8-K
false 0001701108 0001701108 2021-10-11 2021-10-11

 

 

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 11, 2021

 

 

SPERO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38266   46-4590683
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

675 Massachusetts Avenue, 14th Floor

Cambridge, Massachusetts

  02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (857) 242-1600

 

 

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, $0.001 par value per share   SPRO   The 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 11, 2021, Jean-François Formela, M.D. notified the Board of Directors (the “Board”) of Spero Therapeutics, Inc. (the “Company”) of his resignation from the Board and the Compensation Committee and Nominating and Corporate Governance Committee of the Board, effective as of October 11, 2021. His resignation did not result from any disagreement with the Company on any matter relating to the Company’s operations, policies, practices or otherwise.

On October 11, 2021, the Board, upon the recommendation of the Nominating and Corporate Governance Committee of the Board, appointed Kathleen Tregoning to the Board, effective as of October 11, 2021, to fill the vacancy created by Dr. Formela’s resignation. The Board also appointed Ms. Tregoning to serve on the Compensation Committee of the Board. Ms. Tregoning will serve as a Class III Director for the remainder of the Class III term, which is up for reelection at the Company’s 2023 annual meeting of stockholders.

Ms. Tregoning, age 50, has served as Chief Corporate Affairs Officer of Cerevel Therapeutics Holdings, Inc. since July 2020. Previously, from February 2017 to March 2020, Ms. Tregoning served as Executive Vice President for External Affairs at Sanofi S.A., a French multinational pharmaceutical company, where she was responsible for leading an integrated organization that brought together market access, communications, public policy, government affairs, patient advocacy and corporate social responsibility. Prior to joining Sanofi, Ms. Tregoning spent more than a decade at Biogen Inc., a multinational biotechnology company, first as Vice President, Public Policy & Government Affairs, from 2006 to 2015, and then as Senior Vice President, Corporate Affairs, from December 2015 to February 2017. Previously, Ms. Tregoning served as a professional staff member in the United States Congress, where she held health policy roles with the Senate Budget Committee, the House Energy & Commerce Committee, and the House Ways & Means Committee. Ms. Tregoning began her career with Andersen Consulting, where she developed business strategies and processes for clients in a range of industries, and later served as an Assistant Deputy Mayor for Policy & Budget in the office of the Mayor of Los Angeles. Ms. Tregoning graduated from Stanford University with a B.A. in International Relations and holds an M.A. in Public Policy from the Kennedy School of Government at Harvard University.

The Board has affirmatively determined that Ms. Tregoning is an independent director pursuant to the Nasdaq Stock Market’s governance listing standards and those rules and regulations issued pursuant to the Securities Exchange Act of 1934, as amended. There are no arrangements or understandings between Ms. Tregoning and any other person pursuant to which Ms. Tregoning was appointed as a director. There are no transactions to which the Company is a party and in which Ms. Tregoning has a material interest that are required to be disclosed under Item 404(a) of Regulation S-K. Ms. Tregoning has not previously held any positions with the Company and has no family relations with any directors or executive officers of the Company.

Ms. Tregoning will be entitled to the standard compensation paid by the Company to all of its non-employee directors under the Company’s Non-Employee Director Compensation Policy, as amended (pro-rated as applicable to reflect the actual time Ms. Tregoning will serve on the Board for the year), a copy of which is filed as Exhibit 10.6 to the Company’s Annual Report on Form 10-K, filed by the Company on March 16, 2020.

Ms. Tregoning will also enter into an indemnification agreement in the form the Company has entered into with its other non-employee directors, which form is filed as Exhibit 10.4 to the Company’s Registration Statement on Form S-1, as amended (File No. 333-220858), filed by the Company on October 6, 2017 and is incorporated herein by reference.

A copy of the press release announcing Ms. Tregoning’s appointment to the Board is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit

Number

  

Description

99.1    Press Release dated October 12, 2021
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


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.

 

    SPERO THERAPEUTICS, INC.
Dated: October 12, 2021     By:  

/s/ Tamara Joseph

    Name:   Tamara Joseph
    Title:   Chief Legal Officer
EX-99.1

Exhibit 99.1

Spero Therapeutics Appoints Kathleen Tregoning to its Board of Directors

Ms. Tregoning brings more than two decades of experience in biotechnology and public policy to Spero’s Board

CAMBRIDGE, Mass., October 12, 2021 — Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced the appointment of Kathleen Tregoning to its Board of Directors. Currently the Chief Corporate Affairs Officer at Cerevel Therapeutics, Ms. Tregoning has more than two decades of experience in biotechnology and public policy. She succeeds outgoing Director Jean-François Formela, M.D., who has stepped down from Spero’s Board as part of a planned transition, effective upon Ms. Tregoning’s appointment.

“Kathleen is an accomplished industry leader, and we are honored to welcome her to our Board,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “Her extensive executive experience and public policy expertise, along with her deep understanding of external engagement strategies and the global payer environment, will prove invaluable as we prepare for tebipenem HBr’s anticipated launch and continue to advance other programs in our clinical pipeline. We look forward to benefiting from her experience and insights.”

“We would also like to extend our most sincere appreciation to Jean-François for his long-term contributions as a Director during the last eight years of Spero’s journey,” continued Dr. Mahadevia. “He has helped to position Spero for sustained success as we approach our next stage of development.”

Prior to joining Cerevel Therapeutics, Ms. Tregoning served as Executive Vice President for External Affairs at Sanofi, where she led an integrated organization to develop external engagement strategies and optimize patient access to therapies. Prior to her time at Sanofi, Ms. Tregoning spent more than 10 years at Biogen, first as Vice President, Public Policy & Government Affairs and then as Senior Vice President, Corporate Affairs. In the latter role, she was responsible for the development and execution of integrated corporate affairs strategies through effective deployment of communications, patient advocacy, public policy, and government affairs on a global basis. Earlier in her career, Ms. Tregoning was a professional staff member for multiple committees in the United States Congress, and also served as an assistant deputy mayor for policy & budget in the office of the Mayor of Los Angeles. Ms. Tregoning graduated from Stanford University with a B.A. in International Relations and holds an M.A. in Public Policy from the Harvard Kennedy School.

“Spero is bringing true innovation to the critical issue of multi-drug resistant infections, and I am delighted to be joining the board at such an exciting time,” said Ms. Tregoning. “I look forward to working with my fellow Directors as Spero transitions to a commercial organization and brings its transformative antibiotics to patients facing serious infections.”


About Spero Therapeutics

Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug-resistant (MDR) bacterial infections and rare diseases.

Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP.

Spero is also developing SPR720 as a novel oral therapy product candidate for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.

Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is being developed to treat MDR Gram-negative infections in the hospital setting.

Tebipenem HBr is currently not approved for the treatment of complicated urinary tract infection or acute pyelonephritis.

For more information, visit https://sperotherapeutics.com.

Forward Looking Statements

This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the initiation, timing and submission to the FDA of a NDA for tebipenem HBr and the potential approval of tebipenem HBr by the FDA. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Spero’s ability to timely complete the NDA submission to the FDA for tebipenem HBr; Spero’s need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero’s reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to develop and commercialize Spero’s product candidates, if approved; the potential impact of the COVID-19 pandemic; Spero’s ability to retain key personnel and to manage its growth; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero’s views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero’s views as of any date subsequent to the date of this press release.


Investor Relations Contact:

Ted Jenkins

Vice President, Head of Investor Relations

Tjenkins@sperotherapeutics.com

(617) 798-4039

Media Contact:

media@sperotherapeutics.com