arav-8k_20210512.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): May 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

(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 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 5.02.  Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Appointment of Directors

 

Effective May 12, 2021, Aravive, Inc. (the “Company”) increased the size of its Board of Directors from five directors to eight directors and Dr. Peter T. C. Ho, Dr. John A. Hohneker and Mr. Sigurd C. Kirk were appointed as members of its Board of Directors, each to hold office in accordance with the certificate of incorporation and bylaws of the Company until his successor is duly elected and qualified or his earlier death, resignation or removal.  Mr. Kirk was also appointed to serve on the Audit Committee of the Board. Dr. Hohneker was also appointed to serve on the Compensation Committee of the Board. Dr. Ho will serve as a Class III director up for re-election in 2023, Dr. Hohneker will serve as a Class II director up for re-election in 2022 and Mr. Kirk will serve as a Class I director up for re-election in 2021.

 

Biographical information regarding Dr. Ho, Dr. Hohneker and Mr. Kirk is set forth below.

 

There are no family relationships between any of Dr. Ho, Dr. Hohneker and Mr. Kirk and the Company’s directors or executive officers. In addition, none of Dr. Ho, Dr. Hohneker or Mr. Kirk is a party to any transaction, or series of transactions, required to be disclosed pursuant to Item 404(a) of Regulation S-K.

 

In accordance with the Company’s policy as currently in effect, each of the non-employee directors will receive a cash retainer for his service on the Board of Directors and for service on each committee of which he is a member, as well as specified initial and annual equity awards under the Company’s 2019 Equity Incentive Plan. The Company’s non-employee director compensation policy as currently in effect is described under the caption “Executive Compensation — Non-Employee Director Compensation Policy” in the Annual Report on Form 10-K for the year ended December 31, 2020, and this summary is incorporated by reference herein.

 

Each of Dr. Ho, Dr. Hohneker and Mr. Kirk is expected to execute the Company’s standard form of indemnification agreement, a copy of which has been filed as Exhibit 10.10 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-193997) filed with the SEC on March 6, 2014, and such exhibit is incorporated by reference herein.

 

Peter T. C. Ho, M.D., Ph.D.

 

Dr. Ho, age 59, has more than 25 years of biotechnology and pharmaceutical industry experience in numerous operational roles. Dr. Ho served as the Chief Medical Officer of Boston Pharmaceuticals, Inc. from 2018 until 2020. From September 2014 until 2017, Dr. Ho served in various roles at Epizyme, Inc., a commercial stage biopharmaceutical company, including as Executive Vice President and Chief Medical Officer from September 2015 until December 31, 2017 and Chief Development Officer from September 2014 to September 2015. Dr. Ho served as Chief Executive Officer of Metastagen Inc., a pharmaceutical preparation company that he co-founded, from February 2013 until September 2014, as President of BeiGene Ltd., a biopharmaceutical company based in Beijing, China that he co-founded, from October 2010 to December 2012, as Vice President of Oncology Development at Johnson & Johnson from September 2008 to September 2010 and, prior to that, as Senior Vice President of the Oncology Center of Excellence for Drug Development at GlaxoSmithKline. Dr. Ho currently serves on the Scientific Advisory Board of Accent Therapeutics, Inc. and is a Senior Scientific and Medical Advisor to Overland Pharmaceuticals (US) Inc., D3 Bio, Inc., based in Hong Kong, and M4K Pharma, based in Toronto, CA. Over his career, Dr. Ho has been directly responsible for the first-in-human dosing of 19 anticancer agents and has overseen the development of over 60 hematology and oncology compounds in all phases of clinical trials. His work has contributed to eleven NCE or biologics approvals to date: Gleevec®; Arranon®; Tykerb®; Promacta®; Votrient®; Synribo®; Tafinlar®; Mekinist®; Sylvant®; Rydap®, and Tazverik®.

 

Dr. Ho is currently an Adjunct Associate Professor in the Division of Chemical Biology and Medicinal Chemistry at the Eshelman School of Pharmacy, University of North Carolina. Dr. Ho received his M.D. and Ph.D. (pharmacology) degrees from Yale University and then completed a pediatrics residency at The Children's Hospital of Boston followed by clinical fellowships in pediatric hematology/oncology at the Dana-Farber Cancer Institute and in clinical oncology and regulatory sciences jointly through the U.S. FDA and the National Cancer Institute. He received his bachelor’s degree in Biology at Johns Hopkins University.

 

John A. Hohneker, M.D.

 

Dr. Hohneker, age 61, has 30 years of drug development and leadership experience within the biotech and pharmaceutical industry. Dr. Hohneker served as President and Chief Executive Officer of Anokion SA, a biotechnology company, from January 2018 to January 2021. Prior to joining Anokion SA, Dr. Hohneker was President of Research and Development at FORMA Therapeutics Inc., a biotechnology company, from August 2015 to January 2018. From 2001 to 2015, Dr. Hohneker held roles of increasing responsibility at Novartis AG, most recently as Senior Vice President and Global Head of Development, Immunology and Dermatology. Prior to joining Novartis, he held positions of increasing responsibility at Glaxo Wellcome and its legacy company, Burroughs Wellcome.

 


 

Since January 2021, Dr. Hohneker has served on the Board of Directors of Evelo Biosciences, Inc., a publicly-traded company. From January to November 2017, he served on the Board of Directors of Dimension Therapeutics Inc., a biotechnology company, until it was acquired by Ultragenyx Pharmaceutical Inc. Dr. Hohneker received a bachelor’s degree in chemistry from Gettysburg College and an M.D. from the University of Medicine and Dentistry of New Jersey at Rutgers Medical School. He completed his internship and residency in internal medicine and his fellowship in medical oncology, all at the University of North Carolina at Chapel Hill.

 

Sigurd C. Kirk

 

Mr. Kirk, age 54, is a senior corporate business development executive with more than 15 years of pharmaceutical experience in the areas of branded biopharmaceutical, medical device and generic products.  

 

From 2009 until its acquisition by AbbVie Inc. in May 2020, Mr. Kirk held various positions at Allergan plc. (formerly Actavis). From May 2012 until May 2020, Mr. Kirk was Executive Vice President, Corporate Business Development at Allergan plc., where he was a member of the 12-person Executive Leadership Team. He was an integral member assessing development and commercial opportunities, leading due diligence, as well as negotiating and transacting key legal and financial terms.

 

Mr. Kirk also served as Senior Vice President, Global Controller and Chief Accounting Officer for Barr Pharmaceuticals, Inc. from 2003 until 2009.

 

Mr. Kirk started his career at Deloitte & Touche as an Audit Manager, earning his CPA certification. Mr. Kirk received his Bachelor of Business Administration degree from Pace University.

 

Item 7.01.  Regulation FD Disclosure.

 

On May 18, 2021, the Company issued a press release regarding the matters discussed in Items 5.02 above. A copy of the press release is furnished as Exhibit 99.1.

 

The information in this Item 7.01, and in the press release furnished 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 and  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 to this Current Report on Form 8-K:

 

Exhibit

  

Description

 

 

10.1

  

Form of Indemnification Agreement by and between the Registrant and each of its directors and officers (incorporated by reference to Exhibit 10.10 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-193997) filed with the SEC on March 6, 2014)

 

 

 

99.1

 

Press Release dated May 18, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: May 18, 2021

ARAVIVE, INC.

(Registrant)

 

 

 

By:

 

/s/ Gail McIntyre

 

 

 

Name: Gail McIntyre

Title: Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

arav-ex991_52.htm

Exhibit 99.1

 

 

Aravive Announces Three New Appointments to its Board of Directors

 

Further Strengthens Senior Executive Leadership Team

 

HOUSTON, May 18, 2021 – Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, today announced the appointments of John A. Hohneker, M.D., Sigurd C. Kirk, and Peter T.C. Ho, M.D., Ph.D. to its Board of Directors. Mr. Kirk was also appointed to serve on the Audit Committee of the Board. Dr. Hohneker was also appointed to serve on the Compensation Committee of the Board.

 

“We are pleased to welcome Dr. John Hohneker, Mr. Sigurd Kirk, and Dr. Peter Ho to our Board of Directors. They will further strengthen our Board, as they bring extensive drug development and business development expertise to Aravive,” said Fred Eshelman, Pharm.D., Chairman of the Board of Aravive. “Their experience in biopharmaceutical and healthcare senior executive leadership positions will be valuable to the Company as we continue to advance our AVB-500 clinical development program to treat life-threatening cancers. We look forward to their contributions to the future success of Aravive.”

 

Dr. John Hohneker has more than 30 years of experience as an innovative senior biopharmaceutical physician executive and leader with significant drug development experience and a strong track record of success. He currently serves on the Board of Directors of Evelo Biosciences, a publicly traded company, and on the Board of privately held Trishula Therapeutics, Inc.

 

Dr. Hohneker has advanced several drugs (biologics and small molecules) from pre-clinical evaluation through Phases 1-4 and market registration across multiple therapeutic areas, including oncology and immunology. Previously, in various senior management positions, including at Novartis and GlaxoSmithKline, he played a critical role in numerous highly successful commercial product launches.

 

Dr. Hohneker received his M.D. from the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson (previously known as Rutgers) Medical School and completed his internship and residency in internal medicine and his fellowship in medical oncology at the University of North Carolina. He received his bachelor’s degree in Chemistry from Gettysburg College.

 

Mr. Sigurd (Sig) C. Kirk is a senior corporate business development executive with more than 15 years of pharmaceutical leadership experience in the areas of branded biopharmaceutical, medical device and generic products.

 

In his most recent position, Mr. Kirk was Executive Vice President, Corporate Business Development at Allergan, where he was a member of the Executive Leadership Team. He was an integral member assessing development and commercial opportunities, leading due diligence, as well as negotiating and transacting key legal and financial terms.

 

Previously, Mr. Kirk was at Barr Pharmaceuticals, Inc., formerly a $2.8B global specialty pharmaceutical company that was acquired by Teva Pharmaceuticals. In his last role there, he was Senior Vice President, Global Controller and Chief Accounting Officer.

 

Mr. Kirk started his career at Deloitte & Touche as an Audit Manager, earning his CPA certification.

He received his Bachelor of Business Administration degree from Pace University.

 


 

 

Dr. Peter T.C. Ho has more than 25 years of biotechnology and pharmaceutical industry experience in numerous operational roles that have ranged from senior management in large pharmaceutical companies, including leading the oncology discovery and early development group at GlaxoSmithKline, to corporate officer roles in small public biotech (Epizyme) and start-up private biotech (BeiGene and Boston Pharmaceuticals) companies. He also currently serves as Senior Scientific and Medical Advisor to Overland Pharmaceuticals, D3 Bio, and M4K Pharma, and is a Scientific Advisory Board member of Accent Therapeutics.

 

Dr. Ho has significant experience in senior executive leadership roles in the areas of solid tumor and hematologic oncology. In nearly 30 years in private industry and the federal government, he has been directly responsible for the first-time-in-human dosing of 19 anticancer agents and has overseen the development of over 60 hematology and oncology compounds throughout all phases of clinical trials. He has played a key role in the product approvals of several new chemical entities (NCE) and biologics.

 

Dr. Ho is currently an Adjunct Associate Professor in the Division of Chemical Biology and Medicinal Chemistry at the Eshelman School of Pharmacy, University of North Carolina. Dr. Ho received his M.D. and Ph.D. (pharmacology) degrees from Yale University and then completed a pediatrics residency at The Children's Hospital of Boston, followed by clinical fellowships in pediatric hematology/oncology at the Dana-Farber Cancer Institute and in clinical oncology and regulatory sciences jointly through the U.S. FDA and the National Cancer Institute. He received his bachelor’s degree in Biology at Johns Hopkins University.

 

About Aravive

Aravive, Inc. is a clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases. Aravive’s lead therapeutic, AVB-500, is a first-in-class ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth, tumor metastasis, resistance to treatment and decreased survival. AVB-500 has the potential to be combined with multiple anti-cancer therapies across several tumor types, due to its novel mechanism of action and favorable safety profile. AVB-500 has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. The Company is currently evaluating AVB-500 in a registrational Phase 3 trial in platinum resistant ovarian cancer and a Phase 1b/2 trial in clear cell renal cell carcinoma. Aravive plans to initiate a Phase 1b/2 trial evaluating AVB-500 in first-line treatment of pancreatic cancer in the second half of 2021. 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 new directors further strengthening the Company’s Board of Directors, the contributions to be made by the new members of the Board of Directors, plans to investigate AVB-500 in a Phase 1b/2 clinical trial as a first-line treatment for pancreatic cancer, and the potential of AVB-500 to be combined with multiple anti-cancer therapies across several tumor types, due to its novel mechanism of action and favorable safety profile. 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 contributions to be derived from the new

 


 

directors, the ability of the new directors and management team to execute the Company’s business plan, the Company’s ability to recruit for and enroll the expected number of patients into the Phase 3 trial of AVB-500 in PROC and its other trials as planned and its ability to report data as planned, the ability to initiate a Phase 1b/2 trial evaluating AVB-500 in first-line treatment of pancreatic cancer in the second half of 2021, 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 pancreatic cancer and other additional oncology indications, the Company's dependence upon AVB-500, AVB-500's ability to have favorable results in clinical trials and ISTs, the clinical trials of AVB-500 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 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 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.

 

 

 

Contact:

Joseph T. Schepers

VP, Investor Relations, Aravive, Inc.

jschepers@aravive.com

(770) 558-5517