ASX Share rice
Tue 04 Aug 2020 - 06:51:am (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

Fin. & Operations Mang.:

Ms. Annie Lee

Head of Intellectual Property:

Mr. Richard Chadwick Ph.D.

Head of CMC Devel.:

Dr. Michael Gerometta

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, which is in Phase Ib/IIa clinical trials 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 is based in South Yarra, Australia.

OPT Share Price Information

Shares Issued:

269.16M

Market Capitalisation:

$629.83M

Revenue (TTM):

$152.58K

Revenue Per Share (TTM):

$0

Earnings per Share:

$-0.09

Operating Margin (TTM):

$-188.83

Return On Assets (TTM):

$-0.28

Return On Equity (TTM):

$-0.30

Quarterly Revenue Growth (YOY):

-0.952

Gross Profit(TTM):

$-33,834

Diluted Earnings Per Share (TTM):

$-0.069

OPT CashFlow Statement

CashFlow Date:

2019-06-30

Investments:

$320.98K

Change To Liabilities:

$-1,427,978

Total Cashflow From Investing Activities:

$320.98K

Net Income:

$-20,910,061

Total Cash From Operating Activities:

$-24,185,156

Depreciation:

$33.09K

Change To Account Receivables:

$97.95K

Capital Expenditures:

$18.07K

OPT Income Statement

Income Date:

2019-06-30

Income Before Tax:

$-35,547,034

Net Income:

$-20,910,061

Gross Profit:

$-33,834

Operating Income:

$-36,905,493

Other Operating Expenses:

$87.25K

Income Tax Expense:

$-14,636,973

Total Revenue:

$240.11K

Total Operating Expenses:

$36.91M

Cost Of Revenue:

$273.94K

OPT Balance Sheet

Balance Sheet Date:

2019-06-30

Total Liabilities:

$6.54M

Total Stockholder Equity:

$31.12M

Other Current Liabilities:

$25.59K

Total Assets:

$37.66M

Common Stock:

$113.02M

Retained Earnings:

$-86,060,060

Other Liabilities:

$24.84K

Cash:

$21.53M

Total Current Liabilities:

$6.52M

Property - Plant & Equipment:

$54.06K

Net Tangible Assets:

$31.12M

Long-Term Investments:

$714.12K

Total Current Assets:

$36.89M

Net Receivables:

$14.93M

Short-Term Investments:

$768.18K

Accounts Payable:

$5.90M

Non Currrent Assets (Other):

$768.18K

Short-Term Investments:

$768.18

Non Current Liabilities Total:

$24.84K

OPT Share Price History

OPT News

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
09 Jun, 2020
Primary endpoint of response with OPT-302 + Eylea® (aflibercept) achieved: 52.8% of refractory DME patients gained ≥ 5 letters of visual acuity at week 12 following OPT-302.
MELBOURNE, Australia, June 08, 2020 -- Opthea Limited (ASX:OPT) will host a conference call to discuss the results of the Company’s Phase 2a clinical trial evaluating the.
18 May, 2020
Opthea Limited (ASX:OPT) shareholders might be concerned after seeing the share price drop 20% in the last quarter...
18 Mar, 2020
Megan Baldwin has been the CEO of Opthea Limited (ASX:OPT) since 2014. First, this article will compare CEO...
18 Feb, 2020
MELBOURNE, Australia, Feb. 18, 2020 -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing novel biologic therapies to treat eye diseases, today.
14 Jan, 2020
Opthea Limited's (ASX:OPT): Opthea Limited, a biotechnology company, develops and commercializes therapies primarily...
07 Jan, 2020
Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing novel biologic therapies to treat eye diseases, has completed patient recruitment into the Company’s Phase 2a trial evaluating the safety and efficacy of OPT-302 administered in combination with aflibercept (Eylea®) for treatment of diabetic macular edema (DME). “We are delighted to have completed patient enrollment into the Phase 2a DME study which marks another significant milestone in a second disease indication for the Company,” said Dr Megan Baldwin, CEO of Opthea.
14 Oct, 2019
MELBOURNE, Australia, Oct. 14, 2019 -- Opthea Limited (ASX:OPT), a clinical-stage biopharmaceutical company developing novel biologic therapies to treat back-of-the-eye.
12 Oct, 2019
Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
03 Oct, 2019
Opthea Limited (ASX:OPT), a clinical-stage biopharmaceutical company developing novel biologic therapies to treat back-of-the-eye diseases, announced today that Dr Megan Baldwin, the Company’s Chief Executive Officer, will present at the Ophthalmology Innovation Summit (OIS) in San Francisco on Thursday, 10th October, 2019 (US Pacific Daylight Time). Dr Baldwin’s presentation will be made in the “Public Company Spotlight” session of the OIS (https://ois.net/ois-aao-2019/agenda/). The presentation of the Company’s Phase 2b randomised, controlled study of OPT-302 with Lucentis® (ranibizumab) compared to Lucentis alone will include an overview of the study design, safety outcomes and primary and secondary outcomes of the study.
12 Sep, 2019
Megan Baldwin became the CEO of Opthea Limited (ASX:OPT) in 2014. This report will, first, examine the CEO...
06 Sep, 2019
MELBOURNE, Australia, Sept. 06, 2019 -- Opthea Limited (ASX:OPT), a clinical biopharmaceutical company developing novel biologic therapies for eye diseases, announced today.
04 Sep, 2019
MELBOURNE, Australia, Sept. 04, 2019 -- Opthea Limited (ASX:OPT), a clinical biopharmaceutical company developing novel biologic therapies for eye diseases, announced today.
07 Aug, 2019
Opthea Limited's (ASX:OPT): Opthea Limited develops and commercializes therapies primarily for eye disease in...
06 Aug, 2019
OPT-302 Combination Therapy Demonstrated Superiority in Visual Acuity over Lucentis® Company to Host Conference Call Today at 9:00 AM AEST7:00PM EDT (Tuesday, August 6th.