response was observed in 7 of 16 (44%) evaluable patients across both dose levels. 9 of 16 (56%) patients had a best overall response of stable disease.  No patients had progressive disease at their first radiological exam.
  7 of 16 patients have had at least 16 weeks of follow up (at least two post-baseline radiological exams). 5 of the 7 (71%) patients have confirmed partial responses and 2 of the 7 (29%) patients achieved confirmed stable disease.
 
88% (14/16) of patients had tumor decrease from baseline.
 
4 patients had 1 or more target lesions completely disappear. 3 patients were treated with batiraxcept 15 mg/kg and cabozantinib and 1 patient was treated with batiraxcept 20 mg/kg and cabozantinib.
 
2 patients had target lesions decrease from baseline by more than 76%. 1 patient was treated with batiraxcept 15 mg/kg and 1 patient was treated with batiraxcept 20 mg/kg.
  This clinical activity was observed despite cabozantinib dose reductions with median cabozantinib dose intensity of 41 mg (68% of 60 mg prescribed dose).
 
The Company also announced the design of the open-label Phase 2 portion of the clinical trial which is expected to be initiated during the fourth quarter of 2021 and expected to enroll 55 patients across three parts: part A is expected to enroll approximately 25 patients and investigate batiraxcept 15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients; part B is expected to enroll approximately 20 patients and evaluate batiraxcept 15 mg/kg in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC; and part C is expected to evaluate batiraxcept 15 mg/kg monotherapy in approximately 10 patients who are not eligible for curative intent therapies. The batiraxcept dose in all 3 parts will be 15 mg/kg, but the dose remains flexible and the Company will increase to 20 mg/kg if this dose ultimately proves to be favorable.
 
 

 
 
Item 9.01.   Financial Statements and Exhibits.
 
(d) Exhibits.
 
The following exhibits are being furnished with this Current Report on Form 8-K:
 
Exhibit
Number
 
Description
99.1
 
     
99.2   Poster titled “A Phase 1b study of AVB-S6-500 in combination with cabozantinib in patients with advanced clear cell renal cell carcinoma who received front-line treatment”
     
99.3   Corporate Presentation dated November 2021
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

 
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: November 12, 2021
ARAVIVE, INC.
(Registrant)
   
   
 
By:
 
/s/ Gail McIntyre                                       
 
Name:
 
Gail McIntyre
 
Title:
 
Chief Executive Officer
 
 
 
ex_306605.htm

Exhibit 99.1

 

https://cdn.kscope.io/446a7a898b85e5e976a5fd9de914e0fe-a01.jpg

 

 

Aravive Announces Positive Preliminary Data from Phase 1b Trial Evaluating Batiraxcept
(AVB-500) in Combination with Cabozantinib for Treatment of Clear Cell Renal Cell Carcinoma

 

7 of 16 (44%) patients achieved best overall response of partial response

Confirmed response in 5 of 7 (71%) patients who had at least 16 weeks of follow-up

14 of 16 (88%) patients demonstrated tumor decrease from baseline

Batiraxcept has been well-tolerated with no dose-limiting toxicities

Conference call and webcast today at 8:30 a.m. ET

 

Houston, TX, November 12, 2021 – Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, today announced positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC). A subset of these data was included in a poster presentation at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting being held November 10-14, 2021.

 

“We are encouraged by batiraxcept's early profile in patients with clear cell renal cell carcinoma,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. “The current response rate of batiraxcept in combination with cabozantinib is encouraging. Cabozantinib alone produces response rates between 17-28% in a similar population. In heavily pretreated patients, batiraxcept demonstrates clinical activity across the 15 mg/kg and 20 mg/kg doses with a tolerable safety profile. These results reinforce our confidence in the potential of batiraxcept to improve outcomes across multiple types of cancer by targeting the GAS6/AXL signaling pathway. We look forward to initiating the Phase 2 trial in the fourth quarter of 2021 and building on these promising data.”

 

As of November 9, 2021, the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of batiraxcept 15 mg/kg and 20 mg/kg in combination with cabozantinib in patients with 2L+ ccRCC have been evaluated in 18 patients. Clinical activity across these two doses has been evaluated in 16 patients.

 

Safety Data:

 

Analysis of all safety data demonstrates that batiraxcept has been well-tolerated with no dose-limiting toxicities.

 

There have been no batiraxcept-related serious adverse events reported to date.

 

There were no batiraxcept-related Grade 4 or 5 adverse events.

 

3 patients experienced Grade 3 adverse events considered by the investigator as potentially being related to both batiraxcept and cabozantinib.

 

o

At the batiraxcept 15 mg/kg dose, 1 patient experienced transient hypertension and 1 patient experienced transient thrombocytopenia. Both events resolved while still receiving batiraxcept.

 

o

At the batiraxcept 20 mg/kg dose, 1 patient experienced a thromboembolic event, small bowel obstruction, abdominal pain and vomiting. The bowel obstruction, abdominal pain and vomiting resolved while the patient continued batiraxcept treatment.

 

o

All events are known adverse events associated with cabozantinib use.

 

PK/PD Data:

 

PK analyses indicate that batiraxcept trough levels were above the minimally efficacious concentration (MEC) of 13.8 mg/L prior to cycle 2 day 1 in the first 10 efficacy-evaluable patients.

 

 

 

Clinical Activity Data:

 

Best overall response of partial response was observed in 7 of 16 (44%) evaluable patients across both dose levels. 9 of 16 (56%) patients had a best overall response of stable disease. No patients had progressive disease at their first radiological exam.

 

7 of 16 patients have had at least 16 weeks of follow up (at least two post-baseline radiological exams). 5 of the 7 (71%) patients have confirmed partial responses and 2 of the 7 (29%) patients achieved confirmed stable disease.

 

88% (14/16) of patients had tumor decrease from baseline.

 

4 patients had 1 or more target lesions completely disappear. 3 patients were treated with batiraxcept 15 mg/kg and cabozantinib and 1 patient was treated with batiraxcept 20 mg/kg and cabozantinib.

 

2 patients had target lesions decrease from baseline by more than 76%. 1 patient was treated with batiraxcept 15 mg/kg and 1 patient was treated with batiraxcept 20 mg/kg.

 

This clinical activity was observed despite cabozantinib dose reductions with median cabozantinib dose intensity of 41 mg (68% of 60 mg prescribed dose).

 

“The initial Phase 1b data of batiraxcept in combination with cabozantinib are impressive and point toward the role of dual AXL and VEGF inhibition in the treatment of clear cell renal cell carcinoma,” said Eric Jonasch, M.D., Professor of Medicine, The University of Texas MD Anderson Cancer Center. “These early signs of clinical activity coupled with a manageable safety profile introduce a potential new therapeutic approach for patients with advanced kidney cancer.”

 

Poster Presentation Details

 

Title:

A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment

 

Presenter:

Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive

 

Date:

November 13, 2021

 

Time:

7:00 a.m. – 8:30 p.m. ET

 

Location:

Hall E

 

For additional information, please visit the SITC 36th Annual Meeting website: https://www.sitcancer.org/2021/home.

 

Conference Call Information

Aravive will host a conference call and webcast today, November 12, 2021, at 8:30 a.m. ET to discuss these clinical data. The conference call may be accessed by dialing (877) 423-9813 (domestic) and (201) 689-8573 (international) and referring to conference ID 13724115. A webcast of the conference call will be available in the Investors section of the Aravive website at https://ir.aravive.com/. The archived webcast will be available on Aravive’s website after the conference call.

 

 

 

About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC Trial

The Phase 1b portion of the clinical trial is expected to enroll approximately 25 patients in two dosing parts (15 mg/kg and 20 mg/kg) to evaluate tolerability, PK, PD, and clinical activity of batiraxcept in combination with cabozantinib. The open-label Phase 2 portion of the clinical trial is expected to enroll 55 patients across three parts. Part A is expected to enroll approximately 25 patients and investigate batiraxcept 15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients. Part B is expected to enroll approximately 20 patients and evaluate batiraxcept 15 mg/kg in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC. Part C is expected to evaluate batiraxcept 15 mg/kg monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies.

 

About Batiraxcept (AVB-500)

Batiraxcept is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, batiraxcept selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. Batiraxcept is currently being evaluated in multiple clinical trials and has been granted Fast Track designation by the U.S. Food and Drug Administration and orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer.

 

About Aravive

Aravive, Inc. is a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers. The Company is currently evaluating its lead therapeutic, batiraxcept (AVB-500), in a registrational Phase 3 trial in platinum resistant ovarian cancer, a Phase 1b/2 trial in second line plus, clear cell renal cell carcinoma, and a Phase 1b/2 trial in first-line treatment of pancreatic adenocarcinoma. The Company is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016. For more information, please visit www.aravive.com.

 

 

 

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions and includes statements regarding the potential of batiraxcept (AVB-500) to improve outcomes for patients with advanced kidney cancer and the expected enrollment in the Phase 1b and Phase 2 trial portions of the ccRCC trial. 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 potential of batiraxcept as a new therapeutic approach for patients with advanced kidney cancer, the data from patients treated in the future with batiraxcept being consistent with the results reported, the ability to enroll the expected number of patients, the impact of COVID-19 on the Company's clinical strategy, clinical trials, supply chain and fundraising, the Company's ability to expand development into additional indications, the Company's dependence upon batiraxcept, batiraxcept’s ability to have favorable results in clinical trials and ISTs, the clinical trials of batiraxcept having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that batiraxcept 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 batiraxcept; if batiraxcept 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 for the fiscal year ended December 31, 2020, 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:

 

Media:

Aulani Capuchin, Real Chemistry

acapuchin@realchemistry.com

(559) 355-2673

 

Investors:

Luke Heagle, Real Chemistry

lheagle@realchemistry.com

(910) 619-5764

 
HTML Editor

Exhibit 99.2

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Image Exhibit

Exhibit 99.3

 

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