ASX Share rice
Fri 14 May 2021 - 08:51:pm (Sydney)

OPT Share Price

OPTHEA LIMITEDOPTPharmaceuticals, Biotechnology & Life Sciences

OPT Company Information

Name:

Opthea Limited

Sector:

Healthcare

Industry:

Biotechnology

GIC Industry:

Biotechnology

GIC Sub Industry:

Biotechnology

Address:

650 Chapel Street South Yarra VIC Australia 3141

Phone:

61 3 9826 0399

MD, CEO & Exec. Director:

Dr. Megan Baldwin M.A.I.C.D., Ph.D., MAICD

CFO & Company Sec.:

Mr. Michael Tonroe B.Sc., F.C.A., M.A.I.C.D., Bsc(Hons), ACA, MAICD

Fin. & Operations Mang.:

Ms. Annie Lee

Head of Intellectual Property:

Dr. Richard Chadwick

Head of Chemistry, Manufacturing & Controls Devel.:

Dr. Michael Gerometta

Director of Clinical Research:

Dr. Ian Leitch

Independent Consultant:

Dr. James Goding

Company Overview:

Opthea Limited, a biotechnology company, develops and commercializes therapies primarily for eye disease in Australia. The company's development activities are based on the intellectual property portfolio covering Vascular Endothelial Growth Factors (VEGF) VEGF-C, VEGF-D, and VEGF Receptor-3 for the treatment of diseases associated with blood and lymphatic vessel growth, as well as vascular leakage. Its lead molecule is OPT-302, a soluble form of VEGFR-3 for the treatment of wet age-related macular degeneration and diabetic macular edema. The company was formerly known as Circadian Technologies Limited and changed its name to Opthea Limited in December 2015. Opthea Limited was incorporated in 1984 and is based in South Yarra, Australia.

OPT Share Price Information

Shares Issued:

337.66M

Market Capitalisation:

$462.60M

Revenue (TTM):

$228.25K

Revenue Per Share (TTM):

$0

Earnings per Share:

$-0.09

Operating Margin (TTM):

$-174.66

Return On Assets (TTM):

$-0.17

Return On Equity (TTM):

$-0.32

Quarterly Revenue Growth (YOY):

0.288

Gross Profit(TTM):

$-393,700

Diluted Earnings Per Share (TTM):

$-0.155

OPT CashFlow Statement

CashFlow Date:

2020-06-30

Investments:

$482.98K

Change To Liabilities:

$-56,907

Total Cashflow From Investing Activities:

$475.74K

Net Borrowings:

$-100,189

Net Income:

$-16,529,281

Total Cash From Operating Activities:

$-8,782,268

Depreciation:

$144.02K

Other Cashflow From Investing Activities:

$482.98K

Change To Account Receivables:

$11.40K

Sale Purchase Of Stock:

$49.08M

Capital Expenditures:

$7.24K

OPT Income Statement

Income Date:

2020-06-30

Income Before Tax:

$-25,062,400

Net Income:

$-16,529,280

Gross Profit:

$-456,200

Operating Income:

$-25,443,770

Other Operating Expenses:

$201.17K

Income Tax Expense:

$-8,533,123

Total Revenue:

$87.08K

Total Operating Expenses:

$25.44M

Cost Of Revenue:

$543.28K

OPT Balance Sheet

Balance Sheet Date:

2020-06-30

Total Liabilities:

$7.08M

Total Stockholder Equity:

$64.81M

Other Current Liabilities:

$6.13M

Total Assets:

$71.89M

Common Stock:

$162.10M

Retained Earnings:

$-102,589,341

Other Liabilities:

$40.20K

Cash:

$59M

Total Current Liabilities:

$6.92M

Property - Plant & Equipment:

$280.69K

Net Tangible Assets:

$64.81M

Long-Term Investments:

$289.98K

Total Current Assets:

$71.32M

Net Receivables:

$8.82M

Short-Term Investments:

$570.67K

Accounts Payable:

$5.84M

Short-Term Investments:

$570.67

Non Current Liabilities Total:

$160.23K

OPT Share Price History

OPT News

06 Apr, 2021
MELBOURNE, Australia, April 06, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; Nasdaq:OPT) advises that Mr Michael Tonroe has resigned as Company Secretary and Chief Financial Officer (CFO) of the Company, with effect 24 June 2021. Opthea has initiated a search for a permanent replacement with requisite expertise in financial reporting and company secretarial duties for a dual ASX and Nasdaq listed company. Mr Tonroe leaves Opthea at a time of corporate growth and emerging presence in the US to align with the recent listing on Nasdaq and initiation of the Company’s global Phase 3 clinical development program for OPT-302 in wet age-related macular degeneration (wet AMD). Dr Megan Baldwin, CEO and Managing Director of Opthea, commented, “Mr Tonroe joined Opthea in 2014 and since that time has become an integral and valued member of the team, navigating our transition to an ophthalmology focused company, through successful clinical trials, financings and more recently, our US listing on the Nasdaq. As a consistent and supportive colleague, Mike has been a pleasure to work with. On behalf of the Board, we extend our appreciation to Mr Tonroe for his contributions to the Company during his tenure and sincerely wish him well for his future career opportunities.” Mr Tonroe will remain Company Secretary and CFO until the effective date of his resignation and assist in the transition of duties to an interim or permanent replacement in June 2021. Company & Media Enquiries:Join our email database to receive program updates:Megan Baldwin, PhD CEO & Managing DirectorOpthea LimitedTel: +61 (0) 447 788 674megan.baldwin@opthea.comAustralia:Rudi MichelsonMonsoon CommunicationsTel: +61 (0) 3 9620 3333Tel: +61 (0) 3 9826 0399info@opthea.comwww.opthea.comU.S.A. & International: Jason WongBlueprint Life Science GroupTel: +1 415 375 3340, Ext 4Jwong@bplifescience.com About Opthea Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing a novel therapy 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 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. 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 continuation of patient recruitment for Opthea’s pivotal Phase 3 clinical trials of OPT-302 in wet AMD. 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 the final prospectus filed with the SEC on October 19, 2020. 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.
31 Mar, 2021
MELBOURNE, Australia, March 31, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces that it has received an initial Pediatric Study Plan (iPSP) waiver from the US Food and Drug Administration (FDA) for OPT-302, the Company’s lead product candidate currently in Phase 3 clinical development for the treatment of neovascular (wet) age-related macular degeneration. As part of the regulatory review process, a bio-pharmaceutical company that is planning to submit a marketing application of a new medicine with the FDA is required to provide an iPSP detailing the Company’s proposed strategy for investigation of the new medicinal product in the pediatric population. In some instances, a waiver from developing an iPSP for certain conditions may be agreed to by the Agency. Opthea received from the FDA an official, agreed iPSP waiver for OPT-302 across all subsets of the pediatric population (full pediatric age group from birth to < 17 years) for the treatment of wet AMD in combination with intravitreal anti-VEGF-A therapy. The receipt of the agreed iPSP waiver means the Company will not have to conduct an additional study in the pediatric population. Dr Megan Baldwin, CEO of Opthea commented: “The agreed iPSP waiver is an important regulatory milestone in the US that is required to be completed before Opthea is able to submit a marketing application for OPT-302 to the FDA. Opthea will continue the process to further fulfilling regulatory requirements by focusing on our pivotal Phase 3 clinical trials in adult patients that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD.” Additional information on Opthea’s technology and clinical trials can be found at www.opthea.com. Company & Media Enquiries:Join our email database to receive program updates:Megan Baldwin, PhD CEO & Managing DirectorOpthea LimitedTel: +61 (0) 447 788 674megan.baldwin@opthea.comAustralia:Rudi MichelsonMonsoon CommunicationsTel: +61 (0) 3 9620 3333Tel: +61 (0) 3 9826 0399info@opthea.comwww.opthea.comU.S.A. & International: Jason WongBlueprint Life Science GroupTel: +1 415 375 3340, Ext 4Jwong@bplifescience.com About Opthea Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing a novel therapy 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 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. 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 continuation of patient recruitment for Opthea’s pivotal Phase 3 clinical trials of OPT-302 in wet AMD. 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 the final prospectus filed with the SEC on October 19, 2020. 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.
15 Mar, 2021
MELBOURNE, Australia, March 15, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; Nasdaq: OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that the first patient has been treated in the Phase 3 pivotal clinical program of the Company’s first-in-class VEGF-C/D ‘trap’ inhibitor, OPT-302, in participants with treatment-naïve wet (neovascular) age-related macular degeneration (AMD). The first patient was enrolled by Dr Allen Hu, MD, Cumberland Valley Retina Consultants, Hagerstown, Maryland, USA. “Dosing the first patient in our OPT-302 Phase 3 pivotal clinical program in wet AMD marks a very important achievement for Opthea in accelerating the development of this novel VEGF-C/D inhibitor therapy towards market registration," commented Dr Megan Baldwin, Chief Executive Officer of Opthea. "We are now looking forward to quickly ramping up enrolment to meet the interest from participating clinical sites and retinal specialists. OPT-302, which has shown promising efficacy and favorable safety profiles in trials to date, is an important new treatment option which may offer patients improved outcomes when administered in combination with VEGF-A inhibitors.” Opthea is conducting two concurrent global, multi-center, randomized, double-masked, sham-controlled Phase 3 trials known as ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study). Both clinical studies will enroll ~990 treatment-naive patients each and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab (Lucentis®) or 2.0 mg aflibercept (Eylea®), compared to ranibizumab or aflibercept monotherapy, respectively. The primary endpoint of the ShORe and COAST studies is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy. Each patient will also continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period. A number of secondary endpoints will also be evaluated, including other key measures of visual function, as well as anatomical changes in the wet AMD lesions assessed by optical coherence tomography (OCT) and fluorescein angiography imaging. In addition, extended durability of the OPT-302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT-302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor. The initiation of the Phase 3 pivotal clinical program follows the reporting of positive outcomes from the Phase 2b clinical trial of OPT-302 in 366 patients with wet AMD. The results from the Phase 2b study demonstrated a statistically significant superior mean gain in visual acuity in patients treated with OPT-302 combination therapy compared to ranibizumab monotherapy at week 24. The ShORe and COAST Phase 3 trials build upon and maintain key features of the successful Phase 2b wet AMD clinical trial, whilst also evaluating the administration of OPT-302 in combination with ranibizumab and aflibercept over a longer treatment period and in a greater number of patients. Opthea anticipates reporting top-line data in 2023, with the Company intending to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA respectively following completion of the 12-month primary efficacy phase of the trials. Additional information on Opthea’s technology and clinical trials can be found at www.opthea.com and at ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636). Summaries of the ShORe and COAST Phase 3 Clinical Trials are included below. CLINICAL TRIAL SUMMARIES Protocol NumberOPT-302-1004Study TitleA Phase 3 study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (AMD)Study NameShORe – Study of OPT-302 in combination with Ranibizumab in neovascular AMDSponsorOpthea LimitedIndicationNeovascular (wet) age-related macular degeneration (AMD)Study Phase3Primary ObjectiveTo determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular AMDPrimary EndpointMean change from Baseline to Week 52 in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) lettersSecondary Endpoints Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52Change in CST by SD-OCT from Baseline to Week 52Change in the NEI VFQ-25 composite score from Baseline to Week 52Incidence of ocular and non-ocular treatment-emergent adverse eventsProportion of participants losing 15 or more ETDRS BCVA letters from Baseline to Week 52Participant incidence of ADA formationOPT-302 pharmacokinetic parameters Study DesignPhase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked, superiority studyInvestigational Product2.0 mg OPT-302 intravitreal injectionCo-administered anti-VEGF-A therapy0.5 mg ranibizumab intravitreal injectionControlSham intravitreal injectionStudy Arms Three study arms, randomised in a 1:1:1 ratio: Standard Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection with 0.5 mg ranibizumab (50 μl) intravitreal injection, both administered 4-weekly (q4w)Extended Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection (3 doses at 4-weekly intervals, and then 8-weekly [q4w x 3 then q8w]) with sham injection at visits when OPT-302 is not administered, with 0.5 mg ranibizumab (50 μl) intravitreal injection 4-weekly (q4w)Control Sham intravitreal injection with 0.5 mg ranibizumab (50 μl) intravitreal injection, both administered 4-weekly (q4w) Key Eligibility Criteria Participants ≥ 50 years of either gender, with active CNV secondary to AMD confirmed by fluorescein angiography (FA), who are treatment naïveAn ETDRS BCVA score between 60 and 25 (inclusive) letters Protocol NumberOPT-302-1005Study TitleA Phase 3 study of intravitreal OPT-302 in combination with aflibercept, compared with aflibercept alone, in participants with neovascular age-related macular degeneration (AMD)Study NameCOAST – Combination OPT-302 with Aflibercept STudy in neovascular AMDSponsorOpthea LimitedIndicationNeovascular (wet) age-related macular degeneration (AMD)Study Phase3Primary ObjectiveTo determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMDPrimary EndpointMean change from Baseline to Week 52 in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) lettersSecondary Endpoints Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52Change in CST by SD-OCT from Baseline to Week 52Change in the NEI VFQ-25 composite score from Baseline to Week 52Incidence of ocular and non-ocular treatment-emergent adverse eventsProportion of participants losing 15 or more ETDRS BCVA letters from Baseline to Week 52Participant incidence of ADA formationOPT-302 pharmacokinetic parameters Study DesignPhase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked, superiority studyInvestigational Product2.0 mg OPT-302 intravitreal injectionCo-administered anti-VEGF-A therapy2.0 mg aflibercept intravitreal injectionControlSham intravitreal injectionStudy ArmsThree study arms, randomised in a 1:1:1 ratio: Standard Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection at 4-weekly intervals (q4w), with 2.0 mg aflibercept (50 μl) intravitreal injection (3 doses at 4-weekly intervals, and then 8-weekly [q4w x 3 then q8w]).Extended Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection (q4w x 3 then q8w) with sham injection at visits when OPT-302 is not administered, with 2.0 mg aflibercept (50 μl) intravitreal injection (q4w x 3 then q8w).Control Sham intravitreal injection 4-weekly, with 2.0 mg aflibercept (50 μl) intravitreal injection (q4w x 3 then q8w) Key Eligibility Criteria Participants ≥ 50 years of either gender, with active CNV secondary to AMD confirmed by fluorescein angiography (FA), who are treatment naïveAn ETDRS BCVA score between 60 and 25 (inclusive) letters About Opthea Opthea (ASX:OPT; Nasdaq: OPT) is a biopharmaceutical company developing a novel therapy 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 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. 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 continuation of patient recruitment for Opthea’s pivotal Phase 3 clinical trials of OPT-302 in wet AMD. 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 the final prospectus filed with the SEC on October 19, 2020. 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. Company & Media Enquiries:Join our email database to receive program updates:Megan Baldwin, PhDCEO & Managing DirectorOpthea LimitedTel: +61 (0) 447 788 674megan.baldwin@opthea.comAustralia:Rudi MichelsonMonsoon CommunicationsTel: +61 (0) 3 9620 3333Tel: +61 (0) 3 9826 0399info@opthea.comwww.opthea.comU.S.A. & International: Jason WongBlueprint Life Science GroupTel: +1 415 375 3340, Ext 4Jwong@bplifescience.com
10 Mar, 2021
MELBOURNE, Australia, March 10, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT, Nasdaq: OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announced that Dr Megan Baldwin, CEO of Opthea, will virtually present and provide a corporate update at the Oppenheimer 31st Annual Healthcare Conference on Tuesday, March 16, 2021 at 3:50pm ET (Wednesday, March 17, 2021 at 6:50am AEDT). A live webcast of the presentation will be available on the Investors page of the Opthea website at https://www.opthea.com/presentations/. About Opthea Opthea (ASX:OPT; Nasdaq: OPT) is a biopharmaceutical company developing a novel therapy 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 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. 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 initiation of patient recruitment for Opthea’s planned pivotal Phase 3 clinical trials of OPT-302 in wet AMD. 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 the final prospectus filed with the SEC on October 19, 2020. 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. Company & Media Enquiries:Join our email database to receive program updates:Megan Baldwin, PhDCEO & Managing DirectorOpthea LimitedTel: +61 (0) 447 788 674megan.baldwin@opthea.comAustralia:Rudi MichelsonMonsoon CommunicationsTel: +61 (0) 3 9620 3333Tel: +61 (0) 3 9826 0399info@opthea.comwww.opthea.comU.S.A. & International: Jason WongBlueprint Life Science GroupTel: +1 415 375 3340, Ext 4Jwong@bplifescience.com
02 Mar, 2021
We can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...
24 Feb, 2021
ShORe Pivotal Phase 3 Clinical Trial OPT-302 in combination with Ranibizumab COAST Pivotal Phase 3 Clinical Trial OPT-302 with Aflibercept Following consultations with US FDA and EU EMA, two pivotal Phase 3 clinical trial designs are finalized to assess 2 mg OPT-302 administered 4-weekly or 8-weekly in combination with Lucentis® (ShORe study) and Eylea® (COAST study) standard of careInternationally recognized retinal disease specialists, Prof Timothy Jackson and Dr Charles Wykoff, named Chief investigators for the ShORe and COAST trials, respectively. In addition, Dr Jason Slakter, founder of the Digital Angiography Reading Center (DARC) in New York, will contribute expertise in ocular imaging.Opthea confirms planned initiation of Pivotal Phase 3 trials remains on-track for CY 1Q’21 MELBOURNE, Australia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; Nasdaq: OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces that it has finalized the protocol study designs and key start-up activities in readiness for the initiation of the Phase 3 ShORe and COAST pivotal clinical trials of OPT-302 in wet age-related macular degeneration (AMD). Finalization of the Phase 3 trial protocols follows productive consultations with the FDA, EMA and world-renowned Key Opinion Leaders (KOLs) in wet AMD. The trial protocols have also been submitted to relevant regulatory agencies, institutional review boards and human research ethics committees. Two global experts in the treatment of retinal diseases, Prof Timothy Jackson and Dr Charles Wykoff, will be the Chief investigators for the ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) trials, respectively. Professor Jackson, PhD, FRCOphth, is a consultant ophthalmic surgeon at King's College, London, and was also the Chief Investigator on the Opthea Phase 2b wet AMD clinical trial. Dr Wykoff, MD PhD, is the Director of Research, Retina Consultants of Texas and Deputy Chair for Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, Houston Texas. Another eminent retina specialist, Dr Jason Slakter, founder and Director of the Digital Angiography Reading Center (DARC) in New York, and Clinical Professor of Ophthalmology at NYU School of Medicine, will also provide expertise as a leading authority on ocular imaging for the Phase 3 clinical program. “The collaborative nature of our study protocol discussions with our KOLs, the FDA and EMA has been very pleasing and the constructive input received ensures that the design of the OPT-302 Phase 3 program has the potential to generate compelling and persuasive clinical data capable of satisfying regulatory requirements,” said Dr Megan Baldwin, Chief Executive Officer of Opthea. “With the achievement of other key start-up milestones, including successful scale-up of manufacturing and fill-finish of OPT-302 drug product for use in the trials, we now excitedly look forward to initiating the pivotal Phase 3 studies that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD.” The global, multi-centre, double-masked, sham-controlled, pivotal Phase 3 clinical trials will each enrol ~990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab (Lucentis®) (ShORe trial) or 2.0 mg aflibercept (Eylea®) (COAST trial), compared to ranibizumab or aflibercept monotherapy, respectively. In addition, extended durability of the OPT-302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT-302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor. If effective in these Phase 3 studies, OPT-302 could be adopted for administration with either Eylea or Lucentis which had combined sales for retinal diseases of USD$11.9 billion in 2019. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy. Each patient will continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period. Opthea remains on track to initiate the trials in the first quarter of calendar year (CY) 2021 and to report top-line data in the second half CY 2023. If the results at the completion of the primary efficacy phase at week 52 of the Phase 3 clinical trials are favourable, the Company intends to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA respectively for marketing approval for OPT-302 for the treatment of wet AMD in the United States, European Union and other global territories. Additional information on Opthea’s technology and clinical trials can be found appended to this announcement and at www.opthea.com. Company & Media Enquiries:Join our email database to receive program updates:Megan Baldwin, PhDCEO & Managing DirectorOpthea LimitedTel: +61 (0) 447 788 674megan.baldwin@opthea.comAustralia:Rudi MichelsonMonsoon CommunicationsTel: +61 (0) 3 9620 3333Tel: +61 (0) 3 9826 0399info@opthea.comwww.opthea.comU.S.A. & International: Jason WongBlueprint Life Science GroupTel: +1 415 375 3340, Ext 4Jwong@bplifescience.com About the ShORe Pivotal Phase 3 Clinical Trial In the Study of OPT-302 in combination with Ranibizumab, or ShORe, Phase 3 trial, ~990 treatment-naivepatients with wet AMD will be randomized 1:1:1 to one of three treatment groups. Patients randomized to the standard OPT-302 dosing arm will receive standard of care 0.5 mg ranibizumab every four weeks in combination with 2.0 mg OPT-302 on a every 4-week dosing regimen. In the extended OPT-302 dosing arm, 0.5 mg ranibizumab will be administered every four weeks to week 52, in combination with 2.0 mg OPT-302 administered every four weeks for three loading doses, followed by OPT-302 dosing on an every 8-week dosing regimen to week 52, with a sham injection given at visits where OPT-302 is not administered. Patients randomized to the control arm will receive 0.5 mg ranibizumab in combination with sham intravitreal injections administered every four weeks to week 52. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a9349638-ba1f-4094-a755-8093a4bbdbde About the COAST Pivotal Phase 3 Clinical Trial In the Combination OPT-302 with Aflibercept STudy, or COAST, Phase 3 trial, ~990 treatment-naive wet AMD patients will be randomized 1:1:1 to one of three treatment groups. Patients randomized to the standard OPT-302 dosing arm will receive 2.0 mg aflibercept administered every four weeks for three loading doses, followed by aflibercept dosing every eight weeks to week 52, in combination with 2.0 mg OPT-302 administered every four weeks to week 52. In the extended OPT-302 dosing arm, 2.0 mg aflibercept in combination with 2.0 mg OPT-302 will be administered every four weeks for three loading doses, followed by dosing every eight weeks to week 52, with a sham injection given at visits where OPT-302 and aflibercept are not administered. Patients randomized to the control arm, will receive 2.0 mg aflibercept administered every four weeks for three loading doses, followed by dosing every eight weeks to week 52, in combination with sham intravitreal injections administered every four weeks to week 52. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/de959ea2-dff3-4f9b-9754-ca756a624883 The primary and secondary efficacy outcomes for both Phase 3 studies will be determined at the end of the efficacy phase at week 52. Each patient will then continue to be treated for an additional year through week 100 to further evaluate safety and tolerability over a total two-year period. About Opthea Opthea (ASX:OPT; Nasdaq: OPT) is a biopharmaceutical company developing a novel therapy 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 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. 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 initiation of patient recruitment for Opthea’s planned pivotal Phase 3 clinical trials of OPT-302 in wet AMD. 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 the final prospectus filed with the SEC on October 19, 2020. 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.
17 Feb, 2021
MELBOURNE, Australia, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT, Nasdaq: OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announced that Dr Megan Baldwin, CEO of Opthea, will virtually present and provide a corporate update at the 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24, 2021 at 3:40pm ET (Thursday, February 25, 2021 at 7:40am AEDT). A live webcast of the presentation will be available on the Investors page of the Opthea website at https://www.opthea.com/presentations/. About Opthea Opthea (ASX:OPT, Nasdaq: OPT) is a biopharmaceutical company developing a novel therapy 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 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. 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, regarding the Company’s business as well as the proposed Offering. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including market conditions, the satisfaction of customary closing conditions relating to the Offering 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 the final prospectus related to the Offering to be filed with the SEC. 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. Company & Media Enquiries:Join our email database to receiveprogram updates:Megan Baldwin, PhDTel: +61 (0) 3 9826 0399CEO & Managing Directorinfo@opthea.com Opthea Limitedwww.opthea.com Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com Australia:U.S.A. & International:Rudi MichelsonJason WongMonsoon CommunicationsBlueprint Life Science GroupTel: +61 (0) 3 9620 3333Tel: +1 415 375 3340, Ext 4 Jwong@bplifescience.com
21 Oct, 2020
With the business potentially at an important milestone, we thought we'd take a closer look at Opthea Limited's...
16 Oct, 2020
MELBOURNE, Australia, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT, Nasdaq: OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces the pricing of its initial public offering in the United States (the “Offering”) of 8,563,300 American Depositary Shares (“ADS”), representing 68,506,400 ordinary shares, at an initial public offering price of US$13.50 per ADS, before underwriting discounts and commissions. In addition, and in lieu of ADSs, the Company offered and sold to certain investors pre-funded warrants to purchase 936,700 ADSs at a public offering price of US$13.49999 per pre-funded warrant, which represents the initial public offering price per ADS, minus the US$0.00001 per ADS exercise price of each pre-funded warrant. The aggregate gross proceeds to the Company are expected to be approximately US$128.2 million. The Company has also granted the underwriters a 30-day option to purchase up to an additional 1,425,000 ADSs at the initial public offering price per ADS less underwriting discounts and commissions. The ADSs are expected to begin trading on the Nasdaq Global Select Market on October 16, 2020 under the ticker symbol “OPT.” The Offering is expected to close on or about October 20, 2020, subject to the satisfaction of customary closing conditions. Citigroup and SVB Leerink are acting as joint book-running managers for the Offering. Oppenheimer & Co. and Truist Securities are acting as lead managers.A registration statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on October 16, 2020. The Offering is being made only by means of a prospectus. Copies of the final prospectus relating to and describing the terms of the Offering, when available, may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110; by telephone at (800) 808-7525, ext. 6132; or email: syndicate@svbleerink.com.This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.About OptheaOpthea (ASX:OPT, Nasdaq: OPT) is a biopharmaceutical company developing a novel therapy 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 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 CompaniesThere 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, regarding the Company’s business as well as the proposed Offering. Any statement describing Company goals, expectations, intentions or beliefs, including as they relate to the proposed Offering and its expected closing, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including market conditions, the satisfaction of customary closing conditions relating to the Offering 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 the final prospectus related to the Offering to be filed with the SEC. 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.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhDTel: +61 (0) 3 9826 0399 CEO & Managing Directorinfo@opthea.com  Opthea Limitedwww.opthea.com  Tel: +61 (0) 447 788 674  megan.baldwin@opthea.com      Australia:U.S.A. & International: Rudi MichelsonJason Wong Monsoon CommunicationsBlueprint Life Science Group Tel: +61 (0) 3 9620 3333Tel: +1 415 375 3340, Ext 4  Jwong@bplifescience.com
15 Oct, 2020
Opthea, an Australian clinical stage biotech company, is going public to help fund its Phase 3 trials and take on two large biotech companies.About Opthea: The main area of focus for Opthea Ltd (NASDAQ: OPT) is wet age-related macular degeneration, commonly referred to as AMD, and other retinal diseases.The company's OPT-302, is a "biologic designed to inhibit VEGF-C and VEGF-D to complement VEGF-A inhibitors for the treatment of ophthalmic diseases."Anti-VEGF-A therapies are the standard of care for wet AMD. Many patients do not respond to these treatments.OPT-302 is the only biologic inhibitor of VEGF-C and VEGF-D in clinical development.Opthea is planning to launch two Phase 3 trials for wet AMD in combination with anti-VEGF-A therapies compared to the anti-VEGF-A therapy on their own. Top line results are expected in 2023.The company is also targeting diabetic macular edema -- DME -- with a Phase 1b/2a trial.Opthea recently named Jeremy Levin as its chairman. Levin is the chairman of the Biotechnology Innovation Organization, the largest trade organization worldwide for the biotechnology industry.Levin has previously worked as the president and CEO of Teva Pharmaceuticals (NYSE: TEVA) and held roles with Bristol-Myers Squibb (NYSE: BMY) and Novartis (NYSE: NVS).The Opthea Offering: Opthea, which is listed on the Australian Stock Exchange, plans on selling 9.3 million ADSs at a price point of around $17.26. Each ADS will represent eight common shares.The funds from the offering will be used to advance the two Phase 3 trials of OPT-302 and push the trial targeting DME further.Opthea has $42.6 million in cash prior to the offering. With the offering, it believes it can fund operations through the third quarter of 2023. The AMD Market: Opthea believes there is a significant market opportunity for wet AMD that will grow with an aging population. Wet AMD is a rapidly progressing disease that affects the loss of central vision.There are an estimated 1 million people with wet AMD in the United States and 2.5 million in the European Union.Opthea also believes its OPT-302 can beat already approved treatment options on the market."The potential to lead to sales greater than the combined annual sales of ranibizumab and aflibercept," Opthea said in an SEC filing. Lucentis (ranibizumab) and Eylea (aflibercept) are the top two treatment options available for wet AMD and had combined sales of $11.9 billion in 2019 for the U.S. market.Lucentis is sold by Genentech, a Roche Holding (OTCQX: RHHBY) company. Eylea is sold by Regeneron Pharmaceuticals (NASDAQ: REGN).Eylea had sales of $8.1 billion in 2019. The treatment has passed Lucentis due to the fewer injections involved for patients.Plans for Growth: Opthea's goal is to become a leader in retinal diseases treatments. With the help of this offering, the company expects to: * Advance OPT-302 through two Phase 3 trials for the treatment of wet AMD * Expand clinical development of OPT-302 in other retinal diseases like DME * Maximize the commercial potential of OPT-302 through commercialization independently or through collaborations with other companiesOpthea has worldwide commercial rights to all of its clinical trial treatments.See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * Fastly Analysts Have More Questions Than Answers Amid Q3 Warning * Fisker Announces Magna As Partner On ,499 Ocean SUV Ahead Of SPAC Merger(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
12 Oct, 2020
Opthea Limited, a biotechnology company focussed on retinal diseases, announced Sunday it is seeking an initial public offering in the United States.What Happened: The Melbourne Australia-based biopharmaceutical company will offer American Depositary Shares each of which will represent eight of the company's ordinary shares.Opthea is targeting $160 million in gross proceeds in the offering and is giving underwriters a 30-day option to purchase an additional 15% of the ADSs in the IPO.The ADSs will be listed on the Nasdaq Stock Market under the symbol "OPT."Citigroup Inc (NYSE: C) and SVB Leerink have been appointed as joint book-running managers, while Oppenheimer Holdings Inc (NYSE: OPY)-subsidiary Oppenheimer & Co and Truist Financial Corporation's (NYSE: TFC) division Truist Securities are acting as lead managers.On Monday, at press-time, the company's shares traded at $2.18 in Sydney, which would price an ADR at $17.44.Why It Matters: Opthea's focus is on developing a novel therapy for highly preventable and progressive retinal diseases including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).The company's lead clinical candidate OPT-302 is under development for use in combination with anti-VEGF-A monotherapies.The company -- founded in 2012 -- raked in $1 million in revenue for 12 months ended June 30, according to Renaissance Capital.Photo courtesy of OptheaSee more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * LA Lakers Beat Miami Heat 106-93 To Emerge As NBA Champions * Regeneron CEO Says More Testing Needed For Antibody Cocktail After Trump Touted It As COVID-19 'Cure'(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
MELBOURNE, Australia, Oct. 11, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces the launch of its initial public offering (the “Offering”) of American Depositary Shares (“ADS”), each of which will represent eight of the Company’s ordinary shares, in the United States. The target size of the Offering is US$160 million in gross proceeds. The Company also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of ADSs sold in the Offering, at the initial public offering price per ADS less underwriting discounts and commissions. All ADSs to be sold in the Offering will be offered by the Company. Opthea has applied to list its ADSs on the Nasdaq Global Select Market under the ticker symbol “OPT.” The ordinary shares are listed, and upon the completion of the Offering will continue to trade, on the Australian Securities Exchange (ASX) under the symbol “OPT.”Citigroup and SVB Leerink are acting as joint book-running managers for the Offering. Oppenheimer & Co. and Truist Securities are acting as lead managers.The Offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to and describing the terms of the Offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110; by telephone at (800) 808-7525, ext. 6132; or email: syndicate@svbleerink.com.A registration statement relating to the securities referred to herein has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.About OptheaOpthea (ASX:OPT) is a biopharmaceutical company developing a novel therapy 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 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 CompaniesThere 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 ASX announcement may contain forward-looking statements regarding the Company’s business as well as the proposed Offering. Any statement describing Company goals, expectations, intentions or beliefs, including as they relate to the proposed Offering, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including market conditions and the trading price of the Company’s ordinary shares on the ASX. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhD                 CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333 Tel: +61 (0) 3 9826 0399 info@opthea.com www.opthea.com U.S.A. & International: Jason Wong Blueprint Life Science Group Tel: +1 415 375 3340, Ext 4 Jwong@bplifescience.com
05 Oct, 2020
MELBOURNE, Australia, Oct. 05, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that Jeremy Levin, DPhil, MB BChir (Dr Levin) will be appointed to the Company’s Board of Directors, effective October 12, 2020. Dr Levin is Chairman and Chief Executive Officer (CEO) of Ovid Therapeutics Inc (NASDAQ:OVID), and is concurrently the Chairman of the Biotechnology Innovation Organization (BIO), the largest trade organization in the world that represents the biotechnology industry. Prior to founding Ovid, Dr Levin was President and CEO of Teva Pharmaceutical Industries Ltd and before Teva, was a member of the executive committee of Bristol-Myers Squibb Company. Dr Levin joined BMY from Novartis where he was Global Head of Strategic Alliances. He has served on the board of directors of various public and private biopharmaceutical companies, including Biocon Ltd (NSE: BIOCON), and is currently on the board of directors of Lundbeck (OMX: LUN).Dr Levin was voted as one of the 25 most influential biotechnology leaders by Fierce Biotech in 2018 and one of the top 3 biotechnology CEOs in 2020 by The Healthcare Technology Report. In August 2020 he was named to the PharmaVoice 100, an annual list of the most innovative, influential and inspirational people in the life sciences industry. He is the recipient of the Albert Einstein Award for Leadership in Life Sciences and the B’nai B’rith Award for Distinguished Achievement.Dr Levin has practiced medicine at university hospitals in England, South Africa and Switzerland. He earned a First-Class Bachelor’s degree and a Masters’ degree and Doctorate at the University of Oxford. He subsequently received his Bachelor of Medicine and Bachelor of Surgery degrees from the University of Cambridge.Mr Geoffrey Kempler, current Chairman of Opthea has decided to retire from Opthea and not stand for re-election as a director of Opthea at its general meeting on 12 October 2020. Mr Kempler said, “On behalf of Opthea and my fellow Directors, we welcome Dr Levin to the Board. I am delighted that in a planned succession, Dr Levin will assume the role of Chairman of the Board upon my retirement as Chairman at the conclusion of Opthea’s Annual General Meeting on October 12th. Dr Levin’s track record and experience in the biotechnology and pharmaceutical industry, together with his knowledge and support will be instrumental as the company advances its Phase 3-ready product candidate, OPT-302, for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), conditions which affect over 5 million people worldwide.”About Opthea LimitedOpthea (ASX:OPT) is a biopharmaceutical company developing a novel therapy 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 technology is based on two members of the Vascular Endothelial Growth Factor (VEGF) family of proteins, VEGF-C and VEGF-D, and their activation of VEGF receptors. VEGF-C and VEGF-D promote blood vessel development (angiogenesis) and vascular permeability and leakage by binding and activating VEGFR-2 and VEGFR-3, VEGF-C and VEGF-D can also be upregulated to compensate for VEGF-A inhibition, which may represent an important mechanism of clinical resistance to anti-VEGF-A monotherapy. Opthea’s lead product candidate OPT-302, is a soluble form of VEGFR-3 or ‘trap’, designed to address a deficiency in the treatment paradigm for wet AMD and other retinal diseases by targeting VEGF-C and VEGF-D, which are not targeted by current standard of care therapies. OPT-302 is 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 CompaniesThere 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 statementsCertain statements in this ASX announcement may contain forward-looking statements regarding Company business and the therapeutic and commercial potential of its technologies and products in development. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercializing drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavor of building a business around such products and services. Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhD CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com Tel: +61 (0) 3 9826 0399 info@opthea.com www.opthea.com Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333U.S.A. & International: Jason Wong Blueprint Life Science Group Tel: +1 415 375 3340, Ext 4 Jwong@bplifescience.com
25 Sep, 2020
MELBOURNE, Australia, Sept. 25, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces the public filing of a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to a proposed public offering (the “Offering”) of American Depositary Shares (“ADSs”), each of which will represent one or a number of the Company’s ordinary shares in the United States. Concurrent with the proposed public offering, Opthea also intends to list the ADSs on the Nasdaq Global Market (“Nasdaq”). All securities to be sold in the Offering will be offered by Opthea. The number of securities to be sold and the price per ADS under any proposed Offering have not yet been determined.Opthea has applied to list its ADSs on Nasdaq under the ticker symbol “OPT.” The ordinary shares are listed, and upon the completion of the Offering will continue to trade, on the Australian Securities Exchange (ASX) under the symbol “OPT.”Citigroup and SVB Leerink are acting as joint book-running managers for the Offering. Oppenheimer & Co. and Truist Securities are acting as lead managers. The proposed Offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110; by telephone at (800) 808-7525, ext. 6218; or email: syndicate@svbleerink.com.A registration statement relating to the securities referred to herein has been filed with the U.S. Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.About Opthea LimitedOpthea (ASX:OPT) is a biologics drug developer developing a novel therapy to address the unmet need in the treatment of highly prevalent and progressive retinal diseases. Opthea’s product development programs are focused on developing OPT-302 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).  Opthea is developing OPT-302 for use in combination with inhibitors of VEGF-A. Inherent risks of Investment in Biotechnology CompaniesThere 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 commercialisation 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 specialising in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.Forward-looking statementsCertain statements in this ASX announcement may contain forward-looking statements regarding the proposed Offering, the intended listing on Nasdaq, the Company’s business and the therapeutic and commercial potential of its technologies and products in development.  Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services, as well as risks relating to market conditions, completion of the offering and approval to list the ADSs on Nasdaq.  Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.  Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhD CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com  Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333  Tel: +61 (0) 3 9826 0399 info@opthea.com www.opthea.com     U.S.A. & International:  Jason Wong Blueprint Life Science Group Tel: +1 415 375 3340, Ext 4 Jwong@bplifescience.com
10 Sep, 2020
MELBOURNE, Australia, Sept. 10, 2020 (GLOBE NEWSWIRE) -- The directors of Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, are pleased to announce the appointment of Mr Daniel Spiegelman as an independent Non-Executive Director, who will also serve as Chair of the Company’s Audit and Risk Committee, effective from September 10, 2020.   Mr Spiegelman is a respected and credentialed figure in the biotechnology industry who has provided strategic financial management and insight to a number of life science companies during his career. Most recently, Mr Spiegelman served as the Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical from May 2012 to January 2020. He is currently interim CEO of Recardia Therapeutics and Director and Audit Committee Chair of Myriad Genetics, and the privately held companies Tizona Therapeutics and Spruce Biosciences.  Mr Spiegelman’s prior experience includes several roles at Genentech Inc., including Treasurer, and Chief Financial Officer of CV Therapeutics. Mr Spiegelman previously served as a director of a number of companies, including Cascadian Therapeutics (formerly Oncothyreon) until its merger with Seattle Genetics, Relypsa until its merger with Galenica AG, Anthera Pharmaceuticals, Affymax, Omeros Corporation and Cyclacel Pharmaceuticals.Opthea’ Chairman, Mr Geoffrey Kempler said “We are delighted to welcome Mr Spiegelman to the Opthea Board. Mr Spiegelman brings a wealth of industry knowledge and has relevant US corporate governance, compliance and financial management experience, having held numerous executive and Board roles, including as Audit and Risk Committee Chair, with several US public and private companies. Mr Spiegelman is an excellent addition to the Board as we prepare to expand our operations in the US and internationally and advance OPT-302 through Phase 3 clinical development.” Mr Spiegelman commented “I am excited to be joining the Board of Opthea and pleased to be part of the Company’s plans for continued success. I see the potential of Opthea’s OPT-302 program to improve the treatment of patients with highly progressive retinal diseases and to tap into the multi-billion dollar commercial market to address the unmet medical need for patients with these debilitating conditions.”Mr Spiegelman holds a Bachelor of Arts degree from Stanford University and an MBA from the Stanford Graduate School of Business.About Opthea LimitedOpthea (ASX:OPT) is a biologics drug developer developing a novel therapy to address the unmet need in the treatment of highly prevalent and progressive retinal diseases. It retains worldwide rights to a significant intellectual property portfolio around OPT-302. Opthea’s intellectual property is held within its wholly-owned subsidiary Vegenics Pty Ltd. Opthea’s product development programs are focused on developing OPT-302 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak, processes which contribute to the pathophysiology of retinal diseases. Opthea is developing OPT-302 for use in combination with inhibitors of VEGF-A. Opthea has also reported outcomes from an international, multi-centre, prospective, sham-controlled, double-masked, superiority study that enrolled 366 treatment-naïve patients with wet AMD. Participants in the study were randomized in a 1:1:1 ratio to receive one of the following treatment regimens administered once every 4 weeks for 24 weeks (six treatments in total): OPT-302 (0.5 mg) in combination with ranibizumab (Lucentis®) (0.5 mg); OPT-302 (2.0 mg) in combination with ranibizumab (0.5 mg); or sham in combination with ranibizumab (0.5 mg). The study met the primary endpoint demonstrating superior vision gains in participants who received OPT-302 (2.0 mg) in combination with ranibizumab at week 24. Opthea has also reported outcomes from a Phase 1b/2a clinical trial in patients with persistent, centre-involved DME. Further details on the Company’s clinical trials can be found at: www.clinicaltrials.gov, Clinical trial identifiers: NCT02543229, NCT03345082 and NCT03397264.Inherent risks of Investment in Biotechnology CompaniesThere 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 commercialisation 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 specialising in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.Forward-looking statementsCertain statements in this ASX announcement may contain forward-looking statements regarding Company business and the therapeutic and commercial potential of its technologies and products in development. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services. Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhD                                          CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333 Tel: +61 (0) 3 9826 0399 info@opthea.com  www.opthea.com  U.S.A. & International:  Jason Wong Blueprint Life Science Group Tel:  +1 415 375 3340, Ext 4 Jwong@bplifescience.com
24 Aug, 2020
MELBOURNE, Australia, Aug. 24, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT) today announces that it has confidentially submitted a draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission (the “SEC”) relating to a potential initial public offering of American Depositary Shares (“ADSs”) in the U.S. representing Opthea’s ordinary shares, which will remain listed on the Australian Securities Exchange, and concurrent listing of the ADSs on the Nasdaq Stock Market (“Nasdaq”).  Any offering and listing of ADSs on Nasdaq would be intended to support Opthea’s product development activities, including its previously announced Phase 3 trials of OPT-302 for the treatment of wet AMD.  The number of ADSs that may be offered, the number of underlying ordinary shares that may be issued, the price for such instruments and the timing of the offering have not yet been determined.  Any offering is expected to commence after the SEC completes its review process, subject to market conditions, investor demand and shareholder approval. No final decision has been made in respect of any additional listing and there can be no assurance as to the occurrence, timing and/or completion of such a listing. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended (“Securities Act”). This announcement is being issued in accordance with Rule 135 under the Securities Act.Forward-looking statementsCertain statements in this ASX announcement may contain forward-looking statements regarding Company business, financing activities and the therapeutic and commercial potential of its technologies and products in development.  Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercializing drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services.  Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.  Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhD CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333  Tel: +61 (0) 3 9826 0399 info@opthea.com www.opthea.com U.S.A. & International:  Jason Wong Blueprint Life Science Group Tel: +1 415 375 3340, Ext 4 Jwong@bplifescience.com
21 Aug, 2020
* Regulatory engagement provides clear pathway through Phase 3 to support filing for marketing approvals in US and Europe * Regulatory agreement of using Lucentis® and Eylea® in combination with OPT-302 across two pivotal Phase 3 trials increases the potential multi-billion dollar market opportunity * Lucentis® and Eylea® had combined sales for retinal diseases of USD11.9BN in 2019  * Company on-track to initiate Phase 3 trials in early 2021             MELBOURNE, Australia, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical-stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce today that it has successfully completed End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA), and a Scientific Advice meeting with the European Medicines Agency (EMA), to obtain guidance on the Phase 3 clinical development plans of OPT-302 as a treatment for neovascular (wet) age-related macular degeneration (wet AMD).  The outcome of the meetings supports the progression of OPT-302 into Phase 3 and pre-commercial development.  The company is on-track to initiate Phase 3 trials in early 2021.The regulatory engagement conducted with the FDA and EMA covered key elements of the Phase 3 clinical studies and associated manufacturing processes for OPT-302 that will support the submission of a Biologics License Application in the US and Marketing Authorisation Application in Europe for the targeted wet AMD indication.      The FDA and EMA agreed on key aspects of the proposed Phase 3 clinical trial designs, including the conduct of two concurrent, global, multicenter, randomized, sham-controlled studies evaluating OPT-302 in combination with ranibizumab (Lucentis®) (Study OPT-302-1004, referred to as ShORe) or aflibercept (Eylea®) (Study OPT-302-1005, referred to as COAST).  If successful, the investigation of OPT-302 in combination with two approved standard of care VEGF-A inhibitors could enable OPT-302 to be administered with either Eylea or Lucentis which had combined sales for retinal diseases of USD$11.9 billion in 2019.  Furthermore, each trial will compare the clinical efficacy of OPT-302 administered in combination with a VEGF-A inhibitor on an every 4-week and every 8-week dosing regimen in order to understand the durability of OPT-302 treatment effect with less frequent dosing.In the Study of OPT-302 in combination with Ranibizumab (ShORe), treatment-naïve patients with wet AMD will be randomized to one of three treatment arms to receive standard of care 0.5 mg ranibizumab every four weeks in combination with either 2.0 mg OPT-302 on a standard every four weeks dosing regimen or 2.0 mg OPT-302 on an extended every eight weeks dosing regimen after three monthly initiating doses, or with sham injections every four weeks.In COAST, Combination OPT-302 with Aflibercept STudy, treatment-naïve patients with wet AMD will be randomized to one of three treatment arms to receive standard of care 2.0 mg aflibercept on its every eight-week dosing regimen, after three monthly initiating doses, in combination with either 2.0 mg OPT-302 on a standard every four weeks dosing regimen or 2.0 mg OPT-302 on an extended every eight weeks dosing regimen after three monthly initiating doses, or with sham injections every four weeks.Each trial is expected to enroll at least 900 patients worldwide. The primary endpoint is mean change in visual acuity from baseline to week 52 for OPT-302 and anti-VEGF-A combination therapy compared to anti-VEGF-A monotherapy, with the Company intending to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA respectively following completion of this primary efficacy phase of the trials.  Each patient will continue to be treated for a further year to evaluate safety and tolerability over a two-year period.These two OPT-302 Phase 3 trials build upon and maintain key features for consistency with the Company’s positive Phase 2b clinical trial of OPT-302, while evaluating the administration of OPT-302 combination therapy over a longer treatment period and in a greater number of patients.  In addition, the Phase 3 trials are optimized based on Phase 2b outcomes to maximize probability of success and commercial opportunity.  Analysis of the Phase 2b trial demonstrated that OPT-302 combination therapy increased visual acuity by a further +5.7 letters over Lucentis monotherapy in wet AMD patients with minimally classic and occult lesions, representing the majority (~80%) of wet AMD patients.  Based on these positive data, primary analysis of the primary endpoint of the Phase 3 trials will be first conducted in patients with minimally classic and occult lesions administered OPT-302 every 4 weeks, followed by analysis on the every 8 week dosing groups and total patient population. “We are very pleased with the valuable guidance received from the FDA and EMA which provides clear direction as we advance our Phase 3 registration program towards bringing OPT-302 to market” said Dr Megan Baldwin, Chief Executive Officer of Opthea. “We remain focused on further demonstrating, in our Phase 3 program, the potential of OPT-302 combination therapy as a novel and transformative treatment for wet AMD patients suffering vision loss.”“The analysis approach for our Phase 3 clinical trials allows the initial analysis of outcomes to be evaluated in the patient group which, based on data from our Phase 2b trial, would be expected to have the best response to OPT-302 combination therapy.  Further pre-specified statistical analyses also allow us to evaluate the primary endpoint in the total patient population including minimally classic, occult and predominantly classic lesions, which maximizes the commercial opportunity for OPT-302” commented Dr Baldwin.  “We believe this approach achieves the highest probability of success for our Phase 3 program and commercialization strategy.”  The planning for the pivotal Phase 3 studies is well advanced including the manufacturing of OPT-302 drug product to be used in the trials.  Importantly, there are now well-defined regulatory pathways in place to advance the Phase 3 program development of OPT-302 in the treatment of wet AMD in support of future registration filings for marketing approval and commercial launch in the U.S. and Europe.Additional information on Opthea’s technology and clinical trials can be found at www.opthea.com. About Opthea LimitedOpthea (ASX:OPT) is a biologics drug developer focusing on ophthalmic disease therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around VEGF-C, VEGF-D and VEGFR-3. Opthea’s intellectual property is held within its wholly-owned subsidiary Vegenics Pty Ltd. Opthea’s product development programs are focused on developing OPT-302 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).  OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak, processes which contribute to the pathophysiology of retinal diseases.  Opthea is developing OPT-302 for use in combination with inhibitors of VEGF-A. Opthea has reported outcomes from an international, multi-centre, prospective, sham-controlled, double-masked, superiority study that enrolled 366 treatment-naïve patients with wet AMD.  Participants in the study were randomized in a 1:1:1 ratio to receive one of the following treatment regimens administered once every 4 weeks for 24 weeks (six treatments in total): OPT-302 (0.5 mg) in combination with ranibizumab (Lucentis®) (0.5 mg); OPT-302 (2.0 mg) in combination with ranibizumab (0.5 mg); or sham in combination with ranibizumab (0.5 mg).  The study met the primary endpoint demonstrating superior vision gains in participants who received OPT-302 (2.0 mg) in combination with ranibizumab at week 24.  Opthea is also investigating OPT-302 in a Phase 2a clinical trial in patients with persistent, centre-involved DME.  Further details on the Company’s clinical trials can be found at: www.clinicaltrials.gov, Clinical trial identifiers:  NCT02543229, NCT03345082 and NCT03397264.Inherent risks of Investment in Biotechnology CompaniesThere 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 commercialisation 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 specialising in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.Forward-looking statementsCertain statements in this ASX announcement may contain forward-looking statements regarding Company business and the therapeutic and commercial potential of its technologies and products in development.  Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services.  Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.  Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhD  CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com  Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333  Tel: +61 (0) 3 9826 0399 info@opthea.com  www.opthea.com    U.S.A. & International:  Jason Wong Blueprint Life Science Group Tel:  +1 415 375 3340, Ext 4 Jwong@bplifescience.com
20 Aug, 2020
A look at the shareholders of Opthea Limited (ASX:OPT) can tell us which group is most powerful. Large companies...
27 Jul, 2020
Company to host Key Opinion Leader Symposium on Wet AMD & DME on Aug 5th, 7:00pm EDTMELBOURNE, Australia, July 27, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that new data from the Phase 1b/2a clinical study of OPT-302 in patients with treatment refractory diabetic macular edema (DME) has been presented at the 2020 American Society of Retina Specialists (ASRS) Virtual Annual Meeting (24-26 July 2020). The presentation titled “Switching to combination OPT-302 with aflibercept from prior anti-VEGF-A monotherapy in eyes with persistent diabetic macula edema (DME)” was presented by Dr David Boyer, MD, Senior Partner Retina Vitreous Associates Medical Group, Los Angeles, and Clinical Professor at the University of Southern California Roski Eye Institute, Keck School of Medicine.  The presentation was part of the “Diabetic Retinopathy Symposium” and provided an overview of the scientific rationale for targeting VEGF-C/-D for the treatment of DME and new data from Opthea’s Phase 1b/2a clinical trial of OPT-302, including subgroup analyses to evaluate outcomes in patients with a more homogeneous prior treatment history of previous aflibercept (Eylea) therapy. In the subset of patients who received a minimum of at least three consecutive aflibercept intravitreal injections on a regular basis immediately before enrollment into the Phase 2a trial (n=35), a mean improvement in best corrected visual acuity (BCVA) of +6.6 letters (n=22) from baseline to week 12 was observed following OPT-302 + aflibercept combination treatment, compared to +3.4 letters (n=13) for patients continuing on aflibercept monotherapy.In addition, the proportion of patients gaining ≥10 letters from baseline to week 12 in the OPT-302 combination group was 27.3% compared to 0% in the aflibercept monotherapy group. The proportion of patients gaining ≥15 letters from baseline to week 12 was 9.1% in the OPT-302 combination group, compared to 0% patients in the aflibercept monotherapy group. Furthermore, the proportion of patients who lost ≥1 letter of BCVA from baseline to week 12 was 9.1% in the OPT-302 combination therapy group and 23.1% in the aflibercept monotherapy group.Improved anatomical changes were consistent with these functional visual acuity outcomes, as the mean reduction in retinal thickness, measured as central subfield thickness (CST) from baseline to week 12, was -42.3 µm in the OPT-302 combination therapy group and -15.5 µm in the aflibercept monotherapy group.  The proportion of patients with improved CST of ≤300 µm at week 12 was 22.7% in the OPT-302 combination therapy group and 7.7% in the aflibercept monotherapy group. In addition, improved underlying diabetic retinopathy by 2 or more steps was observed in 13.6% of patients in the OPT-302 combination therapy and 7.7% in the aflibercept monotherapy group.“We are very pleased to report favorable visual function and anatomical outcomes following OPT-302 combination therapy in DME patients with persistent disease despite prior treatment with standard-of-care anti-VEGF-A therapy. The new data presented at ASRS includes a subgroup analysis of approximately one third of patients enrolled into the study with a treatment history of prior aflibercept.  This patient population represents a more stringent and less variable patient population in which to investigate the ability of OPT-302 to provide additional benefit, particularly as aflibercept is considered the optimal first-line standard of care treatment to achieve maximal VEGF-A suppression in DME,” said Dr Megan Baldwin, CEO and Managing Director, Opthea Limited.Dr Baldwin also commented “The positive outcomes with OPT-302 combination therapy in these patients is very encouraging, particularly given that treatment refractory patients are considered difficult-to-treat and that outcomes were assessed after only three monthly doses at week 12.  Our DME trial results support further investigation in this indication in larger, randomized, controlled clinical trials.”In addition, the overall safety profile of OPT-302 combination therapy has continued to be favorable and has now shown consistent tolerability alone or in combination with anti-VEGF-A standard of care therapy across two eye indications with over 1850 intravitreal injections administered to nearly 400 patients with wet AMD and DME.  The Phase 2a DME trial is ongoing with additional analyses and the final outcomes for longer term safety and treatment durability to be completed in the second half of calendar year 2020. In addition to the ongoing Phase 2a trial, Opthea continues to undertake planning for its Phase 3 program in wet AMD, including regulatory engagement in the US and Europe, and to progress its manufacturing of OPT-302 for Phase 3 clinical trials.A copy of the data presented at the ASRS 2020 Virtual Meeting has been posted to the ASX and is available on the Opthea website at www.opthea.com.Opthea plans to host a Key Opinion Leader symposium focused on providing insights into the current treatment landscape and an overview of Opthea’s clinical programs in both wet AMD and DME. The virtual online event will be held from 7pm – 8:30pm EDT on Wednesday, August 5, 2020 (9am – 10:30am AEST on Thursday, August 6, 2020) and additional details will provided closer to the event.About Opthea LimitedOpthea (ASX:OPT) is a biologics drug developer focusing on ophthalmic disease therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around VEGF-C, VEGF-D and VEGFR-3. Opthea’s intellectual property is held within its wholly-owned subsidiary Vegenics Pty Ltd. Opthea’s product development programs are focused on developing OPT-302 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).  OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak, processes which contribute to the pathophysiology of retinal diseases.  Opthea is developing OPT-302 for use in combination with inhibitors of VEGF-A. The OPT-302 DME trial was a prospective,  proof-of-concept, clinical study consisting of a dose escalation (Phase 1b) followed by a randomized dose expansion (Phase 2a)  in treatment refractory participants with the aim to evaluate the safety, visual function and anatomic outcomes of switching from anti-VEGF-A monotherapy to combination therapy of OPT-302 with aflibercept.  In the Phase 1b, patients received escalating doses of OPT-302 (either 0.3, 1 or 2 mg) + aflibercept (2 mg) across 3 cohorts.  In the Phase 2a, 144 patients were randomized in a 2:1 ratio to either 2 mg aflibercept + 2 mg OPT-302 or aflibercept + sham.  Aflibercept ± OPT-302 was given once every 4 weeks for a total of 3 doses, and patients then assessed through week 12 for outcomes including safety, effects on BCVA, and anatomic changes. A total of 115 patients enrolled in the study complied sufficiently with the protocol and were included in the Per Protocol population.Opthea has also reported outcomes from an international, multi-centre, prospective, sham-controlled, double-masked, superiority study that enrolled 366 treatment-naïve patients with wet AMD.  Participants in the study were randomized in a 1:1:1 ratio to receive one of the following treatment regimens administered once every 4 weeks for 24 weeks (six treatments in total): OPT-302 (0.5 mg) in combination with ranibizumab (Lucentis®) (0.5 mg); OPT-302 (2.0 mg) in combination with ranibizumab (0.5 mg); or sham in combination with ranibizumab (0.5 mg).  The study met the primary endpoint demonstrating superior vision gains in participants who received OPT-302 (2.0 mg) in combination with ranibizumab at week 24.  Opthea is also investigating OPT-302 in a Phase 2a clinical trial in patients with persistent, centre-involved DME.  Further details on the Company’s clinical trials can be found at: www.clinicaltrials.gov, Clinical trial identifiers:  NCT02543229, NCT03345082 and NCT03397264.Inherent risks of Investment in Biotechnology CompaniesThere 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 commercialisation 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 specialising in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.Forward-looking statementsCertain statements in this ASX announcement may contain forward-looking statements regarding Company business and the therapeutic and commercial potential of its technologies and products in development.  Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services.  Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.  Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates: Megan Baldwin, PhD  CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333  Tel: +61 (0) 3 9826 0399 info@opthea.com www.opthea.com U.S.A. & International:  Jason Wong Blueprint Life Science Group Tel:  +1 415 375 3340, Ext 4 Jwong@bplifescience.com
23 Jul, 2020
MELBOURNE, Australia, July 23, 2020 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that clinical trial results from the Phase 1b/2a study of OPT-302 in diabetic macular edema (DME) patients refractory to anti-VEGF-A therapy, will be presented at the upcoming American Society of Retina Specialists Annual (ASRS) 2020 Virtual Annual Meeting.  The ASRS is the largest vitreoretinal specialty society in the world, with more than 3,000 members from 63 countries and the annual meeting represents one of the largest U.S. conferences for retinal specialists.Dr David Boyer, MD, an internationally recognized vitreo-retinal specialist ophthalmologist and prominent principal investigator will present clinical data from the OPT-302 Phase 1b/2a DME study for the first time at the ASRS 2020 Virtual Annual Meeting. Details of the presentation are as follows: Oral presentation: Switching to combination OPT-302 with aflibercept from prior anti-VEGF-A monotherapy in eyes with persistent diabetic macula edema (DME) Presenter: David Boyer, MD, Senior Partner Retina Vitreous Associates Medical Group, Los Angeles, and Clinical Professor at the University of Southern California Roski Eye Institute, Keck School of Medicine Virtual Meeting Session: Diabetic Retinopathy Symposium Date: Saturday, July 25, 2020 “The Phase 1b/2a clinical data to be presented at ASRS 2020 includes results of OPT-302 combination therapy from nearly 300 injections in over 150 patients with persistent DME despite prior anti-VEGF-A monotherapy.  The acceptance of the oral presentation demonstrates the depth of our science and high level of interest and we look forward to Dr Boyer sharing the data for the first time with the retina specialist community during ASRS,” said Megan Baldwin, CEO and Managing Director, Opthea Limited.  The OPT-302 DME trial was a prospective,  proof-of-concept, clinical study consisting of a dose escalation (Phase 1b) followed by a randomized double-masked, dose expansion study (Phase 2a) in treatment refractory participants with the aim to evaluate the safety, visual function and anatomic outcomes of switching from anti-VEGF-A monotherapy to combination therapy of OPT-302 with aflibercept.  In the Phase 1b study, patients received escalating doses of OPT-302 (either 0.3, 1 or 2 mg) + aflibercept (2 mg) across 3 cohorts.  In the Phase 2a, 144 patients were randomized in a 2:1 ratio to either 2 mg aflibercept + 2 mg OPT-302 or aflibercept + sham.  Aflibercept ± OPT-302 was given once every 4 weeks for a total of three doses. The primary analysis was conducted at week 12, four weeks after the final dose.The slide presentation will be available on the Opthea website at https://www.opthea.com/ following completion of the presentation.  Additional information on Opthea’s technology and clinical trials in wet AMD and DME can be found at www.opthea.com and ClinicalTrials.gov (ID: NCT03345082 and ID: NCT03397264, respectively).About Opthea LimitedOpthea (ASX:OPT) is a biologics drug developer focusing on ophthalmic disease therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around VEGF-C, VEGF-D and VEGFR-3. Opthea’s intellectual property is held within its wholly-owned subsidiary Vegenics Pty Ltd. Opthea’s product development programs are focused on developing OPT-302 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).  OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak, processes which contribute to the pathophysiology of retinal diseases.  Opthea is developing OPT-302 for use in combination with inhibitors of VEGF-A. Opthea has also reported outcomes from an international, multi-centre, prospective, sham-controlled, double-masked, superiority study that enrolled 366 treatment-naïve patients with wet AMD.  Participants in the study were randomized in a 1:1:1 ratio to receive one of the following treatment regimens administered once every 4 weeks for 24 weeks (six treatments in total): OPT-302 (0.5 mg) in combination with ranibizumab (Lucentis®) (0.5 mg); OPT-302 (2.0 mg) in combination with ranibizumab (0.5 mg); or sham in combination with ranibizumab (0.5 mg).  The study met the primary endpoint demonstrating superior vision gains in participants who received OPT-302 (2.0 mg) in combination with ranibizumab at week 24.  Opthea is also investigating OPT-302 in a Phase 2a clinical trial in patients with persistent, centre-involved DME.  Further details on the Company’s clinical trials can be found at: www.clinicaltrials.gov, Clinical trial identifiers:  NCT02543229, NCT03345082 and NCT03397264.Inherent risks of Investment in Biotechnology CompaniesThere 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 commercialisation 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 specialising in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.Forward-looking statementsCertain statements in this ASX announcement may contain forward-looking statements regarding Company business and the therapeutic and commercial potential of its technologies and products in development.  Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such products and services.  Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.  Actual results could differ materially from those discussed in this ASX announcement.Company & Media Enquiries:Join our email database to receive program updates:    Megan Baldwin, PhD  CEO & Managing Director Opthea Limited Tel: +61 (0) 447 788 674 megan.baldwin@opthea.com Tel: +61 (0) 3 9826 0399 info@opthea.com  www.opthea.com       Australia: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333U.S.A. & International:  Jason Wong Blueprint Life Science Group Tel:  +1 415 375 3340, Ext 4 Jwong@bplifescience.com