0001193125-20-273355.txt : 20201021 0001193125-20-273355.hdr.sgml : 20201021 20201021081902 ACCESSION NUMBER: 0001193125-20-273355 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20201019 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20201021 DATE AS OF CHANGE: 20201021 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AVROBIO, Inc. CENTRAL INDEX KEY: 0001681087 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 810710585 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38537 FILM NUMBER: 201249673 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQUARE STREET 2: BLDG. 300, SUITE 201 CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 7819626030 MAIL ADDRESS: STREET 1: ONE KENDALL SQUARE STREET 2: BLDG. 300, SUITE 201 CITY: CAMBRIDGE STATE: MA ZIP: 02139 FORMER COMPANY: FORMER CONFORMED NAME: AvroBio, Inc. DATE OF NAME CHANGE: 20160729 8-K 1 d71632d8k.htm 8-K 8-K
NASDAQ false 0001681087 0001681087 2020-10-19 2020-10-19

 

 

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 19, 2020

 

 

AVROBIO, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38537   81-0710585

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

One Kendall Square

Building 300, Suite 201

Cambridge, MA 02139

(Address of principal executive offices, including zip code)

(617) 914-8420

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, 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:

 

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, $0.0001 par value per share   AVRO   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.

On October 19, 2020, the Board of Directors (the “Board”) of AVROBIO, Inc. (the “Company”) increased the size of the Board from seven directors to eight directors and appointed Gail M. Farfel, Ph.D., as a director of the Company, effective immediately, to fill the vacancy created by such increase. Dr. Farfel was also appointed to serve as a member of the Science & Technology Committee of the Board. Dr. Farfel will serve as a Class I director, to serve until the Company’s annual meeting of stockholders in 2022.

Dr. Farfel will be compensated for her service as a non-employee director under the Company’s Non-Employee Director Compensation Policy, as amended (the “Policy”). In connection with her appointment to the Board and in accordance with the Policy, the Company granted Dr. Farfel an option to purchase 28,000 shares of the Company’s common stock pursuant to the Company’s 2018 Stock Option and Incentive Plan. As a non-employee director, Dr. Farfel is also entitled to receive an annual service retainer of $39,000, which includes $4,000 for her service as a member of the Science & Technology Committee, and additional annual stock option awards, subject to her continued service on the Board.

The Company also entered into an indemnification agreement with Dr. Farfel in connection with her appointment to the Board, which is in substantially the same form as that entered into with the other directors of the Company. There are no arrangements or understandings between Dr. Farfel and any other persons pursuant to which she was appointed as a director, and there are no transactions in which a related person has a direct or indirect material interest that are required to be disclosed pursuant to Item 404(a) of Regulation S-K.

 

Item 7.01.

Regulation FD Disclosure.

On October 21, 2020, the Company issued a press release titled “AVROBIO Appoints Dr. Gail Farfel to its Board of Directors.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information 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 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

99.1    Press Release of AVROBIO, Inc., dated October 21 2020.
104    The cover page from this Current Report on Form 8-K, formatted in Inline XBRL


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.

 

    AVROBIO, INC.
Date: October 21, 2020     By:  

/s/ Geoff MacKay

      Geoff MacKay
      President and Chief Executive Officer
EX-99.1 2 d71632dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

AVROBIO Appoints Dr. Gail Farfel to its Board of Directors

CAMBRIDGE, Mass.—Oct. 21, 2020—AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced the appointment of Gail M. Farfel, Ph.D., to its Board of Directors. Dr. Farfel brings more than 25 years of pharmaceutical development and regulatory experience in rare diseases with both large and small pharmaceutical companies.

“Gail’s deep experience in rare disease, with a focus on neuroscience, and her expertise in leading global product development and regulatory approvals is highly relevant to our growing pipeline of investigational gene therapies that target lysosomal disorders, devastating disorders that impact both the body and brain,” said Geoff MacKay, president and CEO of AVROBIO. “We’re delighted to welcome Gail to the AVROBIO board. Her experience in advancing therapies from early development through commercialization provides us with additional expertise as we continue to advance our pipeline of investigational gene therapies for the treatment of rare lysosomal disorders.”

Dr. Farfel has been executive vice president and global chief development officer at Zogenix, Inc., a rare disease company, since July 2015. At Zogenix, Dr. Farfel leads all product development activities, including preclinical and clinical development, and regulatory strategy. Prior to joining Zogenix, Dr. Farfel was chief clinical and regulatory officer of Marinus Pharmaceuticals, establishing and overseeing clinical, medical and regulatory strategies for adult and pediatric seizure disorders, including a pediatric epileptic orphan disease. Previously, Dr. Farfel was vice president, therapeutic area head for neuroscience clinical development and medical affairs at Novartis Pharmaceuticals Corporation, where she oversaw a portfolio of products for multiple sclerosis, Alzheimer’s disease and Parkinson’s disease.

Dr. Farfel began her career in pharmaceutical drug development at Pfizer Inc., where she worked in clinical development and global medical affairs, directing programs through all stages of clinical development and regulatory submissions.

Dr. Farfel has authored more than 50 scientific articles in the areas of neuropsychopharmacology and drug effects. She currently serves on the board of directors of DURECT Corporation (Nasdaq: DRRX) and is a director on the Board of the American Society for Experimental Neurotherapeutics. She holds a Ph.D. in neuropsychopharmacology from the University of Chicago, where she received the Ginsburg Prize for Dissertation Excellence and is a director on the Medical and Biological Sciences Alumni Board. Dr. Farfel also holds a bachelor’s degree in biochemistry from the University of Virginia.


About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to halt, reverse or prevent disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing preclinical programs in Hunter syndrome and Pompe disease. AVROBIO is powered by the plato® gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

Forward-Looking Statement

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “aims,” “anticipates,” “believes,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected benefits from the appointment of Dr. Farfel to our board of directors, the expected benefits, timing and results of our implementation of our gene therapy programs, as well as the expected benefits of our plato platform.

Any forward-looking statements in this press release are based on AVROBIO’s current expectations, estimates and projections about our industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIO’s product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned preclinical or clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIO’s product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks


associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our development timeline and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIO’s actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled “Risk Factors” in AVROBIO’s most recent Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in AVROBIO’s subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Investor Contact:

Christopher F. Brinzey

Westwicke, an ICR Company

339-970-2843

chris.brinzey@westwicke.com

Media Contact:

Stephanie Simon

Ten Bridge Communications

617-581-9333

stephanie@tenbridgecommunications.com

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