0001193125-22-000611.txt : 20220103 0001193125-22-000611.hdr.sgml : 20220103 20220103161155 ACCESSION NUMBER: 0001193125-22-000611 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20220103 FILED AS OF DATE: 20220103 DATE AS OF CHANGE: 20220103 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Opthea Ltd CENTRAL INDEX KEY: 0001815620 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: C3 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39621 FILM NUMBER: 22502202 BUSINESS ADDRESS: STREET 1: LEVEL 4 STREET 2: 650 CHAPEL STREET CITY: SOUTH YARRA, VICTORIA STATE: C3 ZIP: 3141 BUSINESS PHONE: 61 3 9826 0399 MAIL ADDRESS: STREET 1: LEVEL 4 STREET 2: 650 CHAPEL STREET CITY: SOUTH YARRA, VICTORIA STATE: C3 ZIP: 3141 6-K 1 d263031d6k.htm 6-K 6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of January 2022

Commission File Number: 001-39621

 

 

OPTHEA LIMITED

(Translation of registrant’s name into English)

 

 

Level 4

650 Chapel Street

South Yarra, Victoria 3141

Australia

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☒                    Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


EXHIBITS

 

Exhibit

  

Description

99.1    Press Release dated January 3, 2022


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, thereunto duly authorized.

 

    OPTHEA LIMITED
Date: January 3, 2022     By:  

/s/ Megan Baldwin

      Megan Baldwin, Ph.D.
      Chief Executive Officer and Managing Director
EX-99.1 2 d263031dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

ASX and Media Release

3 January 2022

Opthea Appoints Chief Commercial Officer to Lead

Commercialization of OPT-302 for Wet AMD

Melbourne, Australia; 3 January 2022 – Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, is pleased to announce the appointment of Ms. Judith Robertson as the Company’s first Chief Commercial Officer (CCO), effective 1 January 2021. Concurrently with this appointment, Ms. Robertson has stepped down as a non-executive member of the Opthea Board of Directors, a position she has held since June 2021, to pursue the full-time executive CCO role.

Opthea’s Chief Executive Officer, Dr. Megan Baldwin, commented “I am delighted to welcome Ms. Robertson to the executive management team to lead both the U.S. and global commercialization activities for OPT-302. Ms. Robertson’s appointment reflects her deep commitment to the Company and her conviction in the potential of targeting VEGF-C/-D to improve visual acuity outcomes in patients with wet age-related macular degeneration (AMD). Ms. Robertson’s appointment is timely as we advance our Phase 3 registrational program and commercialization efforts for OPT-302. We look forward to capitalizing on both her deep knowledge of the Company and her experience in overseeing the launch of multiple ophthalmology products.”

Ms. Judith Robertson is an accomplished life sciences commercial executive with an extensive track record for building, leading and launching several commercial organizations. Prior to joining Opthea, Ms. Robertson was most recently Chief Commercial Officer of Eleusis Ltd and was previously Chief Commercial Officer of Aerie Pharmaceuticals, where she oversaw the launch of Rhopressa®, the first product targeting a new mechanism of action for the treatment of glaucoma in 20 years, and the launch of the combination product Rocklatan®. Prior to Aerie, Ms. Robertson was Global Commercial Vice President Immunology and Ophthalmology at Johnson and Johnson, Janssen Pharmaceuticals, and Global Vice President Ophthalmology at Novartis (formerly Alcon). Her prior experience also includes several senior executive commercial roles at Searle and Bristol Myers Squibb including President and General Manager of Bristol Myers Squibb Canada.

Opthea’s Chairman, Dr. Jeremy Levin, commented “On behalf of Opthea’s Board of Directors, I wish to thank Ms. Robertson for her service to the Company as a non-executive director. We are confident that Ms. Robertson’s commercial expertise will continue to be a great asset to the Company as she moves to an executive role. Furthermore, Ms. Robertson’s appointment adds to our goal of building out a substantial presence in the United States, a key market as we look towards commercialization.”

About Opthea

Opthea (ASX:OPT; Nasdaq: OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.

Level 4, 650 Chapel Street, South Yarra, Victoria 3141 Australia T +61 (3) 9826 0399 F +61 (3) 9824 0083

www.opthea.com ABN 32 006 340 567


Inherent risks of Investment in Biotechnology Companies

There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.

Forward-looking statements

Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including, but not limited to, the advancement of Opthea’s Phase 3 registrational program and commercialization efforts for OPT-302 and Opthea’s goal of building out a substantial presence in the United States. Such statements are based on Opthea’s current plans, objectives, estimates, expectations, and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Opthea’s Annual Report on Form 20-F filed with the SEC on October 28, 2021. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement.

Authorized for release to ASX by Megan Baldwin, CEO & Managing Director

 

Company & Media Enquiries:    Join our email database to receive program updates:
U.S.A. & International:   
Sam Martin    Tel: +1 212-600-1902
Argot Partners    info@opthea.com
Tel: +1 212-600-1902    www.opthea.com
opthea@argotpartners.com   
Australia:   
Rudi Michelson   
Monsoon Communications   
Tel: +61 (0) 3 9620 3333   

 

Level 4, 650 Chapel Street, South Yarra, Victoria 3141 Australia T +61 (3) 9826 0399 F +61 (3) 9824 0083

www.opthea.com ABN 32 006 340 567

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