Opthea Ltd 6-K, filed Nov 16, 2022
Opthea Ltd (CKDXF)
About this 6-K
Opthea Ltd filed this 6-K on November 16, 2022.
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 November 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 | Opthea Chairman’s Address to the 2022 Annual General Meeting | |
| 99.2 | Results of 2022 Annual General Meeting | |
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: November 16, 2022 | By: | /s/ Megan Baldwin | ||||
| Megan Baldwin, Ph.D. | ||||||
| Chief Executive Officer and Managing Director | ||||||
Exhibit 99.1
ASX, Nasdaq and Media Release
16 November 2022
Opthea Chairman’s Address to the 2022 Annual General Meeting
Melbourne, Australia; 16 November 2022 – Opthea Limited (NASDAQ:OPT; ASX:OPT)
Good morning to those of you who have joined us from Australia and good afternoon to our US shareholders.
On behalf of the board and management team I am pleased to report that we have continued to make significant progress during the past 12 months as we advance the pivotal Phase 3 program for our innovative therapy OPT-302 in wet AMD. We also wish to update you on our strategic goals and objectives for the current fiscal year and trust you will gain further insight into our plans going forward.
At Opthea, we are driven to address significant unmet medical needs and provide hope of improved vision outcomes for the many patients around the world who suffer from debilitating retinal diseases. As we continue our journey to bring OPT-302 to market as a life-changing therapeutic option for the treatment of wet AMD, we firmly believe the potential benefits to be significant for patients, shareholders and society.
We are pleased with the achievements the Company has made over the past 12 months and highlighted as follows:
| • | We continued to focus on advancing our ongoing Phase 3 clinical studies investigating OPT-302 as a combination therapy for wet AMD, by enrolling patients globally into both the ShORe and COAST trials as we target our approaching milestone of completing patient recruitment. |
| • | We strengthened the Opthea management team and board with Mr Timothy Morris appointed as CFO, together with the welcome addition of two leaders in the fields of ophthalmology, Mr. Quinton Oswald and Dr. Susan Orr, to the board as non-executive directors. |
| • | We significantly bolstered the financial position of the company by recently securing major non-dilutive funding for up to US$170 million from world-leading investors Carlyle, its life sciences franchise Abingworth, and their recently formed development company Launch Therapeutics, together with an US$90 million equity raise. We greatly appreciate this support and belief in our technology which will allow completion of the Phase 3 clinical studies whilst also strengthening our strategic position to maximize the commercial value of OPT-302. |
We are increasingly excited by what lies ahead for Opthea particularly given the positive clinical data for OPT-302 that has demonstrated superior visual acuity in previous Phase 2 trials over standard of care anti-VEGF-A therapy in patients with wet AMD. Our motivation and conviction for the potential opportunity for OPT-302 is also supported by:
| • | The fundamental need to address the unmet need for patients with retinal eye diseases which don’t fully respond to the currently available standard of care treatments; and |
| • | An understanding that there have been no new therapies targeting novel mechanisms approved for wet AMD since the approval of the first VEGF-A inhibitor for wet AMD over 15 years ago. |
Over this next 12 months, our focus will be on successfully executing our Phase 3 trials ShORe and COAST and we will continue to ramp up our pre-commercial efforts that will lay the necessary groundwork for a commercial launch should our trials succeed. While taking these steps, we are building the visibility of our company within the global investor and clinical ophthalmology communities and working to establish Opthea as global innovator for retinal eye disease treatment.
On behalf of the board and management we would like to thank our shareholders for their support and encouragement. Despite continued progress on the clinical trials and the completion of a significant financing we recognize the price performance of the stock has suffered along with many other companies in our industry. In addition to continued focus
on the pivotal studies, Megan and management will look to expand awareness and visibility of the company with investors worldwide with the goal of increasing shareholder value. We look to the future with enthusiasm and a single-minded dedication to the objective of delivering high value, both to families of those with disorders of the eye and to our shareholders.
Thank you for your support and investment in Opthea.
About Opthea Limited
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.
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.
Authorized for release to ASX by Megan Baldwin, CEO & Managing Director
Company & Media Enquiries:
| U.S.A. & International: | Australia: | |
| Sam Martin | Rudi Michelson | |
| Argot Partners | Monsoon Communications | |
| Tel: +1 212 600 1902 | Tel: +61 (0) 3 9620 3333 | |
| opthea@argotpartners.com |
Media:
Silvana Guerci-Lena
NorthStream Global Partners
Tel: +1 973 509 4671
silvana@nsgpllc.com
Join our email database to receive program updates:
Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web: www.opthea.com
Exhibit 99.2
16 November 2022
Market Announcements Office
Australian Securities Exchange Limited
20 Bridge Street
SYDNEY NSW 2000
Dear Ms,
Results of 2022 Annual General Meeting
Opthea Limited (ASX: OPT)
In accordance with Listing Rule 3.13.2 and section 251AA of the Corporations Act, we advise details of the resolutions and the proxies received in respect of each resolution are set out in the attached proxy summary.
Yours faithfully
|
| Karen Adams |
| Company Secretary |
Opthea Limited, Suite 0403, Level 4, 650 Chapel Street, South Yarra, Victoria 3141, Australia
A.C.N. 006 340 567 l Telephone: +61 3 9826 0399 l Website: www.opthea.com
| Opthea Limited Annual General Meeting Wednesday, 16 November 2022 Results of Meeting
|
|
The following information is provided in accordance with section 251AA(2) of the Corporations Act 2001 (Cth) and ASX Listing Rule 3.13.2.
| Resolution details |
Instructions given to validly appointed proxies (as at proxy close) |
Number of votes cast on the poll (where applicable) |
Resolution Result | |||||||||||||||
| Resolution |
Resolution Type |
For | Against | Proxy’s Discretion |
Abstain | For | Against | Abstain* | Carried / Not Carried | |||||||||
| 1 Re-Election of Director - Dr Jeremy Levin |
Ordinary | 167,252,026 75.28% |
53,023,618 23.87% |
1,878,047 0.85% |
374,076 | 169,131,253 76.13% |
53,023,618 23.87% |
374,076 | Carried | |||||||||
| 2 Re-Election of Director - Mr Daniel Spiegelman |
Ordinary | 219,810,263 98.95% |
459,781 0.20% |
1,878,047 0.85% |
379,676 | 221,689,490 99.79% |
459,781 0.21% |
379,676 | Carried | |||||||||
| 3 Re-Election of Director - Dr Julia Haller |
Ordinary | 219,689,121 98.89% |
586,323 0.26% |
1,878,247 0.85% |
374,076 | 221,568,538 99.74% |
586,323 0.26% |
374,076 | Carried | |||||||||
| 4 Adoption of remuneration report |
Ordinary | 177,830,242 82.05% |
38,527,716 17.78% |
356,683 0.17% |
363,664 | 178,188,095 82.22% |
38,527,726 17.78% |
363,664 | Carried | |||||||||
| 5 Issue of options to Mr Lawrence Gozlan under the non-executive director share and option plan |
Ordinary | 166,753,612 75.51% |
53,738,764 24.34% |
325,237 0.15% |
100,090 | 167,080,019 75.66% |
53,738,774 24.34% |
100,090 | Carried | |||||||||
| 6 Issue of options to Mr Daniel Spiegelman under the NED Plan |
Ordinary | 171,936,437 77.30% |
48,557,739 21.83% |
1,933,501 0.87% |
100,090 | 172,261,044 78.01% |
48,557,739 21.99% |
100,090 | Carried | |||||||||
| 7 Issue of options to Mr Michael Sistenich under the NED Plan |
Ordinary | 166,772,584 74.98% |
53,723,092 24.15% |
1,932,001 0.87% |
100,090 | 167,095,691 75.67% |
53,723,102 24.33% |
100,090 | Carried | |||||||||
| 8 Issue of options to Dr Megan Baldwin under the long term incentive plan |
Ordinary | 163,234,536 74.67% |
53,423,472 24.44% |
1,932,001 0.89% |
98,360 | 163,557,643 75.38% |
53,423,472 24.62% |
98,360 | Carried | |||||||||
| 9 Approval of issue of performance rights awarded to Dr Megan Baldwin under the LTIP |
Ordinary | 159,952,205 73.17% |
56,714,799 25.94% |
1,934,001 0.89% |
87,364 | 160,277,312 73.86% |
56,714,809 26.14% |
87,364 | Carried | |||||||||
| 10 Approval of issue of performance rights awarded to Mr Lawrence Gozlan under the NED Plan |
Ordinary | 166,767,044 75.51% |
53,746,328 24.34% |
326,179 0.15% |
78,152 | 167,094,393 75.66% |
53,746,338 24.34% |
78,152 | Carried | |||||||||
| 11 Approval of issue of performance rights awarded to Mr Daniel Spiegelman under the NED Plan |
Ordinary | 166,791,316 74.98% |
53,726,298 24.15% |
1,932,001 0.87% |
78,152 | 167,114,423 75.67% |
53,726,308 24.33% |
78,152 | Carried | |||||||||
| * | Votes cast by a person who abstains on an item are not counted in calculating the required majority on a poll. |
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