Form 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): October 10, 2016

 

 

ADVERUM BIOTECHNOLOGIES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-36579   20-5258327

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File No.)

 

(I.R.S. Employer

Identification No.)

1035 O’Brien Drive

Menlo Park, CA 94025

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 272-6269

 

 

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:

 

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 communication 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))

 

 

 


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

(b), (c)     

The Board of Directors (the “Board”) of Adverum Biotechnologies, Inc. (the “Company”) announced today that on October 10, 2016, Amber Salzman, Ph.D. was appointed Chief Executive Officer of the Company, effective October 14, 2016. The Board also announced that, effective October 14, 2016, Paul B. Cleveland, the Company’s former Chief Executive Officer, will serve as Executive Chairman of the Board.

Dr. Salzman, age 54, has served as a director and as the President and Chief Operating Officer of the Company since the Company’s combination with Annapurna Therapeutics SAS (“Annapurna”) in May 2016. Prior to the combination, Dr. Salzman served as President and Chief Executive Officer of Annapurna from January 2014 through May 2016. Prior to founding Annapurna, Dr. Salzman served as Chief Executive Officer of Alophera Therapeutics, Inc., a rare disease company, from January 2012 to December 2013 and as a director and the President and Chief Executive Officer of Cardiokine, Inc., a specialty pharmaceutical company, from May 2009 until its acquisition by Cornerstone Therapeutics, Inc. in December 2011. Prior to that, as a member of GlaxoSmithKline plc’s R&D executive team, Dr. Salzman led an organization of around 2,000 employees and consultants that planned and managed GlaxoSmithKline’s drug-development projects and was accountable for clinical trials that were comprised of more than 30,000 patients worldwide. Dr. Salzman is also the President of the Stop ALD Foundation, a patient-advocacy group focused on driving improvements in treatments for patients with adrenoleukodystrophy and has led initiatives to accelerate drug development and moderate costs, as well as establish a Development Support Center, in India. She is on the board of directors of the Drexel University Dornsife School of Public Health and ALD Connect, Inc., which is a consortium of academic, industry and patient advocates. Dr. Salzman received a B.A. from Temple University and a Ph.D. from Bryn Mawr College.

In connection with the Company’s combination with Annapurna, Dr. Salzman received 629,766 shares of the Company’s common stock in exchange for her Annapurna capital stock. There are no other transactions between Dr. Salzman and the Company requiring disclosure under Item 404(a) of Regulation S-K.

 

Item 7.01 Regulation FD Disclosure.

On October 14, 2016, the Company issued a press release (the “Appointment Press Release”) announcing the Company’s leadership changes. A copy of the Appointment Press Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference in this Item 7.01.

The information set forth in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.


Item 8.01 Other Events

On October 14, 2016, the Company issued a press release titled “Adverum Biotechnologies Provides Update on Alpha-1 Antitrypsin Deficiency Program” (the “A1AT Press Release”). A copy of the A1AT Press Release is filed herewith as Exhibit 99.2 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

 

Exhibit

No.

  

Description

99.1    Appointment Press Release, dated October 14, 2016.
99.2    A1AT Press Release, dated October 14, 2016.


SIGNATURE

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.

 

Date: October 14, 2016     ADVERUM BIOTECHNOLOGIES, INC.
    By:  

/s/ Leone Patterson

      Leone Patterson, Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    Appointment Press Release, dated October 14, 2016.
99.2    A1AT Press Release, dated October 14, 2016.
EX-99.1

Exhibit 99.1

Adverum Biotechnologies, Inc. Announces New Executive Chair and CEO

Paul Cleveland Named Executive Chairman of the Board

Amber Salzman, Ph.D. Named CEO

MENLO PARK, Calif., October 14, 2016 – Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a gene therapy company committed to discovering and developing novel medicines for patients suffering from diseases with few or burdensome treatment options, today announced that former Chief Executive Officer Paul B. Cleveland has been appointed Executive Chairman of the Board and that Amber Salzman, Ph.D., formerly President and Chief Operating Officer, has been appointed Chief Executive Officer.

“I am grateful to have had the opportunity to serve as CEO of Adverum for the past ten months. We have accomplished a number of important strategic goals during that period, including the closing of the transaction with Annapurna, the announcement of our new name and ticker symbol, multiple additions to both our management team and Board of Directors, and our decision to develop a new wet AMD product candidate. I believe that the time has come for me to retire from a full-time CEO role, and I believe that with Amber as CEO the company will flourish, benefitting both patients and shareholders.”

“I am excited to be able to become the Chief Executive Officer of Adverum,” said Dr. Salzman. “We have laid the groundwork needed to drive several very promising gene therapy programs forward. I want to thank Paul for his leadership and support and I look forward to continuing to work with him to lead the company through its next chapter.”

Dr. Salzman joined Adverum as President and Chief Operating Officer in 2016 after the combination of Annapurna Therapeutics with Avalanche Biotechnologies. She served as co-founder, president and Chief Executive Officer of Annapurna Therapeutics prior to the combination. Prior to Annapurna, Amber served in leadership roles in large pharmaceutical companies, small pharmaceutical companies, and in the rare disease community including her role as chief executive officer of Cardiokine Inc. prior to its acquisition by Cornerstone Therapeutics, Inc. Previously, she served as a member of the GlaxoSmtihKline plc’s R&D executive team where she planned and managed drug-development projects and clinical trials comprising more than 30,000 patients worldwide. She has led initiatives to accelerate drug development and moderate costs, and established a Development Support Center in India. She is the president of the Stop ALD Foundation, a patient-advocacy group driving forward improvements in treatments for patients with adrenoleukodystrophy (ALD), and she played a key role in bringing about the a ALD lentiviral gene therapy treatment. Dr. Salzman received her B.A. from Temple University and her Ph.D. from Bryn Mawr College.


About Adverum Biotechnologies, Inc.

Adverum is a gene therapy company committed to discovering and developing novel medicines that can offer life-changing benefits to patients living with rare diseases or diseases of the eye who currently have limited or burdensome treatment options. Adverum has a robust pipeline that includes product candidates to treat wet AMD, A1AT deficiency, and hereditary angioedema, among other diseases. We are leveraging our next-generation adeno-associated virus (AAV)-based directed evolution platform to generate product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Our focus on the patient is supported by clinical development expertise and core capabilities in vector optimization, process development, manufacturing, and assay development. For more information please visit www.adverumbio.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding Adverum’s plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, financial condition and results of operations, the sufficiency of its cash, cash equivalents and marketable securities, as well as the advancement of, and anticipated development and regulatory milestones and plans related to, Adverum’s product candidates and preclinical and clinical studies, and the commercial potential of its product candidates, all of which are based on certain assumptions made by Adverum on current conditions, expected future developments and other factors Adverum believes are appropriate in the circumstances. Adverum may not consummate any plans or product or clinical development goals in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations or projections disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that Adverum’s resources will not be sufficient for Adverum to conduct or continue planned development programs and planned clinical trials, the risk of a delay in the enrollment of patients in Adverum’s clinical studies or in the manufacturing of products to be used in such clinical studies, risks related to regulatory review of Adverum’s development plans and planned clinical trials and the risk that Adverum will not be able to successfully develop or commercialize any of its product candidates. Risks and uncertainties facing Adverum are described more fully in Adverum’s periodic reports filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

###

Contacts

For Adverum:

Tricia Truehart

Vice President

The Trout Group LLC

646-378-2953

ttruehart@troutgroup.com

EX-99.2

Exhibit 99.2

ADVERUM BIOTECHNOLOGIES PROVIDES UPDATE ON

ALPHA-1 ANTITRYPSIN DEFICIENCY PROGRAM

MENLO PARK, Calif., October 14, 2016 — Adverum Biotechnologies, Inc. (Nasdaq: ADVM) today provided an update on its development program for ADVM-043 (formerly “ANN-001”), a novel gene therapy for Alpha-1 Antitrypsin (A1AT) Deficiency, a rare genetic disorder that may result in serious respiratory and liver disease. Adverum has decided to upgrade the ADVM-043 manufacturing process by implementing its proprietary baculovirus-based production system and plans to transfer the third-party contract manufacturing for ADVM-043 to a large-scale contract manufacturer. This upgrade is designed to increase the production scale, and comply with industry standards so that the same production process is used from clinical trials through commercial stage. The company now expects to begin enrolment of patients in the Phase 1/2 clinical trial for ADVM-043 in the fourth quarter of 2017.

“Adverum has industry-leading capabilities in process development and manufacturing, consisting of a baculovirus-based AAV production system and state-of-the-art purification technology to manufacture AAV vectors of various serotypes. This allows us to deliver a turn-key large scale process to third-party cGMP manufacturers. We plan to leverage our leading manufacturing capabilities and upgrade our ADVM-043 manufacturing process now, to prepare for both our anticipated clinical and commercial product needs,” said Amber Salzman, Ph.D., Chief Executive Officer of Adverum Biotechnologies. “Our goal is to meet with the FDA to review our modified plans in the first quarter of 2017, to allow us to move ahead with patient enrolment in our planned Phase 1/2 clinical trial for ADVM-043 in the fourth quarter of 2017. We are committed to advancing this novel gene therapy for patients with A1AT deficiency, and are planning to be ready to deliver this potential product through a robust commercial-ready manufacturing process.”

The company’s other lead programs for wet age-related macular degeneration (wAMD) and hereditary angioedema (HAE) remain on target to initiate toxicology studies in the first half of 2017.

About Adverum’s Manufacturing Capabilities

Adverum’s industrialized manufacturing process is based on a proprietary baculovirus expression system and state-of-the-art purification technology. This process is highly efficient and scalable, applicable to various serotypes, with current production yields per run up to one hundred times greater than those obtained using conventional AAV production systems. The company has the capability to develop manufacturing processes up to 200L and transfer them turn-key to third party cGMP manufacturers. Further scale up is expected to allow commercial-grade material for diseases with large patient populations. In addition, Adverum has also developed formulations that allow for the production of highly concentrated purified vectors.


About Adverum Biotechnologies, Inc.

Adverum is a gene therapy company committed to discovering and developing novel medicines that can offer life-changing benefits to patients living with rare diseases or diseases of the eye who currently have limited or burdensome treatment options. Adverum has a robust pipeline that includes product candidates to treat wet AMD, A1AT deficiency, and hereditary angioedema, among other diseases. We are leveraging our next-generation adeno-associated virus (AAV)-based directed evolution platform to generate product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Our focus on the patient is supported by clinical development expertise and core capabilities in vector optimization, process development, manufacturing, and assay development. For more information please visit www.adverumbio.com.

Forward-Looking Statements for Adverum Biotechnologies

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding Adverum’s plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, the sufficiency of its resources to fund the advancement of any development program or the completion of any clinical trials, and the safety, efficacy, and projected development timeline and commercial potential of products under development, all of which are based on certain assumptions made by us on current conditions, expected future developments and other factors we believe are appropriate in the circumstances. Adverum may not consummate any plans or product development goals in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that Adverum’s resources will not be sufficient for Adverum to conduct or continue planned development programs and planned clinical trials, the risk of a delay in the enrollment of patients in Adverum’s clinical studies or in the manufacturing of products to be used in such clinical studies, risks related to regulatory review of Adverum’s development plans and planned clinical trials and the risk that Adverum will not be able to successfully develop or commercialize any of its product candidates. Risks and uncertainties facing Adverum are described more fully in Adverum’s periodic reports filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

###

Contact for Adverum:

Tricia Truehart

Vice President

The Trout Group LLC

646-378-2953

ttruehart@troutgroup.com