• Opthea up almost 10pc this morning after funding announcement
  • Radiopharm to open second clinical trial site in Perth


Opthea receives $85m in non-dilutive funding

Retinal diseases focused biotech, Opthea (ASX:OPT), says it will receive the remaining US$35m funding under the Development Funding Agreement (DFA) with global investment firm Carlyle and its life science franchise, Abingworth.

The company says it will also receive a further US$50m financing under an Amended DFA to include a new co-investor. This financing is non-dilutive to shareholders, with no equity issued to Carlyle, Abingworth or the new co-investor.

Opthea’s share price surged over 12% this morning on the announcement.

The investments mark a show of confidence by Carlyle in the potential of sozinibercept (OPT-302), Opthea’s drug to treat patients with wet AMD (Age-Related Macular Degeneration) to provide what Opthea believes is a multi-billion dollar commercial opportunity.

Wet AMD happens when abnormal blood vessels grow in the back of the eye and damage the macula.

Under the terms of the DFA, Carlyle and Abingworth committed US$120 million, of which US$85 million has been received to date.

The remaining committed funds of US$35 million and the additional US$50m announced today will be received on or around December 31, bringing the total committed funding under the amended DFA to US$170 million, the maximum amount allowed under the terms of the DFA.

Opthea says the funding will be used to advance thee Phase 3 clinical trials and precommercialisation activities of sozinibercept (OPT-32).

The terms of the DFA also state that if sozinibercept is approved in a major market, Opthea will make a milestone payment after regulatory approval, and then six subsequent annual fixed success payments and variable success payments of 7% of net sales, with cumulative payments capped at 4x the amount funded to Opthea.

Opthea will also retain full worldwide commercial rights for sozinibercept, and has the option to prepay its obligations in full at any time.

“We’re extremely pleased with this funding that demonstrates investors’ confidence in sozinibercept and its potential for future clinical, regulatory and commercial success,” said Dr. Fred Guerard, CEO of Opthea.

“Both global pivotal trials in wet AMD [COAST and ShORe] are now over 80% enrolled, and aim at confirming the superior efficacy outcomes observed in Opthea’s Phase 2b trial.”


Radiopharm opens second site for Phase 1 trial

Radiotherapeutics company, Radiopharm Theranostics (ASX:RAD), announced that it has received Human Research Ethics Committee (HREC) approval from the Hollywood Private Hospital in Perth, WA that will see it become the second Australian site for its RAD 204 Phase 1 therapeutic study.

The RAD 204 Phase 1 clinical trial will will evaluate the safety and efficacy of the novel radiotherapeutic in patients with advanced PD-L1 positive non-small cell lung cancer (NSCLC), the most common type of lung cancer.

The first site will open at the Princess Alexandra Hospital in Brisbane on 4 January, and now with the addition of the Perth site, the geographic availability of the trial widens and Opthea says recruitment will therefore accelerate accordingly.

The trial is being supported by leading oncology care provider GenesisCare.

Approximately 300,000 new lung cancer cases are expected to be diagnosed in the US by the end of 2023, 81% of which are estimated to be NSCLC patients, while it is estimated that there were more than 2.2 million cases of lung cancer in 2020.


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