PYC Therapeutics

Data from ongoing Phase 1/2 clinical trials of VP-001 will be presented at international scientific conferences, demonstrating positive findings in both safety & efficacy: buff.ly/5VnjGCN The data highlights the utility of VP-001 in treating blinding eye diseases.

The first subject in the Phase 1a trial of PYC-003 has been dosed with $PYC's investigational drug candidate: buff.ly/nJgj6O9 If successful, it has a potential high-velocity approval path with a combined Phase 2/3 study expected following the ongoing trial's completion.

$PYC will hold an investor webinar on Friday 28 March 2025 at 8:00am AWST/11:00am AEDT to provide an update on each of the Company’s pipeline programs and their respective objectives for 2025. Click here to register: buff.ly/9T8uyiw

$PYC has successfully closed the ~$91m institutional component of its Entitlement Offer, which will raise a total of ~$146m. This funds its pipeline of 4 first-in-class drug candidates with disease-modifying potential through major human data read-outs: buff.ly/3QJMgcJ

$PYC today announces that it has received regulatory approval to commence human trials of its drug candidate for PKD: buff.ly/4gA7C6w The Company will now commence clinical studies with initial human safety and efficacy data anticipated within 2025.

$PYC has received approval to escalate dosing from patient cohort 1 to cohort 2 in its ADOA clinical trial, following Safety Review Committee evaluation of the 4-week follow-up data for patients in cohort 1 of this clinical trial: buff.ly/3CF0Pun

$PYC has announced the nomination of PYC-002 for the treatment of Phelan-McDermid Syndrome following studies in patient-derived and animal models: buff.ly/3DdIRiy PYC will now progress PYC-002 into an Investigational New Drug-enabling pathway prior to human trials.

The Company will host an investor webinar at 9am AWST (12pm AEDT) on Thursday 28 November 2024 to present these results. Shareholders can register to attend at: buff.ly/49a3RTm

In preparation for the commencement of First In Human trials of PYC-003 early next year, PYC has successfully completed pre-clinical studies of this drug candidate demonstrating that it is both safe and effective in animal and patient-derived models: buff.ly/3AW3wqN

A/Prof. Fred Chen of the Lions Eye Institute will present data from $PYC’s phase 1/2 studies of VP-001 in patients with RP11 at the APVRS scientific conference: buff.ly/3V5RG43 Highlights include continued improvement in the treated eye on 2 registrational endpoints.

Tomorrow marks World Autosomal Dominant Optic Atrophy (ADOA) Awareness Day, a rare genetic condition characterised by progressive vision loss due to optic nerve degeneration. $PYC’s drug candidate, PYC-001, was the first precision therapy to be dosed in patients with ADOA.

The Safety Review Committee governing the multiple ascending dose study of VP-001 for the treatment of Retinitis Pigmentosa type 11 has approved escalation in dosing to the final patient cohort (75 mcg) in this trial: buff.ly/4hsjBFb

PYC has commenced a Single Ascending Dose study in patients with the blinding idea disease ADOA to evaluate the safety/tolerability and efficacy profile of its drug candidate in this indication: buff.ly/40p9haD The first patient has now received $PYC’s drug candidate.

Associate Prof. Fred Chen of the Lions Eye Institute will present data on the safety/tolerability & efficacy profile of VP-001 in patients who have received a single dose of the drug candidate at the RANZCO meeting to be held in Adelaide from Nov 1-4: buff.ly/3Utpcko $PYC

Yesterday we were pleased to announce an interim update on progress in our RP11 repeat dose clinical trials. Click here to learn more: buff.ly/3AgNh79 $PYC will provide a further update on the outcomes of these two multiple dose studies in 1H 2025.

The US #FDA has granted $PYC Orphan Drug Designation for its drug candidate targeting Retinitis Pigmentosa type 11: buff.ly/3Yw5rv6 VP-001 is the first drug candidate for patients with this blinding disease of childhood to have progressed into human trials.

$PYC has released its 2024 Annual Report: buff.ly/4dEffaH We have opened the critical human data generation window & will now demonstrate the impact of 3 separate drug development programs in patients with 3 separate life-changing diseases over the next 18 months.

Our CEO Dr Rohan Hockings is pleased to present at today’s E&P Healthcare Conference. The slides can be viewed at: buff.ly/3Bsww9f $PYC

The US #FDA has granted $PYC Rare Pediatric Disease (RPD) designation for its PYC-001 drug development program: buff.ly/4dNHGUv PYC is now eligible to receive a Priority Review Voucher upon approval of PYC-001 for vision loss associated with mutations in the OPA1 gene.

$PYC will hold a webinar on Friday 30 Aug at 9am AWST/11am AEST to update investors on progress made in 2024. Shareholders are invited to attend at the McCusker Auditorium at the Harry Perkins Institute North Campus in Nedlands, WA or register online at: buff.ly/46WHVdi